Angioedema caused by over the counter use of dicyclomine hydrochloride and paracetamol fixed dose combination in a child: a case report

Authors describe a case of angioedema in a male child due to over-the-counter (OTC) use of fixed dose combination (FDC) of Tab. dicyclomine hydrochloride (20mg) and paracetamol (500mg) for abdominal pain. Use of OTC drugs in children without a doctor抯 suggestion can lead to unnecessary medication use and is not free of risks. Here, there is a probable causal relationship between the suspected drug and angioedema according to WHO-UMC criteria for Causality Assessment. This case was also reported to the Pharmacovigilance Programme of India (PvPI) through PvPI ADR android application.