Antiinflammatory and antirheumatic agents, non-steroids. Other NSAIDs
ATC code: M01AX17 (Nimesulide)
Brand names
Nimesulide, Aulin
Preferentially inhibits cyclooxygenase-2 (COX-2), reducing prostaglandin synthesis at sites of inflammation. Compared with non-selective NSAIDs, it spares COX-1 and the gastric mucosal barrier. It also suppresses histamine release, neutrophil migration and superoxide anion production. Metabolized in the liver to 4-hydroxynimesulide, the main contributor to hepatotoxicity.
Second line
In 2011, the restricted nimesulide to short courses of up to 15 days for acute pain in adults. The drug has never received approval. Finland, Spain, Ireland and Belgium withdrew the drug due to fulminant hepatic failure cases. In Russia, it remains available OTC, which is out of step with European practice. For acute pain, use is limited to short episodes when classic NSAIDs or paracetamol are ineffective or not tolerated.
Maximum course duration is 15 days. Baseline ALT and AST are checked before therapy. The drug is discontinued if transaminases rise.
Not recommended
Nimesulide is not used in chronic musculoskeletal pain. Courses beyond 15 days carry a cumulative risk of hepatotoxicity, including fulminant hepatic failure with fatal outcome or need for transplantation. 2011 explicitly limits course duration, and chronic use falls outside the regulation.
Not recommended
Nimesulide is not used as an antipyretic in children and is not preferred in adult fever. 2011 banned use in children under 12. In adults with fever, paracetamol and ibuprofen with more favorable safety profiles are preferred.
Boxed warning
No FDA boxed warning (the drug is not registered in the US). The EU and Russian labels explicitly highlight the risk of severe liver injury, including fulminant hepatic failure. EMA 2011 restricted course duration to 15 days.
FDA category C (not registered in the US). Contraindicated in the third trimester – risk of premature closure of the ductus arteriosus and oligohydramnios. During pregnancy, paracetamol or short ibuprofen courses in the second trimester are preferred.
Data on transfer into breast milk are limited. Breastfeeding is interrupted during therapy or alternative analgesics (paracetamol, ibuprofen) are used.
Nimesulide is evaluated for the following indications with varying evidence strength: Acute pain (evidence tier D), Chronic musculoskeletal pain (evidence tier F), Fever refractory to standard antipyretics (evidence tier F). See the full indication matrix with dosing and citations above on this page.
Common side effects of Nimesulide (≥ 1 in 100): Dyspepsia, nausea, diarrhea, Rash, pruritus, ALT/AST increase within 2× ULN, Headache, dizziness. See the Safety section for uncommon and serious reactions.
FDA category C. FDA category C (not registered in the US). Contraindicated in the third trimester – risk of premature closure of the ductus arteriosus and oligohydramnios. During pregnancy, paracetamol or short ibuprofen courses in the second trimester are preferred.
Data on transfer into breast milk are limited. Breastfeeding is interrupted during therapy or alternative analgesics (paracetamol, ibuprofen) are used.
Nimesulide is contraindicated in: Acute or chronic hepatitis, any active liver pathology; ALT or AST > 2× ULN; Age under 12; Pregnancy (especially third trimester), breastfeeding; Active peptic ulcer, GI bleeding. Full list in the Safety section.
No FDA boxed warning (the drug is not registered in the US). The EU and Russian labels explicitly highlight the risk of severe liver injury, including fulminant hepatic failure. EMA 2011 restricted course duration to 15 days.
GI risk is lower, but hepatotoxicity is higher. The overall risk-benefit balance is worse than for classic NSAIDs.
banned in children under 12 (EMA 2011, Russian label).
course is limited to 15 days. For chronic pain, paracetamol or selective COX-2 inhibitors (celecoxib) with better long-term safety data are used.