Nimesulide: Global Regulatory Status

Abstract:

Nimesulide, a preferential cyclooxygenase-2 inhibitory nonsteroidal anti-inflammatory drug, introduced in the 1980s, has been under continuous scrutiny for its risks of idiosyncratic hepatotoxicity. Despite being widely used for acute pain relief in many areas, it has been successively restricted or prohibited by main regulatory bodies: the EMA for the second-line, up to 15 days, acute pain or dysmenorrhea relief with 100 mg twice a day, for which the indication for osteoarthritis was withdrawn; not approved by the Canada’s Health Canada (HC), Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, and Therapeutic Goods Administration (TGA) in Australia and withdrawn early in the UK. However, its main market, India, prohibited the use of both immediate release oral preparations above 100 mg for each dose in December 2025, as allowed by Gazette notification under the Drugs and Cosmetics Act, after recommendations by its experts Drugs Technical Advisory Board/Indian Council of Medical Research for liver toxicity and availability of alternative treatments, although keeping 100 mg strength and former pediatric contraindications. This review emphasizes the fragmented global regulatory status of nimesulide.