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Archives of Pharmacology and Therapeutics

ISSN: 2688-9609

Systematic review Open Access
Volume 8 | Issue 1 | DOI: https://doi.org/10.33696/Pharmacol.8.068

Safety and Efficacy Outcomes of Oral Nimesulide Use as a Nonsteroidal Anti-Inflammatory Drug in Older Adults: A Comprehensive Systematic Review

Mansij Biswas1,*, Anil Jain1, Prince Bakshi1
  • 1Department of Global Medical Affairs, Dr Reddy’s Laboratories Ltd., Hyderabad, Telangana, India
+ Affiliations - Affiliations

Corresponding Author

Mansij Biswas, mansijbiswas@drreddys.com

Received Date: February 20, 2026

Accepted Date: March 23, 2026

Citation:

Biswas M, Jain A, Bakshi P. Safety and Efficacy Outcomes of Oral Nimesulide Use as a Nonsteroidal Anti-Inflammatory Drug in Older Adults: A Comprehensive Systematic Review. Arch Pharmacol Ther. 2026;8(1):6–27.


Copyright: © 2026 Biswas M, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Abstract

Background: Nimesulide, a preferential Cyclooxygenase-2 (COX-2) inhibitor, is frequently prescribed for musculoskeletal conditions in middle-aged (45–64 years) and older adults (≥65 years). Given age-associated alterations in drug metabolism, polypharmacy, and comorbidities, its safety and efficacy in adults >45 years warrants critical re-evaluation.

Objectives: To systematically synthesize and appraise evidence on the safety, tolerability, and therapeutic efficacy of oral nimesulide in adults >45 years across diverse pain-related indications, with emphasis on gastrointestinal, hepatic, renal, and cardiovascular risk domains.

Methods: A comprehensive systematic search of PubMed and Google Scholar in accordance to Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) 2020 guidelines, was conducted from inception through August 2025. Eligible studies included randomized controlled trials, observational studies, and pharmacovigilance datasets. Safety and efficacy outcomes were assessed.

Results: Thirty-four studies encompassing osteoarthritis, lower back pain, musculoskeletal disorders, and oral surgical pain were analyzed. Nimesulide in controlled trials demonstrated gastrointestinal tolerability. Hepatic adverse events were uncommon in interventional studies; however, pharmacovigilance signals indicated a low but measurable incidence of drug-induced liver injury, consistent with nonsteroidal anti-inflammatory drugs (NSAIDs) class effects. Renal and cardiovascular safety outcomes were comparable to other NSAIDs, with no consistent evidence of excess risk. Fixed-dose combinations with paracetamol exhibited favorable tolerability. Analgesic efficacy was consistent, with rapid onset and pain reduction.

Conclusion: Nimesulide demonstrated a favorable short-term safety profile in adults >45 years, with low incidences of serious gastrointestinal, hepatic, renal, and cardiovascular abnormalities. Pharmacovigilance data indicated monitoring of hepatic abnormalities. Evidence supports short-term tolerability, while emphasizing the importance of age-specific safety studies.

Keywords

Oral nimesulide, Nonsteroidal anti-inflammatory drugs, Older adults, Safety, Efficacy, Systematic review

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