J Postgrad Med. 2026 Jun 11. doi: 10.4103/jpgm.jpgm_159_26. Online ahead of print.
ABSTRACT
INTRODUCTION: Adverse drug reactions (ADRs) are an important cause of morbidity, prolonged hospital stay, and increased healthcare costs. Monitoring and reporting ADRs through pharmacovigilance systems help identify drug-related risks and improve patient safety. This study aimed to describe the pattern, characteristics, and outcomes of ADRs reported at a tertiary care teaching hospital under the Pharmacovigilance Programme of India (PvPI).
MATERIALS AND METHODS: A retrospective, observational, cross-sectional study was conducted at the ADR Monitoring Center of a tertiary care teaching hospital. Individual Case Safety Reports submitted to the Vigiflow database between January 2023 and December 2024 were analyzed. This study got approval by ethics committee. Data were evaluated for patient demographics, suspected drugs, system organ class involvement, seriousness, outcomes, and causality using the World Health Organization-Uppsala (WHO-UMC) scale. Descriptive statistics were used to summarize the data.
RESULTS: A total of 299 ADRs were described and analyzed. Adults accounted for the majority of cases, with a slight male predominance. Antimicrobials (29%) were the most commonly implicated drug class. Most ADRs were non-serious. On causality assessment, the majority of reactions were classified as “probable (90.63%)”. The most common adverse event was headache (8.6%). The ADR outcome was recovered/resolved in 64.6%.
CONCLUSION: ADRs are commonly encountered in tertiary care settings, with antimicrobials being the most frequent contributors. Describing and analyzing reported ADR data, increasing awareness among medical students, healthcare professionals, and encouraging regular ADR reporting are essential steps to enhance patient safety and promote rational drug use.
PMID:42301674 | DOI:10.4103/jpgm.jpgm_159_26
