Journal of Pharmaceutical Research
Year: 2026, Volume: 25, Issue: 2, Pages: 112-115
Original Article
Jesmi James1*, Jitha Sushama2, Dhanya Sasidharan Palappallil3
1Associate Professor, Department of Pharmacology, Mount Zion Medical College, Adoor, Pathanamthitta, Kerala, India
2Professor CAP, Department of Pharmacology, Government Medical College, Thiruvananthapuram, Kerala, India
3Professor CAP, Department of Pharmacology, Government Medical College, Kottayam, Kerala, India
*Corresponding Author
Email: [email protected]
Nonsteroidal anti-inflammatory drugs (NSAIDs) are one of the most prescribed drugs in modern medicine. NSAIDs are very effective in decreasing the pain, inflammation and many patients world-wide have found relief in their use. However, they cause various side effects including cutaneous, gastrointestinal (GI) disorders (from minor dyspepsia through to major ulcers, bleeding and perforation), kidney effects and cardiovascular effects. Objective of the study is to study the pattern of Adverse Drug Reactions (ADRs) of NSAIDs in a tertiary care hospital. This was an observational study done in the Dept. of Pharmacology, Government T.D. Medical College, Alappuzha over a period of one year (July 2014- 2015). As a part of pharmacovigilance programme, all ADRs were collected in CDSCO forms and retrospective data was entered from the ADR forms. A total of 255 ADRs were identified during a one-year period, of which 39 (15.29%) cases were due to the use of NSAIDs. The age group was 31-40 years. Males were 35.9% and females were 64.1% with M:F ratio 1:1.8. The drugs involved in ADRs were Diclofenac (38.5%), Paracetamol (30.8%), Aspirin (15.3%), Ibuprofen (5.1%), Piroxicam (2.6%), Ketorolac (2.6%), Indomethacin (2.6%) and Nimesulide (2.6%). Skin was the most commonly affected organ system (71.8%), followed by GIT (15.3%), Renal (7.7%), Respiratory (7.7%) and CNS (5.1%). Causality assessment showed that 71.8% ADRs were possible and 28.2% were probable according to Naranjo’s scale. Severity assessment using the Modified Hartwig and Siegel Scale showed that 76.9% reactions were mild, 15.4% were moderate and 7.7% were severe, out of which one case was reported with Stevens-Johnson Syndrome (SJS). The causative drugs were stopped, and the patients were managed conservatively. No case fatalities were reported. Since ADRs due to NSAIDs may vary from self- limiting rash to severe life-threatening condition, the prescribing clinicians should be aware of the toxic potential of drugs and be vigilant in the spontaneous reporting the ADRs.
Keywords: Adverse Drug Reactions, Non-Steroidal Anti-inflammatory Drugs, pharmacovigilance, Naranjo’s scale, Causality assessment, Severity assessment
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© 2026 Published by Krupanidhi College of Pharmacy. This is an open-access article under the CC BY-NC-ND license (https://creativecommons.org/licenses/by-nc-nd/4.0/)
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