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Abstract

Background

Adverse drug reactions (ADRs) pose significant risks to patient safety, particularly in tertiary care settings characterized by polypharmacy and multiple comorbidities. Monitoring and evaluating ADRs is vital to improving therapeutic outcomes and minimizing harm.

Objective

This study aimed to assess the pattern, severity, predictability, seriousness, and causality of ADRs reported in a tertiary care teaching hospital in Belagavi, India.

Methods

A prospective observational study was conducted on 2035 spontaneously reported ADRs collected between January and December 2024 at the Adverse Drug Reaction Monitoring Centre under the Pharmacovigilance Programme of India (PvPI). Data were analyzed using the WHO-UMC causality assessment, Hartwig and Siegel severity scale, and standard classifications for seriousness and predictability.

Results

Adults (60.54%) and elderly (24.67%) were most frequently affected. Gastrointestinal disorders (23.91%) were the most commonly reported System Organ Class (SOC). Most ADRs were predictable (87.81%) and probable in causality (67.91%). Severe ADRs accounted for 15.97%. Vomiting and headache were the most reported adverse events. Antiretroviral were the most commonly implicated drug class.

Conclusion

The majority of ADRs were predictable and involved widely used drug classes. Strengthening pharmacovigilance practices and implementing targeted clinical interventions are essential to prevent avoidable ADRs and improve patient safety.

Keywords

adverse drug reaction pharmacovigilance drug safety causality assessment System Organ Class patient safety

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References

World Health Organization . Safety of medicines: a guide to detecting and reporting adverse drug reactions: why health professionals need to take action. Geneva: WHO, 2002. [cited 2025 May 10]. Available from. https://apps.who.int/iris/handle/10665/67378

World Health Organization . The importance of pharmacovigilance. Geneva: WHO, 2002. [cited 2025 May 10]. Available from. https://apps.who.int/iris/handle/10665/424932

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From reaction to reporting: Impact of pharmacovigilance in a tertiary care hospital setting at Belagavi