Is Nimesulide Still Used?
Nimesulide is not recommended for use and has been withdrawn from the market in several countries due to serious hepatotoxicity risks, including acute liver failure and death. While it remains available in some countries including South Korea and parts of Latin America, the evidence clearly demonstrates an unfavorable risk-benefit profile that makes its use inadvisable 1, 2.
Evidence of Hepatotoxicity
The hepatotoxic risks of nimesulide are well-documented and severe:
Nimesulide carries a 2.21-fold increased risk of hepatotoxicity compared to no NSAID exposure, and a 3.99-fold increased reporting rate of hepatotoxicity compared to other NSAIDs 1.
Among patients who developed nimesulide-induced liver injury, 21% progressed to acute liver failure, 8.8% died, and 5.3% required liver transplantation 2.
The hepatotoxicity can occur rapidly—within 7-15 days of treatment initiation in some cases—meaning short-term use does not eliminate the risk 2.
Clinical Presentation of Nimesulide-Induced Liver Injury
When hepatotoxicity occurs, it typically presents as:
Hepatocellular injury pattern in 67% of cases, with transaminases elevated nearly 20-fold above the upper limit of normal 2.
Jaundice develops in 81% of affected patients, with total bilirubin elevated 13-fold above normal 2.
The median time to onset is 40 days, though it can occur much earlier 2.
Women are disproportionately affected, comprising 86% of cases, with a mean age of 59 years 2.
Availability in Guidelines
Notably, nimesulide is conspicuously absent from major international clinical practice guidelines for pain and inflammation management:
The 2012 American College of Rheumatology guidelines for gout management list FDA-approved NSAIDs (naproxen, indomethacin, sulindac) and COX-2 inhibitors (etoricoxib, celecoxib) but do not mention nimesulide 3.
The 2016 ASAS-EULAR guidelines for axial spondyloarthritis recommend NSAIDs as first-line treatment but do not include nimesulide among recommended agents 3.
The 2010 NCCN cancer pain guidelines discuss various NSAIDs and their toxicity profiles but do not recommend nimesulide 3.
Safer NSAID Alternatives
Instead of nimesulide, clinicians should use NSAIDs with established safety profiles and guideline support:
For general inflammatory conditions: ibuprofen (up to 3200 mg/day), naproxen, or indomethacin are FDA-approved and guideline-recommended 3.
For patients with GI contraindications: selective COX-2 inhibitors like celecoxib (with appropriate cardiovascular risk assessment) or NSAIDs with proton pump inhibitor co-therapy 3.
For short-term acute pain: ketorolac (15-30 mg IV every 6 hours for maximum 5 days) is an option, though renal, GI, and cardiovascular monitoring is required 3, 4.
Clinical Pitfalls to Avoid
Do not assume that short-term nimesulide use is safe—serious hepatotoxicity can develop within the first two weeks of treatment 2.
Female patients and those over age 60 appear to be at particularly high risk for nimesulide hepatotoxicity 2.
If nimesulide-induced liver injury is suspected, immediate discontinuation is critical, as continued use can progress to fulminant hepatic failure 5, 2.
Monitoring liver enzymes after initiating nimesulide does not prevent serious hepatotoxicity, as the onset can be rapid and unpredictable 5.