The Union Health Ministry of India has banned the manufacture, sale, and distribution of all oral formulations of the painkiller nimesulide containing more than 100 milligrams in immediate-release dosage forms. The prohibition, issued under Section 26A of the Drugs and Cosmetics Act, 1940, was taken after consultation with the Drugs Technical Advisory Board (DTAB) and recommendations from the Indian Council of Medical Research (ICMR), citing serious risks to human health. The ban took effect on December 31, 2025.
The Health Ministry’s notification states that use of high-dose oral nimesulide formulations “is likely to involve risk to human beings and that safer alternatives to the said drug are available.”
Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) with analgesic (pain-relieving) and antipyretic (fever-reducing) properties. It works by inhibiting an enzyme involved in the inflammatory process, thereby reducing pain and swelling. The drug has been used in various countries to treat acute pain, symptoms of osteoarthritis, and primary dysmenorrhea (menstrual pain) in adolescents and adults, typically with recommended use limited in duration and dose.
Nimesulide has been associated with liver toxicity, including rare but serious cases of acute liver injury, jaundice, and hepatic failure. Such adverse hepatic reactions can occur even with short-term use, and severe injury may require hospitalization or liver transplantation. Reports in medical literature have linked the drug to clinically apparent liver injury in multiple cases. 1
Common side effects of nimesulide may include gastrointestinal discomfort, nausea, vomiting, skin rash, dizziness, and elevated liver enzymes. Cases of hepatitis and jaundice have also been reported. Rare but serious events such as gastrointestinal bleeding, renal impairment, and severe allergic reactions (including Stevens-Johnson syndrome) have been documented with NSAIDs, including nimesulide.
Healthcare providers generally recommend limiting nimesulide use to the lowest effective dose for the shortest possible duration, and avoiding it in patients with existing liver disease or risk factors for hepatic injury.
India banned nimesulide use in animals in January 2025 due to hepatic toxicity.
Nimesulide has been under global scrutiny due to its safety profile, particularly concerns about liver toxicity. Several countries have banned or never approved the drug for human use:
Not approved/banned: United States, United Kingdom, Canada, Australia, New Zealand, Japan.
Withdrawn in parts of Europe: Finland, Spain, Ireland, Belgium ceased marketing the drug after reporting severe liver damage.
In some European Union member states, nimesulide continues to be available under restricted conditions with limits on duration and dose to mitigate hepatic risk.
Many regulatory bodies have taken action, ranging from complete withdrawal to strict restrictions largely on the basis of risk-benefit analysis for its use in pain and fever relief compared to other NSAIDs.
India previously banned nimesulide use in children under 12 years of age due to heightened susceptibility to liver toxicity in pediatric populations. This new ban specifically targets higher-dose oral forms for adults.
The ban does not affect all nimesulide products; lower-dose formulations (100 mg or less) and other therapies remain available. Health professionals are advised to review treatment protocols and consider safer alternatives for pain relief, particularly for patients at risk of liver injury.
Individuals currently taking nimesulide or concerned about the drug’s risks should consult a qualified healthcare provider before starting, stopping, or changing any medication.
(Rh/TL)
