[Adverse effects of oxybutynin chloride (Ditropan) in pediatrics].

Background: The side effects of oxybutynin chloride (Ditropan) often include atropinic and allergic reactions. Their relative frequency in children merits a nationwide investigation.

Methods: All the side effects of Ditropan reported to the French Regional ADR monitoring centers and to the pharmaceutical firm Debat between January 1985 and June 1990 were analysed.

[Adverse effects of oxybutynin chloride (Ditropan). Evaluation of the official survey of Regional Pharmacovigilance Centers].

We analyzed the 200 reported cases of adverse reactions to Ditropan (209 side-effects) collated by the Centres Régionaux de Pharmacovigilance and Laboratoire Debat since the drug was first marketed. The frequency of such side-effects was of the order of 1 per 20,917 treatment months. Children were affected four times more frequently than adults.