Aerius Adverse Reactions





Zuellig Pharma
Full Prescribing Info
Adverse Reactions
Tablet/Syrup: In clinical trials in a range of indications including allergic rhinitis and chronic idiopathic urticaria, at the recommended dose of 5 mg daily, undesirable effects with AERIUS tablets were reported in 3% of patients in excess of those treated with placebo. The most frequent adverse events reported in excess of placebo were fatigue (1.2%), dry mouth (0.8%), and headache (0.6%).
Very rare cases (<1:10,000) of hypersensitivity reactions (including anaphylaxis and rash), tachycardia, palpitations, psychomotor hyperactivity, seizures, somnolence, elevations of liver enzymes, hepatitis, increased appetite and increased bilirubin have been reported during the marketing of desloratadine.
Syrup: In clinical trials in a paediatric population, AERIUS syrup was administered to a total of 246 children aged 6 months through 11 years. The overall incidence of adverse events in children 2 through 11 years of age was similar for AERIUS syrup and the placebo groups. In infants and toddlers aged 6 to 23 months, the most frequent adverse events reported in excess of placebo were diarrhea (3.7%), fever (2.3%) and insomnia (2.3%).
Oral solution: At the recommended 5 mg dose, adverse events reported at a higher incidence than placebo included dry mouth and fatigue and headache.
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