Abstract

Pediatric populations are the most vulnerable group with regard to rational drug prescribing since many new drugs are marketed without any proper pharmacovigilence study, thereby increasing the risk of toxicity. The study was aimed to determine the adverse drug reaction (ADR) pattern in pediatric population, over a period of 6 months. A total of 200 patients were enrolled in the study, 15 patients were suspected with ADRs and were confirmed by the physicians attending the pediatric department. Out of 15 cases, 8 were male patients (53.33%) and 7 were female. 46.66% of ADRs were affected in skin and subcutaneous tissue followed by 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 sub type 1 were of the common type. 73.33% of the events were in probable category, 20% of the events were in possible category and 6.66% events are in definite category and also most of the ADRs were of mild varieties (60%) followed by moderate (40%). 73.33% of ADRs were cured and 26.66% were getting better with further therapeutical management. The study indicated the need for a rigid ADR monitoring among pediatric patients to ensure safety of drug therapy. Various pharmacovigilance awareness programs should be conducted to increase the spontaneous reporting of ADRs.

Key words: Adverse Drug Reaction, pediatrics, pharmacovigilance,gastrointestinal system,subcutaneous tissue.