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.

From: Appendix E, Reporting of adverse events

Cover of Drug Class Review: Newer Antihistamines
Drug Class Review: Newer Antihistamines: Final Report Update 2 [Internet].
Carson S, Lee N, Thakurta S.
Portland (OR): Oregon Health & Science University; 2010 May.
Copyright © 2010 by Oregon Health & Science University, Portland, Oregon 97239. All rights reserved.

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