Nisulid

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Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Nisulid

Property Description
Active ingredient Nimesulide
Form Tablet, Granules, Gel
Pharmacological class Non-Steroidal Anti-Inflammatory Drug (NSAID)
General purpose Pain, Inflammation, and Fever relief
Origin Synthetic (Chemically derived)

What Type of Medicine is Nisulid and What is its Composition?

Nisulid is the widely recognized brand name for a medication containing the active ingredient Nimesulide, which is officially classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID). Nimesulide is a synthetic compound, chemically defined as a sulfonanilide and an enolic acid derivative, and functions primarily as a Cyclooxygenase-2 (COX-2) selective inhibitor. Pharmacological studies have supported the compound's selective action on the inflammatory pathway, confirming its role as a targeted agent. This selective mechanism places Nimesulide in a distinct pharmacological sub-class compared to traditional NSAIDs. The drug is prepared as a single product whose therapeutic effect comes solely from the Nimesulide substance. It is commonly manufactured in multiple pharmaceutical preparations, including the solid Tablet and Granules for oral suspension for systemic use, and a Gel for Topical application, offering flexibility in the Route of administration depending on the acute need.

What is the General Purpose of Nimesulide?

The general purpose of Nimesulide is to provide symptomatic relief across the three principal manifestations of inflammation: pain, inflammation, and fever. This is achieved through its fundamental physiological actions, which are Analgesic (pain-relieving), Anti-inflammatory, and Antipyretic (fever-reducing). The medicine is clinically recognized for its effectiveness in rapidly managing acute inflammatory symptoms, such as the initial discomfort following a minor musculoskeletal injury. By modulating the biochemical processes involved in inflammation, this non-opioid medicine helps to diminish the intensity of pain and tissue swelling while simultaneously aiding in the reduction of an elevated temperature. As an NSAID, its role is to manage these symptomatic features within the context of acute inflammatory conditions.

Regulatory References

  1. NIH Substance Registration System

What side effects are possible with Nisulid?

The official safety profile for Nisulid (Nimesulide), classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID), categorizes potential unwanted effects based on frequency and affected body system, as documented in regulatory texts.

Adverse Reaction Classifications

Adverse reactions are organized into System-Organ Classes (SOCs) with common events primarily affecting Gastrointestinal disorders. These Common events include symptoms such as diarrhoea, nausea, and vomiting, along with reversible increases in hepatic enzyme levels. Uncommon reactions may include dizziness and skin reactions like rash or pruritus.

Serious Adverse Reactions and Restrictions

Significant safety concerns are typically classified as Rare or Very Rare. These include severe, potentially life-threatening conditions such as fulminant hepatitis and hepatic failure, as well as severe dermatological reactions like Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). The risk of severe gastrointestinal events, including ulceration, perforation, and haemorrhage, is also officially documented.

Population-Specific Safety Notes

The medicine is subject to specific safety constraints. It is Contraindicated in individuals with severe hepatic impairment, severe renal impairment, or active gastrointestinal ulceration. Official documentation also notes that Older Adults may be at an increased frequency risk for adverse reactions, particularly severe gastrointestinal bleeding. The documented risk patterns emphasize that treatment should be limited to the shortest possible duration.

Overdose and Emergency Response

Overdose and When to Seek Help: Official Regulatory Information

This information describes the documented risks and required emergency actions for Nisulid (nimesulide) overdose, based strictly on official government regulatory sources.


Documented Overdose Manifestations

In cases of acute overdose, official prescribing information lists the following clinical signs and symptoms:

  • Gastrointestinal Effects: Nausea, vomiting, and epigastric pain (upper abdominal discomfort).
  • Central Nervous System (CNS) Effects: Drowsiness (somnolence) and lethargy (tiredness).

Severe Outcomes and Toxicity

An acute overdose carries a risk of serious toxicity. The most severe outcomes explicitly documented include gastrointestinal haemorrhage and acute hepatic failure (severe liver damage), which has been reported as fatal in very rare cases. Patients are also monitored for potential impairment of renal (kidney) function.

Required Emergency Actions

  • Seek immediate medical attention for a suspected overdose. Regulatory documents classify this situation as potentially requiring urgent hospital treatment.
  • No Specific Antidote: There is no specific antidote available for nimesulide overdose. Management is symptomatic and supportive.
  • Procedural Steps: Officially described supportive measures include the potential use of gastric lavage and the administration of activated charcoal within the first four hours of ingestion for potentially life-threatening cases.

Therapeutic Uses of Nisulid

What Nisulid treats: Main Uses and Benefits

Symptomatic Relief for Acute Pain and Fever

This medication is used for managing symptoms related to physical discomfort, such as acute pain, and to help manage symptoms related to systemic imbalance, such as an elevated body temperature (fever). Nisulid is commonly used when short-term symptomatic assistance is needed and may help patients cope with difficult symptomatic periods.

It is relevant in conditions characterized by periods of heightened symptoms, including acute pain, the discomfort associated with primary dysmenorrhoea (menstrual pain), and symptoms linked to organ-specific functional stress, such as those during flare-ups of osteoarthritis.

Nisulid is commonly applied in contexts where discomfort arises from the musculoskeletal system, such as strains, sprains, or minor postoperative procedures. It is commonly used during phases when symptoms become more noticeable and is relevant in scenarios where additional management of discomfort is required following post-traumatic events. It contributes to easing the overall symptom load and supports the patient during difficult episodes by easing distress.

Quick Fact: Relief for Symptoms related to inflammatory or irritative states

Eligibility and Restrictions for Use

Eligibility and Contraindications

Nisulid (Nimesulide) is a restricted medication that must only be used as a second-line treatment when other options have failed. The use is strictly limited to the shortest possible duration, with a maximum of 15 consecutive days.

Populations Who MUST NOT Use Nisulid (Contraindicated)

Contraindicated Group Condition/Status
Age Restriction Children under 12 years of age.
Organ Impairment Any degree of Hepatic Impairment; Severe Renal Impairment (CrCl < 30 ml/min).
Gastrointestinal Risk Active gastric/duodenal ulceration, a history of recurrent ulceration, or Gastrointestinal bleeding/perforation.
Allergies Known hypersensitivity to nimesulide or a history of allergic reactions to Aspirin or other NSAIDs.
Other Severe heart failure, severe coagulation disorders, active bleeding (e.g., cerebrovascular), alcoholism, drug addiction, or concurrent fever/flu-like symptoms.

Pregnancy and Lactation Status

Nisulid is Contraindicated during the third trimester of pregnancy and while breastfeeding. It is also not recommended for women in the first two trimesters or for women attempting to conceive, as it may impair female fertility.

Populations Requiring Caution

Special caution and clinical monitoring are advised for older adults and for patients with mild to moderate renal impairment or cardiac impairment.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Nimesulide, the active ingredient in Nisulid, has officially documented interaction patterns that necessitate specific precautions or prohibitions when combined with other substances, as detailed in regulatory information.

Contraindicated and Non-Recommended Combinations

Regulatory authorities formally prohibit co-administration with other medicines classified as potentially hepatotoxic. Furthermore, use with other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including Acetylsalicylic Acid (Aspirin) at therapeutic doses, is not recommended due to an increased risk of complications, such as gastrointestinal bleeding. Similarly, the combination with anti-coagulant agents (e.g., Warfarin) is not recommended due to a heightened risk of bleeding and hemorrhage.

Pharmacokinetic and Exposure Alterations

Nimesulide is documented as an inhibitor of the Cytochrome P450 2C9 (CYP2C9) enzyme. This may result in increased plasma concentrations of medicines metabolized by this pathway. Specific drugs whose serum levels may be elevated due to reduced clearance include Lithium and Methotrexate.

Additionally, co-administration with the diuretic Furosemide may lead to a measurable reduction in Furosemide's cumulative excretion and its diuretic effect. Caution is also advised regarding the potential to increase plasma levels of Digoxin.

Population-Specific and Product Restrictions

Regulatory documents advise caution when combining Nimesulide and Furosemide in susceptible renal or cardiac patients. Patients are also advised to avoid alcohol abuse during treatment due to the documented risk of hepatic reactions.

Mechanism of Action

Nisulid, which is nimesulide, operates mechanistically as a relatively selective inhibitor of the enzyme Prostaglandin G/H Synthase 2 (also known as COX-2). This interaction occurs at the active site, blocking the conversion of arachidonic acid into prostaglandins. The targeted inhibition of COX-2 leads to a significant decrease in the intracellular synthesis and subsequent extracellular release of prostaglandins, which are key lipid mediators. This molecular action results in a modulation of cellular signaling cascades that are reliant on prostaglandin signaling. Furthermore, nimesulide exhibits non-COX-dependent mechanisms, including the inhibition of lactotransferrin and the scavenging of reactive oxygen species, particularly those released by activated neutrophils. The collective downstream consequence is a systemic reduction in the overall level of pro-inflammatory lipid mediators and proteolytic enzymes within circulating plasma and targeted tissues.

Dosage and Administration Information

Nisulid Official Administration Guidelines

Nisulid (nimesulide) is prescribed under guidelines that define its correct method of administration and maximum duration of use. The medicine is intended for short-term use only.


Dosage and Method of Administration

Patient Group Dose and Frequency Administration Instructions
Adults and Adolescents (over 12 years) 100 mg twice daily (bid) Take after meals (with food). Swallow the tablet whole with water.
Children (under 12 years) Contraindicated The medicine must not be used in this age group.
Renal Impairment (mild-to-moderate, creatinine clearance 30-80 mL/min) No dose adjustment necessary Follow the standard adult dosing regimen.

Duration and Treatment Limit

The maximum duration of a single treatment course with Nisulid must be limited to the shortest possible duration as required by the clinical situation and should not exceed 15 days. The lowest effective dose should always be used for the shortest time.


Procedural Summary

  1. Take the 100 mg tablet after consuming food.
  2. Swallow the tablet whole with a glass of water.
  3. Repeat the 100 mg dose approximately 12 hours later (twice daily).
  4. The entire course of treatment must be discontinued at the earliest time that symptoms allow, and in no case should it exceed 15 days.

These official instructions define the standardized procedure for using this medicine, emphasizing a fixed daily regimen and a strict constraint on the maximum treatment length.

Recent Clinical Evidence

Research evidence / Overview of studies for Nisulid

Evidence for Use in Acute Pain Syndromes

Research exploring how symptoms change over time in acute pain syndromes has been examined through short-term Randomized Controlled Trials (RCTs) and systematic reviews. These studies was evaluated in settings comparing the agent against placebo and other pain relievers to assess outcomes related to physical discomfort. The findings from these numerous studies describe patterns observed in the studies, particularly a measured change in pain scores and patient-reported outcomes describing perceived discomfort when compared to placebo groups over the short observation intervals.

However, the evidence remains limited regarding outcomes beyond the treatment course. The research provides insight into short-term changes, but there is limited information for outcomes extending beyond the 15-day maximum treatment window that regulators rely on. The evidence base provides limited insight into specific sub-groups of patients with complex comorbidities or severe, acute pain presentations.


Evidence for Use in Primary Dysmenorrhoea

Studies focusing on episodes where symptoms become more noticeable due to primary dysmenorrhoea (menstrual pain) primarily rely on short-term Randomized Controlled Trials (RCTs). These trials were applied in research contexts involving fluctuating or unstable symptoms in women and Adolescents. Comparative studies explored metrics related to symptom change when observing this agent against active comparators used for menstrual pain. Research explored measures of discomfort observed in these groups.

What remains uncertain is the durability of these patterns over extended use. Follow-up durations were limited, typically only covering one or a few menstrual cycles. Data are still emerging, and there is limited information for long-term outcomes associated with repeated use of the medication over many years.


Evidence for Use in Acute Musculoskeletal Injuries

The research describing how symptoms are measured for acute musculoskeletal injuries (like sprains and strains) centers on Randomized Controlled Trials (RCTs) that often utilize the topical gel formulation. Trials monitored changes measured during the study period, where patterns were described related to local pain change metrics and swelling assessment when comparing the group receiving the agent versus the topical placebo. Findings help contextualize how patients reported their experience regarding their local activity level. As the underlying conditions are acute and temporary, follow-up durations were limited to the recovery phase, typically around 4 to 10 days.

Frequently Asked Questions (FAQ)

Common questions about Nisulid (FAQ)

Q: What is Nisulid and what is it used for?

Nisulid (nimesulide) is a type of medicine known as a Nonsteroidal Anti-inflammatory Drug (NSAID). It works by reducing inflammation and pain in the body. It is mainly used to treat acute pain and to relieve the symptoms of osteoarthritis (a degenerative joint disease).

Q: How does Nisulid work?

Nisulid works by selectively blocking an enzyme called cyclooxygenase-2 (COX-2). This enzyme is responsible for producing inflammatory substances called prostaglandins at the site of injury or disease. By blocking COX-2, Nisulid helps to reduce pain, swelling, and fever.

Q: Who should not take Nisulid?

Nisulid is not suitable for everyone. You should not take Nisulid if you have:

  • A known allergy or hypersensitivity to nimesulide or any of the other ingredients, or to other NSAIDs (like aspirin or ibuprofen).
  • A history of bleeding in the stomach or intestine, or a stomach ulcer related to previous NSAID use.
  • Severe liver problems.
  • Severe kidney problems.
  • Severe heart failure.
  • The last three months of pregnancy.
  • Active gastrointestinal bleeding or peptic ulcer.

Q: Can I take Nisulid if I have a liver condition?

No. You should not take Nisulid if you have a severe liver problem. Nisulid is processed by the liver, and taking it with existing severe liver impairment can increase the risk of serious liver-related side effects. Always inform your healthcare provider about any liver conditions you have before starting treatment.

Q: What are the common side effects of Nisulid?

Like all medicines, Nisulid can cause side effects, though not everybody gets them. The most common side effects often involve the digestive system and may include:

  • Stomach upset or nausea (feeling sick).
  • Vomiting.
  • Diarrhea.
  • Minor changes in liver function tests (usually detected in blood tests).

Less common, but more serious side effects can affect the stomach, liver, and kidneys, especially with long-term use or in high doses.

Q: How long can I take Nisulid for?

Nisulid should only be used for the shortest possible duration to control your symptoms, and for a maximum of 15 days for treating acute pain or osteoarthritis symptoms. This is because using it for long periods increases the risk of serious side effects, particularly affecting the liver. Your healthcare provider will determine the appropriate duration for your condition.

Q: Does Nisulid interact with other medications?

Yes, Nisulid can interact with several other medications, which may change how they work or increase the risk of side effects. Important interactions include:

  • Anticoagulants (blood thinners, like warfarin) - Increases the risk of bleeding.
  • Corticosteroids - Increases the risk of stomach ulcers or bleeding.
  • Diuretics and some blood pressure medicines - Nisulid can reduce their effectiveness and may affect kidney function.
  • Lithium - Nisulid can increase lithium levels in the blood, potentially leading to toxicity.

Always provide your healthcare provider with a complete list of all medicines you are currently taking, including prescription, over-the-counter, and herbal supplements, before starting Nisulid.

How should Nisulid be stored and disposed of?

The storage and disposal of Nisulid (Nimesulide) must strictly adhere to the conditions documented in official product labeling to ensure stability and safety.

Storage Requirements

Condition Regulatory Rule
Temperature Store below 30 C or at controlled room temperature (e.g., 20 C to 25 C).
Protection Keep the product protected from light and moisture in a dry place.
Container Store in the original container with the packaging tightly closed.

Handling and Disposal

Storage must remain out of the sight and reach of children at all times. The medicine must not be used after the expiration date printed on the packaging.

For disposal, do not throw Nisulid into household waste or wastewater. Unused or expired medication must be discarded according to local regulations for pharmaceutical waste, which often involves designated collection points.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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