Evidence Table 12Adverse events1, 2

ReportAdverse eventsInterventionsNotes; Difference in proportion of patients reporting adverse events (95% CI)
Adam, Gore, and Price, 1978Clonidine (Dixarit®), 0.025 mg, 3x/day for 6 mos (could be increased to max. of 0.050 mg, 3x/day for 6 mos)PlaceboInformation on AEs provided only on the 26 patients who withdrew from trial.
Number of patients evaluable for AEs:N/S (See note)N/S (See note)
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:2 (palpitations & dyspnoea; nausea, epigastric discomfort, abdominal distension)1 (nausea, vomiting, flatulence, skin irritation)
Adly, Straumanis, and Chesson, 1992Fluoxetine, doses ranged from 20 mg every other day to 40 mg/dayPlaceboData at left are only for those patients who completed the trial (18/32). One patient in the fluoxetine group withdrew prematurely due to AEs (anxiety and insomnia). No patients withdrew from the placebo group due to AEs.
Number of patients evaluable for AEs:99
Number of patients reporting AEs:3 (33%)3 (33%)
Total number of AEs reported:64
Number of patients reporting:n (%)n (%)
Insomnia2 (22%)2 (22%)
Anxiety1 (11 %)1 (11 %)
Excitement1 (11 %)0
Strange skin sensations1 (11 %)0
Floating sensation1 (11 %)0
Weakness/fatigue01 (11 %)
Withdrawals due to AEs:(See note)(See note)
Agnoli, Bussone, Mailland, et al., 1991Dihydroergokryptine (DEK), 10 mg/day for 6 mosFlunarizine, 5 mg/day for 6 mosAbstract reporting limited results. Investigators stated only that the overall rate of AEs was similar in the two groups.
Number of patients evaluable for AEs:5448
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:4 (causative AEs N/S)0
Ahuja and Verma, 1985Propranolol 40 mg, 3x/day for 8 wksPlaceboRegarding AEs, investigators reported only that there were "no significant side effects of propranolol observed during the trial period." No information was provided on AEs that might have resulted from the placebo treatment.
Number of patients evaluable for AEs:26* (See note)26* (See note)
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:N/SN/S
Albers, Simon, Hamik, et al., 1989Nifedipine, 60–90 mg/day for 6 mosPropranolol, 120–180 mg/day for 6 mosNifedipine vs. propranolol: 0.16 (−0.025 to 0.34)
Number of patients evaluable for AEs:2018
Number of patients reporting AEs:20 (100%)15 (83%)
Total number of AEs reported:5217
Number of patients reporting:n (%)n(%)
Dizziness13 (65%)3 (17%)
Warm, swollen, red legs9 (45%)0
Fatigue08 (44%)
Increased HA frequency4 (20%)3 (17%)
Tachycardia6 (30%)0
Facial flushing6 (30%)0
Nausea6 (30%)0
Decrease in concentration4 (20%)0
Shakiness4 (20%)0
Depression03 (17%)
Withdrawals due to AEs:13 (causative AEs N/S)5 (causative AEs N/S)
Al Deeb, Biary, Bahou, et al., 1992Flunarizine, 10 mg/day for 3 mosPlaceboLimited information provided on AEs. Four of 50 patients (8%) withdrew due to AEs "such as tiredness or weight-gain, depression or giddiness." The investigators did not report from which treatment group these withdrawals came.
Number of patients evaluable for AEs:N/SN/S
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:(See note)(See note)
Al-Qassab and Findley, 1993Propranolol (long-acting), 160 mg, 1x/day for 2 mosPropranolol (long-acting), 80 mg, 1x/day for 2 mosPlaceboOf the 45 patients randomized to treatment, 1 was withdrawn due to AEs. Investigators did not describe the AE or report the treatment group from which the patient withdrew. Authors reported only that "reported side effects during the three treatment periods were similar and were not statistically significant." It was also reported that the incidence of side effects were similar on the active drug as on placebo.
Number of patients evaluable for AEs:N/S (See note)N/S (See note)N/S (See note)
Number of patients reporting AEs:N/SN/SN/S
Total number of AEs reported:N/SN/SN/S
Withdrawals due to AEs:N/S (See note)N/S (See note)N/S (See note)
Andersson, 1973Methysergide, 1 mg, 4x/day for 3 mosPizotifen, 0.5 mg, 4x/day for 3 mosLimited information reported on AEs. Among patients who experienced AEs but did not withdraw from the trial, restlessness and pain in the legs were the most common AEs associated with methysergide; weight gain was the most common AE associated with pizotifen.
Number of patients evaluable for AEs:N/SN/S
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:4 (muscle pain in legs [3], severe phlebitis [1])9 (weight gain [4], drowsiness [2], vertigo and drowsiness [2], muscle pains in legs [1])
Andersson, Dahl, Hansen, et al., 1983Metoprolol, 200 mg, 1x/day for 8 wksPlaceboData at left appear to concern only the 65/71 patients included in the efficacy analyses, but this is not clear.

Metoprolol vs. placebo: 0.24 (0.0049 to 0.46)
Number of patients evaluable for AEs:30 (See note)35 (See note)
Number of patients reporting AEs:16 (53%)10 (29%)
Total number of AEs reported:3132
Number of AEs reported:n (%)n (%)
Sleep disturbances11 (35%)9 (28%)
Fatigue9 (29%)1 (3%)
Gastrointestinal3 (10%)6 (19%)
Bradycardia01 (3%)
Paraesthesia2 (6%)4 (13%)
Depression2 (6%)2 (6%)
Others3 (10%)10 (31%)
Withdrawals due to AEs:1 (N/S)1 (N/S)
Andersson and Petersen, 1981Femoxetine, 200 mg, 2x/day for 3 mos; dose reduced by half during first weekPropranolol, 80 mg, 2x/day for 3 mos; dose reduced by half during first weekThe data reported at left appear to include only those patients who completed the trial (37/49 patients randomized to treatment), though this is not entirely clear. Two patients withdrew prematurely due to unspecified AEs associated with femoxetine; two withdrew due to unspecified AEs associated with propranolol.
Number of patients evaluable for AEs:37*37*
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:1430
Number of patients reporting:n (%)n (%)
Tiredness4(11%}8 (22%)
Menstrual disorder1 (3%)10 (27%)
Depression1 (3%)3 (8%)
Nausea1 (3%)2 (5%)
Feeling unwell2 (5%)0
Insomnia1 (3%)1 (3%)
Dizziness1 (3%)1 (3%)
Exanthema1 (3%)1 (3%)
Precordial pain1 (3%)0
Gastric distress1 (3%)0
Palpitations01 (3%)
Unrest of the legs01 (3%)
Paresthesia01 (3%)
Irritability01 (3%)
Withdrawals due to AEs:(See note)(See note)
Ansell, Fazzone, Festenstein, et al., 1988Nimodipine, 120 mg/day for 4 mosPlaceboInvestigators reported only that no patients withdrew due to AEs and that no "serious" AEs were reported. AEs were recorded at monthly clinic visits.
Number of patients evaluable for AEs:3434
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:00
Anthony and Lance, 1968Indomethacin, 25 mg, 3x/day for 1–9 mosPlacebo, 3x/day for 1 rnoSee Evidence Table 1 on study design. Investigators stated that no patients withdrew due to AEs.
Number of patients evaluable for AEs:38 (See note)19 (See note)
Number of patients reporting AEs:15 (39%)N/S
Total number of AEs reported:357
Number of patients reporting:n (%)n (%)
Full head5 (13%)4 (21%)
Indigestion7(18%)1 (5%)
Lightheadedness5 (13%)0
Insomnia5 (13%)0
Dizziness2 (5%)2 (11%)
Poor concentration3 (8%)0
Bifrontal headache2 (5%)0
Depression1 (3%)0
Irritability1 (3%)0
Tiredness1 (3%)0
Unsteadiness1 (3%)0
Nausea1 (3%)0
Epigastric pain1 (3%)0
Withdrawals due to AEs:00
Anthony, Lance, and Somerville, 1972Prindolol, 2.5 mg, 4x/day for 1– 20 mosClonidine, 75 μg, 3x/day for 1–18 mosCarbamazepine, 200 mg, 3x/day for 1–4 masAEs reported for entire (partial crossover) trial (see Evidence Table 1 for details of trial design). Withdrawals from the prindolol group were due to increasing headache (2); and dizziness, nausea, vomiting, paraesthesiae, lassitude and exhaustion, and cramps (1 each).

Carbamazepine vs. prindolol: 0.34 (0.17 to 0.49)

Carbamazepine VS. clonidine: 0.12 (−0.060 to 0.29)

Clonidine vs. prindolol: 0.22 (0.074 to 0.36)
Number of patients evaluable for AEs:79*73*51*
Number of patients reporting AEs:15 (19%)30 (41%)27 (53%)
Total number of AEs reported:214140
Number of patients reporting:n (%)n (%)n (%)
Drowsiness, tiredness, weakness2 (3%)15(21%)7 (14%)
Nausea2 (3%)5 (7%)6 (12%)
Giddiness, ataxia1 (1%)010 (20%)
Faintness, dizziness3 (4%)5 (7%)3 (6%)
Dry mouth, sore tongue, bad taste010 (14%)0
Cramps, limb pains6 (8%)1 (1%)2 (4%)
Irritability, agitation4 (5%)2 (3%)2 (4%)
Epigastric discomfort01 (1%)1 (2%)
Insomnia, nightmares01 (1%)1 (2%)
Itching skin, rash002 (4%)
Blurred vision002 (4%)
Lack of concentration002 (4%)
Vomiting1 (1%)00
Increased appetite001 (2%)
Bruising, prominent veins01 (1%)0
Swelling of throat001 (2%)
Paraesthesiae1 (1%)00
Jaundice1 (1%)00
Withdrawals due to AEs:8 (See note)8 (causative AEs N/S)12 (causative AEs N/S)
Arthur and Hornabrook, 1971Pizotifen (BC 105), 3 mg/day for 1 moPlaceboInformation on AEs provided only on the 52/63 patients from whom efficacy data were obtained, which included the three patients who withdrew due to severe AEs.

Of patients treated with pizotifen, weight gain was reported by 26 of the 44 patients (59%) for whom data were available. Fifteen of 46 patients (33%) treated with placebo reported weight gain.

Pizotifen VS. placebo: 0.30 (0.14 to 0.45)
Number of patients evaluable for AEs:52* (See note)52* (See note)
Number of patients reporting AEs:22 (42%)6 (12%)
Total number of AEs reported:226
Number of patients reporting:n (%)n (%)
Bizarre feelings in head01 (2%)
“Dead” feelings in legs01 (2%)
Depression4 (8%)N/S
Dizziness1 (2%)N/S
Drowsiness11 (21%)N/S
Enuresis1 (2%)N/S
Faintness01 (2%)
Fatigue2 (4%)2 (4%)
Increased appetite1 (2%)N/S
Nausea01 (2%)
Wakefulness2 (4%)N/S
Withdrawals due to AEs:3 (drowsiness [2 – 1 with diplopia & blurred vision], dizziness [1])N/S
Autret and de Chasteigner, 1987DHE (timed-release), 5 mg, 2x/day for 2 mosPlaceboAbstract providing limited information. Investigators stated that all 115 patients who started the treatment phase of the trial completed it. No information was provided on AEs reported during the trial.
Number of patients evaluable for AEs:5857
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:00
Baldrati, Cortelli, Procaccianti, et al., 1983Aspirin, mean dose (± SD) 13.5 ± 1.2 mg/kg/day, for 3 mosPropranolol, mean dose (± SD) 1.8 ± 0.1 mg/kg/day, for 3 mosOverall AE rates were reported only for those patients who completed the trial (12/18). AEs associated with aspirin were gastric distress, palpitations, weight gain, and constipation (number of patients reporting these N/S). AEs associated with propranolol were palpitations, gastric distress, dizziness, insomnia, and constipation number of patients reporting these N/S).

Three patients withdrew before completing the trial due to AEs associated with aspirin (gastric distress in all three cases); two withdrew due to AEs associated with propranolol (hypotension, worsening of HA).

Aspirin vs. propranolol: 0.00 (−0.37 to 0.37)
Number of patients evaluable for AEs:12*12*
Number of patients reporting AEs:6 (50%)6 (50%)
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:(See note)(See note)
Bánk, 1994Amitriptyline, 25 mg, 1x/day for 12 wksFluvoxamine, 50 mg, 1x/day for 12 wksFluvoxamine vs. amitriptyline: −0.18 (−0.40 to 0.060)
Number of patients evaluable for AEs:2930
Number of patients reporting AEs:12 (41%)7 (23%)
Total number of AEs reported:12N/S
Number of patients reporting:n (%)n (%)
Drowsiness12 (41%)N/S
Dry mouth0N/S
Nausea0N/S
General weakness0N/S
Withdrawals due to AEs:7 (all due to drowsiness)3 (drowsiness, severe constipation, feeling of pressure in abdomen)
Barrie, Fox, Weatherall, et al., 1968Ergotamine, 0.17 mg, 3x/day for up to 2 mosErgotamine, 0.33 mg, 3x/day for up to 2 mosMethysergide,1 mg, 3x/day for up to 2 mosMethysergide, 2 mg, 3x/day for up to 2 mosData on AEs were reported only for the four treatment arms at left (of six), and only for all four treatment periods combined.
Number of patients evaluable for AEs:73687654
Number of patients reporting AEs:N/SN/SN/SN/S
Total number of AEs reported:23255361
Number of patients reporting:n (%)n (%)n (%)n (%)
Drowsiness6 (8%)7 (10%)9 (12%)9 (17%)
Depression3 (4%)6 (9%)7 (9%)8 (15%)
Nausea, vomiting1 (1%)3 (4%)11 (14%)8 (15%)
Vertigo, “muzzy head”3 (4%)4 (6%)4 (5%)9 (17%)
Swollen joints, stiffness or cramps6 (8%)05 (7%)7 (13%)
Digestive disturbance02 (3%)7 (9%)7 (13%)
Swollen eyes, visual disturbance01 (1%)1 (1%)4 (7%)
Other4 (5%)2 (3%)9 (12%)9 (17%)
Withdrawals due to AEs:N/SN/SN/SN/S
Bassi, Brunati, Rapuzzi, et al., 1992Flunarizine, 10 mg, 1x/day for 4 mosFlunarizine, 10 mg, 1x/day for one wk, then 3 mg, 1x/day for total of 4 mosThe data reported at left are for those patients who completed the trial (29/40). Two patients, one from each treatment group, withdrew prematurely due to unspecified AEs.

Flunarizine, 10 mg vs. 3 mg: 0.49 (0.16 to 0.74)
Number of patients evaluable for AEs:1514
Number of patients reporting AEs:13 (86%)5 (38%)
Total number of AEs reported:135
Number of patients reporting:n (%)n (%)
Sleepiness5 (33%)2 (14%)
Weight gain5 (33%)2 (14%)
Depression2 (13%)1 (7%)
Rash1 (7%)0
Withdrawals due to AEs:(See note)(See note)
Behan, 1985Clonidine (Dixarit®), 50 μg, 2x/day for 1 mo; 50–75 μg, 2x/day for 2d moPizotifen (Sanomigran®), 1.5 mg, 1x/night for 1 mo; 1.5–3.0 mg, 1x/night for 2d moFive patients taking pizotifen experienced weight gain, and one reported drowsiness. Four patients in the pizotifen group and 7 in the clonidine group withdrew from the study, but investigators did not state whether or not withdrawals resulted from AEs.
Number of patients evaluable for AEs:N/S (See note)N/S (See note)
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:N/S1 (weight gain)
Behan and Reid, 1980Propranolol, 40 mg, 3x/day for 3 mosMethysergide, 1 mg, 3x/day for 3 mosData at left concern only the 36 patients who completed the trial. AEs reported by these patients in association with methysergide included nausea, vomiting, dizziness, nightmares, circumoral numbness, and abdominal cramps (number of patients reporting each of these symptoms not given). AEs associated with propranolol included generalized weakness and dizziness (9 patients), coldness of hands and circumoral paraesthesia (1), excessive tearing (1), and depression (1).

3 patients withdrew prematurely from the trial due to AEs associated with methysergide (severe chest pains and intermittent claudication [2], bilateral spasm of brachial arteries [1]). No patients withdrew due to AEs associated with propranolol

Propranolol vs. methysergide: −0.11 (−0.32 to 0.11)
Number of patients evaluable for AEs:36*36*
Number of patients reporting AEs:12 (33%)16 (44%)
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:(See note)(See note)
Bellavance and Meloche, 1990Naproxen sodium, 550 mg, 2x/day for 12 wksPizotyline, 0.5 mg, 3x/day for 12 wksPlaceboPatients questioned about AEs At monthly clinic visits.

Naproxen sodium vs. placebo: 0.061 (−0.092 to 0.21)

Pizotyline vs. placebo: 0.078 (−0.077 to 0.23)

Naproxen sodium vs. pizotyline: −0.017 (−0.18 to 0.14)
Number of patients evaluable for AEs:585856
Number of patients reporting AEs:15 (26%)16 (28%)11 (20%)
Total number of AEs reported:N/SN/SN/S
Number of patients reporting:n (%)n (%)n (%)
Gastrointestinal symptoms8 (14%)7 (12%)3 (5%)
Central nervous system symptoms4 (7%)4 (7%)5 (9%)
Skin symptoms2 (3%)01 (2%)
Weight gain06 (10%)1 (2%)
Other AEs4 (7%)2 (3%)4 (7%)
Withdrawals due to AEs:3 (gastric ulcer [1], epigastric burning [2])2 (weight gain [1], sleepiness [1])2 (hematoma and epigastric pain [1], parasthesia [1])
Boisen, Deth, Hübbe, et al., 1978Clonidine, 0.05 mg (in 2 tabs), 2x/day for 8 wksPlaceboData at left concern only those 49 patients (of 71) who completed the crossover. In this group, the most common AEs reported were drowsiness, dizziness, and nausea. Two patients withdrew prematurely due to AEs associated with clonidine (fainting, severe vomiting).

Clonidine VS. placebo: 0.14 (−0.02 to 0.29)
Number of patients evaluable for AEs:49* (See note)49* (See note)
Number of patients reporting AEs:13 (26%)6 (12%)
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:(See note)(See note)
Bono, Criscuoli, Martignoni, et al., 1982Pizotifen, 1.40 mg/day for 2 mosOxitriptan, 400 mg/day for 2 mosLimited data were provided on AEs, but appear to have been drawn from all 80 patients randomized to treatment. Figures at left are from the 13/80 patients (16%) who withdrew from the trial. Data from these patients were not included in the efficacy analyses.

Of the 67 patients completing the trial and included in the efficacy analyses, weight gain was reported by 22/34 (65%) who took pizotifen and by 9/33 (27%) who took oxitriptan.
Number of patients evaluable for AEs:(See note)(See note)
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:N/S5 (nausea, diarrhea, pyrosis, drowsiness)
Bonuso, Di Stasio, Barone, et al., 1983DHE (timed-release), 5 mg, 2x/day for 2 mosAmitriptyline, 75 mg/day (dosing schedule not described) for 2 mosInvestigators reported only that the most common AEs reported with DHE were nausea and stomach ache; the most common AEs associated with amitriptyline were drowsiness and dry mouth.
Number of patients evaluable for AEs:N/SN/S
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:23
Børgesen, Nielsen, and Møller, 1974Propranolol, 40 mg, 3x/day for 12 wksPlaceboLittle information was provided on AEs from the 45 patients randomized to treatment in this crossover trial. Investigators reported that patients had been informed before the trial began that they might experience AEs such as fatigue, drowsiness, and diarrhea. Many patients reported such side effects, both when receiving propranolol and when receiving placebo. Investigators reported that "none of the side effects were persistent or intolerable."
Number of patients evaluable for AEs:N/S (See note)N/S (See note)
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:02 (N/S)
Bousser, Chick, Fuseau, et al., 1988DHE + aspirin (timed-release), 5 mg + 40 mg, 2x/day for 2 mosPlaceboData on AEs were reported only for those patients who completed the trial (38/45). Six patients treated with DHE + aspirin and one treated with placebo reported such symptoms as nausea, sleepiness, gastralgia, and abdominal discomfort (numbers reporting each symptom N/S). Four patients on placebo temporarily suspended treatment due to AEs (diarrhea, vomiting, gastralgia), as did one of the same patients on DHE + aspirin (diarrhea).
Number of patients evaluable for AEs:38*38*
Number of patients reporting AEs:7 (18%)5 (13%)
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:(See note)(See note)
Bradley, Hudgson, Foster, et al., 1968Flumedroxone, 10 mg, 3x/day for 3 mosPlaceboData at left concern only those patients who completed the trial (39/48). Two patients withdrew prematurely due to AEs associated with flumedroxone (severe polymenorrhagia and nausea; mastitis and glandular-fever-like syndrome).

AEs reported by male patients in association with flumedroxone included drowsiness, dyspepsia, and decreased libido (no n's reported). Six of 14 women of reproductive age reported polymenorrhagia. One of these six also reported engorgement of the breasts and varicose veins.

Flumedroxone vs. placebo: 0.28 (0.078 to 0.46)
Number of patients evaluable for AEs:39*39*
Number of patients reporting AEs:17 (44%)6 (15%)
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:(See note)(See note)
Bredfeldt, Sutherland, and Kruse, 1989Clonidine (Dixarit®), ≈ 0.2 mg/day via 1 transdermal (Catapres TTS-2®) patch/wk for 6 wksPlaceboInvestigators reported that "[i]n general, both patches were well tolerated by study participants." Of patients completing the trial, 6 reported skin irritation under clonidine patch; 1 experienced fatigue (treatment N/S); and "several" experienced dry mouth (treatment N/S). No AEs were reported for patients taking placebo.

Some patients (number N/S) were also taking OTC meds containing acetaminophen or narcotic preparations prescribed by physicians.
Number of patients evaluable for AEs:N/S (See note)N/S (See note)
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:3 (overtired)0
Briggs and Millac, 1979Timolol, 10 mg, 2x/day for 12 wksPlaceboLimited data were provided on AEs. The data at left concern all 14 patients randomized to treatment in this crossover trial.
Number of patients evaluable for AEs:14* (See note)14* (See note)
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Number of patients reporting:n (%)n (%)
Cold extremities1 (7%)0
Visual disturbance01 (7%)
Withdrawals due to AEs:01 (constipation & fluid retention)
Buscaino, Sorge, Bussone, et al., 1991DHE (timed-release), 10 mg, 1x/day for 2 mosDHE (timed-release), 5 mg, 2x/day for 2 mos10 mg, 1x/day vs. 5 mg, 2x/day: −0.022 (−0.17 to 0.12)
Number of patients evaluable for AEs:4545
Number of patients reporting AEs:6 (13%)7 (16%)
Total number of AEs reported:6
Number of patients reporting:n (%)n (%)
Epigastralgia1 (2%)4 (9%)
Heartburn1 (2%)1 (2%)
Nausea1 (2%)0
Increase in appetite1 (2%)1 (2%)
Auricular tinnitus01 (2%)
Polyphagism01 (2%)
Paresthesia1 (2%)0
Rise in diastolic BP1 (2%)0
Headache01 (2%)
Withdrawals due to AEs:1 (heartburn)4 (epigastralgia [2]; epigastralgia, auricular tinnitus, and polyphagism [1]; heartburn [1])
Bussone, Baldini, D'Andrea, et al., 1987Nimodipine, 120 mg/day for 12 wksFlunarizine, 10 mg/day for 12 wksNimodipine vs. flunarizine: −0.28 (−0.55 to 0.030)
Number of patients evaluable for AEs:1416
Number of patients reporting AEs:2 (14%)7 (44%)
Total number of AEs reported:29
Number of patients reporting:n (%)n (%)
Weight increase05 (31%)
Erythema02 (13%)
Abdominal discomfort1 (7%)0
Exacerbation of insomnia1 (7%)0
Drowsiness/daytime sedation01 (6%)
Depression01 (6%)
Withdrawals due to AEs:1 (causative AEs N/S)2 (causative AEs N/S)
Cangi, Boccuni, Zanotti, et al., 1989Dihydroergokryptine (DEK), 10 mg, 2x/day for 2 mosMethysergide, 1 mg, 2x/day for 2 mosThis was an abstract reporting interim results of a longer-term trial. Regarding AEs, investigators reported only that "both drugs have been well tolerated by patients" (p. 449).
Number of patients evaluable for AEs:N/SN/S
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:N/SN/S
Canonico, Scapagnini, Genazzani, et al., 1989Dihydroergokryptine (DEK), 10 mg, 2x/day for 2 mosPlaceboAbstract providing limited information. Dropouts were not described.

DEK vs. placebo: 0.039 (−0.0027 to 0.080)
Number of patients evaluable for AEs:102*102*
Number of patients reporting AEs:4 (4%)0
Total number of AEs reported:N/S0
Withdrawals due to AEs:(See note)(See note)
Carrieri, Orefice, and Sorge, 1988Indobufen, 200 mg, 2x/day for 3 mosPlaceboData at left appears to be for those patients who completed 3 mos of treatment (35/40). None of the 5 patients who withdrew prematurely did so due to AEs.

Indobufen vs. placebo: 0.049 (−0.15 to 0.24)
Number of patients evaluable for AEs:1817
Number of patients reporting AEs:2 (11%)1 (6%)
Total number of AEs reported:21
Number of patients reporting:n (%)n (%)
Transient heartburn2 (11%)1 (6%)
Withdrawals due to AEs:00
Carroll and Maclay, 1975Pizotifen (Sanomigran®), inc'd from 0.5 mg, 1x/day to 0.5 mg, 3x/day for 2 wks or until end of trial -- if relief insufficient, dose increased to 1 mg, 3x/day until end of 2-mo trialPlaceboInvestigators reported that of all 27 patients randomized to treatment, 4 reported weight gain (treatment N/S); 2 reported having hemiparaesthesia and apprehension, as well as other (unspecified) AEs, after being treated with placebo.

Of 27 patients, several withdrew from the trial. One withdrew after treatment with pizotifen for feeling "drugged, dazed, hungry, and depressed"; 2 withdrew for weight gain (treatment N/S); 1 withdrew because of depression (treatment N/S); and 1 withdrew because of "worsening HA" (treatment N/S).
Number of patients evaluable for AEs:(See note)(See note)
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:(See note)(See note)
Carroll, Reidy, Savundra, et al., 1990Propranolol (long-acting), 160 mg/day for 12 wksPropranolol (long-acting), 80 mg/day for 12 wksFour patients reported "tiredness" during the placebo washout period, one of whom withdrew for this reason. Three additional patients withdrew after failure to respond to the trial medication, and five withdrew for unspecified reasons.

Propranolol (long-acting) 160 mg vs. propranolol (long-acting) 80 mg: 0.17 (−0.017 to 0.35)
Number of patients evaluable for AEs:51* (See note)51* (See note)
Number of patients reporting AEs:27 (53%)18 (35%)
Total number of AEs reported:N/SN/S
Number of patients reporting:n (%)n (%)
Tiredness9 (18%)11 (22%)
Withdrawals due to AEs:3 (dizziness, visual disturbance, insomnia & depression)1 (nausea & drowsiness)
Cerbo, Casacchia, Formisano, et al., 1986Flunarizine, 15 mg/day for 2 mosPizotifen, 1.5 mg/day for 2 mos
Number of patients evaluable for AEs:21*21*
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:1724
Number of patients reporting:n (%)n (%)
Drowsiness9 (43%)10 (48%)
Weight gain4 (19%)11 (52%)
Asthenia2 (10%)2 (10%)
Constipation1 (5%)0
Xerostomia1 (5%)0
Decrease of libido01 (5%)
Withdrawals due to AEs:04 (weight gain [1], reasons for other three withdrawals N/S)
Couch, Bearss, and Verhulst, 1987Fenoprofen, 600 mg, 3x/day for 12 wksFenoprofen, 200 mg, 3x/day for 12 wksPlaceboNo information provided on AEs.
Number of patients evaluable for AEs:N/SN/SN/S
Number of patients reporting AEs:N/SN/SN/S
Total number of AEs reported:N/SN/SN/S
Withdrawals due to AEs:N/SN/SN/S
Couch and Hassanein, 1979

and

Couch and Hassanein, 1976
Amitriptyline, 50–100 mg/day for 4–8 wksPlaceboLimited information reported (none in interim report [1976]). Patients were questioned about specific AEs. "Dry mouth," "bad taste," and "drowsiness" were significantly more common with amitriptyline. There were no significant differences in the occurrence of other AEs.
Number of patients evaluable for AEs:5561
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:5 (rash [2], hypertension [1], nausea [1], numbness in hands and feet [1])2 (both chest pain)
Dahlöf, 1987Propranolol, 40 mg, 3x/day for 1 moPlaceboLimited information was provided on AEs. Patients had been asked to record any central nervous system-related AEs on a visual analog scale. Investigators reported that such AEs were "significantly more frequent during the month of propranolol treatment in comparison to placebo."
Number of patients evaluable for AEs:28* (See note)28* (See note)
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:00
Das, Ahuja, and Narainaswamy, 1979Clonidine, 25 μg, 2x/day for 6 wksPlaceboInvestigators did not report information on withdrawals (for any reason), so data at left concern only those patients who completed the crossover.

Investigators reported that "[n]o side effects of clonidine were observed" but did not report whether or not patients taking placebo experienced AEs.
Number of patients evaluable for AEs:20*20*
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:0N/S
Withdrawals due to AEs:0 (See note)N/S (See note)
De Benedittis and Massei, 1986Oxitriptan, 400 mg/day orally for 2 mosPlaceboData on AEs at left are from the 31/40 patients from whom efficacy data were obtained.

Oxitriptan vs. placebo: −0.032 (−0.22 to 0.16)
Number of patients evaluable for AEs:31*31*
Number of patients reporting AEs:5 (16%)6 (19%)
Total number of AEs reported:N/SN/S
Number of patients reporting:n (%)n (%)
Gastric distress:2 (6%)3 (10%)
Drowsiness:1 (3%)0
Pyrosis:1 (3%)0
Weight gain:1 (3%)0
Dizziness:01 (3%)
Palpitations:01 (3%)
Unspecified:02 (6%)
Withdrawals due to AEs:01 (N/S)
Dennerstein, Morse, Burrows, et al., 1988Estradiol gel, 1.5 mg/day, 7 days/mo for 2 mosPlaceboEstradiol vs. placebo: 0.18 (0.0013 to 0.34)
Number of patients evaluable for AEs:22*22*
Number of patients reporting AEs:4 (18%)0
Total number of AEs reported:40
Number of patients reporting:n (%)n (%)
Amenorrhea2 (9%)0
Skin rash1 (5%)0
Ache in leg1 (5%)0
Withdrawals due to AEs:2 (skin rash, ache in leg)0
Diamond and Freitag, 1993

and

Freitag, Diamond, and Diamond, 1991
Flunarizine, 10 mg/day for 5 mosPlaceboNo further information provided on AEs.
Number of patients evaluable for AEs:N/SN/S
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:5 (causative AEs N/S)3 (causative AEs N/S)
Diamond and Medina, 1976Propranolol, 80 (or up to mg 160 mg/day) for 4 wks (or up to 8 wks)PlaceboThe data at left concern all patients randomized to treatment in this crossover trial. Investigators reported that “most side effects were transient and clinically unimportant.” AEs occurring on both treatments were nausea, light-headedness, fatigue, difficulty catching breath, mild depression, and heartburn. AEs occurring only after treatment with propranolol were diarrhea, abdominal cramps, irritability, insomnia, and sleepiness. Investigators did not report AEs occurring only after treatment with placebo.
One patient treated with the active drug had precordial pain, with a normal electrocardiogram, and blood in sputum and stools. The relationship of these symptoms to propranolol was not proven.
Propranolol vs. placebo: 0.072 (−0.036 to 0.18)
Number of patients evaluable for AEs:83*83*
Number of patients reporting AEs:15(18%)9 (11 %)
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:6 (N/S)1 (N/S)
Diamond, Solomon, Freitag, et al., 1987Fenoprofen, 600 mg, 3x/day for 12 wksFenoprofen, 200 mg, 3x/day for 12 wksPlacebo
Number of patients evaluable for AEs:N/SN/SN/S
Number of patients reporting AEs:N/SN/SN/S
Total number of AEs reported:N/SN/SN/S
Number of patients reporting:n(%)n (%)n (%)
Gastrointestinal symptomsN/S (13.5%)N/S (10%)N/S (4%)
Fatigue and/or somnolenceN/S (4%)N/S (16%)N/S (3.3%)
Withdrawals due to AEs:4 (GI symptoms, 3; fatigue, 1)3 (GI symptoms, 3)4 GI symptoms, 1; fatigue, 1; photosensitivity, 1; blurred vision, 1)
Ekbom, 1975Alprenolol, 200 mg, 2x/day for 6 wksPlaceboThe data at left appear to concern all patients randomized to treatment, but this is not clear. Investigators reported that two additional patients withdrew from treatment with the active drug “because of illness,” but did not clarify whether the illness was considered an AE.
Number of patients evaluable for AEs:33* (See note)33* (See note)
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Number of patients reporting:n (%)n (%)
Retrosternal burning sensations on swallowing3 (9%)0
Perspiration2 (6%)0
Dryness of mouth1 (3%)0
Dizziness1 (3%)0
Tiredness and dizziness1 (3%)0
Withdrawals due to AEs:1 (depression and palpitation)N/S
Ekbom and Lundberg, 1972Pindolol, 2.5–5 mg, 3x/day for 1 moPlaceboNo further information provided. Data on withdrawals due to AEs were not reported separately for the two doses of pindolol.
Number of patients evaluable for AEs:2010
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:4 (orthostatic hypotension [2], increased HA [1], dizziiness and cystopyelitis [1])0
Ekbom and Zetterman, 1977Oxprenolol, 80 mg, 3x/day for 2 mosPlaceboInvestigators stated only that “no serious side-effects were noted” (p. 183).
Number of patients evaluable for AEs:34*34*
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:00
Elkind, Webster, Herbertson, et al., 1989aGuanfacine, 1.0 mg/day for 12 wksGuanfacine, 0.5 mg/day for 12 wksPlaceboThree patients withdrew due to unspecified AEs. Investigators did not identify treatment groups from which patients withdrew, but reported that no AEs were “serious.”
Number of patients evaluable for AEs:121312
Number of patients reporting AEs:N/SN/SN/S
Total number of AEs reported:N/SN/SN/S
Withdrawals due to AEs:N/S (See note)N/S (See note)N/S (See note)
Ferrari, Wilkinson, Hirt, et al., 1991
Study 1
Tropisetron 50 mg/day for 3 mosTropisetron, 25 mg/day for 3 mosPlaceboInvestigators reported that they assessed all patients randomized to treatment for AEs. Data at left concern the 7/146 patients (5%) who withdrew due to AEs, who were excluded from efficacy analyses. Additional AEs reported were constipation in 54, 55, and 9 cases occurring in the tropisetron 50 mg, tropisetron 25 mg, and placebo groups, respectively. “Other” unspecified AEs were reported in 33, 19, and 24 cases in patients treated with tropisetron 50 mg, tropisetron 25 mg, and placebo, respectively.
In 13 patients (tropisetron 50 mg, 7; tropisetron 25 mg, 5; placebo, 1), constipation led to the reduction of the dose by 0.5–1 capsule every other day.
Number of patients evaluable for AEs:50 (See note)47 (See note)49 (See note)
Number of patients reporting AEs:N/SN/SN/S
Total number of AEs reported:877433
Number of patients withdrawing due to:n (%)n (%)n (%)
Constipation2 (4%)2 (4%)0
Skin reaction2 (4%)00
Tremor (hands/foot)001 (2%)
Withdrawals due to AEs:4 (listed above)2 (listed above)1 (listed above)
Ferrari, Wilkinson, Hirt, et al., 1991
Study 2
Tropisetron, 15 mg/day for 3 mosPlaceboInvestigators reported that they assessed all patients randomized to treatment for AEs. Data at left concern the 3/58 patients (5%) who withdrew due to AEs, who were excluded from efficacy analyses. Additional AEs reported were constipation in 42 cases occurring in the group treated with tropisetron 15 mg. No cases of constipation were reported in the placebo group. “Other” unspecified AEs were reported in 37 and 35 cases in patients treated with tropisetron 15 mg and placebo, respectively.
Number of patients evaluable for AEs:38 (See note)20 (See note)
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:7935
Number of patients withdrawing due to:n (%)n (%)
Constipation1 (3%)0
Hypoglycemia1 (3%)0
Nausea/vomiting1 (3%)0
Withdrawals due to AEs:3 (listed above)0
Fiorini, Sances, Martignoni, et al., 1991Dihydroergokryptine (DEK), 10 mg, 2x/day for 2 mosPlaceboAbstract reporting limited information. No data reported on AEs.
Number of patients evaluable for AEs:20*20*
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:00
Formisano, Falaschi, Cerbo, et al., 1991Nimodipine, 120 mg/day for 4 mosPropranolol, 120 mg/day for 4 mos
Number of patients evaluable for AEs:1210
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:126
Number of patients reporting:n (%)n (%)
Gastric discomfort4 (33%)0
Paraesthesia2 (17%)1 (10%)
Weight gain2(17%)0
Flushing2(17%)0
Menstrual irregularities1 (8%)1 (10%)
Dizziness02 (20%)
Insomnia1 (8%)0
Arterial hypotension01 (10%)
Asthma01 (10%)
Withdrawals due to AEs:1(flushing)2(arterial hypotension [1], asthma [1])
Forssman, Henriksson, Johannsson, et al., 1976Propranolol, 80 mg, 3x/day for 10 wks (gradually increased)Placebo
Number of patients evaluable for AEs:38*38*
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:229
Number of patients reporting:n (%)n (%)
Increase in weight > 2 kg5 (13%)0
Insomnia5 (13%)1 (3%)
Tiredness4 (11%)3 (8%)
Uncharacteristic dizziness3 (8%)2 (5%)
Feeling of numbness, paraesthesiae2 (5%)1 (3%)
Nausea2 (5%)1 (3%)
Increased appetite1 (3%)0
Palpitations1 (3%)1 (3%)
Withdrawals due to AEs:2 (tiredness, dizziness)2 (tiredness, dizziness)
Forssman, Henriksson, and Kihlstrand, 1972Pizotifen, 2–3 mg/day for 10 wksMethysergide, 4–6 mg/day For 10 wksOne patient suspended treatment during both treatment periods due to AEs (drowsiness and irritation).

Pizotifen vs. methysergide: 0(−0.18 to 0.18)
Number of patients evaluable for AEs:22*22*
Number of patients reporting AEs:20 (91%)20 (91%)
Total number of AEs reported:1925
Number of patients reporting:n (%)n (%)
Drowsiness9 (41%)8 (36%)
Increased appetite and weight gain6 (27%)3 (14%)
Nausea05 (23%)
Dizziness2 (9%)1 (5%)
Diarrhea1 (5%)2 (9%)
Depression03 (14%)
Feelings of irritation1 (5%)1 (5%)
Feeelings of tightness02 (9%)
Withdrawals due to AEs:1 (See note)1 (See note)
Forssman, Lindblad, and Zbornikova, 1983Atenolol, 100 mg/day for 3 mosPlaceboThe data at left appear to concern all 24 patients randomized to treatment in this crossover trial, but this is not clear.
Number of patients evaluable for AEs:24* (See note)24* (See note)
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Number of patients reporting:n (%)n (%)
Slight dizziness of orthostatic type6 (25%)1 (4%)
Diffuse tiredness2 (8%)0
Withdrawals due to AEs:1 (mood alterations)N/S
Frediani, Grazzi, Zanotti, et al., 1991Dihydroergokryptine (DEK), 10 mg, 2x/day for 4 mosDHE (timed-release), 5 mg, 2x/day for 4 mosDEK vs. DHE: 0.067 (−0.14 to 0.27)
Number of patients evaluable for AEs:29*29*
Number of patients reporting AEs:7 (24%)5 (17%)
Total number of AEs reported:86
Number of patients reporting:n (%)n (%)
Gastric pain3 (10%)1 (3%)
Constipation2 (7%)2 (7%)
Nausea2 (7%)1 (3%)
Dizziness1 (3%)0
Malaise01 (3%)
Skin rash01 (3%)
Withdrawals due to AEs:3 (gastric pain and/or nausea)1 (skin rash)
Freitag and Diamond, 1984Nadolol, up to 240 mg/day (3 groups combined) for 3 mosPlaceboInvestigators reported that one patient developed a significant bradycardia (≤ 45 beats per minute). Medication was discontinued and the patient was subsequently dropped from the study.
Number of patients evaluable for AEs:248
Number of patients reporting AEs:4 (17%)N/S
Total number of AEs reported:5 (21%)N/S
Number of patients reporting:n (%)n (%)
Fatigue3 (13%)N/S
Bradycardia1 (4%)N/S
Withdrawals due to AEs:1 (See note)N/S
Frenken and Nuijten, 1984Flunarizine, 10 mg/day for 12 wksPlaceboFlunarizine vs. placebo: 0.14 (− 0.44)
Number of patients evaluable for AEs:1718
Number of patients reporting AEs:10 (59%)8 (44%)
Total number of AEs reported:128
Number of patients reporting:n (%)n (%)
Daytime sedation7 41%)3 (17%)
Weight gain3 (18%)0
Stomach complaints04 (22%)
Other2 (12%)1 (6%)
Withdrawals due to AEs:00
Gawel, 1987Nimodipine, 120 mg/day for 3 mosPizotifen, 3 mg/day for 3 mosAbstract reporting limited results. The most common AEs associated with nimodipine were nausea and flushing, and with pizotifen, weight gain and sedation. Six patients overall withdrew prematurely, but it is not clear how many (if any) of these were due to AEs.

Nimodipine vs. pizotifen: 0.099 (−0.26)
Number of patients evaluable for AEs:60*60*
Number of patients reporting AEs:21 (35%)15 (25%)
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:N/SN/S
Gawel, Kreeft, Nelson, et al, 1992Flunarizine, 10 mg/day for 4 mosPropranolol, 160 mg/day for mosInvestigators did not provide a numerical breakdown of specific AEs, but reported that propranolol was associated with a greater incidence of dizziness, hypoaesthesia, insomnia, agitation, nausea, diarrhea, and dyspepsia. Fatigue and weight gain were more common in the flunarizine group. The incidence of depression was comparable in the two groups (3.3%).
Number of patients evaluable for AEs:4445
Number of patients reporting AEs:33 (75%)36 (80%)
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:3 (depression, weight gain, fatigue)5 (bloating, weight gain; bloating; rash; increased HA; increased HA, depression)
Gelmers, 1983Nimodipine, 40 mg, 3x/day for 3 mosPlaceboNimodipine vs. placebo: −0.098 (−0.31 to 0.12)
Number of patients evaluable for AEs:3030
Number of patients reporting AEs:6 (20%)9 (30%)
Total number of AEs reported:619
Number of patients reporting:n (%)n (%)
Vertigo and/or dizziness06 (20%)
Abdominal discomfort5 (17%)0
Weight loss1 (3%)0
Back pain01 (3%)
Blurred vision01 (3%)
Derealization01 (3%)
Bifrontal HA01 (3%)
Total body pruritus01 (3%)
Withdrawals due to AEs:00
Gerber, Diener, Scholz, et al., 1991Nifedipine, 40 mg/day for 2 mosMetoprolol, 200 mg/day for 2 mosPropranolol, 160 mg/day for 2 mosAEs reported for high-dosage phase of trial only. Percentages at left are estimated from graph.
Number of patients evaluable for AEs:N/SN/SN/S
Number of patients reporting AEs:N/SN/SN/S
Total number of AEs reported:N/SN/SN/S
Number of patients reporting:n (%)n (%)n (%)
Fatigue(38%)(60%)(33%)
Vertigo(32%)(20%)(22%)
Sleep disorders(9%)(10%)(11%)
Body weight increase(15%)(5%)(11%)
Circulatory disturbances(8%)(5%)(28%)
Swollen legs(31%)0(5%)
Withdrawals due to AEs:N/S0N/S
Gerber, Schellenberg, Thom, et al., 1995Cyclandelate, 1200 mg/day for 8 wks, 1600 mg/day for 8 wksPropranolol, 120 mg/day for 8 wks, 160 mg/day for 8 wksThe only AEs described were those deemed by the investigators to be drug-related.

Cyclandelate vs. propranolol: −0.047 (−0.18 to 0.093)
Number of patients evaluable for AEs:4242
Number of patients reporting AEs:4 (10%)6 (14%)
Total number of AEs reported:68
Number of patients reporting:n (%)n (%)
Allergic reaction/exanthema1 (2%)3 (7%)
GI or cardiovascular problems1 (2%)3 (7%)
Dizziness2 (5%)1 (2%)
Worsening of HA1 (2%)0
Tiredness/loss of motivation01 (2%)
Excessive thirst1 (2%)0
Withdrawals due to AEs:N/SN/S
Gomersall and Stuart, 1973Amitriptyline, 30–60 mg/day for 27 wksPlaceboData reported at left are for the 20 patients (of 26) who completed the trial. One patient withdrew prematurely due to increased HAs while taking placebo.

Amitriptyline vs. placebo: 0.15 (−0.13 to 0.40)
Number of patients evaluable for AEs:20*20*
Number of patients reporting AEs:16 (80%)13 (65%)
Total number of AEs reported:2615
Number of patients reporting:n (%)n (%)
Drowsiness10 (50%)4 (20%)
Dry mouth7 (35%)2 (10%)
Nausea2 (10%)2 (10%)
Increased HAs1 (5%)3 (15%)
Weight gain1 (5%)2 (10%)
Depression1 (5%)1 (5%)
Hypertension1 (5%)1 (5%)
Constipation1 (5%)0
Disturbing dreams1 (5%)0
Dizziness1 (5%)0
Withdrawals due to AEs:0(See note)
Grotemeyer, Scharafinski, Schlake, et al., 1990Aspirin, 500 mg, 3x/day for 3 mosMetoprolol, 200 mg, 1x/day for 3 mosInvestigators reported data only on those patients who withdrew from the trial due to AEs.
Number of patients evaluable for AEs:28*28*
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:5 (gastrointestinal AEs)2 (drowsiness)
Grotemeyer, Schlake, and Husstedt, 1989Etilefrene pivalate, 20 mg/day for 3 mosFlunarizine, 5 mg/day for 3 mosAbstract reporting limited results.
Number of patients evaluable for AEs:N/SN/S
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:01 (gastritis)
Grotemeyer, Schlake, Husstedt, et al., 1987Flunarizine, 10 mg/day for 3 mosMetoprolol, 200 mg/day for 3 mosAbstract reporting limited results. Some (unspecified number of) patients in both groups reported weight gain, which was more pronounced with flunarizine than with metoprolol (2.6% vs. 0.8% on average).
Number of patients evaluable for AEs:28*28*
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:02 (hypotonic reaction)
Havanka-Kanniainen, Hokkanen, and Myllylä, 1985bNimodipine, 120 mg/day for 8 wksPlaceboLimited information was provided on AEs. Investigators reported that "no marked side effects were reported." Patients recorded possible AEs in their HA diaries.
Number of patients evaluable for AEs:33*33*
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Number of patients reporting:n (%)n (%)
Vertigo3 (9%)N/S
Flushing2 (6%)N/S
Itching1 (3%)N/S
Withdrawals due to AEs:00
Havanka-Kanniainen, Hokkanen, and Myllylä, 1987Nimodipine, 120 mg/day for 3 mosPlzotifen, 1.5 mg/day for 3 mos
Number of patients evaluable for AEs:50*50*
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Number of patients reporting:n (%)n (%)
Weight gain016 (32%)
Fatigue05 (10%)
Vertigo04 (8%)
Nausea04 (8%)
Withdrawals due to AEs:00
Havanka-Kanniainen, Hokkanen, and Myllylä, 1988Propranolol (long-acting), 160 mg, 1x/day for 3 mosPropranolol (long-acting), 80 mg, 1x/day for 3 mosLimited information reported on AEs. 1 patient withdrew due to AEs (nausea, vomiting, tiredness, and insomnia) associated with propranolol (dose N/S). Other side effects reported included cold hands and feet, fatigue, and vivid dreams.
Number of patients evaluable for AEs:48*48*
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:(See note)(See note)
Hering and Kuritzky, 1992Sodium valproate, 400 mg, 2x/day for 8 wksPlaceboFigures at left are for those patients who completed the trial (29/32). Three patients withdrew prematurely due to unspecified AEs, one while taking sodium valproate and two while taking placebo. Data on AEs were collected during monthly clinic visits.

Sodium valproate vs. placebo: 0.13 (−0.044 to 0.30)
Number of patients evaluable for AEs:29*29*
Number of patients reporting AEs:6 (21%)2 (7%)
Total number of AEs reported:N/SN/S
Number of patients reporting:n (%)n (%)
Dyspepsia2 (7%)0
Nausea2 (7%)0
Mild weariness2 (7%)0
Constipation01 (3%)
Dizziness01 (3%)
Withdrawals due to AEs:(See note)(See note)
Herrmann, Horowski, Dannehl, et al., 1977Lisuride, 25 mcg, 3x/day for 3 mosMethysergide, 2 mg, 3x/day for 3 mosDetailed information was provided only about those AEs that led patients to withdraw from the trial. Investigators reported that the difference in the number of patients withdrawing due to AEs was significant (p<0.05).
Data on AEs were collected at monthly clinic visits, where patients were specifically asked about AEs commonly associated with ergot therapy. Investigators acknowledged that this may have had the effect of increasing the overall frequency of reported AEs.
Number of patients evaluable for AEs:130123
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Number of patients withdrawing due to:n (%)n (%)
Nausea7 (5%)21 (17%)
Vomiting2 (2%)18 (15%)
Dizziness3 (2%)16 (13%)
Gastrointestinal complaints6 (5%)10 (8%)
Drowsiness4 (3%)5 (4%)
Myalgia and neuralgia06 (5%)
Paraesthesia05 (4%)
Tachycardia04 (3%)
Angina-like symptoms03 (2%)
Eye pain03 (2%)
Tiredness03 (2%)
Withdrawals due to AEs:22 (See note)48 (See note)
Herrmann, Krištof, and Sastre y Hernandez, 1978Lisuride, dose gradually increased during first wk of trial up to 0.075 mg/day for 6 mosPlaceboThe data at left appear to concern all 240 patients randomized to treatment, not just the 214 from whom efficacy data were obtained; however, this is not clear.

The AEs at left are those for which significant differences were found between the treatments. Investigators stated that significant differences had also been noted between the two treatments for these AEs prior to treatment.

Investigators reported having "examined" other AEs both prior to and during the trial, but it is not clear whether or not those AEs were reported by patients. The other AEs were: euphoria, nausea, sleep disturbances, dryness of mouth, dysphoric mood, diarrhea, stenocardial complaints, numbness, hallucinations, hot flushes, muscular weakness and pains, and vomiting.
Number of patients evaluable for AEs:103 (See note)111 (See note)
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Number of patients reporting:n (%)n (%)
Cold feelings in extremities44 (43%)13 (12%)
Skin manifestations14 (14%)6 (5%)
Tachycardia12 (12%)6 (5%)
Vertigo25 (24%)7 (6%)
Withdrawals due to AEs:2 (N/S)0
Hübbe, 1973Pizotifen, 1 mg, 3x/day for 8 wksProchlorperazine, 5 mg, 3x/day for 8 wksData at left are for those patients who completed the trial and were included in the efficacy analysis. Three patients withdrew before completing the trial, one due to lack of efficacy and two for unknown reasons.
Number of patients evaluable for AEs:40*40*
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:7633
Number of patients reporting:n (%)n (%)
Weight gain29 (73%)16 (40%)
Drowsiness19 (48%)9 (23%)
Increased appetite8 (20%)1 (3%)
Irritability6 (15%)2 (5%)
Dizziness5 (13%)3 (8%)
Dyspepsia3 (8%)o
Hot flushes1 (3%)2 (5%)
Edema2 (5%)o
Paresthesia2 (5%)o
Palpitations1 (3%)o
Withdrawals due to AEs:(See note)(See note)
Hudgson, Foster, and Newell, 1967Flumedroxone, 5 mg, 3x/day for 4 mosMethysergide, 1 mg, 3x/day for 4 mosFlumedroxone vs. methysergide: 0.20 (0.053 to 0.33)
Number of patients evaluable for AEs:40*40*
Number of patients reporting AEs:9 (23%)1 (3%)
Total number of AEs reported:150
Number of patients reporting:n(%)n (%)
Polymenorrhea5(13%)0
Worsening of HA3 (8%)o
Nausea, vomiting, and vertigo01 (3%)
Withdrawals due to AEs:4 (worsening of HA [3], syncope [1])1 nausea, vomiting, and vertigo)
Hughes and Foster. 1971Pizotifen (BC105), inc'd from 0.5 mg, 1x/day to 0.5 mg. 3x/day for 10 days; then 1 mg, 3x/day for 6 wksPlacebo
Number of patients evaluable for AEs:26*26*
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Number of patients reporting:n (%)n (%)
Facial flushing1 (4%)N/S
Increased appetite (voracious)2 (8%)0
Increased tiredness5 (19%)N/S
Increased vomiting1 (4%)N/S
Increased weight gain10 (38%)0
Withdrawals due to AEs:00
Jacobs, 1972Opipramol. 50 mg. 3x/day for 12 wksPlaceboNo patients known to have withdrawn due to AEs; no further information provided.
Number of patients evaluable for AEs:N/SN/S
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:00
Jensen, Brinck, and Olesen, 1994Sodium valproate (slow-release), 1000–1500 mg/day for 12 wksPlaceboData on AEs were collected during monthly clinic visits.
Sodium valproate vs. placebo: 0.16 (−0.020 to 0.33)
Number of patients evaluable for AEs:43*43*
Number of patients reporting AEs:14 (33%)7 (16%)
Total number of AEs reported:N/SN/S
Number of patients reporting:n (%)n (%)
Nausea5 (12%)2 (5%)
Drowsiness5 (12%)2 (5%)
Weight gain3 (7%)1 (2%)
Vertigo3 (7%)0
Abdominal pain2 (5%)1 (2%)
Increased appetite1 (2%)1 (2%)
Diarrhea1 (2%)0
Restless legs1 (2%)0
Dry mouth1 (2%)0
Tremor1 (2%)0
Pain in neck/shoulders1 (2%)0
Dyspnea1 (2%)0
Tinnitus01 (2%)
Withdrawals due to AEs:4 (nausea [3], vertigo [2]. weight gain [1]. dry mouth [1], tremor [1])2 (abdominal pain [1], weight gain [1], increased appetite [1])
Johannsson, Nilsson, Widelius, et al., 1987Atenolol, 100 mg, 1x/day for 3 mosPlaceboNo further information provided on AEs.
Number of patients evaluable for AEs:63*63*
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:03 (intolerable HA [1], nausea and fatigue [1], sleep disturbances [1])
Johnson, Hornabrook, and Lambie, 1986Mefenamic acid, 250 mg, 3x/day for 3 mosPropranolol, 40 mg, 3x/day for 3 mosPlaceboInvestigators described only those AEs they believed could be attributed to the study medication.
Mefenamic acid vs. placebo: 0.049 (−0.11 to 0.20)
Propranolol vs. placebo: 0.044 (−0.11 to 0.19)
Mefenamic acid vs. propranolol: 0.0046 (−0.17 to 0.18)
Number of patients evaluable for AEs:22*23*24*
Number of patients reporting AEs:2 (9%)2 (9%)1 (4%)
Total number of AEs reported:221
Number of patients reporting:n (%)n (%)n (%)
GI symptoms/diarrhea2 (9%)1 (4%)0
Depression01 (4%)0
Dizziness001 (4%)
Withdrawals due to AEs:1 (diarrhea)1 (N/S)1 (dizziness)
Johnson, Kadam, Hylands, et al., 1985Continuation of feverfew, 50 mg/day for 6 mosWithdrawal of feverfew (placebo)The data at left appear to concern all 17 patients randomized to treatment rather than the 15 who completed treatment, but this is not clear. Investigators noted that all patients taking placebo reported at least one AE, whereas four patients taking feverfew reported none.
Two patients taking placebo withdrew because they experienced recurring headaches after having been in remission prior to the trial. (Note: In this report, “worsening headaches” are not considered AEs.)
The two patients taking feverfew who reported stiffness or pain in joints had always had these symptoms.
Continuation vs. withdrawal: −0.46 (−0.75 to −0.086)
Number of patients evaluable for AEs:8 (See note)9 (See note)
Number of patients reporting AEs:4 (50%)9 (100%)
Total number of AEs reported:919
Number of patients reporting:n (%)n (%)
Nervousness, tension, less calm, jumpy05 (56%)
Tension or frequent non-migrainous HAs03 (33%)
Insomnia, disturbed sleep, nocturnal restlessness02 (22%)
Stiffness or pain in joints2 (25%)3 (33%)
Tiredness02 (22%)
Nausea01 (11 %)
Lighter, irregular periods01 (11%)
Slightly heavier periods1 (13%)1 (11%)
Palpitations1 (13%)0
Colicky abdominal pain1 (13%)0
Urinary frequency01 (11%)
Withdrawals due to AEs:0 (See note)1 (disturbed sleep & stiffness in joints) (See note)
Kallanranta, Hakkarainen, Hokkanen, et al., 1977(Study 1) Clonidine, 75 μg/day for 4 wks(Study 1) Placebo(Study 2) Clonidine, 150 μg/day for 8 wks(Study 2) Practolol, 150 mg/day for 8 wksNo information was provided for withdrawals (for any reason).
Investigators stated that “increased clonidine use was associated with increased side effects, especially nausea and sedation.”
Clonidine vs. placebo (Study 1): 0(−0.14 to 0.14)
Clonidine vs. practolol (Study 2): −0.16 (−0.34 to 0.03)
Number of patients evaluable for AEs:50*50*50*50*
Number of patients reporting AEs:8 (16%)8 (16%)15 (30%)23 (46%)
Total number of AEs reported:881827
Number of patients reporting:n (%)n (%)n (%)n (%)
Dry mouth1 (2%)3 (6%)00
Nausea2 (4%)1 (2%)7 (14%)9 (18%)
Sedation1 (2%)2 (4%)6 (12%)13 (26%)
Vertigo01 (2%)4 (8%)4 (8%)
Weight gain1 (2%)01 (2%)0
Other (mood changes, skin irritations)3 (6%)1 (2%)01 (2%)
Withdrawals due to AEs:N/S (See note)N/S (See note)N/S (See note)N/S (See note)
Kallos and Kallos-Deffner, 1971Cafergot comp.®, 1 cap, 2x/day for 2 menstrual periodsPlacebo
Number of patients evaluable for AEs:20*20*
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Number of reports of (NB: a single patient may have reported a given symptom twice):n (%)n (%)
Nausea/vomiting1124
Muscle pain95
Visual disturbances00
Withdrawals due to AEs:N/SN/S
Kangasniemi, 1979Pizotifen (Sandomigrin®), inc’d from 0.5 mg, 1x/day to 0.5 mg, 3x/day for 3 mos (or 14 wks, not clear)Iprazochrome (Migrenon®), inc’d from 5 mg, 1x/day to 5 mg, 3x/day for 3 mos (or 14 wks, not clear)Data at left concern only the 34/50 patients who completed the trial and from whom efficacy data were obtained. An additional 3 patients, excluded from efficacy analyses, withdrew from the trial due to unspecified AEs (2 from pizotifen, 1 from iprazochrome).
Number of patients evaluable for AEs:34*34*
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:315
Number of patients reporting:n (%)n (%)
Weight gain25 (74%)4 (12%)
Tiredness5 (15%)0
Palpitations1 (3%)0
Vertigo, dizziness01 (3%)
Withdrawals due to AEs:(See note)(See note)
Kangasniemi, Andersen, Andersson, et al., 1987Metoprolol 200 mg/day for 8 wksPlaceboThe data at left are for the 73 of 77 patients included in the efficacy analyses.
Number of patients evaluable for AEs:73* (See note)73* (See note)
Number of patients reporting AEs:26 (36%)13(18%)
Total number of AEs reported:5225
Number of AEs reported:n (%)n (%)
Gastrointestinal16(31%)3 (6%)
Others16(31%)15 (29%)
Fatigue/tiredness13 (25%)4 (8%)
Sleep disturbances4 (8%)0
Cardiovascular3 (6%)3 (6%)
Withdrawals due to AEs:1 (bradycardia)0
Kangasniemi, Falck, Långvik, et al., 1978Oxitriptan, 500 mg, 4x/day for 3 mosPlacebo (Ievoleucine), 320 mg, 4x/day for 3 mosInvestigators reported that no AEs were reported from pts taking oxitriptan. No information was provided on AEs resulting from the placebo treatment.
Number of patients evaluable for AEs:8*8*
Number of patients reporting AEs:00
Total number of AEs reported:00
Withdrawals due to AEs:00
Kangasniemi and Hedman, 1984Metoprolol (controlled-release), 200 mg/day, 1x/day for 8 wksPropranolol, 80 mg, 2x/day for 8 wks
Number of patients evaluable for AEs:36*36*
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:5465
Number of patients reporting:n (%)n (%)
Fatigue14 (39%)11 (31%)
CNS symptoms11 (31%)14 (39%)
GI symptoms8 (22%)9 (25%)
Sleep disturbances3 (8%)10 (28%)
CV or respiratory symptoms2 (6%)5 (14%)
Others16 (44%)16 (44%)
Withdrawals due to AEs:02 (causative AEs N/S)
Kangasniemi, Nyrke, Lang, et al., 1983Femoxetine, 200 mg, 2x/day for 3 mos; dose reduced by half during first weekPropranolol, 80 mg, 2x/day for 3 mos; dose reduced by half during first weekData at left are (apparently) for the 24 patients who completed the trial. Three other patients withdrew due to AEs associated with propranolol (tiredness, dizziness, increase in weight). There were no withdrawals due to AEs associated with femoxetine.
Number of patients evaluable for AEs:24*24*
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:1438
Number of patients reporting:n (%)n (%)
Dizziness3 (13%)10 (42%)
Tiredness1 (4%)9 (38%)
Sleep disturbances1 (4%)5 (21%)
Feeling unwell2 (8%)3 (13%)
Exanthema1 (4%)3 (13%)
Palpitations1 (4%)3 (13%)
Increase in weight03 (13%)
Gastric distress1 (4%)1 (4%)
Sweating1 (4%)1 (4%)
Decrease in weight2 (8%)0
Dry mouth1 (4%)0
Withdrawals due to AEs:(See note)(See note)
Kåss and Nestvold, 1980Clonidine (Catapresan®), 50 μg, 2x/day for 16 wksPropranolol (Inderal®), 80 mg, 2x/day for 16 wksData at left appear to concern those 21 patients (of 23) who completed the crossover, but this is unclear.

Prior to trial, patients given a test dose of 40 mg propranolol followed by testing of blood pressure and pulse rate after 30 min and 3 hrs to "exclude unwanted immediate side effects."

Investigators reported that 2 patients taking propranolol received reduced daily dosage due to dizziness.
Clonidine vs. propranolol: −0.09 (−0.37 to 0.20)
Number of patients evaluable for AEs:21* (See note)21* (See note)
Number of patients reporting AEs:11 (52%)13 (62%)
Total number of AEs reported:1115
Number of patients reporting:n (%)n (%)
Anxiety01 (5%)
Dizziness1 (5%)5 (24%) (See note)
Fatigue8 (38%)4 (19%)
Gastrointestinal1 (5%)0
Insomnia05 (24%)
Hair loss1 (5%)0
Withdrawals due to AEs:00
Kjærsgård Rasmussen, Holt-Larsen, Borg, et al., 1994Tolfenamic acid, 100 mg, 3x/day for 12 wksPropranolol, 40 mg, 3x/day for 12 wksTolfenamic acid vs. propranolol: 0.0015 (minus;0.17 to 0.17)
Number of patients evaluable for AEs:62*67*
Number of patients reporting AEs:26 (42%)28 (42%)
Total number of AEs reported:2820
Number of patients reporting:n (%)n (%)
Gastrointestinal symptoms11 (18%)11 (16%)
Dysuria6 (10%)1 (1%)
Dizziness, fatigue, tremor, drop in BP8 (13%)7 (10%)
Weight gain2 (3%)1 (1%)
Rash1 (2%)0
Withdrawals due to AEs:5 (GI symptoms [4], rash [1])9 (GI symptoms [4]; dizziness, etc. [5])
Klapper, 1994Divalproex sodium, average dose 1100 mg/day, for 2 mosPropranolol, average dose 140 mg/day, for 2 mosInvestigator reported data on AEs only for those patients who withdrew due to AEs.
Number of patients evaluable for AEs:24*24*
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Number of patients withdrawing due to:n (%)n (%)
Fatigue2 (8%)2 (8%)
Gastrointenstinal symptoms3 (13%)0
Increasing HAs1 (4%)1 (4%)
Low white blood count2 (8%)0
Rash1 (4%)0
Withdrawals due to AEs:9 (See note)3 (See note)
Klapper, 1996Divalproex sodium, 1500 mg/day for 12 wksDivalproex sodium, 1000 mg/day for 12 wksDivalproex sodium, 500 mg/day for 12 wksPlacebo"Gastrointestinal events" were the primary cause of withdrawal from the divalproex sodium groups (3 in the 500- mg group, 2 in the 1000-mg group, and six in the 1500-mg group). No other details were provided.
Divalproex sodium 1500 mg vs. placebo: 0.067 (−0.090 to 0.22)
Divalproex sodium 1000 mg vs. placebo: −0.051 (−0.22 to 0.12)
Divalproex sodium 500 mg vs. placebo: −0.039 (−0.21 to 0.13)
Number of patients evaluable for AEs:44434544
Number of patients reporting AEs:38 (86%)32 (74%)34 (76%)35 (80%)
Total number of AEs reported:N/SN/SN/SN/S
Number of patients reporting most common AEs (> 10% of pts treated with active med):n (%)n (%)n (%)n (%)
Nausea34 (77%)9 (21%)27 (60%)7 (16%)
Infection20 (45%)16 (37%)18 (40%)18 (41%)
Dyspepsia16 (36%)19 (44%)7 (16%)9 (20%)
Asthenia23 (52%)9 (21 %)9 (20%)9 (20%)
Dizziness20 (45%)7 (16%)7 (16%)5 (11%)
Somnolence18 (41%)7 (16%)7 (16%)5 (11%)
Back pain14 (32%)5 (12%)7 (16%)9 (20%)
Diarrhea18 (41%)5 (12%)7 (16%)5 (11%)
Pain11 (25%)7 (16%)9 (20%)7 (16%)
Tremor16 (36%)7 (16%)00
Vomiting11 (25%)5 (12%)4 (9%)2 (5%)
Withdrawals due to AEs:12 (See note)6 (See note)7 (See note)2 (See note)
Krakowski and Engisch, 1973Pizotifen, 2 mg, 3x/day for 12 wksPlaceboData at left are for all 29 patients randomized to treatment and include the 7 patients who withdrew early and for whom efficacy data were not analyzed.
Pizotifen vs. placebo: 0.20 (−0.048 to 0.43)
Number of patients evaluable for AEs:15 (See note)14 (See note)
Number of patients reporting AEs:7 (47%)9 (64%)
Total number of AEs reported:3933
Number of patients reporting:n (%)n (%)
Swelling of feet12 (80%)1 (7%)
Drowsiness8 (53%)4 (29%)
Dizziness4 (27%)1 (7%)
Dry mouth4 (27%)1 (7%)
Nervousness3 (20%)9 (64%)
Depressed2 (13%)5 (36%)
Nausea2 (13%)5 (36%)
Bloated feeling1 (7%)2 (14%)
Febrile feeling1 (7%)0
Backache01 (7%)
Muscle cramps1 (7%)0
Pruritis1 (7%)0
Stimulated01 (7%)
Tremor01 (7%)
Twitching01 (7%)
Weight gain01 (7%)
Withdrawals due to AEs:0N/S
Kuritzky and Herlng, 1987Propranolol (long-acting), 160 mg, 1x/day for 1 moPlaceboAbstract reporting limited information. Investigators stated that the most common AEs associated with propranolol were tiredness, insomnia, and dizziness.
Number of patients evaluable for AEs:38*38*
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:2 (dizziness, somnolence)0
Lamsudin and Sadjimin, 1993Nifedipine, 20 mg/day for 3 mosFlunarizine, 10 mg/day for 3 mosInvestigators reported figures for tachycardia and sedation only, broken down by treatment month. Figures at left are for the last month of treatment (3).
Number of patients evaluable for AEs:3840
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Number of patients reporting:n (%)n (%)
Tachycardia12 (32%)6 (15%)
Sedation6 (16%)8 (20%)
Withdrawals due to AEs:00
Lance and Anthony, 1968Pizotifen inc'd from 0.025 mg, 3x/day to 1 mg, 3x/day for 1 moPlaceboData at left for pizotifen appear to include not only the 25 patients in this trial, but an additional 15 patients treated with pizotifen from another study described in the article.

Two patients who were included in efficacy analyses withdrew due to AEs, one because of aching in the legs and one because of a continual feeling of unsteadiness and heaviness in the head "like a drunken hangover." Investigators did not specify from which treatment groups the patients withdrew.
Number of patients evaluable for AEs:40 (See note)25 (See note)
Number of patients reporting AEs:19 (48%)N/S
Total number of AEs reported:297
Number of patients reporting:n (%)n (%)
Drowsiness, languour12 (30%)0
Increased appetite, craving for sweets, gain in weight7 (18%)0
Aching of legs2 (5%)0
Swelling of ankles2 (5%)0
Swelling of abdomen2 (5%)0
Depression, irritability2 (5%)3 (12%)
Nausea2 (5%)1 (4%)
Blurred vision1 (3%)0
Dizziness02 (8%)
Skin rash01 (4%)
Withdrawals due to AEs:(See note)(See note)
Lance, Fine, and Curran, 1963Methysergide, 2 mg, 3x/day for 1 moPlaceboThis report described results of treatment of patients with several different types of HA, and from controlled and uncontrolled portions of the trial. The data on AEs were not reported separately for migraine patients participating in the controlled portion of the trial; thus, the data at left are for all patients included in all phases of the trial. It was reported that 6 of 56 migraine patients taking methysergide during the controlled portion of the trial withdrew due to AEs.

Methysergide vs. placebo: 0.23 (0.12 to 0.35)
Number of patients evaluable for AEs:18350
Number of patients reporting AEs:66 (36%)6 (12%)
Total number of AEs reported:1286
Number of patients reporting:n (%)n (%)
Nausea29 (16%)1 (2%)
Giddiness12 (7%)1 (2%)
Drowsiness9 (5%)0
Lassitude9 (5%)0
Anxiety, insomnia, vivid dreams4 (2%)3 (6%)
Abdominal pain5 (3%)0
Aching in legs5 (3%)0
Blocked nose5 (3%)0
More frequent periods5 (3%)0
Sensation of swelling of throat, tongue5 (3%)0
Diarrhea4 (2%)1 (2%)
Depression4 (2%)0
Uncoordination, ataxia of gait4 (2%)0
Blurred vision3 (2%)0
Paresthesia3 (2%)0
Faintness3 (2%)0
Skin rash3 (2%)0
Epistaxis3 (2%)0
Vomiting2 (1%)0
Tightness in chest2 (1%)0
Palpitations2 (1%)0
Hot flushes2 (1%)0
Constipation1 (< 1%)0
Flatulence1 (< 1%)0
Dyspnea1 (< 1%)0
Sensation of swelling of face1 (< 1%)0
Sensation of swelling of legs1 (< 1%)0
Withdrawals due to AEs:160
Langohr, Gerber, Koletzki, et al., 1985Clomipramine, dose gradually increased to 100 mg/day for total of 4 wksMetoprolol, gradually increased to 100 mg/day for total of 4 wksPlaceboLittle information provided on AEs. Individual AEs listed at left were the most common AEs in the two active treatment groups.
Number of patients evaluable for AEs:N/SN/SN/S
Number of patients reporting AEs:N/SN/SN/S
Total number of AEs reported:793016
Number of patients reporting:n (%)n (%)n (%)
Insomnia152N/S
Sweating91N/S
Tiredness79N/S
Constipation61N/S
Nausea52N/S
Dizziness41N/S
Loss of appetite31N/S
Restlessness22N/S
Withdrawals due to AEs:18N/SN/S
Lawrence, Hossain, and Littlestone, 1977Pizotifen, inc’d from 0.5 mg, 1x/day to 0.5 mg, 3x/day for 10 days; then 1.0 mg, 3x/day for 10 wksPlaceboData at left concern only those 28/36 patients from whom efficacy data were obtained.
Number of patients evaluable for AEs:14 (See note)14 (See note)
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Number of patients reporting:n (%)n (%)
Weight gain4 (29%)2 (14%)
Nausea and vomiting1 (7%)1 (7%)
Withdrawals due to AEs:01 (dizziness)
Leandri, Rigardo, Schizzi, et al., 1990Nicardipine, 40 mg/day for 2 mosPlaceboInvestigators reported that no patients complained of symptoms related to low blood pressure. No significant changes in weight were observed.
Number of patients evaluable for AEs:36*36*
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:1616
Number of patients reporting:n (%)n (%)
Gastralgia5 (14%)8 (22%)
Dizziness6 (17%)5 (14%)
HA precipitated (once)4 (11%)1 (3%)
Dyspepsia1 (3%)2 (6%)
Withdrawals due to AEs:1 (dyspepsia)2 (dyspepsia)
Lindegaard, Övrelid, and Sjaastad, 1980Naproxen(Naprosyn®),250 mg, 2x/day for 6 wksPlaceboThe article did not describe dropouts. On AEs, the authors stated only that “there was no difference between naproxen and placebo with regard to side-effects.”
Number of patients evaluable for AEs:28*28*
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:(See note)(See note)
Louis, 1981Flunarizine, 10 mg/day for 3 mosPlaceboPossible AEs recorded at monthly clinic visits.

Flunarizine vs. placebo: 0(−0.14 to 0.14)
Number of patients evaluable for AEs:2929
Number of patients reporting AEs:2 (7%)2 (7%)
Total number of AEs reported:22
Number of patients reporting:n (%)n (%)
Daytime sedation2 (7%)0
Dry mouth02 (7%)
Withdrawals due to AEs:00
Louis, Schoenen, and Hedman, 1985aClonidine, 50 μg, 2x/day for 8 wksMetoprolol, 50 mg, 2x/day for 8 wksData at left appear to concern all patients, including those who withdrew prematurely from study. Three patients withdrew after treatment with clonidine (subjective toxic effect, lack of effect; nervousness, lack of effect; dizziness, lack of effect). One additional patient withdrew during the washout period due to thrombosis in superior retinal half of left eye. No patients withdrew because of AEs associated with metoprolol.

Following the baseline period but prior to treatment, 8 patients in addition to those at left reported 12 AEs: cardiovascular (1); CNS-related (3); fatigue (3); gastrointestinal (4); others (1).

Clonidine vs. metoprolol: −0.03 (−0.25 to 0.19)
Number of patients evaluable for AEs:31* (See note)31* (See note)
Number of patients reporting AEs:21 (68%)22 (71%)
Total number of AEs reported:4241
Number of patients reporting:n (%)n (%)
Cardiovascular2 (6%)0
CNS-related14 (45%)16 (52%)
Fatigue7 (23%)10 (32%)
Gastrointestinal9 (29%)7 (23%)
Others10 (32%)8 (26%)
Withdrawals due to AEs:(See note)0 (See note)
Louis and Spierings, 1982Flunarizine, 10 mg/day for 4 mosPizotifen, 2–3 mg/day for 4 mos
Number of patients evaluable for AEs:3834
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:2015
Number of patients reporting:n (%)n (%)
Weight gain8(21%)7 (21%)
Daytime sedation6 (16%)4 (12%)
Gastric discomfort6 (16%)4 (12%)
Withdrawals due to AEs:1 (weight gain)1 (weight gain)
Lücking, Oestreich, Schmidt, et al., 1988
(Study 1)
Flunarizine, 10 mg/day for 4 mosPropranolol, 120 mg/day for 4 mosFlunarizine VS. propranolol: −0.049 (−0.13 to 0.034)
Number of patients evaluable for AEs:211223
Number of patients reporting AEs:52 (25%)66 (30%)
Total number of AEs reported:N/SN/S
Number of patients reporting:n (%)n (%)
GI disorders15 (7%)22 (10%)
Sedation/fatigue17 (8%)18 (8%)
Vertigo11 (5%)16 (7%)
Weight gain6 (3%)8 (4%)
Hyposthenia5 (2%)5 (2%)
Withdrawals due to AEs:6 (nausea, sedation, gastric pain, vertigo [numbers with each N/S])11 (nausea, changes in heart rate, hallucinations, sedation, vertigo, GI disorders, weight gain, eczema)
Lücking, Oestreich, Schmidt, et al., 1988
(Study 2)
Flunarizine, 10 mg/day for 4 mosPropranolol, 120 mg/day for 4 mosFlunarizine VS. propranolol: −0.10 (−0.30 to 0.10)
Number of patients evaluable for AEs:4344
Number of patients reporting AEs:16 (37%)21 (48%)
Total number of AEs reported:N/SN/S
Number of patients reporting:n (%)n (%)
Sedation/fatigue10 (23%)4 (9%)
GI disorders09 (21%)
Weight gain5 (12%)3 (7%)
Vertigo1 (2%)2 (5%)
Hyposthenia1 (2%)2 (5%)
Withdrawals due to AEs:2 (causative AEs N/S)4 (causative AEs N/S)
Ludin, 1989Flunarizine, 10 mg/day for 4 mosPropranolol, 120 mg/day for 4 mosFlunarizine vs. propranolol: 0.013 (−0.23 to 0.26)
Number of patients evaluable for AEs:2732
Number of patients reporting AEs:13 (48%)15 (47%)
Total number of AEs reported:1823
Number of patients reporting:n (%)n (%)
Tiredness/sleepiness7 (26%)3 (9%)
GI symptoms2 (7%)6 (19%)
Dizziness3 (11%)2 (6%)
Weight gain2 (7%)3 (9%)
Increased appetite04 (13%)
Insomnia1 (4%)2 (6%)
Hair loss02 (6%)
Dyspnoea1 (4%)0
Urticaria/pruritus1 (4%)0
Oedema1 (4%)0
Nausea01 (3%)
Withdrawals due to AEs:2 (tiredness/sleepiness, insomnia)3 (hair loss, GI symptoms, tiredness/sleepiness)
Lundberg, 1969Flumedroxone, 5 mg, 2x/day for 1 moPlaceboLimited information provided on AEs. 8/30 women completing the trial (apparently some in each treatment group) reported "menstrual disturbances: Other AEs were characterized as "infrequent” and "mild."
Number of patients evaluable for AEs:2525
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:00
Malvea, Gwon, and Graham, 1973Propranolol, dose N/S, for 6 wksPlacebo
Number of patients evaluable for AEs:31*31*
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:17N/S
Number of patients reporting:n (%)n (%)
Nausea5 (16%)N/S
Fatigue5 (16%)N/S
Numbness1 (3%)N/S
Heartburn1 (3%)N/S
Heaviness in leg and arm1 (3%)N/S
Light-headedness1 (3%)N/S
Vomiting1 (3%)N/S
Tingling in leg and arm1 (3%)N/S
Depression1 (3%)N/S
Withdrawals due to AEs:00
Markley, Cheronis, and Piepho, 1984Verapamil, 240 mg/day for 8 wksPlacebo
Number of patients evaluable for AEs:14*14*
Number of patients reporting AEs:6 (43%)N/S
Total number of AEs reported:6N/S
Number of patients reporting:n (%)n (%)
Constipation6 (43%)0
Withdrawals due to AEs:1 (severe constipation)0
Martucci, Manna, Mattesi, et al., 1983DHE (timed-release), 5 mg, 2x/day for 45 daysPlaceboLimited information provided on AEs.
Number of patients evaluable for AEs:90*90*
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:6 (pyrosis and epigastralgia [4], insomnia [1], allergic skin reaction [1])0
Masel, Chesson, Peters, et al., 1980Aspirin + dipyridamole, 325 + 25 mg, 3x/day, for 3 mosPlaceboThe data at left appear to refer only to the 25/40 patients who completed the trial. None of the 15 patients who withdrew prematurely did so due to AEs.
Number of patients evaluable for AEs:25*25*
Number of patients reporting AEs:00
Total number of AEs reported:00
Withdrawals due to AEs:00
Mastrosimone, laccarino, and de Caterina, 1992Cyclandelate, 1600 mg/day for 3 mosPizotifen, 1.5 mg/day for 3 mosCyclandelate vs. pizotifen: −0.49 (−0.69 to −0.26)
Number of patients evaluable for AEs:3526
Number of patients reporting AEs:8 (23%)19 (73%)
Total number of AEs reported:819
Number of patients reporting:n (%)n (%)
Weight gain1 (3%)6 (23%)
Asthenia2 (6%)3 (12%)
GI disturbances2 (6%)2 (8%)
Somnolence1 (3%)2 (8%)
Visual disturbances03 (12%)
Vertigo1 (3%)1 (4%)
Other1 (3%)2 (8%)
Withdrawals due to AEs:00
Mathew, 1978Oxitriptan, 300 mg/day for 8 wksPlaceboLimited information was provided on AEs. Investigators only reported that "slight drowsiness and mild diarrhea" were the most common AEs from oxitriptan. They did not report the number of AEs from placebo.
Number of patients evaluable for AEs:12* (See note)12* (See note)
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:N/SN/S
Mathew, 1981See notes column, at right. Trial reported results separately for migraine-only and mixed HA patients.Very limited data were reported on AEs. Among migraine-only patients, the incidence of AEs was "more or less comparable" in the.various treatment groups; 18/340 patients (5%) withdrew due to AEs. Among patients with mixed HAs, 29/375 (8%) withdrew due to AEs; AEs were highest in the control (ergotamine) group. In both HA groups, no unusual AEs were reported when propranolol and amitriptyline were used simultaneously.
Eight interventions were tested over 6 mos:
Ergotamine + analgesics, used abortively (control)
Propranolol, 60–160 mg/day
Amitriptyline, 25–75 mg/day
Biofeedback (+ relaxation)
Propranolol + amitriptyline
Propranolol + biofeedback
Amitriptyline + biofeedback
Propranolol + amitriptyline + biofeedback
Mathew, Saper, Silberstein, et al., 1995Divalproex sodium, average dose 1087 mg/day, for 12 wksPlaceboInvestigators reported data only on those AEs for which there was a significant difference between the two groups.
Number of patients evaluable for AEs:7037
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Number of patients reporting:n (%)n (%)
Nausea32 (46%)5 (14%)
Asthenia22 (31%)3 (8%)
Somnolence21 (30%)2 (5%)
Vomiting13 (19%)0
Tremor9(13%)0
Alopecia9(13%)0
Withdrawals due to AEs:9 (nausea [2], rash [1], vomiting [1], decreased mental acuity [1], fatigue [1], elevated liver function test results [1], chest/GI pain [1], weight gain [1 ])2 (rash [1], depression [1])
McArthur, Marek, Pestronk, et al., 1989Nifedipine, 60–90 mg/day for 3 mosPlacebo
Number of patients evaluable for AEs:24*−24*
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:4610
Number of patients reporting:n (%)n (%)
Dizziness11 (46%)0
Edema11 (46%)0
Gastric symptoms4 (17%)6 (25%)
Flushing7 (29%)2 (8%)
Exacerbation of HA severity4 (17%)0
Mental symptoms3 (13%)0
Acute onset of HA w/dose titration2 (8%)0
Weight gain2 (8%)0
Fatigue2 (8%)0
Diarrhea01 (4%)
Leg cramps01 (4%)
Withdrawals due to AEs:5 (causative AEs N/S)1 (causative AEs N/S)
Mendenopoulos, Manafi, Logothetis, et al., 1985Flunarizine, 10 mg/day for 3–4 mosPlaceboNo indication of how data on AEs were gathered.

Flunarizine VS. placebo: 0.0084 (−0.16 to 0.18)
Number of patients evaluable for AEs:911
Number of patients reporting AEs:00
Total number of AEs reported:00
Withdrawals due to AEs:00
Meyer and Hardenberg, 1983Nimodipine, 60 mg/day for 8 wks and 120 mg/day for 8 wksThis was a dose-comparison trial, but AEs were not reported separately for the two doses.
Number of patients evaluable for AEs:27*
Number of patients reporting AEs:11 (40%)
Total number of AEs reported:28
Number of patients reporting:n (%)
Muscular complaints12 (44%)
GI complaints5 (19%)
Behavioral changes5 (19%)
Other CNS symptoms3 (11%)
Vascular complaints2 (7%)
Dermatological changes1 (1%)
Withdrawals due to AEs:N/S
Micieli, Trucco, Agostinis, et al., 1985Nimodipine, 120 mg/day for 3 mosPizotifen, 1.5 mg/day for 3 mosAbstract reporting limited information. Authors stated that no significant AEs were reported with nimodipine.
Number of patients evaluable for AEs:20*20*
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Number of patients reporting:n (%)n (%)
Drowsiness09 (45%)
Weight gain (1–3 kg)06 (30%)
Withdrawals due to AEs:N/SN/S
Migraine-Nimodipine European Study Group (MINES), 1989aNimodipine, 120 mg/day for 12 wksPlaceboNimodipine vs. placebo: 0.10 (−0.070 to 0.27)
Number of patients evaluable for AEs:4346
Number of patients reporting AEs:12 (28%)8 (17%)
Total number of AEs reported:128
Number of patients reporting:n (%)n (%)
Increased HA4 (9%)2 (4%)
Dizziness1 (2%)3 (6%)
Vasodilatation2 (5%)1 (2%)
Asthenia2 (5%)0
Myalgia2 (5%)0
Depression02 (4%)
Tachycardia1 (2%)0
Withdrawals due to AEs:3 (increased HA [2], tachycardia [1])4 (causative AEs N/S)
Migraine-Nimodipine European Study Group (MINES), 1989bNimodipine, 120 mg/day for 12 wksPlaceboNimodipine vs. placebo: 0.12 (0.010 to 0.23)
Number of patients evaluable for AEs:9498
Number of patients reporting AEs:24 (26%)13 (13%)
Total number of AEs reported:2413
Number of patients reporting:n (%)n (%)
Increased HA8 (9%)2 (2%)
GI problems4 (4%)4 (4%)
Vasodilatation5 (5%)1 (1%)
Nausea2 (2%)1 (1%)
Palpitation2 (2%)1 (1%)
Dizziness1 (1%)2 (2%)
Tachycardia2 (2%)0
Rash02 (2%)
Withdrawals due to AEs:5 (4 due to increased HA; 1 due to unspecified AEs)3 (causative AEs N/S)
Mikkelsen and Falk, 1982Tolfenamic acid, 100 mg, 3x/day for 10 wksPlaceboGastrointestinal symptoms are said to have included mild dyspepsia, gaseous abdominal distension, constipation, diarrhea, and bloating. "Other" AEs included difficulty breathing, insomnia, failure of impressing ability, and a pressing feeling in the head.
Number of patients evaluable for AEs:38*38*
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:2119
Number of patients reporting:n (%)n (%)
Gastrointestinal symptoms (see note)13 (34%)12 (32%)
Increase in weight and oedema4 (11%)5 (13%)
Dysuria1 (2%)1 (2%)
Other AEs (see note)3 (6%)1 (2%)
Withdrawals due to AEs:2 (increase in weight, diarrhea)1 (tingling in hands and feet)
Mikkelsen, Kjærsgaard-Pedersen, and Christiansen, 1986Propranolol, 40 mg, 3x/day for 12 wksTolfenamic acid, 100 mg, 3x/day for 12 wksPlaceboData at left are for those patients who completed the trial (31/39). Three patients withdrew due to AEs before completing the trial: two due to AEs associated with propranolol (fatigue and difficulty working; fatigue, tremor, and general indisposition), and one due to AEs associated with tolfenamic acid ("indistinct psychical symptoms").

Propranolol vs. placebo: 0(−0.15 to 0.15)

Tolfenamic acid vs. placebo: −0.031 (−0.17 to 0.11)

Propranolol vs. tolfenamic acid: 0.031 (−0.11 to 0.17)
Number of patients evaluable for AEs:31*31*31*
Number of patients reporting AEs:3 (10%)2 (6%)3 (10%)
Total number of AEs reported:323
Number of patients reporting:n (%)n (%)n (%)
Diarrhea01 (3%)1 (3%)
Fatigue1 (3%)00
Polyuria1 (3%)00
Low back pain1 (3%)00
Slight sedation01 (3%)0
Slight neurological symptoms001 (3%)
Hot flushes001 (3%)
Withdrawals due to AEs:(See note)(See note)(See note)
Mondrup and Møller, 1977Clonidine, 50–75 μg, 2x/day for 12 wksPlacebo, 2–3 tabs, 2x/day for 12 wksData at left appear to concern only the 21 patients (of 32) who completed the crossover, but it is unclear. No patients withdrew due to AEs. However, 5 patients (2 on clonidine and 3 on placebo) were withdrawn from the study because of "unacceptable worsening of the headaches." One patient (on placebo) became HA free and withdrew.
Number of patients evaluable for AEs:21* (See note)21* (See note)
Number of patients reporting AEs:N/SNIS
Total number of AEs reported:18 (86%)8 (38%)
Number of patients reporting:n (%)n (%)
Dryness of mouth3 (14%)1 (5%)
Dyspepsia3 (14%)1 (5%)
Slight dizziness4 (19%)1 (5%)
Slight tiredness8 (38%)5 (24%)
Withdrawals due to AEs:0 (See note)0 (See note)
Monro, Swade, and Coppen, 1985Mianserin, 30 mg/day for 1 wk, 60 mg/day for 15 wksPlaceboNo information provided on AEs.
Number of patients evaluable for AEs:N/SN/S
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:N/SN/S
Murphy, Heptinstall, and Mitchell, 1988 #4580Feverfew, ≈82 mg/day (mean dose) for 4 mosPlaceboData at left appear to concern all 72 patients randomized to treatment, but this is not clear.
Number of patients evaluable for AEs:72* (See note)72* (See note)
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:2836
Number of patients reporting:n (%)n (%)
Mouth ulceration10 (14%)16 (22%)
Indigestion4 (6%)2 (3%)
Heartburn3 (4%)3 (4%)
Dizziness/lightheadedness2 (3%)2 (3%)
Skin rash1 (1%)3 (4%)
Diarrhea1 (1%)2 (3%)
Abdominal bloating1 (1%)1 (1%)
Sore mouth1 (1%)1 (1%)
Nausea1 (1%)1 (1%)
Flatulence1 (1%)1 (1%)
Weight gain2 (3%)0
Constipation1 (1%)0
Night sweats01 (1%)
Paraesthesiae in legs01 (1%)
Bleeding per rectum01 (1%)
Somnolence01 (1%)
Withdrawals due to AEs:2 (heartburn [1], dizziness/lightheadedness [1])3 (paraesthesiae in legs [1], skin rash [1], bleeding per rectum [1])
Nanda, Johnson, Gray, et al., 1978Acebutolol, 400 mg, 2x/day for 12 wksPlaceboLimited information provided on AEs. Investigators stated that “no serious side-effects were reported” during the trial (p. 21).
Number of patients evaluable for AEs:43*43*
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:00
Nappi, Sandrini, Savoini, et al., 1987Cyclandelate, 1600 mg/day for 3 mosFlunarizine, 5 mg/day for 3 mosLimited information provided on AEs. Incidence of specific AEs reported at left is for the third month of treatment only.
Number of patients evaluable for AEs:2020
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Number of patients reporting:n (%)n (%)
Weight gainN/S9 (45%)
DrowsinessN/S5 (25%)
Gastric complaints3 (15%)N/S
AstheniaN/S2 (10%)
Withdrawals due to AEs:1 (gastric complaints)2 (drowsiness)
Nattero, Biale, Savi, et al., 1991Pizotifen, 1.5 mg, 3x/day for 16 wksLisuride, 0.075 mg, 3x/day for 16 wksData at left are for the “most common” AEs reported and appear to concern only those 47/110 patients who completed both cycles of the crossover trial, but this is not clear. No information was provided on other AEs or on the number of patients who withdrew due to AEs.
Number of patients evaluable for AEs:N/S (See note)N/S (See note)
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Number of patients reporting:n (%)n (%)
Weight gain38%N/S
Gastrointestinal disorders32%50%
Somnolence12%12%
Withdrawals due to AEs:N/SN/S
Neuman, Demarez, Harmey, et al., 1986DHE (timed-release), 5 mg, 2x/day for 1 moPlaceboInvestigators stated only that “no notable side-effects were registered in either of the two groups” (p. 13).
Number of patients evaluable for AEs:2020
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:00
Noone, 1980Clomipramine, 10 mg, 3x/day for B wksPlaceboThese data are for those patients who completed the trial (10/21 randomized to treatment). Two patients withdrew before completing due to unspecified AEs; both were taking clomipramine at the time.

Clomipramine vs. placebo: 0.47 (0.086 to 0.76)
Number of patients evaluable for AEs:10*10*
Number of patients reporting AEs:6 (60%)1 (10%)
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:(See note)0
Olerud, Gustavsson, and Furberg, 1986Nadolol, 40–160 mg, 1x/day for 6 mosPropranolol, 40–80 mg, 2x/day for 6 mosLimited information provided. Investigators stated that “most” reported AEs were typical of beta-blockers.

Nadolol vs. propranolol: 0.12 (−0.22 to 0.45)
Number of patients evaluable for AEs:1315
Number of patients reporting AEs:6 (46%)5 (33%)
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:1 (cold fingers, tiredness)0
Olsson, Behring, Forssman, et al., 1984Metoprolol, 50 mg, 2x/day for 8 wksPropranolol, 40 mg, 2x/day for 8 wks
Number of patients evaluable for AEs:56*56*
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:158141
Number of patients reporting:n (%)n (%)
CNS symptoms36 (64%)24 (43%)
GI symptoms24 (43%)16 (29%)
Sleep disturbances17 (30%)22 (39%)
Fatigue14 (25%)17 (30%)
Cardiovascular symptoms12 (21%)12 (21%)
Other55 (98%)50 (89%)
Withdrawals due to AEs:00
O’Neill and Mann, 1978Aspirin, 650 mg, 2x/day for 3 mosPlaceboAspirin vs. placebo: 0.24 (−0.033 to 0.47)
Number of patients evaluable for AEs:12*12*
Number of patients reporting AEs:3 (25%)0
Total number of AEs reported:30
Number of patients reporting:n (%)n (%)
Gastritis3 (25%)0
Withdrawals due to AEs:1 (gastritis)0
Orholm, Honoré, and Zeeberg, 1986Femoxetine, 200 mg/day initially, increasing over first nine days to 600 mg/day for total of 16 wksPlaceboThese data appear to include only those patients who completed the trial or were known to have withdrawn due to AEs (59/65 patients randomized to treatment), though this is not entirely clear.

Femoxetine vs. placebo: 0.17 (−0.027 to 0.36)
Number of patients evaluable for AEs:2930
Number of patients reporting AEs:8 (28%)3 (10%)
Total number of AEs reported:143
Number of patients reporting:n (%)n (%)
Tremor3 (10%)0
Nausea3 (10%)0
Palpitation1 (3%)1 (3%)
Vomiting1 (3%)0
Stomach pain1 (3%)0
Orthostatic dizziness1 (3%)0
Tiredness1 (3%)0
Lack of appetite1 (3%)0
Constipation1 (3%)0
Perspiration1 (3%)0
Edema01 (3%)
Urticarial exanthema01 (3%)
Withdrawals due to AEs:4 (nausea, orthostatic dizziness; tiredness, stomach pain; tremor, nausea, palpitation, lack of appetite; tremor)2 (edema, palpitation)
Osterman, 1977Pizotifen, inc’d from 0.5 mg, 1x/day to 1 mg, 3x/day for 8 wksIprazochrome, inc’d from 2.5 mg, 1x/day to 5 mg, 3x/day for 8 wksPlaceboThe data at left appear to concern only those 27 patients who completed all three treatments of the crossover trial, plus one patient who only completed treatment with iprazochrome and placebo. These were the patients (of the 30 originally randomized to treatment) for whom efficacy data were analyzed. One patient, not included in efficacy analyses, withdrew due to “abdominal problems due to both placebo and pizotifen.”
Investigators stated that AEs were frequent during treatment with pizotifen, with drowsiness and weight gain being the most common. Investigators also reported that there was no difference between iprazochrome and placebo with respect to AEs.
Number of patients evaluable for AEs:27* (See note)27* (See note)27* (See note)
Number of patients reporting AEs:N/SN/SN/S
Total number of AEs reported:681211
Number of patients reporting:n (%)n (%)n (%)
Weight gain > 1.5 kg21 (78%)1 (4%)2 (7%)
Weight gain > 4 kg8 (30%)00
Drowsiness15 (56%)6 (22%)4 (15%)
Of above “drowsiness,” those which were “severe”9 (33%)1 (4%)1 (4%)
Increased appetite and hunger12 (44%)2 (7%)3 (11%)
Depression3 (11%)2 (7%)1 (4%)
Withdrawals due to AEs:1 (N/S)00
Palferman, Gibberd, and Simmonds, 1983Propranolol, 40 mg, 3x/day for 2 mosPlaceboInvestigators stated that, among patients completing the trial, minor AEs, most commonly fatigue, were reported exclusively in association with propranolol.
Number of patients evaluable for AEs:16*16*
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:01 (dizziness)
Pedersen and Møller, 1966Methysergide (prolonged-action), 6 mg/day for 6 wksPlaceboData at left are for those patients who completed the trial (60/102). Seven patients withdrew prematurely due to AEs associated with methysergide (intermittent claudication [3]; cardiac symptoms [2]; severe dizziness, nausea, and vomiting [2], in one case accompanied by generalized edema and an increase in body weight). No patients withdrew due to AEs associated with placebo.

Methysergide vs. placebo: 0.15 (−0.0075 to 0.30)
Number of patients evaluable for AEs:60*60*
Number of patients reporting AEs:20 (33%)11 (18%)
Total number of AEs reported:3116
Number of patients reporting:n (%)n (%)
Leg symptoms12 (20%)5 (8%)
Fatigue6 (10%)4 (7%)
Cardiac symptoms4 (7%)4 (7%)
Dizziness3 (5%)1 (2%)
Nausea3 (5%)1 (2%)
Edema3 (5%)1 (2%)
Withdrawals due to AEs:(See note)(See note)
Pini, Ferrari, Guidetti, et al., 1985Flunarizine, 20 mg/day for 14 days, then 10 mg/day for up to 106 daysPlaceboLimited information provided on AEs. No patients experienced AEs requiring them to withdraw or impairing their usual activities. Significant weight gain was reported by 29% of patients on flunarizine. Motor disturbances such as extra-pyramidal reactions were not observed.
Number of patients evaluable for AEs:14 or 1514 or 15
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:00
Pita, Higueras, Bolaños, et al., 1977Propranolol, 40 mg, 4x/day for 2 mosPlaceboPropranolol vs. placebo: 0.31 (−0.024 to 0.59)
Number of patients evaluable for AEs:9*9*
Number of patients reporting AEs:3 (33%)0
Total number of AEs reported:30
Number of patients reporting:n (%)n (%)
Orthostatic hypotension1 (11 %)0
Light pyrosis2 (22%)0
Withdrawals due to AEs:1 (orthostatic hypotension)0
Pradalier, Serratrice, Collard, et al., 1989bPropranolol (long-acting) 160 mg, 1x/day for 3 mosPlacebo
Number of patients evaluable for AEs:3124
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Number of patients reporting (in response to questionnaire):n (%)n (%)
Tiredness8 (26%)7 (29%)
Insomnia5 (16%)5 (21%)
Constipation3 (10%)7 (29%)
Dyspnea6 (19%)1 (4%)
Depression2 (6%)5 (21 %)
Dizziness3 (10%)2 (8%)
Dyspepsia2 (6%)3 (13%)
Diarrhea3 (10%)1 (4%)
Cold extremities04 (17%)
Headache1 (3%)2 (8%)
Nausea1 (3%)0
Eye troubles01 (4%)
Rash01 (4%)
Wheezing01 (4%)
Impotence01 (4%)
Withdrawals due to AEs:00
Presthus, 1971Pizotifen, 0.5 mg. 3x/day for 5 wksMethysergide, 1 mg, 3x/day for 5 wks
Number of patients evaluable for AEs:21*21*
Number of patients reporting AEs:N/S1 (5%)
Total number of AEs reported:201
Number of patients reporting:n (%)n (%)
Weight gain14 (67%)0
Fatigue3 (14%)0
Drowsiness1 (5%)0
Dysphoria1 (5%)0
Restless legs1 (5%)0
Exanthema01 (5%)
Withdrawals due to AEs:01 (exanthema accompained by fatigue, nausea, vomiting, and diarrhea)
Rascol, Montastruc, and Rascol, 1986Flunarizine, 10 mg/day for 2 masPizotifen, 2.19 mg/day for 2 mos (lower during 1st wk)Flunarizine vs. pizotifen: −0.0047 (−0.29 to 0.29)
Number of patients evaluable for AEs:2114
Number of patients reporting AEs:6 (29%)4 (29%)
Total number of AEs reported:105
Number of patients reporting:n (%)n (%)
Weight gain6 (29%)4 (29%)
Oversleeping1 (5%)0
Dreaming1 (5%)0
Hot flushes1 (5%)0
Drowsiness1 (5%)0
Asthenia01 (7%)
Withdrawals due to AEs:1 (weight gain and drowsiness)1 (weight gain and asthenia)
Rompel and Bauermeister, 1970Carbamazepine, 600 mg/day for 6 wksPlaceboCarbamazepine vs placebo: 0.39 (0.20 to 0.56)
Number of patients evaluable for AEs:48*48*
Number of patients reporting AEs:30 (63%)11 (23%)
Total number of AEs reported:N/SN/S
Number of patients reporting:n (%)n (%)
Vertigo or giddiness23 (48%)2 (4%)
Drowsiness5 (10%)0
Nausea4 (8%)3 (6%)
Dry mouth2 (4%)0
Heavy eyes2 (4%)0
Constipation2 (4%)0
Vomiting1 (2%)0
Weight gain1 (2%)1 (2%)
Sweating1 (2%)0
Rash1 (2%)0
Dysuria1 (2%)0
Blocked nose01 (2%)
Lack of drive01 (2%)
Flushing01 (2%)
Blunted feeling01 (2%)
Heavy head01 (2%)
Withdrawals due to AEs:1 (causative AEs N/S)0
Ryan, 1968Pizotifen, 2 mg, 2x/day for 4 wksMethysergide, 2 mg, 2x/day for 4 wksPlaceboThis article says nothing about dropouts and therefore appears to be reporting only on those patients who completed the trial.
Number of patients evaluable for AEs:62*62*62*
Number of patients reporting AEs:N/SN/SN/S
Total number of AEs reported:342410
Number of patients reportingn (%)n (%)n (%)
Drowsiness14 (23%)4 (6%)3 (5%)
Weight gain8 (13%)1 (2%)0
Nausea2 (3%)4 (6%)2 (3%)
Dry mucous membranes4 (6%)1 (2%)2 (3%)
Nervousness1 (2%)3 (5%)1 (2%)
Vertigo1 (2%)2 (3%)1 (2%)
Abdominal cramps2 (3%)1 (2%)0
Bloated sensation1 (2%)2 (3%)0
Leg cramps02 (3%)0
Insomnia02 (3%)0
Increased appetite1 (2%)00
Vomiting01 (2%)0
Floating sensation001 (2%)
Edema in extremities01 (2%)0
Withdrawals due to AEs:(See note)(See note)(See note)
Ryan, 1971Pizotifen (BC105), inc’d from 0.5 mg, 1x/day to 1.0 mg. 3x/day for 2 wks; then dosage adjusted according to a protocol for 10 wksPlaceboData at left on AEs appear to concern all patients randomized to treatment, but this is unclear. Investigators reported that one patient withdrew from pizotifen treatment due to increased blood pressure. Three others withdrew for unspecified reasons (pizotifen 1, placebo 2).
Number of patients evaluable for AEs:27 (See note)24 (See note)
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:5414
Number of patients reportingn (%)n (%)
Increased appetite17 (63%))0
Drowsy16 (60%)6 (25%)
Weight gain7 (26%)0
Nausea6 (22%)5 (21%)
Ankle edema2 (7%)0
Nervous2 (7%)1 (4%)
Vertigo2 (7%)0
Dry mouth1 (4%)0
Vomiting1 (4%)2 (8%)
Withdrawals due to AEs:1 (increased blood pressure)N/S (See note)
Ryan, 1978Ovral® (norgestrel 0.5 mg + ethinyl estradiol 0.05 mg), 1x/day for 2 mosNo treatmentLimited information provided on AEs. AEs reported with Ovral® included nausea and/or vomiting, abdominal cramping, depression, drowsiness, dry mouth, and pigmented skin (no n’s reported).
Number of patients evaluable for AEs:40*40*
Number of patients reporting AEs:28 (70%)N/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:00
Ryan, 1984Nadolol, 160 mg/day for 3 mosNadolol, 80 mg/day for 3 mosPropranolol, 160 mg/day for 3 mosNo further information provided on AEs.
Number of patients evaluable for AEs161616
Number of patients reporting AEsN/SN/SN/S
Total number of AEs reported:N/SN/SN/S
Withdrawals due to AEs:01 (gastric symptoms)0
Ryan, Diamond, and Ryan, 1975Clonidine, 0.025 – 0.075 mg, 2x/day for 8 wksPlaceboInvestigators did not provide the number of patients affected, the number of AEs reported, or the treatment groups associated with AEs. Authors only reported that the same number of AEs were experienced with each treatment and that no AEs incapacitated patients. The most common AEs were nausea, nervousness, and tiredness. Other rare AEs were dry mouth, drowsiness, vertigo, sleepiness, insomnia, and an increased number of HAs.
Number of patients evaluable for AEs:133*133*
Number of patients reporting AEs:N/S (See note)N/S (See note)
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:00
Ryan and Ryan, 1981Aspirin + dipyridamole. 325 + 75 mg. 4x/day for 8 wksAspirin, 325 mg, 4x/day for 8 wksDipyridamole
75 mg. 4x/day for 8 wks
PlaceboNo information on dropouts was provided. Data at left may be for those patients who completed the trial only; this is unclear.
Number of patients evaluable for AEs:40404040
Number of patients reporting AEs:N/SN/SN/SN/S
Total number of AEs reported:202165
Number of patients reporting:n (%)n (%)n (%)n (%)
Increased HA5 (13%)06 (15%)2 (5%)
Nausea6 (15%)1 (3%)4 (10%)0
Vomiting2 (5%)01 (3%)0
Vertigo1 (3%)02 (5%)0
Cramps2 (5%).000
Head pressure2 (5%)000
Skin bruises1 (3%)000
Frequent urination1 (3%)000
Hot flashes01 (3%)00
Diarrhea001 (3%)0
Chest pain001 (3%)0
Tinnitus001 (3%)0
Sensitivity to odors0001 (3%)
Chills0001 (3%)
Rapid heart beat0001 (3%)
Withdrawals due to AEs:(See note)(See note)(See note)(See note)
Ryan, Ryan, and Sudilovsky, 1983Nadolol, 240 mg/day for 3 mosNadolol, 160 mg/day for 3 mosNadolol, 80 mg/day for 3 mosPlaceboData at left on AEs concern all 80 patients randomized to treatment. One patient dropped out. Investigators did not report the treatment group from which the patient withdrew or the reason for withdrawal.
Number of patients evaluable for AEs:20202020
Number of patients reporting AEs:10 (50%)5 (25%)5 (25%)5 (25%)
Total number of AEs reported:N/SN/SN/SN/S
Number of patients reporting:n (%)n (%)n (%)n (%)
Drowsiness1131
Vertigo1210
Insomnia2000
Sweaty1000
Blurred vision1000
Tinitus0001
Kidney stone0000
Bloating0111
General weakness1000
Nausea1000
Chest pain1000
Weak extremities0001
Decreased sex0100
Numbness in extremities1000
Withdrawals due to AEs:(See note)(See note)(See note)(See note)
Sances, Martignoni, Fioroni, et al., 1990Naproxen sodium, 550 mg, 2x/day for 3 (n= 17) or 6 (n = 18) mosPlacebo, for 3 mosThe article appears to report data on AEs only for those patients who completed the trial (35/40), and does not separately report data from the controlled (mos 1–3) and uncontrolled (mos 4–6) portions of the trial. Two patients withdrew due to AEs (severe gastralgia and nausea) before completing the controlled trial; it is not stated which treatment they were using at the time they withdrew. On the trial design, see Evidence Table 1.
Number of patients evaluable for AEs:35 (See note)17 (See note)
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Number of patients reporting:n (%)n (%)
Mild-mod nausea and epigastric distress9 (26%)N/S
Withdrawals due to AEs:(See note)(See note)
Sances, Martignoni, Rosettino, et al., 1989Lisuride, 0.05 mg, 3x/day for 3 mosPlaceboLimited data on AEs were provided. Investigators reported that 4/40 patients (10%) dropped out due to nausea, vomiting, and hypotension, but did not specify from which treatment groups they withdrew or whether or not dropouts were included in efficacy analyses.
Number of patients evaluable for AEs:2020
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:(See note)(See note)
Saper, Silberstein, Lake, et al., 1994Fluoxetine, doses ranging from 20–40 mg/day, for 12 wksPlaceboCombined AE data were reported for migraine (n = 57) and CDH (n = 54) patients. List of specific AEs does not represent all AEs reported by patients.

Fluoxetine vs. placebo: 0.18 (0.012 to 0.33)
Number of patients evaluable for AEs:61 (See note)50 (See note)
Number of patients reporting AEs:51 (84%)33 (66%)
Number of patients reporting severe AEs:5 (8%)2 (4%)
Total number of AEs reported:N/SN/S
Number of patients reporting:n (%)n (%)
Fatigue15 (25%)13 (26%)
Sleeping problems17 (28%)4 (8%)
Tremors12 (20%)3 (6%)
Stomach pain8 (13%)0
Weight loss (5–15 Ibs)5 (8%)1 (2%)
Withdrawals due to AEs:00
Sargent, Solbach, Damasio, et al., 1985Naproxen sodium, 550 mg, 2x/day for 15 wksPropranolol, 40 mg, 2x/day for 2 wks, 3x/day for 12 wks, 2x/day for 1 wkPlaceboAE data were reported for the 149 patients who started the first active treatment period, but investigators did not report how these patients were distributed among the three treatment groups.

The authors reported that patients in the naproxen sodium group reported more GI complaints than patients in the other two groups, and that the incidence and severity of non-GI AEs were comparable in the naproxen sodium and propranolol groups.
Number of patients evaluable for AEs:N/SN/SN/S
Number of patients reporting AEs:383028
Total number of AEs reported:N/SN/SN/S
Withdrawals due to AEs:3 (rash)00
Shafar, Tallett, and Knowlson, 1972Clonidine, 50 μg, 2x/day for 16 wksPlaceboAEs reported at left are for the 50 patients (of 65) included in efficacy analyses only. Of those dropping out of study, 2 withdrew after being treated with clonidine (1 for “general malaise,” 1 because HAs worsened). Three others withdrew for reasons unrelated to AES, and 10 withdrew for reasons unknown to investigators.

Clonidine vs. placebo:

0.16 (−0.02 to 0.33)
Number of patients evaluable for AEs:50* (See note)50* (See note)
Number of patients reporting AEs:20 (40%)12 (24%)
Total number of AEs reported:3617
Number of patients reporting (complete list:)n (%)n (%)
Anxiety:6 (12%)2
Depression:01 (2%)
Dry mouth:8 (16%)2 (4%)
Fatigue:1 (2%)0
Gastrointestinal:12 (24%)9 (18%)
Palpitation, flushes:5 (10%)2 (4%)
Rash:1 (2%)0
Others (trivial):3 (6%)1 (2%)
Withdrawals due to AEs:(See note)(See note)
Shekelle and Ostfeld, 1964Methysergide, 2 mg, 3x/day for 5 wksPlaceboData at left are for those patients who completed the trial (13/16). None of the three patients who withdrew prematurely did so due to AEs.

Methysergide vs. placebo: 0.073 (−0.18 to 0.32)
Number of patients evaluable for AEs:13*13*
Number of patients reporting AEs:2 (15%)1 (8%)
Total number of AEs reported:21
Number of patients reporting:n (%)n (%)
Mild ache in calves1 (8%)1 (8%)
Hair loss1 (8%)0
Withdrawals due to AEs:(See note)(See note)
Shimell, Fritz, and Levien, 1990Flunarizine, 10 mg/day (dose achieved gradually over 4 days) for 4 mosPropranolol, 180 mg/day (dose achieved gradually over 20 days) for 4 mos
Number of patients evaluable for AEs:2829
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:1731
Number of patients reporting:n (%)n (%)
Sleepiness/tiredness6 (21%)8 (28%)
Weight gain9 (32%)4 (14%)
Nightmares2 (7%)3 (10%)
Drowsiness03 (10%)
Irritability03 (10%)
Disturbed sleep03 (10%)
Lethargy02 (7%)
Skin rash01 (3%)
Bitter taste01 (3%)
Tingling sensation01 (3%)
Hot flushes01 (3%)
Excessive diuresis01 (3%)
Withdrawals due to AEs:2 (weight gain)3 (nightmares [2], rash [1])
Shukla, Garg, Nag, et al., 1995Nifedipine, 15 mg/day for 4 wksPlaceboData reported appear to be for those patients who completed the trial (28/36), though this is unclear. Investigators stated that they did not observe any cases of worsening of HA or hypotension associated with nifedipine. Patients were asked about AEs at end of each treatment period.

Nifedipine vs. placebo: 0.035 (−0.058 to 0.13)
Number of patients evaluable for AEs:28*28*
Number of patients reporting AEs:1 (4%)0
Total number of AEs reported:10
Number of patients reporting:n (%)n (%)
Nervousness1 (4%)0
Withdrawals due to AEs:00
Sicuteri, 1973Oxitriptan (L-5-hydroxytryptophan or 5-HTP), 100 mg, 2x/day for 40 daysMethysergide,1 mg, 2x/day for 40 daysVery limited information was provided about AEs. Authors reported that oxitriptan was very well tolerated: an increase in appetite and/or body weight was reported in a few cases, but no patients withdrew due to AEs.
Number of patients evaluable for AEs:2020
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:0N/S
Sjaastad and Stensrud, 1969Pizotifen, 1 mg, 4x/day for 8 wksPlaceboLimited data on AEs were provided for this crossover trial, and investigators did not report whether information on AEs were from all 24 patients randomized to treatment or from the 20 from whom efficacy data were obtained.

Fourteen patients treated with pizotifen gained weight and all had “tremendous appetites.” An unspecified number of patients were drowsy and easily fatigued (treatment N/S). Two patients (treatment N/S) also experienced vertigo.
Number of patients evaluable for AEs:(See note)(See note)
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:(thrombophlebitis [1])0
Sjaastad and Stensrud, 1971Clonidine (Catapresan®), 25 μg, 3x/day for 3 wksPlaceboData at left appear to concern only those patients who completed the crossover. Investigators reported that a few patients experienced the throbbing, pounding sensation of a HA attack, but without any accompanying pain.

Investigators stated that 4 patients withdrew for unknown reasons.
Number of patients evaluable for AEs:26* (See note)26* (See note)
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:12 (46%)0
Number of patients reporting:n (%)n (%)
Drowsiness8 (31%)0
Dryness of mouth3 (12%)0
Thirst1 (4%)0
Withdrawals due to AEs:N/S (See note)N/S (See note)
Sjaastad and Stensrud, 1972Pindolol, 2.5 or 5 mg, 3x/day for 4 wksPlacebo
Number of patients evaluable for AEs:28*28*
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:222
Number of patients reporting:n (%)n (%)
Dizziness or faintness6 (21%)0
Nausea3 (11%)0
Lethargy3(11%)0
Chest discomfort1 (4%)1 (4%)
Increased appetite, weight gain1 (4%)1 (4%)
Flushing1 (4%)0
Palpitations1 (4%)0
Restlessness1 (4%)0
Dryness of mouth1 (4%)0
Dyspnea1 (4%)0
Reduced ability to concentrate1 (4%)0
“Feeling of unreality”1 (4%)0
Feeling of inability to judge distance1 (4%)0
Withdrawals due to AEs:3 (causative AEs N/S)0
Smits, van der Meer, Pfeil, et al., 1993Estradiol (Estraderm TTS® patch), 50 μg/day for 8 days during 1–2 menstrual cyclesPlaceboLimited information reported on AEs. Itching in the area of the patch was reported in 9% of menstrual cycles during which Estraderm TTS® was used and in no cycles during which the placebo patch was used. Breast tenderness and bleeding pattern changes were no more common with Estraderm TTS® than with placebo.
Number of patients evaluable for AEs:20*20*
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:00
Stensrud and Sjaastad, 1976aClonidine (Catapresan®), 75–150 μg/day for 7 wksPlaceboInvestigators provided no information on AEs. Two patients withdrew from the study, one for a reason unrelated to AEs. No explanation was given for the other’s withdrawal.
Number of patients evaluable for AEs:27* (See note)27* (See note)
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:N/S (See note)N/S (See note)
Solomon, 1986Verapamil, 240 mg/day for 2 mosPropranolol (long-acting), 120 mg/day for 2 mosPlaceboAbstract reporting limited results. Data at left are for those patients who completed the trial (15/?). Investigators reported that, apart from the specific AEs listed at left, AEs were “similar” in the three groups. Three patients withdrew before completing the trial due to AEs associated with verapamil (1 rash, 2 headache). Two withdrew due to AEs associated with propranolol (1 wheezing, 1 fatigue).
Number of patients evaluable for AEs:15*15*15*
Number of patients reporting AEs:N/SN/SN/S
Total number of AEs reported:N/SN/SN/S
Number of patients reporting:n (%)n (%)n (%)
Constipation5N/SN/S
Lightheadedness/fatigueN/S3N/S
Withdrawals due to AEs:(See note)(See note)(See note)
Solomon and Kunkel, 1993Flurbiprofen, 100 mg, 2x/day for 8 wksPlaceboInvestigators reported only AEs they considered to be “drug-related.”

Flurbiprofen vs. placebo: 0.16 (0.019 to 0.29)
Number of patients evaluable for AEs:31*31*
Number of patients reporting drug-related AEs:5 (16%)0
Total number of drug-related AEs reported:80
Number of patients reporting:n (%)n (%)
Blood in stool2 (6%)0
Burning (no further specification)1 (3%)0
Drop in hemoglobin1 (3%)0
Drop in hematocrit1 (3%)0
Abdominal cramps with diarrhea1 (3%)0
Epigastric pain with emesis1 (3%)0
Cold sores in mouth1 (3%)0
Withdrawals due to AEs:2 (abdominal pain and burning)0
Solomon, Steel, and Spaccavento, 1983Verapamil, 320 mg/day for 3 mosPlaceboLimited information provided on AEs. Investigators reported that there were no major side effects with verapamil. One patient had symptomatic hypotension during last month of trial.
Number of patients evaluable for AEs:N/SN/S
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:02 (causative AEs N/S)
Somerville and Herrmann, 1978Lisuride, dose gradually increased to 0.025 mg, 3x/day, on Day 5 and used thereafter for 3 mosPlaceboData at left are for 17/150 patients (11 %) who withdrew due to AEs and were included in efficacy analyses. Investigators reported that other less severe AEs were “encountered frequently” by patients in both treatment groups. These AEs, all of which occurred more frequently in the lisuride- treated group, were muscle aches and pains, dizziness, cold feelings in the extremities, and palpitations.

Lisuride vs. placebo: 0.10 (−0.0097 to 0.22)
Number of patients evaluable for AEs:66 (See note)66 (See note)
Number of patients withdrawing due to AEs:12(18%)5 (8%)
Total number of AEs reported:188
Number of patients reporting:n (%)n (%)
Fatigue, weakness3 (5%)0
Nausea2 (3%)2 (3%)
Chest pains2 (3%)1 (2%)
Back pains1 (2%)0
Blurred vision1 (2%)0
Depersonalization1 (2%)0
Depression1 (2%)1 (2%)
Drowsiness1 (2%)1 (2%)
Eye irritation1 (2%)0
Hallucinations1 (2%)0
Impotence1 (2%)0
Muscle aches and pains1 (2%)0
Numbness of tongue01 (2%)
Subcutaneous hemorrhage1 (2%)2 (3%)
Vertigo1 (2%)0
Withdrawals due to AEs:12 (for reasons listed above)5 (for reasons listed above)
Sørensen, Hansen, and Olesen, 1986Flunarizine, 10 mg/day for 4 mosPlaceboData on AEs collected at monthly clinic visits.

Flunarizine vs. placebo: 0.067 (−0.071 to 0.20)
Number of patients evaluable for AEs:29*29*
Number of patients reporting AEs:3 (10%)1 (3%)
Total number of AEs reported:31
Number of patients reporting:n (%)n (%)
Daytime sedation3 (10%)1 (3%)
Withdrawals due to AEs:1 (daytime sedation)0
Sørensen, Larsen, Rasmussen, et al., 1991Flunarizine, 10 mg/day for 5 mosMetoprolol (slow-release), 200 mg/day for 5 mos
Number of patients evaluable for AEs:7275
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:7269
Number of patients reporting:n (%)n (%)
Drowsiness/sedation26 (36%)21 (28%)
Weight gain23 (32%)9 (12%)
GI symptoms5 (7%)10 (13%)
Sleep disturbances/vivid dreams4 (6%)10(13%)
Muscle fatigue/cold paresthesia3 (4%)10 (13%)
Depression6 (8%)2 (3%)
Dizziness/vertigo1 (1%)4 (5%)
Cardiovascular symptoms/hypotension2 (3%)1 (1%)
Extrapyramidal symptoms2 (3%)1 (1 %)
Respiratory symptoms01 (1%)
Withdrawals due to AEs:10 (depression [4], weight gain [4]. drowsiness/sedation [1], unknown [1])1 (depression)
Steardo, Bonuso, Di Stasio, et al., 1982Propranolol, 40 mg, 3x/day for 6 mosMetoprolol, 100 mg, 3x/day for 6 mosMethysergide, 6–10 mg/day for 6 mosLimited information provided on AEs.
Number of patients evaluable for AEs:333036
Number of patients reporting AEs:N/SN/SN/S
Total number of AEs reported:N/SN/SN/S
Withdrawals due to AEs:486
(dizziness [2], bradycardia [1], pre- cordialgia [1])(bradycardia [5], hypotension [3])(paresthesia [3], gastralgia [2], pre- cordialgia [1])
Steardo, Marano, Barone, et al., 1986Flunarizine, 10 mg/day for 5 mosMethysergide, 6 mg/day for 5 mosLimited information on AEs was reported. Investigators stated that fewer than 7% of patients reported daytime sedation/drowsiness with flunarizine. No weight gain was associated with flunarizine.
Number of patients evaluable for AEs:5351
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:07 (gastric disturbances [5], peripheral circulatory insufficiency [2])
Steiner, Joseph, Hedman, et al., 1988Metoprolol, 50 mg, 2x/day for 2 mosPlaceboInvestigators reported that drowsiness and dizziness were experienced with both treatments, but did not state how many patients reported these AEs.

Metoprolol vs. placebo: 0.049 (−0.14 to 0.23)
Number of patients evaluable for AEs:2831
Number of patients reporting AEs:5 (18%)4 (13%)
Total number of AEs reported:
Number of patients reporting:n (%)n (%)
Drowsiness(See note)(See note)
Dizziness(See note)(See note)
Nightmares1 (4%)0
Weight increase1 (4%)0
Dyspnea1 (4%)0
Heartburn1 (4%)0
Milk pruritis01 (3%)
Withdrawals due to AEs:1 (heartburn)0
Stellar, Ahrens, Meibohm, et al., 1984Timolol, 20–30 mg/day, taken in two doses, for 2 mosPlacebo
Number of patients evaluable for AEs:107*107*
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Number of patients reporting (most common AEs):n (%)n (%)
Insomnia7 (7%)2 (2%)
Light-headedness3 (3%)2 (2%)
Fatigue3 (3%)1 (1%)
Withdrawals due to AEs:2 (chest pain [1], severe epigastric distress [1])0
Stensrud and Sjaastad, 1974Ketoprofen, 50 mg, 3x/day for 6 wksPlaceboInvestigators reported only those AEs considered to be drug-related, and appear to have reported them only for those patients who completed the trial (24/26). Two patients withdrew before completing the trial for unspecified reasons.
Ketoprofen vs. placebo: 0.080 (−0.048 to 0.21)
Number of patients evaluable for AEs:24*24*
Number of patients reporting drug-related AEs:2 (8%)0
Total number of drug-related AEs reported:20
Number of patients reporting:n (%)n (%)
Nausea2 (8%)0
Withdrawals due to AEs:(See note)(See note)
Stensrud and Sjaastad, 1976bPropranolol, 40 mg, 4x/day for 4 wksPlaceboLimited information was provided on AEs. Investigators reported only that “in practically all cases, a varying degree of bradycardia and a slight reduction in blood pressure were found during the Inderal® [propranolol] period.”
Number of patients evaluable for AEs:20* (See note)20* (See note)
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:1 (dyspnoea & palpitations)0
Stensrud and Sjaastad, 1979Clonazepam (Rivotrll®), 1–2 mg/day for 4 wks to 1 yrPlaceboInvestigators did not provide separate AE data for the 1-mg/day and 2-mg/day doses of clonazepam, or for the 4-wk controlled trial treatment period and the extended open trial. The incidence of AEs associated with placebo was also not reported.
Number of patients evaluable for AEs:38*38*
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Number of patients reporting:n (%)n (%)
Drowsiness23 (61%)N/S
Dizziness10 (26%)N/S
Irritability2 (5%)N/S
Withdrawals due to AEs:3 (lethargy and sleepiness [3 -- all after completing controlled portion of trial])0
Stensrud and Sjaastad, 1980aAtenolol, 50 mg, 2x/day for 6 wksPropranolol, 80 mg, 2x/day for 6 wksPlaceboAtenolol vs. placebo: 0.028 (−0.047 to 0.10)
Number of patients evaluable for AEs:35*35*35*
Number of patients reporting AEs:1 (3%)N/S0
Total number of AEs reported:1120
Number of patients reporting:n (%)n (%)n (%)
Reduced physical capacity1 (3%)6 (17%)0
Nausea03 (9%)0
Cold hands/feet01 (3%)0
Dizziness01 (3%)0
Sleeping difficulties01 (3%)0
Withdrawals due to AEs:01 (dizziness)0
Sternieri, Bussone, Manzoni, et al., 1991Lornoxicam, 4 mg, 3x/day for 2 mosPlaceboLornoxicam vs. placebo: 0.17 (0.021 to 0.32)
Number of patients evaluable for AEs:4852
Number of patients reporting AEs:13 (27%)5 (10%)
Total number of AEs reported:N/SN/S
Number of patients reporting:n (%)n (%)
Abdominal discomfort9 (19%)0
Withdrawals due to AEs:4 (causative AEs N/S)2 (causative AEs N/S)
Sudilovsky, Elkind, Ryan, et al., 1987Nadolol, 160 mg, 1x/day for 2 mosNadolol, 80 mg, 1x/day for 2 mosPropranolol, 80 mg, 2x/day for 2 mosNo further information provided on AEs.
Number of patients evaluable for AEs:474944
Number of patients reporting AEs:N/SN/SN/S
Total number of AEs reported:N/SN/SN/S
Withdrawals due to AEs:2 (fatigue and depression [1], urticaria [1])2 (HA and dizziness [1], nausea [1])4 (fatigue and memory disturbance [1], vertigo and urticaria [1], dyspnea and chest tightness [1], paresthesia [1])
Sudilovsky, Stern, and Meyer, 1986bNadolol, 240, 160, or 80 mg/day for 2 mosPlaceboAbstract -- no data reported on AEs.
Number of patients evaluable for AEs:N/SN/S
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:00
Szekely, Merryman, Croft, et al., 1989Naproxen sodium, 550 mg, 2x/day, during perimenstrual period for 2 mosPlaceboData at left are for those patients who completed the trial (22/30). Investigators reported that 2 patients withdrew before completing the trial due to AEs, one with stomatitis, one with ecchymoses. There is no indication which treatment these two patients were taking at the time of their withdrawal.
Number of patients evaluable for AEs:22*22*
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Number of patients reporting (most common) AEs:n (%)n (%)
Gastrointestinal symptoms10 (45%)8 (36%)
Central nervous symptom complaints5 (23%)7 (32%)
Withdrawals due to AEs:(See note)(See note)
Tfelt-Hansen, Standnes, Kangasniemi, et al., 1984Propranolol, 80 mg, 2x/day for 3 mosTimolol, 10 mg, 2x/day for 3 mosPlaceboPropranolol vs. placebo: 0.14 (−0.0010 to 0.28)
Timolol vs. placebo: 0.18 (0.033 to 0.32)
Propranolol vs. timolol: −0.036 (−0.18 to 0.11)
Number of patients evaluable for AEs:83*83*83* 23 (28%) N/S
Number of patients reporting AEs:35 (42%)38 (46%) N/S
Total number of AEs reported:N/SN/SN/S
Number of patients reporting (most common AEs):n (%)n (%)n (%)
Fatigue/tiredness11 (13%)18 (22%)15 (18%)
Dizziness4 (5%)5 (6%)2 (2%)
Nausea5 (6%)2 (2%)2 (2%)
Sleep disturbances3 (4%)4 (5%)2 (2%)
Depression3 (4%)2 (2%)0
Abnormal dreaming02 (2%)0
Withdrawals due to AEs:N/SN/SN/S
Thomas, Behari, and Ahuja, 1991Flunarizine, 10 mg/day for 12wksPlaceboLimited information provided on AEs. Data at left concern only those 15 patients (of 29) who completed the crossover. One patient withdrew prematurely due to AEs associated with flunarizine (galactorrhea).
Number of patients evaluable for AEs:15*15*
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Number of patients reporting:n (%)n (%)
Daytime sedation10 (67%)N/S
Weight gain (2–5 kg)8 (53%)N/S
Withdrawals due to AEs:(See note)(See note)
Titus, Dávalos, Alom, et al., 1986Oxitriptan (5-hydroxytryptophan or 5-HTP), 600 mg/day for 6 mosMethysergide, 3 mg/day for 6 mosThe article reports unclear and (at least apparently) inconsistent information about the number of patients who had to “discontinue treatment” (5, all methysergide) or who had treatment “withdrawn” (4 methysergide, 5 oxitriptan) due to AEs.

Methysergide VS. oxitriptan: 0.038 (−0.15 to 0.22)
Number of patients evaluable for AEs:4540
Number of patients reporting AEs:13 (29%)10 (25%)
Total number of AEs reported:1810
Number of patients reporting:n (%)n (%)
Abdominal pain6 (13%)0
Gain in weight4 (9%)1 (3%)
Nausea3 (7%)2 (5%)
Diarrhea3 (7%)0
Numbness or pain in legs03 (8%)
Insomnia and anxiety1 (2%)1 (3%)
Impotence02 (5%)
Drowsiness01 (3%)
Amenorrhea1 (2%)0
Withdrawals due to AEs:? (See note)? (See note)
Vilming, Standnes, and Hedman, 1985Pizotifen, inc’d from 0.5 mg, 1x/day to 0.5 mg, 3x/day for 8 wksMetoprolol, 50 mg, 2x/day for 8 wksData at left concern only the patients who completed the crossover trial and from whom efficacy data were obtained. The total number of patients and AEs are the sum of the numbers reported for the first and second months of treatment.
Number of patients evaluable for AEs:30* (See note)30* (See note)
Number of patients reporting AEs:UnclearUnclear
Total number of AEs reported:7666
Withdrawals due to AEs:3 (edema/lack of effect [1], sedation [1], weight gain/depression/restless legs [1])1(nightmares)
Weber and Reinmuth, 1972Propranolol, 20 mg, 4x/day for 3 mosPlaceboLimited data were provided on AEs. Investigators only reported that one patient complained of abdominal cramps and diarrhea, but did not specify which treatment the patient was receiving.
Number of patients evaluable for AEs:N/SN/S
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:00
Welch, Ellis, and Keenan, 1985Naproxen sodium, 550 mg, 2x/day for 8 wksPlaceboOf the 46 patients who entered the first treatment period, 6 dropped out before ever taking naproxen sodium, and 3 dropped out before ever taking placebo.

Naproxen sodium vs. placebo: 0.016 (−0.16 to 0.19)
Number of patients evaluable for AEs:40*43*
Number of patients reporting AEs:9 (23%)9 (21%)
Total number of AEs reported:1414
Number of patients reporting AEs:n (%)n (%)
Gastrointestinal problems6 (15%)3 (7%)
Dizziness/faintness2 (5%)0
Pains1 (3%)2 (5%)
Urinary problems1 (3%)1 (2%)
Other1 (3%)3 (7%)
Withdrawals due to AEs:4 (exacerbation of tachycardia [1], fear of developing GI problems [1], gastric burning [2])1 (“vague somatic complaints”])
Wessely, Baumgartner, Klingler, et al., 1987Gabapentin, 900 mg/day for 3 mosPlaceboVery limited information was reported on AEs. Withdrawals were due to nausea, tiredness, and dizziness (no breakdown by treatment group).
Number of patients evaluable for AEs:1620
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:2 (See note)1 (See note)
Widerøe and Vigander, 1974Propranolol, 40 mg, 4x/day for 3 mosPlaceboNo information was reported on AEs from this controlled trial.
Number of patients evaluable for AEs:30* (See note)30* (See note)
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:00
Wilkinson, 1970Clonidine, 50 μg, 2x/day for 6 wksClonidine, 25 μg, 2x/day for 6 wksPlacebo (lactose)Four patients withdrew from the study, 2 for unspecified reasons, 2 because they “were worse.”

Little information on AEs was reported. The investigator only stated that there were “no serious side effects” and that “a few patients ha[d] become depressed.”
Number of patients evaluable for AEs:23*23*23*
Number of patients reporting AEs:N/SN/SN/S
Total number of AEs reported:N/SN/SN/S
Withdrawals due to AEs:N/S (See note)N/S (See note)N/S (See note)
Wilkinson, Agnoli, Gerber, et al., 1989Lisuride (Cuyalit®), 0.05 mg, 3x/day for 3 mosLisuride (Cuyalit®), 0.025 mg, 3x/day for 3 mosLimited data were provided on AEs. Investigators reported only that AEs were infrequent and that there were no statistically significant differences between the two treatments for AEs.
Number of patients evaluable for AEs:4943
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:6 (N/S)9 (N/S)
Wörz, Reinhardt-Benmalek, Foeh, et al., 1992Bisoprolol, 5 mg, 1x/day for 3 mosMetoprolol, 100 mg/day for 3 mos14 patients withdrew due to unspecified AEs, but no breakdown was provided by intervention.

Bisoprolol vs. metoprolol: 0.032 (−0.061 to 0.12)
Number of patients evaluable for AEs:125*125*
Number of patients reporting AEs:23 (18%)19 (15%)
Total number of AEs reported:N/SN/S
Number of patients reporting (most common AEs only):n (%)n (%)
Dizziness8 (6%)4 (3%)
Tiredness/fatigue3 (2%)7 (6%)
Sleep disturbances2 (2%)6 (5%)
Cardiovascular/hypotensive reactions6 (5%)1 (<1%)
GI disturbances5 (4%)2 (2%)
Withdrawals due to AEs:N/S (See note)N/S (See note)
Zeeberg, Orholm, Dalsgaard Nielsen, et al., 1981Femoxetine, 200 mg/day for first wk, 300 mg/day therafter, for total of 12 wksPlaceboThese data appear to include only those patients who completed the trial or were known to have withdrawn due to AEs (48/59 patients randomized to treatment), though this is not entirely clear.

Femoxetine vs. placebo: 0.22 (0.012 to 0.40)
Number of patients evaluable for AEs:2325
Number of patients reporting AEs:6 (26%)1 (4%)
Total number of AEs reported:
Number of patients reporting:n (%)n (%)
Nausea3 (13%)0
Changes in mood2 (9%)0
Prolonged menstrual bleeding1 (4%)0
Tiredness, indisposition1 (4%)0
Palpitation1 (4%)0
Dry mouth1 (4%)0
Paraesthesia (tongue)1 (4%)0
Excessive sweating01 (4%)
Withdrawals due to AEs:3 (nausea and prolonged menstrual bleeding; nausea and changes in mood; tiredness and indisposition)0
Ziegler and Ellis, 1985Naproxen sodium, 550 mg, 2x/day for 8 wksPlaceboNaproxen sodium vs. placebo: −0.049 (−0.20 to 0.11)
Number of patients evaluable for AEs:40*40*
Number of patients reporting AEs:5 (13%)7 (18%)
Total number of AEs reported:78
Number of patients reporting:n (%)n (%)
Gastrointestinal symptoms4 (10%)4 (10%)
Drowsiness1 (3%)1 (3%)
Aches and pains01 (3%)
Other (incl. uncoordination, slurred speech, blurred vision, hypertension, and itching)02
Withdrawals due to AEs:1 (stomach pain and burning)0
Ziegler, Hurwitz, Hassanein, et al., 1987

and

Ziegler, Hurwitz, Preskorn, et al., 1993
Amitriptyline, 50–150 mg/day for 4–8 wksPropranolol, 80–240 mg/day for 4–8 wksPlaceboInvestigators stated that 3 patients withdrew prematurely due to unspecified “toxic reactions.” They did not say which of the interventions were associated with these reactions. No further information was provided on AEs.
Number of patients evaluable for AEs:N/SN/SN/S
Number of patients reporting AEs:N/SN/SN/S
Total number of AEs reported:N/SN/SN/S
Withdrawals due to AEs:(See note)(See note)(See note)
Zuddas, Mulas, Del Zompo, et al., 1985Lisuride, dose gradually increased until it was 0.025 mg, 3x/day on Day 7 and thereafter for 3 mosPlaceboNo data provided on AEs.
Number of patients evaluable for AEs:15 (See note)15 (See note)
Number of patients reporting AEs:N/SN/S
Total number of AEs reported:N/SN/S
Withdrawals due to AEs:N/SN/S
1

Key to abbreviations: μg = microgram; 5-HTP = oxitriptan; AEs = adverse; BP = blood pressure; CDH = chronic daily headache; CI = confidence interval; CNS = central nervous system; DEK = dihydroergokryptine; DHE = dihydroergotamine; GI = gastrointestinal; HA = headache; inc’d = increased; kg = kilogram; L-5-hydroxytryptophan = oxitriptan; max. = maximum; mg = milligram; mo = month; n = sample size; N/S = not specified; OTC = over-the-counter; tab = tablet; vs. = versus; TIS = transdermal therapeutic system; wk = week

2

An asterisk denotes a crossover trial.

From: Evidence Tables

Cover of Drug Treatments for the Prevention of Migraine Headache
Drug Treatments for the Prevention of Migraine Headache.
Technical Reviews, No. 2.3.
Gray RN, Goslin RE, McCrory DC, et al.

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