Adverse drug reactions of systemic antihistamines in children in the Netherlands

BackgroundAntihistamines are used for the treatment of allergic rhinitis, allergic conjunctivitis, chronic spontaneous urticaria and atopic eczema.ObjectiveTo study the reports of adverse drug reactions (ADRs) in children using antihistamines to provide prescribers with an overview of the possible toxicity.DesignWe studied ADRs in children reported to the Netherlands Pharmacovigilance Centre Lareb in the years 1991–2014, assessed the Naranjo score and, when possible, computed the reporting OR.ResultsSerious ADRs included one death (malignant neuroleptic syndrome), cardiac arrhythmia (one case) and convulsions (three cases). Skin eruptions, headache and somnolence were the most frequently reported ADRs. Aggression and agitation were also reported.ConclusionsToxicity can occur with second-generation antihistamines. The main toxicity relates to skin eruptions and central nervous system problems.