Stadeltine Adverse Reactions

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.
Eyes 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 tissues 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.