Clinical trial data: Adults and adolescents above 12 years of age: In therapeutic studies in women and men 12 to 71 years, 15.1% of the patients in the levocetirizine 5 mg group had at least one adverse drug reaction compared to 11.3% in the placebo group; 91.6% of these adverse drug reaction were mild to moderate.
In therapeutic trials, the dropout rate due to adverse events was 1.0% (9/935) with levocetirizine 5 mg and 1.8% (14/771) with placebo. Clinical therapeutic trials with levocetirizine included 935 subjects exposed to the drug at the recommended dose of 5 mg daily.
Adverse drug reactions (ADRs) are listed as follows by MedDRA system organ class and by frequency. 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).
Nervous system disorders: Common: headache, somnolence
Gastrointestinal disorders: Common: dry mouth. Uncommon: abdominal pain
General disorders and administration site conditions: Common: fatigue. Uncommon: asthenia. The incidence of sedating adverse drug reactions such as somnolence, fatigue, and asthenia was altogether more common (8.1%) under levocetirizine 5 mg than under placebo (3.1%).
Post marketing data: Immune system disorders: Not known: hypersensitivity including anaphylaxis
Metabolism and nutrition disorders: Not known: increased weight, increased appetite
Psychiatric disorders: Not known: aggression, agitation, hallucination, depression, insomnia, suicidal ideation, nightmares
Nervous system disorders: Not known: convulsions, paraesthesia, dizziness, syncope, tremor, dysgeusia
Eye disorders: Not known: visual disturbances, blurred vision, oculogyration
Ear and labyrinth disorders: Not known: vertigo
Cardiac disorders: Not known: palpitations, tachycardia
Respiratory, thoracic and mediastinal disorders: Not known: dyspnoea
Gastrointestinal disorders: Not known: nausea, vomiting, diarrhoea
Hepatobiliary disorders: Not known: hepatitis, abnormal liver function test
Skin and subcutaneous tissue disorders: Not known: angioneurotic oedema, fixed drug eruption, pruritus, rash, urticaria
Musculoskeletal and connective tissue disorders: Not known: myalgia, arthralgia
Renal and urinary disorders: Not known: dysuria, urinary retention
General disorders and administration site conditions: Not known: oedema
Skin reactions occurring after discontinuation of levocetirizine: After levocetirizine discontinuation, pruritus has been reported (see Precautions).