Nimesulide is a non-steroidal anti-inflammatory, analgesic and antipyretic, which is used to relieve various types of inflammation, as well as fever or pain from a sore throat, headache or menstrual cramps, for example.
This medication can be purchased in pharmacies or drugstores in the form of tablets, capsules, drops, powder, suppositories or ointments, either as a brand name or as its generic name, nimesulide.
Although it is widely used in some countries, nimesulide has not been approved by the U.S. Food and Drug Administration (FDA) due to safety concerns, particularly the risk of liver injury. It is therefore not available for purchase in the United States.
Legal status
Nimesulide has not been approved by the FDA in the United States. Other countries such as Canada, the UK, Australia, New Zealand and Japan have also not authorized it.
In the European Union, the European Medicines Agency (EMA) allows its use as a second-line treatment for acute pain and primary dysmenorrhea in certain member states. Treatment is limited to a maximum of 15 days and a daily dose of 200 mg. Some EU countries, including Finland, Spain and Ireland, have withdrawn the drug over liver toxicity concerns.
In India, its use in children under 12 years was banned in 2011. In several Latin American countries, including Argentina, nimesulide has been withdrawn from the market.
Indications for use
Nimesulide can be prescribed to treat:
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Earache
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Sore throat
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Toothache
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Menstrual cramps
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Pain after dental surgery
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Osteoarthritis
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Fever
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Headache
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Joint pain
When used in the form of a gel or ointment, nimesulide can help to relieve pain from injuries to the tendons, ligaments, muscles and joints.
How to take nimesulide (dosing forms & usage guidelines)
Treatment with nimesulide varies depending on the form of the medication and the condition being treated.
Nimesulide is available as:
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Tablets (100 mg): 100 mg orally every 12 hours after meals
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Capsules (200 mg): One capsule orally once daily
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Oral suspension: 50 mg/mL, dose according to body weight
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Topical gels or ointments: Apply twice daily for 7–15 days
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Suppositories: 100 mg rectally every 12 hours
No dosage adjustment is needed for elderly patients or those with mild-to-moderate kidney impairment. Nimesulide should not be used in severe kidney or liver impairment, and it is contraindicated in children under 12 years.
If a dose is missed, it should be taken as soon as remembered unless it is almost time for the next dose. Under no circumstances should the dose be doubled. Treatment should always be as short as possible and oriented by a doctor, not exceeding 15 days according to EMA guidelines.
Alternatives to nimesulide
Several NSAIDs can be considered as alternatives depending on patient characteristics:
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Ibuprofen: 400 mg every 6–8 hours
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Diclofenac: 50 mg twice daily
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Celecoxib: 100–200 mg twice daily (lower GI risk but possible cardiovascular risk)
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Naproxen: 250–500 mg twice daily
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Meloxicam: 7.5–15 mg once daily
These alternatives may be preferred for some patients depending on safety profile, underlying health conditions, and potential contraindications.
Safety & side effects
The most common side effects of nimesulide include nausea, vomiting, diarrhea and abdominal pain. These effects are usually mild and temporary.
Less common side effects may include constipation, increased gas, dizziness, headache and skin reactions such as itching, rash or swelling.
Rare but serious side effects include liver-related complications, which may present as yellowing of the skin or eyes, dark urine, persistent nausea or fatigue. These events are more likely to occur within the first few weeks of treatment and require immediate medical attention.
Drug interactions & contraindications
Nimesulide should be used cautiously with anticoagulants (warfarin), as increased bleeding risk can occur. It can reduce the effectiveness of diuretics like furosemide and should not be combined with other hepatotoxic drugs (e.g., cyclosporine, alcohol).
It is contraindicated in:
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Severe liver or kidney impairment
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History of hepatotoxic reaction to nimesulide
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Active gastrointestinal bleeding or peptic ulcer
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Severe heart failure
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Pregnancy (especially third trimester) and breastfeeding
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Children under 12 years
Because of these contraindications, nimesulide should always be used with medical supervision and only when the potential benefits outweigh the risks.