Xyzal Tác dụng không mong muốn

Clinical Trial Data: In therapeutic studies in women and men aged 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 reactions 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%).
Additional adverse reactions of medical significance observed at a higher incidence than in placebo in adults and adolescents aged 12 years and older exposed to levocetirizine are syncope (0.2%) and weight increased (0.5%).
Paediatric Patients: In two placebo-controlled studies in paediatric patients aged 6-11 months and aged 1 year to less than 6 years, 159 subjects were exposed to levocetirizine at the dose of 1.25 mg daily for 2 weeks and 1.25 mg twice daily respectively. The following incidence of adverse drug reactions was reported under levocetirizine.
Psychiatric disorders: Common: sleep disorders.
Nervous system disorders: Common: somnolence.
Gastrointestinal disorders: Common: diarrhoea, constipation.
Uncommon: vomiting.
In children aged 6-12 years double blind placebo controlled studies were performed where 243 children were exposed to 5 mg levocetirizine daily for variable periods ranging from less than 1 week to 13 weeks. The following incidence of adverse drug reactions was reported.
Nervous system disorders: Common: somnolence.
Uncommon: headache.
Respiratory, thoracic and mediastinal disorders: Common: cough.
General disorders and administration site conditions: Common: pyrexia.
Please note that even if clinical data presented in this section are available in children aged 6 months to 12 years, there is no sufficient data to support the administration of the product in infants and toddlers aged less than 2 years.
Post Marketing Data: In addition to the adverse reactions reported during clinical studies and listed above, very rare cases of the following adverse drug reactions have been reported in post-marketing experience.
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.
Nervous system disorders: Not known: convulsions, paraesthesia, dizziness, syncope, tremor, dysgeusia.
Eye disorders: Not known: visual disturbances, blurred vision.
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.