Xyzal Adverse Reactions

Clinical Trial Data: In therapeutic studies in women and men 12-71 years, 15.1% of the patients in the levocetirizine 5-mg group had at least 1 adverse drug reaction compared to 11.3% in the placebo group. The 91.6% of these adverse drug reactions were mild to moderate.
In therapeutic trials, the dropout rate due to adverse events was 1% (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 reactions are ranked under headings of frequency using the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000); 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 eg, somnolence, fatigue and asthenia was altogether more common (8.1%) under levocetirizine 5 mg than under placebo (3.1%).
Oral Solution/Drops: Pediatric Patients: In 2 placebo-controlled studies in pediatric patients 6-11 months and 1 year to <6 years, 159 subjects were exposed to levocetirizine 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: Diarrhea, constipation. Uncommon: Vomiting.
In children 6-12 years, double-blind placebo-controlled studies were performed where 243 children were exposed to levocetirizine 5 mg daily for variable periods ranging from <1 week to 13 weeks. The following incidence of adverse drug reactions was reported.
Nervous System Disorders: Common: Somnolence. Uncommon: Headache.
Note that even if clinical data presented in this section are available in children 6 months to 12 years, there are no sufficient data to support the administration of Xyzal to infants and toddlers <2 years.
Post-marketing Data: In addition to the adverse reactions mentioned previously and reported during clinical studies, 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 and appetite.
Psychiatric Disorders: Not Known: Aggression, agitation, hallucination, depression, insomnia, suicidal ideation.
Nervous System Disorders: Not Known: Convulsions, paresthesia, 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: Dyspnea.
Gastrointestinal Disorders: Not Known: Nausea, vomiting.
Hepatobiliary Disorders: Not Known: Hepatitis, abnormal liver function test.
Skin and Subcutaneous Tissue Disorders: Not Known: Angioneurotic edema, fixed drug eruption, pruritus, rash, urticaria.
Musculoskeletal and Connective Tissue Disorders: Not Known: Myalgia.
Renal and Urinary Disorders: Not Known: Dysuria, urinary retention.
General Disorders and Administration Site Conditions: Not Known: Edema.