ABSTRACT
Background: Adverse drug reactions (ADRs) are an important cause of morbidity and mortality across the world and contribute to a significant economic burden on healthcare resources and community. In children, monitoring ADRs is essential as adequate clinical trials are lacking in this group. So, this study was undertaken to assess the ADR pattern in a paediatric population in a tertiary care hospital.Methods: A cross sectional, retrospective study was done at ADR monitoring centre (AMC) for a period of 3 years in a tertiary care hospital. All the ADRs reported by the Department of Paediatrics to AMC were collected and analyzed for age group affected, demographic profile, ADR pattern, drug group, systems affected, causality and severity of the ADR.Results: During the study period, a total of 102 ADRs were reported to the AMC from the paediatric department. Out of 102 ADRs reported, males represented 60.8% and females represented 39.2%. Maximum number of ADRs were seen in the age group of 1-5 years (43.3%). Most common ADR reported was maculopapular rash (27.5%) followed by diarrhoea (14.7%). The most common drug class causing ADRs are antibiotics (36.3%) followed by anticonvulsants (18.6%). Vaccines contributed to 14.7% of all reported ADRs. Majority of the ADRs were of probable (70.6%) causality and moderate (52%) in severity.Conclusions: ADRs were reported more among under 5 years of age and antibiotics were the common implicated causative agents. Most of the reactions were of moderate severity. Information acquired through ADR reporting may be useful in identifying and minimizing preventable ADRs and augmenting the knowledge of the prescribers to deal with ADRs more efficiently.