Stadeltine Adverse Reactions

The following adverse reactions from post-marketing experience are listed by class and frequency: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Not known: Immune system disorders: hypersensitivity including anaphylaxis.
Metabolism and nutrition disorders: increased appetite.
Psychiatric disorders: aggression, agitation, hallucination, depression, insomnia, suicidal ideation, nightmare.
Nervous system disorders: convulsion, paraesthesia, dizziness, syncope, tremor, dysgeusia.
Ear and labyrinth disorders: vertigo.
Eye disorders: visual disturbances, blurred vision, oculogyration.
Cardiac disorders: palpitations, tachycardia.
Respiratory, thoracic and mediastinal disorders: dyspnoea.
Gastrointestinal disorders: nausea, vomiting, diarrhoea.
Hepatobiliary disorders: hepatitis.
Renal and urinary disorders: dysuria, urinary retention.
Skin and subcutaneous tissue disorders: angioneurotic oedema, fixed drug eruption, pruritus, rash, urticaria.
Musculoskeletal, connective tissues, and bone disorders: myalgia, arthralgia.
General disorders and administration site conditions: oedema.
Investigations: weight increased, abnormal liver function tests.
Description of suspected adverse reactions: After levocetirizine discontinuation, pruritus has been reported.