PATTERN AND OUTCOMES OF SPONTANEOUSLY REPORTED CUTANEOUS ADVERSE DRUG REACTIONS AT A TERTIARY CARE TEACHING HOSPITAL IN NORTHEAST INDIA: A RETROSPECTIVE PHARMACOVIGILANCE STUDY

Abstract

Background: Cutaneous adverse drug reactions (CADRs) are an important component of medicine safety, and spontaneous reporting provides useful information on the patterns encountered in routine clinical practice. Objective: To describe the demographic profile, reaction morphology, suspected medications, seriousness, outcomes and reporting departments of spontaneously reported CADRs at a tertiary care teaching hospital in Northeast India. Methods: A retrospective descriptive analysis was conducted on 104 CADR reports recorded from August 2021 to November 2024. Demographic and report characteristics were summarised using frequencies, percentages and standard descriptive statistics. Results: The mean age was 37.16 ± 13.35 years; 54 (51.92%) reports involved males and 93 (89.42%) involved adults aged 19–60 years. Maculopapular rash accounted for 63 (60.58%) reports and fixed drug eruption for 41 (39.42%). Suspected medications were grouped as non-antiretroviral antimicrobials in 81 (77.88%) reports, paracetamol in 14 (13.46%) and antiretrovirals in 9 (8.65%). The most frequently recorded individual medications were the ofloxacin ornidazole fixed-dose combination (35; 33.65%) and co-trimoxazole (24; 23.08%). Most reports originated from Dermatology (73; 70.19%), followed by the ART Centre (28; 26.92%). Sixty-nine (66.35%) reports were non-serious. Outcomes were recovered in 73 (70.19%), recovering in 8 (7.69%), not recovered in 19 (18.27%) and unknown in 4 (3.85%). Conclusion: Maculopapular rash was the predominant reported CADR, and non-antiretroviral antimicrobials constituted the largest suspected medication category. The findings support continued pharmacovigilance and systematic follow-up of cutaneous drug reactions in routine care.