Clinical Studies: Overview: Clinical studies have shown that cetirizine at the recommended dosage has minor undesirable 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 treatment with cetirizine hydrochloride.
Listing of ADRs: 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.
Paediatric population: 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 experience: In addition to the adverse reactions reported during clinical studies and listed previously, the following undesirable effects have been reported in post-marketing experience.
Undesirable effects are described according to MedDRA System Organ Class and by estimated frequency based on post-marketing experience.
Frequencies are defined as follows: 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 disorders: Very rare: thrombocytopenia.
Immune system disorders: Rare: hypersensitivity.
Very rare: anaphylactic shock.
Metabolism and nutrition disorders: Not known: increased appetite.
Psychiatric disorders: Uncommon: agitation.
Rare: aggression, confusion, depression, hallucination, insomnia.
Very rare: tics.
Not known: suicidal ideation, nightmare.
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.
Ear and labyrinth disorders: Not known: vertigo.
Cardiac disorders: Rare: tachycardia.
Gastro-intestinal disorders: Uncommon: diarrhoea.
Hepatobiliary disorders: Rare: hepatic function abnormal (increased transaminases, alkaline phosphatase, γ-GT and bilirubin).
Not known: hepatitis.
Skin and subcutaneous tissue disorders: Uncommon: pruritus, rash.
Rare: urticaria.
Very rare: angioneurotic oedema, fixed drug eruption.
Not known: acute generalized exanthematous pustulosis.
Musculoskeletal and connective tissue disorders: Not known: arthralgia.
Renal and urinary disorders: Very rare: dysuria, enuresis.
Not known: urinary retention.
General disorders and administration site conditions: Uncommon: asthenia, malaise.
Rare: oedema.
Investigations: Rare: weight increased.
Description of selected adverse reactions: After discontinuation of cetirizine, pruritus (intense itching) and/or urticaria have been reported.