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Carson S, Lee N, Thakurta S. Drug Class Review: Newer Antihistamines: Final Report Update 2 [Internet]. Portland (OR): Oregon Health & Science University; 2010 May.

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Drug Class Review: Newer Antihistamines: Final Report Update 2 [Internet].

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Appendix EReporting of adverse events

Adverse events from head-to-head and active control trials in adults (Original Report)a

Author
Year
Adverse eventsTotal withdrawalsWithdrawals from AEs
Head-to-head trials
Ciprandi 199729

L: loratadine 10 mg qd
C: cetirizine 10 mg qd
No significant AEs reportedTotal: 00
Hampel 200331

F: fexofenadine 180mg qd
C: cetirizine 10mg qd
Total AEs: 16.7%
AEs per group:
F: 16.9%
C: 16.6%
F: less overall drowsiness
P=0.0110, NS effect on motivation
Total: 3.2%
F: 2.8%
C: 3.6%
1.2% AEs
3 efficacy
Safety evaluated in AE population
Howarth 199932

F1: fexofenadine 120 mg qd
F2: fexofenadine 180 mg qd
C: cetirizine 10 mg qd
P: placebo
Treatment-related AEs:
F1: 23%
F2: 23%
C: 25%
P: 25 %
Total: 14%
Similar among groups (numbers per group NR)
F: 2%
C: <1%
P: 2%
Prenner 200033

L: loratadine 10 mg qd
F: fexofenadine 120 mg qd
F 22.1% vs. L 18.2% had ≥1 AE.
Considered treatment related in F 8.3% L 5.3%
NRNR
Van Cauwenberge 200036

L: loratadine 10 mg qd
F: fexofenadine 120 mg qd
P: placebo
16.4% of total
F: 16.8%
L: 17.5%
P: 14.7%
Total: 10%
F: 9%
L: 12%
P: 11%
F: 1%
L: 2%
P: 3%
Guerra 199474

L: loratadine 10mg
C: cetirizine 10mg
P: placebo
20.7% Total NSD.
L: 15.8%
C: 27.5%
P: 15.8%
C: 1C: 2.5% stomach pain
Active control trials
Frolund 199072

L: loratadine 10 mg qd
C: clemastine 1 mg bid
P: placebo
32.9% Total
L: 15% (P<0.05)
C: 58.8%, sedation significant
P: 49% placebo
Total: 13.5%
L: 9.4%
C: 5.8%
P: 25.4%
L: 0%
C: 1.9%: 1 AE/2 efficacy
P: 0%
Breneman 199687

C: cetirizine 10mg qd
H: hydroxyzine 25 mg tid
P: placebo
C: 18%
H: 30%
P: 6%
H vs. P. P=0.001
Total: 4.8%
C: 1.7%
H: 6.3%
P: 6.1%
Somnolence:
C: 1.7%
H: 6.3%
P: 6.1%
Berger 200327

D: desloratadine 5 mg
A1: azelastine nasal
A2: azelastine nasal + loratadine
P: placebo
Most common per treatment:
Bitter taste
A1: 11% vs. A2: 4%
D: Headache 3%, pharyngitis 4%
P: headache 7%
Somnolence:
A1: 2%; A2: 1%; D: 1%; P: 1%
A1: 2%
D: 1%
P: 1%
A1: 2% (moderate chest pain, lightheadedness)
D: 1% (headache and nausea)
P: 1% (rash)
Dockhorn 198756

L: loratadine 10 mg
C: clemastine 2 mg
P: placebo
More AEs (considered probably or possibly treatment-related) in C
C: 37%
L: 21%
P: 20% (p≤0.01)
More sedation in C:
C: 22%
L: 6% (p≤0.01)
NRNR
a

Only fair- and good-quality studies are presented in the table. Poor-quality studies are listed in Appendix F.

Abbreviations: bid, twice daily; mg, milligrams; NSD, no significant difference; NR, not reported; qd, once daily; tid, 3 times daily.

Adverse events from studies in adults (includes only studies from update 2003–2005)a

Type of AEAdverse eventCetirizineFexofenadineLoratadine
NEUROLOGICAL
MAJOR
MINORFatigue/Asthenia6.8% vs. rupatadine 10.5%, NSD526.0%; vs. rupatadine 10 mg 10.7%; vs. rupatadine 20 mg 11.7%: NSD55
Headache19.7% vs. 15.3% rupatadine, NSD522.2% vs. cetirizine 0%, NSD75
5% vs. placebo 3%79
18%; vs. fluticasone 17%168
12.1%; vs. rupatadine 10 mg 23.4%; vs. rupatadine 20 mg 14.3%, NSD55
5.8%; vs. ebastine 10 mg 4.3%; vs. ebastine 20 mg 3.2%; vs. placebo 4.3%53
Somnolence2.6% vs. azelastine 1.3%30
8.5% vs. rupatadine 9.6%, NSD52
Drowsiness: 7.7% vs. fexofenadine 4.5%, NSD75
Drowsiness: 4.5% vs. cetirizine 7.7%, NSD757.8%; vs. rupatadine 10 mg 12.5%; vs. rupatadine 20 mg 25%, significant but P value not given55
0%; vs. ebastine 10 mg 1.6%; vs. ebastine 20mg 2.7%; vs. NR placebo53
Unspecified0% vs. ebastine 4.6% vs. placebo 0%113
GASTROINTESTINAL
MAJOR
MINORAbdominal pain0% vs. fexofenadine 2.2%, NSD752.2% vs. cetirizine 0%, NSD75
Constipation5.8% vs. fexofenadine 0 %, NSD750% vs. 5.8% cetirizine, NSD75
Dry mouth1.7% vs. rupatadine 10 mg 1.8% vs. rupatadine 20 mg 3.6%, NSD55
Epigastric pain3.8% vs. fexofenadine 0%, NSD750% vs. 3.8% cetirizine, NSD75
Unspecified0% vs. ebastine 3.2% vs. placebo 3.5%113
HEMATOLOGICAL
MAJOR
MINORAbnormalities in complete blood count
RESPIRATORY
MAJOR1 patient had asthma requiring hospitalization79
MINORCough3.8% vs. fexofenadine 0%, NSD750% vs. 3.8% fexofenadine, NSD754.3% vs. rupatadine 10 mg 8.0% vs. rupatadine 20 mg 5.4%55
Epistaxis<1% vs. azelastine 2.0%30
Nasal discomfort<1% vs. azelastine 1.3%30
Pharyngitis1.7% vs. rupatadine 10 mg 7.1% vs. rupatadine 20 mg 4.5%, NSD55
Unspecified12.2% vs. ebastine 10 mg 8.5% vs. ebastine 20 mg 7.5% vs. placebo 10.2%53
CARDIAC
MAJORQT intervalNo clinically relevant ECG changes vs. placebo79Prolonged QTc: 1.6%; vs. ebastine 10 mg 3.2%; vs. ebastine 20 mg 2.2%; vs. placebo 0.5%53
Prolonged QTc: 3.6%; vs. ebastine 20 mg 3.9%; vs. placebo 5.6%113
MINORUnspecified2.5%; vs. ebastine 2.8%; vs. placebo 4.2%113
OTHER
MAJORBack pain4.3%; vs. rupatadine 10 mg 3.6%; vs. rupatadine 20 mg 4.5%, NSD55
MINORBitter taste<1% vs. azelastine 3.3%30
Feet swelling0% vs. 2.2% fexofenadine, NSD752.2% vs. cetirizine 0%, NSD75
HypospadiasOR of hypospadias with loratadine exposure: 1.29 (0.62–2.68)167
Use of nonsedating antihistamines, including loratadine, OR: 1.33 (0.73–2.40)167
a

Only fair- and good-quality studies are presented in the table. Poor-quality studies are listed in Appendix F.

Abbreviations: mg, milligrams; NR, not reported; NSD, no significant difference; OR, odds ratio QT, cardiac output; QTc, corrected QT interval for heart rate.

There were no data on desloratadine identified in update 1.

Adverse events from studies in children (Original Report and Update 1)a

Type of AEAdverse eventCetirizineDesloratadineFexofenadineLoratadine
NEUROLOGICAL
MAJORSomnolence and irritability (1 patient, led to withdrawal)110
MINORBehavioral screeningNSD vs. placebo117, 147
Fatigue4.0% vs. chlorpheniramine 6.3% 101
5.3% vs. placebo 0%, NSD109
5.9% vs. placebo 7.5%104
Headache6.3% vs. chlorpheniramine 0%101
0% vs. placebo 6.3%, NSD109
15.1% vs. placebo 19.7%99
3.2% vs. placebo 1.6%98
15% vs. placebo 18.8%149
1.8 vs. placebo 5.4% (2–5 years)156
1.7 vs. placebo 6.7% (6–11 years)156
1–2% in treatment and placebo groups14425% vs. fluticasone 42%103
Somnolence5.5% vs. placebo 0%95
NSD vs. placebo117, 147
21.4% vs. placebo 30.2%148
1/38 patients withdrew due to somnolence vs. 0 in loratadine group110
0% vs. dexchlorpheniramine 4.3%102
3% vs. placebo 5%, NSD169
0.5 vs. placebo 1.0%, NSD155
Insomnia23.8% vs. placebo 44.2%1480 vs. placebo 1.0%, NSD155
Irritability0 vs. placebo 0.5%, NSD155
Nervousness28.6% vs. placebo 44.2%148
Vertigo1.6% vs. placebo 0%98
GASTROINTESTINAL
MAJOR
MINORAbdominal pain9.6% vs. chlorpheniramine 4.8%101
9.4% vs. placebo 4.5%99
9.3% vs. placebo 4.3%149
Abnormal liver function9.4% vs. placebo 0%104
NSD vs. placebo in blood chemistry117, 147
Dry mouth1.6% vs. placebo 0%98
Increased appetite1.6% vs. placebo 0%98
Nausea1.6% vs. chlorpheniramine 0%101
HEMATOLOGICAL
MAJORNeutropenia (asymptomatic) in 1 child100
MINORAbnormalities in complete blood countNSD vs. placebo107
Leucocytosis: 5% vs. placebo 7%104
NSD vs. placebo117, 147
CARDIAC
MAJORQT intervalNSD vs. placebo (2 week follow-up)99
NSD vs. placebo117, 147
NSD QT cetirizine vs. placebo148
NSD QTc vs. placebo149
NSD rate, PR, QRS or QT vs. placebo156NSD QTc vs. placebo92
RESPIRATORY
MAJOR
MINORCoughing3% vs. placebo 5%, NSD169
Epistaxis7.1% vs. placebo 4.3%99
7.1% vs. placebo 4.3%149
4.8% (moderate) vs. dexchlorpheniramine 0%102
4% vs. fluticasone 7%103
Pharyngitis10.1% vs. placebo 13.6%99
1.6% vs. placebo 4.9%98
10.0% vs. placebo 13.0%149
10% vs. fluticasone 16%103
18.8% vs. 18.1%, NSD155
OTHER
MAJORAccidental overdose2 children vs. 8 placebo117, 147
MINORRash3.2% vs. placebo 0%98
1/40 patients withdrew due to rash110
Mean increase height and weightNSD vs. placebo117, 147
Fever5.5 vs. placebo 5.4% (2–5 years)156
5.5 vs. placebo 5.4% (6–11 years)156
3% vs. placebo 5%, NSD169
a

Only fair- and good-quality studies are presented in the table. Poor-quality studies are listed in Appendix F.

Abbreviations: NSD, no significant difference; QT, cardiac output; QTc, corrected QT interval for heart rate.

Copyright © 2010 by Oregon Health & Science University, Portland, Oregon 97239. All rights reserved.
Bookshelf ID: NBK50565

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