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Objective: To study the dermatological adverse drug reactions (CADRs) in paediatric patients in a tertiary care teaching hospital. Methods: A retrospective study was undertaken to analyse adverse drug events in paediatric department of a tertiary care teaching hospital. Case sheets were studied and analysed for data of CADRs and dermatological adverse event marked as ADR by the consultant dermatologist and paediatrician was included in the study. Causality, preventability and severity were analysed by Pharmacologist using standard scales. Gender inclination, most common class of drug causing dermatological ADRs, types of dermatological ADRs including most common ADR, associated risk factors, mono pharmacy or polypharmacy were included in the study. Results: 2015 medical record sheets were analysed in a period of one year (january2016-december2016).104 patients were identified with dermatological ADRs. Overall incidence was 5.15% of which 58% were females. Antimicrobials were the commonest drug class(71.15%) causing dermatological ADRs followed by NSAIDs(11.53%),antiepileptics(10.57%) and others(2.88%).76 % of ADRs were of moderate degree (assessed by Modified Hartwig and Siegel Scale) .79% cases fell in probable category of preventability assessed by Modified Schumock and Thornton Scale. According to Naranjo’s scale of causality assessment, 71.15 % cases scored into probable, 21.15 % definitive and 7.69% were of possible category. Maculopapular rash (64.42%) followed by FDE (18.26%), urticaria (15.38%) were the CADRs that occurred in most patients .74% cases were prescribed polypharmacy. Conclusion: Dermatological adverse affects though just a part of the whole spectrum of ADR is a matter of concern because it causes apprehension in parents along with associated morbidity and mortality in patients. More effective ADR reporting, early intervention and more studies especially in paediatric age group covering various aspects of ADRs are required.

Adverse Cutaneous Drug Reactions in Paediatric patients in a Tertiary Care Hospital-Study of causality, preventability and severity