Aerius Adverse Reactions

In clinical trials in a pediatric 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%).
In clinical trials in a range of indications including allergic rhinitis and chronic idiopathic urticaria, at the recommended dose of 5mg 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 of hypersensitivity reactions (including anaphylaxis and rash), tachycardia, palpitations, psychomotor hyperactivity, somnolence, seizures, elevations of liver enzymes, hepatitis, increased bilirubin and increased appetite have been reported during the marketing of desloratadine.