Table 140Evidence summary table: haloperidol versus risperidone – specific adverse events

OutcomeStudiesParticipantsEffect EstimateI2Less with
Behavior and psychosis
Abnormal thinking10112550.61 (0.25, 1.51)NEND
Accommodation disturbances120,149214031.37 (0.99, 1.89)0%ND
Agitation61,72,81,10149161.30 (0.96, 1.76)7%ND
Anxiety61,81,10135510.95 (0.67, 1.34)67%ND
Asthenia52,71,117,120,149515961.20 (1.02, 1.41)0%risperidone
Concentration difficulty64,71,117,120415561.18 (0.97, 1.43)65%ND
Decreased appetite641420.55 (0.25, 1.20)NEND
Depression101,11825440.63 (0.34, 1.16)0%ND
Deterioration731126NENEND
Drug overdose11812890.33 (0.01, 7.95)NEND
Decreased sexual desire120,149214031.07 (0.72, 1.59)0%ND
Fatigue60,6421041.00 (0.63, 1.60)0%ND
Hallucination10112551.00 (0.49, 2.02)NEND
Increased appetite641421.20 (0.43, 3.33)NEND
Manic reaction12811056.87 (0.36, 129.81)NEND
Nervousness10112551.20 (0.68, 2.14)NEND
Paranoia10112551.16 (0.54, 2.52)NEND
Sexual disturbances521410.35 (0.02, 8.10)NEND
BMI and weight
Weight gain10112550.19 (0.05, 0.81)NEhaloperidol
Cardiovascular
ECG abnormalities12811051.31 (0.31, 5.56)NEND
Hypotension6111131.41 (0.06, 33.44)NEND
Orthostatic tachycardia6111130.60 (0.03, 11.27)NEND
Orthostatic hypotension52,61,6431960.76 (0.39, 1.48)0%ND
Palpitation52,642831.18 (0.44, 3.13)0%ND
Cholinergic and anticholinergic
Decreased salivation7111172.54 (0.69, 9.35)NEND
Dry mouth52,60,64,10144001.44 (0.89, 2.33)0%ND
Hypersalivation851770.15 (0.01, 2.89)NEND
CNS
Dizziness101,128,15134841.20 (0.72, 1.99)22%ND
Sedation641420.87 (0.56, 1.33)NEND
Somnolence52,53,101,128,15155491.09 (0.79, 1.50)0%ND
Vertigo52,642830.56 (0.23, 1.38)63%ND
Endocrine (prolactin - thyroid)
Amenorrhea64,71,120,149415621.17 (0.80, 1.71)0%ND
Galactorrhea13215550.08 (0.00, 1.36)NEND
EPS
Akathisia52,60,71,101,139,146,14976191.79 (1.31, 2.44)0%risperidone
Dystonia60,139,14931391.01 (0.41, 2.50)19%ND
EPS61,117,128,138,15156751.86 (1.46, 2.36)0%risperidone
Oculogyric crisis851770.15 (0.01, 2.89)NEND
Tremor52,85,101,12844782.09 (1.23, 3.53)0%risperidone
Genital, urinary, and breast
Breast tension641424.00 (0.49, 32.87)NEND
Dry vagina1491410.53 (0.11, 2.56)NEND
Ejaculatory dysfunction64,71,120,149415620.68 (0.43, 1.07)0%ND
Erectile dysfunction64,71,120315211.19 (0.83, 1.70)18%ND
Gynecomastia13215550.14 (0.01, 2.76)NEND
Micturition disturbances52141NENEND
GI
Constipation52,53,64,101,120,128,149718701.04 (0.78, 1.38)35%ND
Diarrhea10112551.36 (0.72, 2.57)NEND
Dyspepsia12811050.98 (0.42, 2.27)NEND
Nausea/Vomiting53,61,64,85,10155111.17 (0.74, 1.87)0%ND
Hematology
Agranulocytosis145178NENEND
Ophthalmology
Blurred vision60,6421040.47 (0.17, 1.30)40%ND
Respiratory and airway
Rhinitis10112551.00 (0.60, 1.67)NEND
Sleep
Insomnia52,61,81,101,120,151620781.03 (0.85, 1.26)10%ND
Sleep disorder52,8521182.47 (0.90, 6.76)33%ND
Systemic AE
Headache52,53,61,64,81,85,101,128,15199640.83 (0.63, 1.08)0%ND
Increased sweating52,642831.54 (0.59, 3.99)41%ND
Infection531247.00 (0.40, 122.44)NEND
Pain10112550.48 (0.21, 1.06)NEND

Significant results are in bold; AE = adverse event; BMI = body mass index; CNS = central nervous system; ECG = electrocardiogram; EPS = extrapyramidal symptoms/syndrome; GI = gastrointestinal; I2 = I–squared; ND = no difference; NE = not estimable

From: Appendix N, Summary Tables of Adverse Events

Cover of First-Generation Versus Second-Generation Antipsychotics in Adults: Comparative Effectiveness
First-Generation Versus Second-Generation Antipsychotics in Adults: Comparative Effectiveness [Internet].
Comparative Effectiveness Reviews, No. 63.
Abou-Setta AM, Mousavi SS, Spooner C, et al.

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