What is the use of nimesulide tablet? Applications, risks, and international status

October 6, 2025 •

3 min read

Nimesulide is a nonsteroidal anti-inflammatory drug (NSAID) used widely in numerous countries for its pain-relieving and fever-reducing properties, though it is restricted or unapproved in others due to safety concerns. So, what is the use of nimesulide tablet, and what are its potential benefits and serious risks, such as liver toxicity?

Quick Summary

Nimesulide is an NSAID with analgesic, anti-inflammatory, and antipyretic properties, primarily prescribed for short-term management of acute pain, fever, and dysmenorrhea due to concerns over liver toxicity.

Key Points

Acute Pain and Fever Relief: Nimesulide is prescribed for the short-term treatment of acute pain and fever in countries where it is approved.
Selective COX-2 Inhibition: It functions as a selective NSAID, primarily inhibiting the COX-2 enzyme to reduce inflammation and pain.
Not Approved in Many Countries: Due to significant liver toxicity risks, nimesulide is unapproved in the U.S. and has been restricted or withdrawn from several other countries.
Strict Usage Restrictions: In countries where it is available, use is limited to short durations (e.g., max 15 days) and specific conditions to mitigate liver risk.
Serious Liver Injury Risk: The most significant concern is hepatotoxicity, with severe, and sometimes fatal, liver injury reported even with short-term use.
Contraindications: Nimesulide is contraindicated in individuals with severe liver or kidney impairment, gastrointestinal bleeding, and during pregnancy.

Primary Uses of Nimesulide Tablets

Nimesulide is a nonsteroidal anti-inflammatory drug (NSAID) that provides pain relief, reduces inflammation, and lowers fever. In countries where it is approved, it's mainly used for short-term treatment of acute pain and inflammatory conditions.

Specific uses include managing various types of acute pain, such as musculoskeletal and post-operative pain. It is also effective for reducing acute fever and treating primary dysmenorrhea (painful menstrual cramps). Additionally, it can help with pain and inflammation from conditions like earaches or sore throats. Its use is strictly limited to short periods, typically no more than 15 days, to minimize side effects.

The Mechanism of Action and Multifactorial Effects

Nimesulide primarily works by inhibiting cyclooxygenase (COX) enzymes, which are involved in producing prostaglandins that cause pain and inflammation. It has a relative preference for inhibiting COX-2 over COX-1, potentially leading to fewer gastrointestinal issues than some other NSAIDs. Its effects are also attributed to other actions like reducing oxidant release and histamine from immune cells.

Serious Safety Concerns and International Status

The main safety concern with nimesulide is the risk of serious liver damage (hepatotoxicity). This has resulted in different regulatory statuses worldwide. It has never been approved in the United States and has been withdrawn from markets in several countries like Spain, Finland, and Ireland due to liver injury risks. The European Medicines Agency (EMA) has restricted its use in the EU to second-line treatment for acute pain and dysmenorrhea, with a maximum treatment duration of 15 days, and discontinued its use for chronic conditions. While liver injury is rare, it can be severe, potentially requiring liver transplant or leading to death. The risk exists even with short-term use.

Contraindications and Drug Interactions

Nimesulide should not be used by certain individuals or with particular medications.

Contraindications:

Severe liver or kidney problems.
Previous liver issues with nimesulide.
Active stomach bleeding or ulcers.
Severe heart failure or bleeding disorders.
Fever or flu-like symptoms.
Allergy to nimesulide, aspirin, or other NSAIDs.
Third trimester of pregnancy or breastfeeding.
Children under 12.

Drug Interactions:

Increases bleeding risk with anticoagulants like warfarin.
Can reduce the effect of diuretics like furosemide.
Should not be combined with other substances harmful to the liver, including alcohol.

Nimesulide vs. Other NSAIDs: A Comparison

Nimesulide differs from other NSAIDs like ibuprofen and diclofenac, particularly in its risk profile and international availability.


Feature	Nimesulide	Ibuprofen	Diclofenac
COX Selectivity	Preferential COX-2 inhibitor	Non-selective COX-1 and COX-2 inhibitor	Non-selective COX-1 and COX-2 inhibitor
Onset of Action	Relatively rapid (within 15-30 minutes)	Relatively rapid	Rapid
Primary Risk	Hepatotoxicity (liver damage), with concerns leading to market restrictions and withdrawals	Gastrointestinal (GI) side effects, including bleeding and ulcers	Gastrointestinal (GI) and cardiovascular risks, depending on formulation and dose
Long-Term Use	Not recommended due to liver toxicity risk	Can be used long-term under medical supervision for certain conditions	Use for chronic conditions is more established but requires monitoring
International Status	Unapproved in U.S., Canada, UK. Restricted (max 15 days) and for specific uses in EU.	Widely approved for over-the-counter and prescription use internationally	Widely approved, but with varying restrictions and risk warnings
Key Indication	Acute pain, fever, primary dysmenorrhea	Mild-to-moderate pain, fever, menstrual cramps, arthritis	Pain, inflammation, and rheumatic diseases

Administration and Considerations

For adults and adolescents over 12, nimesulide is typically taken after meals. The use should be for the shortest time needed to manage symptoms. Dosage adjustments may not be necessary for the elderly or those with mild-to-moderate kidney issues, but it is contraindicated in severe liver or kidney impairment.

Conclusion

In conclusion, nimesulide tablets are used for short-term relief of acute pain, inflammation, and fever in areas where approved. As a preferential COX-2 inhibitor, it acts quickly and may cause fewer GI issues than non-selective NSAIDs. However, the significant risk of serious liver toxicity has led to its restriction or withdrawal in many countries. If available, it must be used cautiously, under medical guidance, and only for limited durations. Report any signs of liver problems like nausea or dark urine to a doctor immediately. For further details on its safety and regulation, refer to the European Medicines Agency.

Frequently Asked Questions

A nimesulide tablet is primarily used for the short-term treatment of acute pain, inflammation, and fever in regions where it is medically approved.

No, nimesulide is not approved for use in the United States or several other countries, including Canada and the UK, mainly due to concerns over its liver toxicity risks.

It acts as a selective non-steroidal anti-inflammatory drug (NSAID) by preferentially inhibiting the cyclooxygenase-2 (COX-2) enzyme, which is responsible for producing prostaglandins that cause pain and inflammation.

In regions with regulatory guidelines, treatment with nimesulide is typically limited to a maximum of 15 days.

Common side effects include gastrointestinal issues like nausea and diarrhea. The most serious risk is severe liver toxicity, which can occur even with short-term use and requires immediate medical attention.

Nimesulide is contraindicated for individuals with severe liver or kidney disease, a history of gastrointestinal bleeding or ulcers, severe heart failure, and for pregnant or breastfeeding women.

No, due to the higher risk of liver toxicity with prolonged use, regulatory agencies like the European Medicines Agency (EMA) have restricted its use for long-term conditions such as painful osteoarthritis.

If a patient experiences symptoms of liver injury (e.g., anorexia, nausea, fatigue, dark urine), they should stop taking nimesulide immediately and inform their doctor.

While it is a relatively COX-2 selective NSAID, nimesulide can still interfere with platelet function and should be used with caution in patients with bleeding disorders.