Nimesulide Induced Hepatotoxicity: Clinical Evidence, Case Studies, and Current Regulatory Status

  • Unique Paper ID: 197470
  • Volume: 12
  • Issue: 11
  • PageNo: 6826-6832
  • Abstract:
  • Background Nimesulide is a nonsteroidal anti-inflammatory drug (NSAID) used to treat acute pain, fever, osteoarthritis, and menstrual cramps in adults. While it is highly effective often outperforming drugs like paracetamol or aspirin in reducing fever and inflammation its safety profile, specifically regarding the liver, remains a subject of intense medical debate. Findings Research indicates a complex "risk vs. benefit" scenario. Clinical Benefits: Nimesulide provides rapid analgesia and is generally well-tolerated by the gastrointestinal and renal systems compared to other NSAIDs. Hepatotoxicity Risks: Significant evidence suggests nimesulide increases the risk of liver injury. Meta-analyses show users are twice as likely to experience hepatotoxicity compared to non-users. In severe cases, this has led to fulminant hepatic failure, liver transplants, and death. Regulatory Status: Due to these risks, the drug has been banned in many countries (such as the US and Switzerland) and restricted in others. In India, while the pediatric use of nimesulide was banned in 2011, it remains available for adults despite ongoing concerns regarding its safety. While Nimesulide is a potent and effective anti-inflammatory, it carries a significantly higher risk of liver damage than other drugs in its class. Short-term use (less than 15 days) can still trigger adverse hepatic reactions. Therefore, while its efficacy is proven, its use requires strict medical supervision and a careful assessment of the patient’s liver health.

Copyright & License

Copyright © 2026 Authors retain the copyright of this article. This article is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

BibTeX

@article{197470,
        author = {Gaurav Bhujangrao Jadhao and Anjali Raju Deshmukh and Vaishnavi Vinod Gaikwad},
        title = {Nimesulide Induced Hepatotoxicity: Clinical Evidence, Case Studies, and Current Regulatory Status},
        journal = {International Journal of Innovative Research in Technology},
        year = {2026},
        volume = {12},
        number = {11},
        pages = {6826-6832},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=197470},
        abstract = {Background Nimesulide is a nonsteroidal anti-inflammatory drug (NSAID) used to treat acute pain, fever, osteoarthritis, and menstrual cramps in adults. While it is highly effective often outperforming drugs like paracetamol or aspirin in reducing fever and inflammation its safety profile, specifically regarding the liver, remains a subject of intense medical debate. Findings Research indicates a complex "risk vs. benefit" scenario. Clinical Benefits: Nimesulide provides rapid analgesia and is generally well-tolerated by the gastrointestinal and renal systems compared to other NSAIDs. Hepatotoxicity Risks: Significant evidence suggests nimesulide increases the risk of liver injury. Meta-analyses show users are twice as likely to experience hepatotoxicity compared to non-users. In severe cases, this has led to fulminant hepatic failure, liver transplants, and death. Regulatory Status: Due to these risks, the drug has been banned in many countries (such as the US and Switzerland) and restricted in others. In India, while the pediatric use of nimesulide was banned in 2011, it remains available for adults despite ongoing concerns regarding its safety. While Nimesulide is a potent and effective anti-inflammatory, it carries a significantly higher risk of liver damage than other drugs in its class. Short-term use (less than 15 days) can still trigger adverse hepatic reactions. Therefore, while its efficacy is proven, its use requires strict medical supervision and a careful assessment of the patient’s liver health.},
        keywords = {Nimesulide, NSAIDs, Cox-2 Inhibitors, Hepatotoxicity, Hepatic failure, Liver transplant, Acute pain, Osteoarthritis, Menstrual cramps, Drug ban, medical supervision, India (2011 ban).},
        month = {April},
        }

Cite This Article

Jadhao, G. B., & Deshmukh, A. R., & Gaikwad, V. V. (2026). Nimesulide Induced Hepatotoxicity: Clinical Evidence, Case Studies, and Current Regulatory Status. International Journal of Innovative Research in Technology (IJIRT), 12(11), 6826–6832.

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