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Nimesulide

Antiinflammatory and antirheumatic agents, non-steroids. Other NSAIDs

ATC code: M01AX17

Brand names: Nimesulide, Aulin

Updated · Methodology

Indications

D

Acute pain

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.

Sources

  1. ГРЛС: Нимесулид – Государственный реестр лекарственных средств (2024)

ICD-10: R52.0 · ICD-11: MG31

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

F

Chronic musculoskeletal pain

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.

Sources

  1. PLoS One: Nimesulide-induced hepatotoxicity: A systematic review and meta-analysis. (2019)
  2. Arch Toxicol: Serious liver injury induced by Nimesulide: an international collaborative study. (2021)
  3. Clin Liver Dis: Nonsteroidal anti-inflammatory drug-induced hepatotoxicity. (2007)

ICD-10: M79.1 · ICD-11: MG30.3

F

Fever refractory to standard antipyretics

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.

Sources

  1. Clinical Gastroenterology and Hepatology: Drug-induced Liver Injury in Latin America: 10-year Experience of the Latin American DILI (LATINDILI) Network (2025)
  2. Digestive and Liver Disease: Comment on: Severe hemolytic anemia and fatal hepatic failure associated with nimesulide (2009)
  3. Ann Ist Super Sanita: Effects of the European restrictive actions concerning nimesulide prescription: a simulation study on hepatopathies and gastrointestinal bleedings in Italy. (2010)

ICD-10: R50.9 · ICD-11: MG26

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

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.

Safety

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.

Contraindications

  • 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
  • NSAID-induced asthma, urticaria, angioedema
  • Severe heart failure
  • Severe renal impairment (eGFR < 30 mL/min/1.73 m²)
  • Co-administration with other hepatotoxic drugs
  • Alcoholism, substance abuse

Serious adverse effects

  • Fulminant hepatic failure
  • Cholestatic hepatitis
  • Anaphylactic reactions
  • Stevens-Johnson syndrome, toxic epidermal necrolysis
  • Acute renal failure

Common adverse effects

  • Dyspepsia, nausea, diarrhea
  • Rash, pruritus
  • ALT/AST increase within 2× ULN
  • Headache, dizziness

Uncommon adverse effects

  • Arterial hypertension, edema
  • GI bleeding, mucosal erosions

Pregnancy: can you take Nimesulide?

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.

Breastfeeding: can you take Nimesulide?

Data on transfer into breast milk are limited. Breastfeeding is interrupted during therapy or alternative analgesics (paracetamol, ibuprofen) are used.

Calculate RID

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Timing and administration

Taken after meals with water. Standard single dose 100 mg, twice daily. Course no longer than 15 days.

Monitoring

Baseline ALT and AST are obtained. The drug is not prescribed if transaminases exceed 2× ULN. LFTs are repeated at 7–10 days for courses over 7 days. Onset of jaundice, dark urine, right upper quadrant pain, nausea or persistent vomiting requires immediate discontinuation and physician consultation.

Special situations

Not combined with other hepatotoxic drugs (high-dose paracetamol, methotrexate, isoniazid, amiodarone). Not combined with alcohol. Contraindicated in chronic liver disease. In patients over 65 and in heart failure, cardiovascular NSAID risk is assessed.

Common myths

Myth: «Nimesil is safer for the stomach than ibuprofen and diclofenac». Fact: GI risk is lower, but hepatotoxicity is higher. The overall risk-benefit balance is worse than for classic NSAIDs.

Myth: «can be given to children for fever». Fact: banned in children under 12 ( 2011, Russian label).

Myth: «Nise is a long-term anti-inflammatory for arthrosis». Fact: course is limited to 15 days. For chronic pain, paracetamol or selective COX-2 inhibitors (celecoxib) with better long-term safety data are used.

Drug–drug interactions

1 pair found. Sorted from critical to minor.

CriticalKetorolacNon-steroidal anti-inflammatory drugs (NSAIDs)

Mechanism

Ketorolac is a potent non-selective NSAID; nimesulide is a selective COX-2 inhibitor. Despite different selectivity, gastrointestinal and renal effects are additive. Toradol Section 4.3 specifically lists all NSAIDs as contraindications.

Symptoms

Black or tarry stools (melena), vomiting blood or coffee-ground material, epigastric pain. Acute kidney injury and a rise in blood pressure are also possible. Risk of bleeding multiplies in patients over 65 and with prior peptic ulcer disease.

Management

The combination is not prescribed. Use one NSAID at the minimum effective dose with PPI cover (pantoprazole). Alternative: paracetamol as baseline analgesia.

Sources

Pair details →Ketorolac →

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Frequently asked

What is Nimesulide used for?

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.

What are the side effects of Nimesulide?

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.

Is Nimesulide safe during pregnancy?

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.

Is Nimesulide compatible with breastfeeding?

Data on transfer into breast milk are limited. Breastfeeding is interrupted during therapy or alternative analgesics (paracetamol, ibuprofen) are used.

Can you drink alcohol while taking Nimesulide?

Not combined with alcohol.

Who should not take Nimesulide?

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.

Does Nimesulide carry an FDA 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.

Nimesil is safer for the stomach than ibuprofen and diclofenac

GI risk is lower, but hepatotoxicity is higher. The overall risk-benefit balance is worse than for classic NSAIDs.

can be given to children for fever

banned in children under 12 (EMA 2011, Russian label).

Nise is a long-term anti-inflammatory for arthrosis

course is limited to 15 days. For chronic pain, paracetamol or selective COX-2 inhibitors (celecoxib) with better long-term safety data are used.

Official sources

Direct links to regulator labels. Open in a new tab.

Other drugs in this group

Proteolytic enzyme complex (bromelain, papain, pancreatin, trypsin, chymotrypsin, rutoside), Aceclofenac, Boswellia, Celecoxib, Diclofenac, Ibuprofen, Lornoxicam, Dexketoprofen

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