Cetirizine Side Effects
Some side effects of cetirizine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to cetirizine: oral solution, oral tablets and chewable tablets
Side effects include:
Adults and children ≥12 years of age: Somnolence, fatigue, dry mouth. Insomnia reported with cetirizine hydrochloride-pseudoephedrine hydrochloride fixed combination.
Children 2–11 years of age: Headache, pharyngitis, abdominal pain.
Children 6 months to 2 years of age: Irritability, fussiness, insomnia, fatigue, malaise.
For Healthcare Professionals
Applies to cetirizine: oral capsule, oral syrup, oral tablet, oral tablet chewable, oral tablet dispersible
Nervous system side effects have included headache (16%), fatigue (5.6%), and somnolence (5% to 20%). Somnolence tends to be dose-related and generally occurs more frequently with doses higher than 10 mg per day. Other nervous system side effects include dizziness (1.8%), insomnia (1.5%), and nervousness (1.1%). Post marketing reports have included aggression reaction and convulsions.
Cetirizine appears to be more sedating than loratadine.
Gastrointestinal side effects have included dry mouth (5.7%) and nausea or vomiting (2.2%). Pharyngitis, dyspepsia, and increased appetite have occasionally been reported.
Hepatic side effects have included rare liver function test abnormalities which resolved spontaneously following discontinuation of cetirizine therapy. At least one case of recurrent acute hepatitis has also been associated with cetirizine use.
Respiratory side effects have included relatively rare reports of wheezing, coughing, bronchitis, sinusitis, and asthma.
Dermatologic side effects have included reports of maculopapular and urticarial eruptions. Fixed drug eruptions have also been associated with cetirizine.
General side effects have included epistaxis (1.1%) and accidental injury (1.1%).
Hypersensitivity side effects have included a case report of an anaphylactic reaction.
Delusional thinking and depression has been reported in an 18-year-old woman started on cetirizine; the symptoms resolved once cetirizine was discontinued.
Postmarketing psychiatric side effects have included reports of aggressive reaction, hallucinations, suicidal ideation and suicide.
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