Real-world drug safety surveillance in south India: Experience from an ADR monitoring center

BackgroundAdverse drug reactions (ADRs) are a major cause of medication-related morbidity and contribute significantly to healthcare burden. Systematic evaluation of ADRs is essential for strengthening pharmacovigilance and improving patient safety.ObjectiveTo assess the severity, predictability, preventability, causality, management, and outcomes of ADRs reported to an Adverse Drug Reaction Monitoring Centre (AMC) in a tertiary care teaching hospital.MethodsAn observational study was conducted using ADR reports submitted to the AMC between January and December 2025. Eligible reports were extracted from the VigiFlow database and analyzed using standardized pharmacovigilance assessment tools. Descriptive statistics were used to summarize the data.ResultsA total of 1,994 ADR reports were analyzed. Adults (59.0%) and elderly patients (28.0%) accounted for most reports. Mild ADRs predominated (64.3%), while 77.2% were classified as predictable Type A reactions. Preventability assessment showed that 72.9% of ADRs were either definitely or probably preventable. Most ADRs were non-serious (81.6%) and categorized as probable (65.1%) on causality assessment. Gastrointestinal disorders were the most commonly affected organ class, and anti-invectives were the most frequently implicated drug class.ConclusionMost ADRs were mild, predictable, and potentially preventable, highlighting opportunities to enhance medication safety through rational prescribing, therapeutic monitoring, and strengthened pharmacovigilance practices.