ABSTRACT
Pediatric populations are the most vulnerable group with regard to rational drug prescribing since many new drugs aremarketed without any proper pharmacovigilance study, thereby increasing the risk of toxicity. The study was aimedto determine the adverse drug reaction (ADR) pattern in the pediatric population over a period of 6 months. A total of200 patients were enrolled in the study, 15 patients were suspected with ADRs and were confirmed by the physiciansattending the pediatric department. Out of 15 cases, eight were male patients (53.33%) and seven were female patients.46.66% of ADRs were affected in the skin and subcutaneous tissue, followed by the gastrointestinal system (40%).Most common group of showing ADRs were found to be antibiotics (66.65%), followed by anticonvulsants (19.99%).Type B reactions were the most commonly observed ADRs, of which subtype 1 was of the common type. 73.33% ofthe events were in the probable category, 20% of the events were in the possible category, and 6.66% events were inthe definite category and also most of the ADRs were of mild varieties (60%), followed by moderate (40%). 73.33% ofADRs were cured and 26.66% were getting better with further therapeutical management. The study indicated the needfor a rigid ADR monitoring among pediatric patients to ensure the safety of drug therapy. Various pharmacovigilanceawareness programs should be conducted to increase the spontaneous reporting of ADRs.