Zyrtec Tác dụng không mong muốn

Clinical Trial Data: Clinical studies have shown that cetirizine at the recommended dosage has minor adverse effects on the CNS, including somnolence, fatigue, dizziness and headache.
In some cases, paradoxical CNS stimulation has been reported.
Although cetirizine is a selective antagonist of peripheral H1-receptors and is relatively free of anticholinergic activity, isolated cases of micturition difficulty, eye accommodation disorders and dry mouth have been reported.
Instances of abnormal hepatic function with elevated hepatic enzymes accompanied by elevated bilirubin have been reported. Mostly this resolves upon discontinuation of the drug.
Double blind controlled clinical trials comparing cetirizine to placebo or other antihistamines at the recommended dosage (10 mg daily for cetirizine), of which quantified safety data are available, included more than 3200 subjects exposed to cetirizine.
From this pooling, the following adverse reactions were reported for cetirizine 10 mg in the placebo-controlled trials at rates of 1.0 % or greater: (See Table 2.)


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Although statistically more common than under placebo, somnolence was mild to moderate in the majority of cases.
Objective tests as demonstrated by other studies have demonstrated that usual daily activities are unaffected at the recommended daily dose in healthy young volunteers.
Adverse reactions at rates of 1 % or greater in children aged from 6 months to 12 years, included in placebo-controlled clinical trials are: (See Table 3.)


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Post Marketing Data: Adverse reactions are ranked under headings of frequency using the following convention: Very common ≥1/10; Common ≥1/100 to <1/10; Uncommon ≥1/1000 to <1/100; Rare ≥1/10000 to <1/1000; Very rare <1/10000; Not known (cannot be estimated from the available data).
Blood and lymphatic system disorders: Very rare: thrombocytopenia.
Immune system disorders: Rare: hypersensitivity.
Very rare: anaphylactic shock.
Psychiatric disorders: Uncommon: agitation.
Rare: aggression, confusion, depression, hallucination, insomnia.
Very rare: tic.
Nervous system disorders: Uncommon: paraesthesia.
Rare: convulsions.
Very rare: dysgeusia, dyskinesia, dystonia, syncope, tremor.
Not known: amnesia, memory impairment.
Eye disorders: Very rare: accommodation disorder, blurred vision, oculogyration.
Cardiac disorders: Rare: tachycardia.
Gastrointestinal disorders: Uncommon: diarrhoea.
Hepatobiliary disorders: Rare: hepatic function abnormal (transaminases increased, blood bilirubin increased, blood alkaline phosphatase increased, Gamma-glutamyl transferase increased).
Skin and subcutaneous tissue disorders: Uncommon: pruritus, rash.
Rare: urticaria.
Very rare: angioedema, drug eruption.
Renal and urinary disorders: Very rare: dysuria, enuresis.
General disorders and administration site conditions: Uncommon: asthenia, malaise.
Rare: oedema.
Investigations: Rare: weight increased.
Oral solution: Metabolism and nutrition disorders: Not known: increased appetite.
Psychiatric disorders: Not known: suicidal ideation.
Ear and labyrinth disorders: Not known: vertigo.
Renal and Urinary disorders: Not known: urinary retention (see Precautions).