Adverse drug reactions of oral non-steroidal anti-inflammatory drugs and its fixed drug combinations: A 5-year retrospective observational study

Abstract

Background: Non-steroidal anti-inflammatory drugs (NSAIDs) are very commonly prescribed worldwide. Due to this, the incidence of adverse drug reactions (ADRs) to NSAIDs is increased. Aims and Objectives: This study aims to analyze the ADRs reported to NSAIDs. Patient demographics, organ system affected severity of ADRs, and their causal association with the drug will be studied. Materials and Methods: It was a retrospective analysis of ADRs reported to oral NSAIDs and its combinations over a period of 5 years from January 2015 to December 2020. Prior ethics committee approval was obtained. These ADRs were collected as part of pharmacovigilance activities. Results: A total of 100 ADRs were reported due to NSAIDs. Most ADRs due to NSAIDs were reported in 30–39 years age group. Female gender was most affected by ADRs. Diclofenac was the most common NSAID causing ADRs. Skin and subcutaneous organ system was most affected. Six ADRs were reported as serious. Sixty-seven ADRs were categorized as probable using the World Health Organization causality assessment scale. Conclusion: NSAIDs are commonly prescribed drugs. Analyzing the ADRs reported to NSAIDs will help in finding the risk factors. Based on this knowledge, rational prescription of NSAIDs can be done which will improve the patient safety.