Нимесил

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Нимесил

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Medically reviewed

Rosario Oropesa

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 Нимесил

Property Description
Active ingredient Nimesulide
Form Granules for oral suspension
Pharmacological class Nonsteroidal Anti-inflammatory Drug (NSAID)
General purpose Symptomatic relief of pain, inflammation, and fever
Origin Synthetic compound (Sulphanilide derivative)

What Type of Medicine is Нимесил and What is its Primary Classification?

Нимесил is a synthetic pharmaceutical preparation containing the active compound Nimesulide, and is globally classified as a Nonsteroidal Anti-inflammatory Drug (NSAID). The preparation's core therapeutic purpose is to offer combined symptomatic treatment by simultaneously delivering analgesic (pain-relieving), anti-inflammatory, and antipyretic (fever-reducing) effects. The granules for oral suspension formulation is a key feature, designed for oral administration after dissolution in water.

Nimesulide is specifically recognized as a preferential Cyclooxygenase-2 (COX-2) Inhibitor, meaning its primary mechanism targets the COX-2 enzyme, a key driver of inflammatory pathways. This focused action is clinically recognized for managing acute discomfort, such as the symptoms associated with dental pain or musculo-skeletal strain. Nimesulide is used globally for its anti-inflammatory efficacy.

Composition of Нимесил: Active Ingredient, Chemical Type, and Form

The medicinal product Нимесил is a single-ingredient product containing the active substance Nimesulide. The prevalent dosage form is its unique presentation as granules for oral suspension, which is mixed with water just prior to ingestion. This form of administration is often associated with the rapid onset of its effect, which is a differentiating feature of the preparation.

Nimesulide is structurally identified as a sulphanilide derivative, which confirms its origin as a synthetic compound. The granules contain the active Nimesulide alongside excipients, ensuring that the entire therapeutic benefit—the anti-inflammatory, analgesic, and antipyretic action—is solely attributable to the controlled absorption and action of the Nimesulide molecule itself.

What side effects are possible with Нимесил?

Possible side effects and safety information

The official safety profile for Nimesulide, the active ingredient in Нимесил, outlines adverse reactions categorized by frequency and the body system affected. A critical regulatory focus is the documented risk of serious Hepatotoxicity (liver damage), including rare, severe, and fatal cases of fulminant hepatic failure. This risk dictates strict constraints on how the medicine can be used.

Adverse reactions are classified according to regulatory standards:

  • Common (affecting up to 1 in 10 people): Nausea, diarrhea, vomiting, and asymptomatic, transient elevation of liver enzymes.
  • Uncommon (affecting up to 1 in 100 people): Peripheral oedema (fluid retention) and hypertension.
  • Very Rare (affecting less than 1 in 10,000 people): Serious skin reactions (such as Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis), gastrointestinal perforation, and severe renal failure.

As an NSAID, Nimesulide carries the class-wide risk of serious Gastrointestinal Complications (e.g., bleeding and perforation) and an increased risk of Arterial Thrombotic Events (e.g., myocardial infarction and stroke). The risk of liver injury is associated with the length of exposure. Consequently, regulatory bodies mandate that treatment must be limited to the shortest possible duration and not exceed 15 days.

Specific safety constraints are detailed for certain populations. The medicine is contraindicated in patients with any degree of hepatic impairment, severe renal impairment, children under 12 years of age, and women in the third trimester of pregnancy.

Overdose and Emergency Response

Overdose Map: Overdose and when to seek help — Official Regulatory Information for Nimesulide

Overdose Scope

Property Official Regulatory Statement
Documented Overdose Presentations Symptoms may include lethargy, drowsiness, nausea, vomiting, and epigastric pain.
Physiological Systems Affected (as stated in label) Potential severe outcomes involve the gastrointestinal system (bleeding, ulceration), renal system (acute renal failure), and hepatic system (hepatic failure, rarely fatal).
Dose-related or Exposure-related Factors Overdose risk is associated with suspected ingestion exceeding the recommended dose.
Population-specific Overdose Notes Elderly patients are documented as being particularly susceptible to severe toxic effects of NSAID overdose, including fatal gastrointestinal bleeding.
Emergency-response statements Administration of activated charcoal (up to one hour post-ingestion) and gastric lavage (if indicated/within first four hours) may be considered to reduce absorption.
When immediate medical help is required It is required to seek immediate medical attention for all suspected cases of overdose and to contact emergency services or a poison control center right away.

Overdose Classifications (High-Level)

Classification Property Official Regulatory Statement
Severity classification Overdose may lead to severe or life-threatening outcomes, including hepatic failure and coma.
Regulatory basis Information derived from the regulatory prescribing documents (e.g., EMA SmPC equivalents and general NSAID toxicity summaries).
Overdose-context constraints Management requires symptomatic and supportive treatment and monitoring; no specific antidote is known.

Resulting Overdose Structure

Official Overdose Statements:

  • The official labeling documents lethargy, nausea, vomiting, and epigastric pain as documented manifestations of Nimesulide overdose.
  • Acute renal failure, gastrointestinal bleeding, and hepatic failure are listed as potential severe or life-threatening outcomes following an overdose.
  • No specific antidote is known for acute Nimesulide toxicity; treatment is required to be symptomatic and supportive.
  • All suspected overdose incidents mandate that the user seek immediate medical attention and contact emergency services.
  • Clinical monitoring and monitoring of renal and hepatic function are required components of post-overdose management.

Connection to the overall overdose profile: Regulatory documents define the Nimesulide overdose profile by identifying specific initial signs, such as drowsiness and epigastric pain, alongside the risk of severe systemic damage, particularly to the liver and kidneys. This profile mandates that immediate medical help must be sought for any suspected overdose due to the absence of a specific antidote and the documented potential for serious, life-threatening complications. Management is strictly described as consisting of symptomatic and supportive treatment under hospital monitoring conditions.

Therapeutic Uses of Нимесил

The core therapeutic purpose of Нимесил is to provide supportive symptomatic relief for acute states generally marked by a combination of physical discomfort, inflammation, and fever. The medication may be part of symptomatic management as it is applied in addressing symptoms related to physical discomfort, helps ease symptoms related to inflammatory states, and contributes to easing symptoms related to systemic imbalance.

The medication is considered relevant in scenarios marked by increased discomfort and is commonly used across conditions presenting with acute episodes. The primary indications include symptomatic support for acute pain stemming from minor trauma (sprains, strains) or post-operative discomfort, the management of painful osteoarthritis flares, and the easing of symptoms associated with primary dysmenorrhea. The use helps address symptom clusters that may become intense or disruptive.

This supportive relief may assist with maintaining functional stability and helps improve day-to-day comfort during symptomatic periods.


Quick Fact: Relief for Pain & Inflammation Нимесил is commonly used when short-term symptomatic assistance is needed in contexts involving heightened systemic burden, such as managing acute inflammatory pain or episodic menstrual discomfort.

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Nimesulide — Official Regulatory Information

Official regulatory documents strictly define the patient population eligible to use Nimesulide, primarily restricting its use to adults (18 years and older) for the shortest possible duration, not exceeding 15 days. It is officially classified as a second-line treatment option.


Contraindicated Populations (Must Not Use)

  • Age: Children under 12 years of age.
  • Organ Function: Patients with hepatic impairment, a history of hepatotoxic reactions to Nimesulide, or severe renal impairment (creatinine clearance < 30 ml/min).
  • Comorbidity: Patients with active peptic ulcer, recurrent ulceration/haemorrhage, severe heart failure, or active bleeding disorders.
  • Reproductive Status: Women in the third trimester of pregnancy and those who are breastfeeding.

Restricted or Conditional Use

  • Older Adults (Geriatric): Use requires careful clinical monitoring due to increased risks.
  • Early Pregnancy: Not recommended during the first and second trimesters.
  • Mild to Moderate Impairment: Patients with mild to moderate renal impairment require caution, though dose adjustment may not be necessary.

These explicit classifications, driven by regulatory bodies, determine who is permitted, restricted, or absolutely prohibited from using Nimesulide.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Nimesulide, the active ingredient in Нимесил, has officially documented interaction patterns that are primarily classified as pharmacokinetic and pharmacodynamic, according to regulatory labeling. These interactions can significantly alter the plasma concentrations of co-administered drugs or increase the risk of certain adverse events.

Pharmacokinetic Interactions (Exposure Modification)

Nimesulide is documented as an inhibitor of the Cytochrome P450 2C9 ( CYP2C9) enzyme. This inhibition may result in increased systemic exposure of other medicines that are substrates for CYP2C9. Furthermore, regulatory data indicates that Nimesulide can reduce the renal clearance of specific medicines, leading to increased plasma concentrations of agents such as Lithium and Methotrexate.

Timing-based caution is required if co-administration with low-dose Methotrexate occurs within 24 hours.

Pharmacodynamic Interactions (Risk Augmentation)

Co-administration with several medicinal product categories is documented to lead to an additive increase in risk. Combining Nimesulide with Anticoagulants (e.g., Warfarin), Antiplatelet agents, SSRIs, or systemic Corticosteroids is associated with an increased risk of gastrointestinal bleeding and ulceration. Monitoring of coagulation parameters is required during concurrent use with anticoagulants.

Nimesulide may also reduce the intended pharmacological effect of certain agents. Official labeling states that co-administration with Diuretics, ACE Inhibitors, or ARAs can lead to a reduction of the antihypertensive or diuretic effect. These combinations also pose an increased risk of worsening renal function. Interactions are officially noted as potentially more clinically significant in elderly patients.

Mechanism of Action

️ How Nimesil Works: Mechanism of Action

Selective Enzyme Inhibition and Pathway Modulation

The primary action of Nimesil is the selective inhibition of the Cyclooxygenase-2 ( COX-2) enzyme. This mechanism acts within the Arachidonic Acid Cascade, blocking the enzyme's ability to produce pro-inflammatory chemical messengers called prostaglandins . This targeted suppression of prostaglandin synthesis is the first molecular step that shapes the drug's overall resulting pathway consequences.

Dual Action on Pain Signaling and Thermoregulation

The mechanistic cascade translates into a dual physiological consequence by operating both peripherally (at tissue sites) and centrally (in the brain). By reducing prostaglandins, the drug attenuates the inflammatory cascade and decreases the sensitization of peripheral nociceptors in local tissues. Simultaneously, its central action in the hypothalamus modulates the hypothalamic set point for thermoregulation.

Constraining Excessive Physiological Responses

The drug engages mechanisms that influence pathways involved in heightened physiological responses that are largely driven by COX-2 activity. This effect is relevant across systems where targeted pathway adjustment is required to limit the generation of key inflammatory mediators, ultimately resulting in changes in mediator concentration within the targeted biological systems.

Dosage and Administration Information

How to Use Нимесил: Official Administration Guidelines

The use of Нимесил (Nimesulide 100 mg granules) follows specific protocols concerning the route, dosage, frequency, and duration of treatment.

Standard Dosage and Frequency

The medication is to be administered exclusively via the oral route (by mouth). The standard regimen for adults is fixed at 100 mg per dose, taken twice daily.

Administration Feature Official Instruction
Route of Administration Oral
Standard Adult Dose 100 mg per dose
Frequency Twice daily (b.i.d.)
Maximum Daily Dose 200 mg

Preparation and Intake Conditions

To ensure proper use, the contents of the single-dose sachet must be fully dissolved in a glass of non-carbonated water immediately before ingestion. Critically, the medication must be taken after meals (post-prandial).

Duration and Population Restrictions

The total treatment course for Нимесил is strictly time-limited. It must be used for the shortest possible duration required to manage symptoms, and in no case should the total treatment period exceed 15 days.

  • Pediatric Use: The medication is contraindicated for use in children under 12 years of age.
  • Older Adults: While dose reduction is not uniformly required, the prescribing physician must consider an individual risk assessment.

Recent Clinical Evidence

Research evidence / Overview of studies for Нимесил


Evidence for Acute Pain Relief and Inflammation

Research involving Nimesulide was evaluated in numerous short-term, randomized controlled trials (RCTs) and systematic reviews that focus on conditions associated with acute or disruptive episodes. These studies primarily included adults and adolescents over 12 years old who were experiencing outcomes related to physical discomfort, such as pain after dental procedures, orthopedic surgery, or minor traumatic injuries like sprains. Researchers monitored study participants to track outcomes related to systemic or functional imbalance.

The research explored comparisons of Nimesulide against inactive substances (placebo) and other active reference compounds in the same drug class. Findings describe patterns observed in the studies where the onset of measured pain changes was reported. Studies report how symptoms evolved in the observed populations during research exploring short-term symptom changes, indicating that the measured changes often aligned with those seen with other NSAIDs used in research exploring how symptoms change over time.

Evidence for Primary Menstrual Pain (Dysmenorrhea)

Nimesulide was studied for its application in conditions characterized by fluctuating or episodic manifestations, specifically primary dysmenorrhea (common menstrual pain). The research relies on short-term RCTs that examined participants during periods of increased symptom activity. These studies primarily focused on measuring outcomes related to physical discomfort, such as the reduction in pain scores, and other patient-reported outcomes describing perceived discomfort.

These findings help contextualize how patients reported their experience, noting measured changes in pain intensity that were generally consistent with those observed with other NSAIDs used in studies examining symptom intensity or variability. Research exploring outcomes related to secondary causes, such as endometriosis, remains insufficient.

What Research Gaps and Uncertainty Remain

The overall research landscape indicates that the available studies utilized limited follow-up durations across almost all key research. Long-term effects are not fully established because trials were not designed to examine the durability of the response beyond the short-term intervals studied. The certainty remains low regarding the clinical patterns associated with extended usage. Furthermore, data for certain groups remain insufficient, such as specific evidence focusing on older adults with complex health profiles.

Frequently Asked Questions (FAQ)

Common questions about Нимесил (FAQ)

Q: What is the main difference between Нимесил and common over-the-counter painkillers?

Official product information classifies Nimesulide, the active ingredient, as a selective Cyclooxygenase-2 ( COX-2) inhibitor belonging to the Nonsteroidal Anti-inflammatory Drug ( NSAID) class. Unlike many common painkillers, its use is often restricted as a second-line treatment option. Regulatory constraints limit the total duration of treatment to a maximum of 15 days due to documented safety concerns.

Q: Can Нимесил be used to treat pain from chronic conditions?

According to official regulatory decisions, Nimesulide is restricted to the treatment of acute pain and primary menstrual pain (dysmenorrhea). To minimize the risk of prolonged exposure, its use for chronic conditions, such as painful osteoarthritis, is generally advised against.

Q: Are allergic reactions to Нимесил common or severe?

Regulatory documents categorize allergic reactions by frequency. Hypersensitivity reactions are listed as rare, while very rare reactions include severe forms such as anaphylactoid reactions and serious skin disorders like Stevens-Johnson Syndrome.

Q: Is it true that the powder form is absorbed faster than solid pill forms of similar drugs?

Official pharmacokinetic studies indicate that the granule formulation is associated with a fast onset of analgesic activity. Peak plasma concentrations after taking the oral suspension are typically reached within a window of 1.22 to 2.75 hours.

Q: Is it necessary to take Нимесил after food, and why?

Official prescribing information describes the required administration of the medicine after meals (post-prandial). This approach is specified because taking the medication with food may help reduce the risk of gastrointestinal (stomach) upset.

Q: Is Нимесил considered a strong painkiller compared to other NSAIDs?

Clinical reviews and official documents describe Nimesulide as a nonsteroidal anti-inflammatory drug with significant activity. Studies indicate that its efficacy for treating acute pain is generally comparable to that of other reference compounds in the same drug class.

Q: What is the difference between the mechanism of action of Нимесил and paracetamol?

Nimesulide acts as a selective COX-2 inhibitor, blocking prostaglandins to provide pain relief, inflammation reduction, and fever reduction. Paracetamol (acetaminophen) is generally understood to have a different mechanism, primarily targeting pain and fever but lacking significant peripheral anti-inflammatory action.

Q: Are there any general warnings about taking Нимесил before or after surgery?

Official product information specifies that Nimesulide is contraindicated (must not be used) during the period following coronary artery bypass graft ( CABG) surgery. As an NSAID, the official documents indicate that use in perioperative settings requires careful consideration due to the potential to increase the risk of bleeding.

Q: What kind of monitoring is recommended during treatment with Нимесил?

Official safety warnings describe that treatment is generally discontinued if symptoms compatible with hepatic injury, such as dark urine, abdominal pain, or fatigue, develop. Additionally, patients considered to be at increased risk, such as older adults or those taking anticoagulants, are subjects for careful clinical monitoring as described in official labeling.

Q: How long does it usually take for Нимесил to start working?

Official pharmacokinetic data indicates Nimesulide has a fast onset of analgesic activity. Peak concentration levels in the blood are typically reached within 1.22 to 2.75 hours after the medicine is taken orally.

Q: How long do the pain-relieving effects of Нимесил typically last?

The duration of the drug's activity is considered when setting the officially described dosing intervals. The mean terminal elimination half-life of Nimesulide is reported to be between 1.80 and 4.73 hours.

Q: What are the signs of liver issues that a patient should be generally aware of?

Official product warnings describe that the medicine is generally discontinued if symptoms compatible with hepatic injury are experienced. These warning signs include a loss of appetite (anorexia), nausea, vomiting, abdominal pain, fatigue, or the development of dark urine.

Q: Why is Нимесил restricted or not approved for use in some countries?

Official regulatory decisions indicate that restrictions are primarily due to the drug's risk profile. Systemic Nimesulide carries an increased risk of serious hepatotoxicity (liver damage), including rare, severe, and potentially fatal cases of fulminant hepatic failure.

Q: Can Нимесил be taken with alcohol?

Official regulatory warnings state that the concomitant use of Nimesulide with alcohol abuse is a situation to avoid. This is specified due to the potential for alcohol to increase the risk of hepatic reactions (liver issues) associated with the medicine.

Q: Does Нимесил cause drowsiness or affect a person's ability to concentrate?

Official regulatory documents list central nervous system effects such as dizziness (uncommon) and drowsiness (very rare) as possible undesirable effects. Labeling indicates that caution is generally required when performing tasks like driving or operating machinery if these effects are experienced.

Q: What happens if a dose of Нимесил is missed?

Official general patient information describes that when a dose is missed, taking a double dose to compensate is generally avoided. The recommended approach described is to continue taking the medicine at the next regularly scheduled time.

Q: What is the purpose of the sugar or flavoring components in the granule sachet?

The sugar and flavoring components are inactive excipients, which are substances added to the product for formulation purposes. According to official product composition, these components are included primarily to improve the palatability and taste of the oral suspension, which supports the proper use of the medicine.

Q: Is it true that patients with asthma have restrictions on using Нимесил?

Yes, the official contraindications state that Nimesulide is generally avoided in patients with a history of hypersensitivity reactions to aspirin or other NSAIDs. These reactions include conditions such as bronchial asthma or bronchospasm.

Q: Can the powder be mixed with liquids other than plain water?

The official instructions for use describe the requirement that the contents of the sachet are fully dissolved in a glass of non-carbonated water. Regulatory documents do not provide information or confirmation regarding mixing the powder with alternative liquids.

How should Нимесил be stored and disposed of?

How to Store and Dispose of Нимесил?

Strict adherence to official storage and disposal requirements is essential for maintaining product stability and safety. Нимесил (Nimesulide) must be kept out of the sight and reach of children to prevent accidental ingestion.

Storage and Handling Constraints

Requirement Official Regulatory Instruction
Temperature Store in a dry place at a controlled temperature, typically below 25 C (77 F).
Protection Keep the medicine in its original container and protect it from moisture and direct heat.
Accessibility Keep locked up and out of the reach of children.

Disposal Instructions

To discard expired or unused medicine, do not flush it down a toilet or pour it into a drain unless specifically instructed by an official guideline. The primary disposal method is through a medication take-back program. If a take-back program is unavailable, mix the product with an unpalatable substance (such as kitty litter or coffee grounds), seal it in a container, and place it in the household trash. Disposal must conform to local, regional, and national waste regulations.

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

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