Adverse Drug Reaction Assessment in the Paediatric Population: A Non-Interventional Pharmacovigilance Study

Adverse drug reactions (ADRs) in children are under-reported due to limited clinical trials, off-label prescribing, and lack of caregiver awareness.Pharmacovigilance is essential to evaluate and prevent drug-related harm in paediatric populations.The objective is to identify adverse drug reactions in paediatric patients using the WHO-UMC causality assessment scale and document the pattern and severity of adverse events (AEs).Non-interventional observational study was conducted in 140 paediatric subjects (< 13 years).Clinical history, anthropometrics, and adverse events were documented.Causality was assessed using the WHO-UMC ADR Probability Scale.Descriptive statistics were applied.The mean age of subjects was 7.42 ± 2.94 years; 72.86% were male.All subjects had no significant medical history.The mean ADR probability score was 0.43 ± 1.46, indicating doubtful causality.A total of 53 AEs were identified: nausea (16.35%), gastritis (8.81%), drowsiness (2.52%), rash (2.52%), abdominal pain (1.89%), stomach pain (0.63%), and swollen eyes (0.63%).All AEs were mild in intensity.It was Concluded that ADR incidence in the study population was low and predominantly mild.Causality scores indicate minimal association with drug therapy.Strengthening paediatric pharmacovigilance programs remains essential to ensure medication safety.