Efridol

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Efridol

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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 Efridol

This foundational section defines the medicine Efridol, its composition, classification, and general purpose, strictly excluding details on dosages, specific treatment protocols, side effects, or warnings.

Property Description
Active ingredient Nimesulide
Forms Tablet, Granules for Oral Suspension, Topical Gel
Pharmacological class Nonsteroidal Anti-inflammatory Drug (NSAID)
General purpose Relieves pain, reduces inflammation, lowers fever
Origin Synthetic (Sulfonanilide derivative)

What is Efridol and What Class of Medicine is it?

Efridol is the trade name for a product containing the active pharmaceutical ingredient Nimesulide, which is broadly classified as a Nonsteroidal Anti-inflammatory Drug (NSAID). Chemically, Nimesulide is a synthetic compound, specifically a sulfonanilide derivative, formulated as a single-component product. Nimesulide belongs to the group of oxicams or enolic acid derivatives, further refining its structural classification. This classification reflects its application in addressing inflammatory symptoms.


The Active Ingredient: Nimesulide's Selective Action and General Purpose

Nimesulide is recognized as a second-generation NSAID because it demonstrates a preferred or selective inhibition of the Cyclooxygenase-2 (COX-2) enzyme, which is primarily responsible for producing inflammatory chemicals. This selective mechanism is central to the drug's overall general purpose: to function as an anti-inflammatory, an analgesic (pain-relieving), and an antipyretic (fever-reducing) agent. Nimesulide is used for its role in reducing the body's response to inflammation. The medicine is typically used for the general management of discomfort associated with inflammatory states.


Efridol Forms: Systemic Tablets, Granules, and Topical Gel

Efridol is available in several high-level preparations, including tablets and granules for oral suspension for systemic absorption, and a topical gel for localized external use. The availability of the oral granules for suspension is a differentiating factor, offering an alternative to solid tablets for some patients. The topical gel, utilizing a specific gel matrix, is positioned for targeted relief by delivering Nimesulide directly to local tissues via the skin. This variety in formulation enhances the utility of Efridol for both generalized and specifically targeted relief of inflammation.

What side effects are possible with Efridol?

Possible Side Effects and Safety Information: Efridol (Nimesulide)

Efridol (Nimesulide) is a non-steroidal anti-inflammatory drug (NSAID) whose safety profile requires particular attention due to risks of severe liver injury (hepatotoxicity).

Serious and Clinically Significant Adverse Reactions

The most significant safety concern associated with Efridol is the risk of severe hepatic reactions, which include acute hepatitis, liver failure, and in rare cases, outcomes requiring liver transplantation or resulting in death. This risk is present even following short-term use, prompting regulatory restrictions on duration.

Other serious, though rare, adverse reactions that have been reported with NSAIDs include:

  • Gastrointestinal bleeding, ulceration, or perforation.
  • Severe skin reactions, such as Stevens-Johnson syndrome.
  • Exacerbation of pre-existing severe heart failure.

Key Adverse Reactions and Frequencies

Adverse reactions commonly reported (in 1% to 10% of patients) often involve the gastrointestinal system and include:

  • Diarrhea
  • Nausea
  • Vomiting
  • Dizziness

Less common side effects may involve the nervous system (e.g., somnolence) and skin (e.g., rash, pruritus).

Regulatory Restrictions and Contraindications

To mitigate the risk of hepatotoxicity, regulatory authorities have placed strict limitations on the use of Efridol:

  • Duration of treatment is restricted to a maximum of 15 days.
  • It is contraindicated in individuals with a history of hepatotoxic reactions to Nimesulide.
  • Contraindications also include active gastrointestinal ulcer or bleeding, severe heart failure, severe renal impairment, and hepatic impairment.
  • Use is generally contraindicated in children under 12 years of age and during pregnancy.

Overdose and Emergency Response

Overdose and When to Seek Help

This information describes the documented profile of Nimesulide overdose based strictly on government regulatory documents.

Overdose Scope
Documented Overdose Presentations: Nimesulide overdose may present with nausea, vomiting, and epigastric pain. Central nervous system effects such as lethargy, drowsiness, confusion, and in severe cases, convulsions, are officially noted. Fluctuations in tachycardia and blood pressure have also been documented.
Physiological Systems Affected: The systems of highest regulatory concern include the hepatic system (potential for fulminant hepatic failure), the renal system (risk of acute failure), and the gastrointestinal system (risk of severe bleeding).
Population-Specific Overdose Notes: Overdose with the topical gel formulation is not expected due to low systemic absorption. Elderly patients are recognized as being particularly susceptible to severe NSAID adverse effects, necessitating closer monitoring.
When Immediate Medical Help is Required: Regulatory documents mandate that immediate medical attention or urgent hospital treatment is required following any suspected overdose. Contact a Poisons Information Center or emergency medical services without delay is the required action.
Antidote Status: No specific antidote is known for Nimesulide overdose.

Resulting Overdose Structure

The regulatory profile defines the overdose situation by emphasizing the severe potential for organ failure and gastrointestinal hemorrhage. This risk necessitates that urgent medical assistance be sought immediately. Management is strictly symptomatic and supportive, which includes mandatory monitoring of renal and hepatic function—a key requirement reflecting the drug’s recognized toxicological profile in official documentation.

Therapeutic Uses of Efridol

What Efridol Treats: Main Uses and Benefits

Efridol is commonly used for short-term symptomatic relief and is applied in clinical settings that involve acute or unstable symptom patterns. Its role is to support the management of difficult episodes by easing the overall symptom load. The medication's therapeutic uses are relevant across symptom axes associated with acute pain, the symptomatic management of discomfort related to conditions like osteoarthritis, and the easing of challenging symptoms related to primary dysmenorrhoea (menstrual pain).

The medication is applied in situations where additional symptomatic support is needed for certain distressing symptoms, helping to ease physical distress during temporary acute phases.


Easing Acute Symptom Burdens and Functional Strain

Efridol is relevant in contexts marked by increased discomfort or tension, such as when symptoms related to physical discomfort or inflammatory states appear suddenly and create noticeable physiological strain. It is commonly used to help with symptom clusters that may become intense or disruptive, providing support that helps ease the overall burden of symptoms during a temporary acute phase. This supportive relief assists with maintaining functional stability during episodes of heightened discomfort.


Quick Fact: Used for managing Episodic Symptom Flares


Regulatory References

  1. European Medicines Agency Nimesulide referral

Eligibility and Restrictions for Use

Who can and cannot use Efridol?

Official regulatory information strictly defines the patient population eligible for Efridol (Nimesulide) through specific exclusions and restrictions based on age, organ function, and pre-existing conditions.

Populations Allowed Systemic use is permitted for adults and adolescents aged 12 years and older for approved short-term indications. The regulatory profile notes that older adults may use the medicine but advises appropriate clinical monitoring.

Absolute Contraindications Efridol is formally contraindicated and must not be used by children under 12 years of age. Use is strictly prohibited for patients with any degree of hepatic impairment or active liver disease, severe renal impairment (creatinine clearance below 30 mL/min), severe heart failure, or a history of active gastrointestinal ulceration or recurrent bleeding. Patients with severe coagulation disorders, alcoholism, drug addiction, and those with known hypersensitivity to the drug are also excluded.

Conditional and Restricted Use The medicine is contraindicated during the third trimester of pregnancy and is not recommended for use in the first two trimesters or while breastfeeding. Use is restricted and requires caution in patients with mild to moderate renal impairment.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official interaction profile of Efridol (Nimesulide) is defined by its effects on drug metabolism and additive pharmacodynamic risks, as documented in government regulatory labeling.

Interaction Classification Documented Substances and Effects
Contraindicated Combinations Co-administration is prohibited with other potentially hepatotoxic substances (e.g., paracetamol), with the simultaneous use of other Nonsteroidal Anti-inflammatory Drugs (NSAIDs), and in cases of alcohol abuse.
Metabolic Interactions Efridol acts as an inhibitor of the CYP2C9 enzyme, a mechanism that may increase the plasma concentration of co-administered CYP2C9 substrate drugs, such as Warfarin or Phenytoin.
Pharmacodynamic Risks Concomitant use with anticoagulant agents (Warfarin, Acenocoumarol), anti-platelet agents (Acetylsalicylic acid), or Selective Serotonin Reuptake Inhibitors (SSRIs) increases the formally documented risk of bleeding complications.
Exposure Alterations Efridol may reduce the clearance of Lithium, potentially leading to elevated plasma levels and toxicity. It may also increase the serum concentration of Methotrexate and enhance the nephrotoxicity of Cyclosporine.
Timing Rules Caution is required if administered less than 24 hours before or after treatment with Methotrexate to manage the risk of increased toxicity.

The interaction profile reflects both pharmacokinetic and pharmacodynamic constraints. These include the risk of diminished efficacy when combined with Diuretics (e.g., Furosemide) and Antihypertensive drugs. Additionally, elderly patients and those with existing renal or cardiac impairment are noted in official labeling as having an increased susceptibility to interaction-related adverse effects, necessitating caution.

Mechanism of Action

Efridol, with the active ingredient Nimesulide, operates through a distinct pharmacodynamic mechanism primarily defined by the selective inhibition of the Cyclooxygenase-2 (COX-2) enzyme. This enzyme is induced at sites of tissue insult.

Selective Inhibition of COX-2

The drug functions as a competitive, reversible inhibitor, binding to the COX-2 active site and preventing the conversion of arachidonic acid into pro-inflammatory mediators, specifically prostaglandin PGE2. This molecular action fundamentally limits the biochemical precursors necessary for the inflammatory process to escalate.

Systemic Physiological Modulation

Suppression of prostaglandin synthesis modulates two system-level responses. Peripherally, reduced PGE2 diminishes the chemical sensitization of nerve endings, supporting the maintenance of the normal pain signaling threshold. Centrally, inhibition of PGE2 in the hypothalamus prevents the upward reset of the thermal set-point, facilitating the physiological process of temperature homeostasis.

Beyond COX-2, the mechanism also involves the modulation of ancillary enzymes, including certain Matrix Metalloproteases, which are associated with tissue degradation, contributing to the overall anti-inflammatory physiological effect.

Dosage and Administration Information

How to Use Efridol: Administration and Dosing

Efridol, containing Nimesulide, is used according to administration protocols intended for acute, short-term symptomatic relief. Usage principles are standardized across approved dosage forms to ensure correct application and adherence to the minimum effective dose principle.

Approved Administration and Dosage Forms

Efridol is administered through Oral (systemic) and Topical (local) routes. Systemic forms include Tablets and Granules for Oral Suspension (typically 100 mg strength), while the local form is a Gel (3% w/w).

Standard Systemic Dosing and Timing

Parameter Instruction
Standard Dose 100 mg per dose
Frequency Twice a day (bid)
Maximum Daily Dose 200 mg
Timing with Food Must be taken after a meal

Duration and Population-Specific Rules

Systemic treatment is limited to the shortest possible duration, with a maximum course length of 15 days. The systemic use of Nimesulide is contraindicated in children under 12 years and in individuals with hepatic or severe renal impairment. For localized relief, the topical gel is applied to the affected area 2 to 3 times daily. No standard dosage adjustment is generally required for the elderly or for adolescents aged 12 to 18 years.

Recent Clinical Evidence

Research Evidence: Overview of Studies for Efridol (Nimesulide)

This overview summarizes the key types of research studies that have been conducted to evaluate Efridol (Nimesulide), detailing the study populations, outcomes measured, and the limitations noted in regulatory and scientific reviews. It is intended to describe the research landscape, not to offer clinical advice or recommend treatment.


Evidence for Use in Acute Pain and Fever Reduction

Research exploring the properties of Efridol concerning acute pain primarily relies on short-term randomized controlled trials (RCTs) that compared the compound against both inactive placebos and other active agents. The key outcomes monitored in these trials were related to physical discomfort, specifically measuring changes in pain intensity using standardized scales, and monitoring the time to the start of measured symptom changes in adults. For antipyretic activity, this was often evaluated as a secondary part of larger pain trials, where research examined temporary physiological imbalance by monitoring the change in body temperature and the duration of the fever. Long-term patterns are not fully established for acute pain, as the research designs did not involve extended follow-up.


Evidence for Symptomatic Management of Osteoarthritis

Efridol was studied for its use in addressing symptoms related to osteoarthritis (OA). The evidence base includes medium-term RCTs and observational settings. Researchers assessed how the research evaluated outcomes reflecting daily functioning or activity level, primarily through scales like the WOMAC index, as well as patient-reported pain scores. Data regarding the patterns beyond this limited window remain insufficient. The follow-up durations were often limited to three months, meaning there is limited information for long-term outcomes or the consequences of use over many years. Findings primarily focus on measures of symptom change rather than objective changes to the joint or disease modification.


Key Evidence Gaps and Areas of Scientific Uncertainty

The research provides context but not individual predictions. Findings describe group patterns, and the evidence highlights what is known and where research still needs to grow. The primary gaps noted in the evidence landscape include: limited information for long-term outcomes relating to continuous or repeated use, and data for certain groups remain insufficient, especially for complex patient cohorts or for specific age brackets (e.g., older adults) where the research base is less extensive than in the general adult population.

Key Studies & References Efficacy and safety of nimesulide in the treatment of osteoarthritis: a systematic review of the literature

Frequently Asked Questions (FAQ)

Common questions about Efridol (FAQ)


Q: How long does it typically take for people to notice the effects of Efridol?

Clinical data indicate that Efridol exhibits a rapid absorption profile. Reduction in pain and inflammation has been observed in some individuals within 15 minutes after taking the oral form. This quick action is consistent with the medicine's designation for acute, short-term symptomatic relief.


Q: Does Efridol have an official rating for drowsiness or driving safety?

Official documents state that Efridol may cause side effects such as dizziness or somnolence (drowsiness). For this reason, the regulatory advice is to avoid driving or operating complex machinery until it is known how the medicine affects the individual’s ability to concentrate. This is a common precaution for medications affecting the central nervous system.


Q: What types of food, if any, have been noted to interact with Efridol?

Official instructions indicate that the medicine should be administered after a meal. This timing is intended to help reduce the possibility of gastrointestinal side effects like nausea or stomach upset. Clinical data indicates that taking the medicine with food does not significantly impact how well the body absorbs it.


Q: Does Efridol interact with the common cold or flu medications sold over-the-counter?

The regulatory documents state that the medicine should not be taken with other Nonsteroidal Anti-inflammatory Drugs (NSAIDs). It also must not be taken with potentially liver-toxic substances, such as paracetamol, which is a common ingredient in many over-the-counter cold and flu remedies. Regulatory documents warn that combining these types of substances may significantly increase the risk of serious side effects.


Q: Is Efridol known to cause a metallic taste in the mouth?

While not listed among the most common adverse reactions, official reports include a side effect described as bitterness in the mouth. This has typically been reported in individuals receiving continuous treatment. If unusual changes are experienced, professional guidance should be sought.


Q: How long does Efridol usually stay active in the body after a dose?

The length of time the medicine stays active in the body is measured by its half-life, which is the time it takes for the concentration to reduce by half. Official pharmacokinetics data indicates that the mean terminal elimination half-life for Efridol is typically between 1.8 and 4.7 hours.


Q: Does Efridol affect appetite or cause changes in weight?

Regulatory documents list loss of appetite (anorexia) as a reported side effect. While not one of the most common issues, this change is documented in the safety profile. If a persistent change in appetite is noted while the medicine is being taken, consulting a healthcare professional is advisable.


Q: Is Efridol available over-the-counter in any country?

Nimesulide, the active ingredient in Efridol, is generally classified as a Prescription Only Medicine (℞) in the countries where it is approved. This means it requires a valid prescription from a licensed healthcare provider before it can be dispensed.


Q: What is the recommended approach for a missed dose of Efridol?

Official guidance states that if a dose is missed, it should be taken as soon as it is remembered, unless it is almost time for the next scheduled dose. If that is the case, the missed dose should be skipped and the regular schedule resumed. Taking a double dose to compensate for a missed one is explicitly discouraged.


Q: Is there a specific monitoring requirement, like regular blood tests, when taking Efridol?

The medicine has a strict limitation of 15 days of continuous use to mitigate risks of liver injury. If, in exceptional circumstances, treatment duration exceeds 15 days, regulatory warnings advise that liver function tests should be performed periodically. Treatment should be immediately discontinued if signs of liver injury or abnormal liver test results occur.


Q: Is Efridol considered a drug that needs a special type of prescription?

Efridol is classified as a Prescription Only Medicine (℞). This means that a valid prescription from a licensed professional is required for it to be dispensed. This regulatory classification is standard for medications of this type.


Q: Is Efridol known to cause hair loss or skin changes?

Official regulatory documents mention that the medication can be associated with rare but serious skin reactions, such as Stevens-Johnson syndrome. Less common effects involving the skin also include a general rash or pruritus (itching). Hair loss is not typically listed among the common side effects.


Q: Do older adults experience different types of side effects from Efridol than younger people?

While no standard dose adjustment is needed for older adults, regulatory warnings indicate that this population has an increased susceptibility to adverse effects affecting the digestive system, kidneys, liver, and heart. For this reason, appropriate clinical monitoring is generally advised for older patients receiving treatment.


Q: What research has been done on Efridol's effect on sleep patterns or insomnia?

The official product information lists somnolence (drowsiness) as a less common side effect related to the nervous system. However, regulatory documents do not provide extensive research findings on the medication's specific impact on overall sleep patterns or insomnia.


Q: Can Efridol affect blood sugar levels?

The official interaction profile notes that Efridol may interfere with the effects of certain antidiabetic medicines, such as insulin and oral hypoglycemics. If a patient is taking this medication along with antidiabetics, caution is required due to the potential for altered blood sugar control.


Q: Can Efridol be used by people who have sensitivities to gluten or lactose?

Regulatory labeling warns that some formulations of the medicine may contain excipients, such as lactose. Therefore, individuals who have an intolerance to certain sugars should seek guidance from a healthcare professional before initiating treatment. This information is usually detailed in the package leaflet or SmPC.


Q: Does Efridol have any known effects on fertility in men or women?

As Efridol belongs to the class of Nonsteroidal Anti-inflammatory Drugs (NSAIDs), its use may temporarily impair female fertility. For this reason, official guidance generally advises against using this medicine in women who are actively trying to conceive.


Q: Is there a Black Box Warning associated with Efridol in the U.S.?

Efridol, which contains Nimesulide, has not been approved for sale or marketing by the US Food and Drug Administration (FDA). Therefore, it does not carry an FDA Black Box Warning, a specific regulatory requirement for drugs marketed in the United States.

How should Efridol be stored and disposed of?

Efridol (Nimesulide) must be stored and disposed of according to the requirements stated in the official regulatory labeling.

Labeled Storage and Stability

Condition Requirement
Temperature Store below 25 C (controlled room temperature).
Protection Keep in the original package to protect from moisture.
Stability Oral granules must be used immediately after reconstitution; storage of the mixed suspension is not permitted.

Official Handling and Disposal

All medicine must be kept out of the sight and reach of children.

Do not dispose of unused or expired Efridol via household waste or by flushing it down the wastewater system. To protect the environment, dispose of the medicine by returning it to a pharmacist or using a local official medicine take-back program.

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

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