Tufnil

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Tufnil

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Medically reviewed

Laura Arias

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 Tufnil

Quick Facts

Property Description
Active ingredient Tolfenamic Acid (Acidum tolfenamicum)
Form Tablet, Capsule (Oral)
Pharmacological class Non-Steroidal Anti-Inflammatory Drug (NSAID)
Common purpose General Analgesia, Anti-inflammation, Antipyresis
Origin Synthetic Compound (Fenamate)

What Type of Medicine is Tufnil?

Tufnil is a product containing the active ingredient Tolfenamic Acid, which is formally classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID). This places it within the fenamate chemical subgroup, derived from anthranilic acid. Tolfenamic Acid is the International Nonproprietary Name (INN) for this single-component pharmaceutical agent. Tufnil is typically intended for oral administration, available in solid dosage forms such as tablets and capsules. The compound is an established analgesic and anti-inflammatory agent.

Composition and Origin: Is Tolfenamic Acid Synthetic?

The substance Tolfenamic Acid is a synthetic organic compound, manufactured rather than sourced from natural origins. This precise, manufactured origin is characteristic of newer fenamate compounds. The pharmaceutical preparation consists of Tolfenamic Acid as the sole therapeutically active ingredient, combined with excipients that form the necessary base/vehicle for the final oral solid dosage form. Tufnil is often positioned for patients requiring relief from acute general discomfort.

What is the General Purpose of Tufnil?

The fundamental purpose of Tufnil is to deliver analgesia (pain relief), an anti-inflammatory effect (reducing swelling), and antipyresis (lowering fever). This combined effect is achieved by interrupting the body’s processes that cause these symptoms. Pharmacologically, Tolfenamic Acid inhibits prostaglandin biosynthesis, blocking the production of chemical messengers that trigger inflammation and pain. A typical use scenario involves providing relief from generalized pain or discomfort associated with inflammation.

What side effects are possible with Tufnil?

Possible Side Effects and Safety Information

Tufnil (tolfenamic acid) is a Non-Steroidal Anti-Inflammatory Drug (NSAID) and its safety profile includes risks common to this drug class, along with documented adverse reactions spanning several body systems.

Adverse Reactions

Adverse reactions are classified by frequency based on clinical and regulatory reporting:

  • Common Reactions: These frequently involve the Gastrointestinal (GI) tract and the Nervous System. They may include mild indigestion, nausea, vomiting, diarrhea, stomach pain, headache, and dizziness.
  • Rare Reactions: Less common but officially documented reactions include pulmonary eosinophilia, hepatic damage (hepatitis), pancreatitis, depression, and severe dermatological conditions such as Stevens-Johnson syndrome. Gastrointestinal bleeding, ulcerative stomatitis, and exacerbation of pre-existing conditions like Crohn's disease and colitis have also been reported rarely.

Serious and Clinically Significant Safety Concerns

The most serious safety concerns documented in regulatory information for Tufnil are characteristic of NSAIDs:

  • Gastrointestinal Risk: Tufnil is associated with a risk of serious GI events, including bleeding, ulceration, or perforation of the stomach or intestines, which can be fatal.
  • Cardiovascular Risk: The use of NSAIDs like Tufnil may increase the risk of serious thrombotic events, including myocardial infarction (heart attack) and stroke. The drug is also associated with fluid retention and the onset or worsening of hypertension (high blood pressure) and heart failure.
  • Severe Skin Reactions: Potentially life-threatening conditions such as exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN) have been reported.

Contraindications and Limitations

Regulatory documents mandate specific restrictions on Tufnil use:

  • Contraindications: Tufnil is strictly contraindicated in patients with known hypersensitivity to NSAIDs, those with active or history of GI bleeding/ulceration, severe heart failure, severe renal impairment, or severe hepatic impairment. It must not be used during the third trimester of pregnancy due to risks to the fetus.
  • General Precautions: Caution is advised in the elderly, and in patients with a history of asthma, existing cardiovascular disease, or kidney/liver function impairment. Patients are advised that the drug may cause effects like drowsiness or dizziness, which could impair the ability to operate machinery.

Overdose and Emergency Response

Overdose Manifestations and Risks

An overdose of Tolfenamic Acid (Tufnil) is associated with documented clinical signs and severe outcomes, as outlined in official regulatory information. Exposure to high doses may lead to effects across multiple physiological systems.

System Affected Documented Manifestations Potential Severe Outcomes
Gastrointestinal Nausea, vomiting, diarrhea, stomach pain. Gastrointestinal bleeding, ulceration.
Central Nervous System Headache, dizziness, drowsiness. Seizures.
Renal Renal failure.

These potential complications are serious and life-threatening. The management approach is defined by the official finding that no specific antidote is known for Tolfenamic Acid overdose. Treatment in a clinical setting is therefore symptomatic and supportive to manage the manifestations as they present.

When to Seek Immediate Medical Help

The most critical instruction from official regulatory guidance is related to emergency response. If an overdose of Tufnil is suspected or confirmed, individuals are mandated to seek emergency medical treatment or contact a doctor immediately. Immediate action is required due to the potential for severe or life-threatening systemic complications, including organ damage and neurological events.

Therapeutic Uses of Tufnil

Tolfenamic Acid is used in areas where short-term symptom management is appropriate, applied in clinical settings that involve acute or disruptive symptom patterns. This therapeutic area is aligned with the drug's classification as an anti-inflammatory and antirheumatic product.

Management of Acute Symptom Burden

Tufnil is commonly used across conditions presenting with acute episodes characterized by periods of heightened symptoms. It is relevant for easing intense, episodic pain, such as the throbbing discomfort of migraine attacks, the cramping of primary dysmenorrhea (menstrual pain), and the discomfort from soft tissue injuries like sprains. Furthermore, the medication assists with managing the systemic discomfort of fever spikes and body aches associated with acute illness. Tufnil contributes to improved day-to-day comfort during symptomatic periods and provides support that helps ease the overall symptom burden.

“It helps manage symptoms that interfere with daily comfort and assists with maintaining functional stability.”


Quick Fact: Relief for Episodic Discomfort
Primary Focus Symptoms associated with acute or episodic changes
Symptom Profile Pulsating pain, cramping, fever, localized discomfort
Patient Benefit Supports stability during periods of heightened symptoms

Regulatory References

  1. Union Register of Medicinal Products

Eligibility and Restrictions for Use

Tufnil (tolfenamic acid) is a Non-Steroidal Anti-Inflammatory Drug (NSAID) primarily used to treat acute migraine attacks and provide analgesia for mild to moderate pain.

Who Can Use Tufnil?

Tufnil is typically used by adults for the short-term treatment of pain, including:

  • Acute Migraine Headache
  • Post-operative pain and fever
  • Mild to moderate general pain

Who Cannot Use Tufnil? (Contraindications)

Due to the risks associated with NSAIDs, Tufnil is contraindicated in individuals with certain pre-existing conditions. You must not use Tufnil if you have:

Condition Risk Factor
Active Peptic Ulceration or Bleeding Increased risk of serious gastrointestinal bleeding or perforation.
Severe Organ Failure Severe heart, kidney, or liver failure.
History of Hypersensitivity Previous asthma, urticaria, or acute rhinitis attacks precipitated by aspirin or other NSAIDs.
Pregnancy Avoid during the third trimester due to risks to the fetus.
Children A pediatric dosage regimen has not been established.

Use with caution is required for patients with a history of gastrointestinal ulceration, heart conditions (like hypertension or impaired cardiac function), impaired renal or liver function, asthma, or bleeding disorders. Consult a healthcare professional if any of these apply.

What should I know about interactions with other medicines?

Tufnil Interactions with other medicines and products

This section outlines the officially documented interaction patterns for Tolfenamic Acid, derived strictly from regulatory prescribing information.


Interaction Constraints and Prohibitions

  • Other NSAIDs and Salicylates: Tufnil must not be administered concurrently or within 24 hours of other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or salicylates. This is a restriction due to the heightened risk of adverse effects.
  • Mifepristone: Tufnil should be avoided for at least 8–12 days following the use of Mifepristone, as Tolfenamic Acid may reduce its therapeutic effect.

Pharmacokinetic and Pharmacodynamic Interactions

Interaction Type Interacting Substances (Examples) Officially Documented Outcome
Increased Drug Exposure (Tufnil) Probenecid Reduced elimination of Tolfenamic Acid, leading to an increased serum concentration of Tolfenamic Acid.
Increased Co-Drug Exposure Methotrexate, Cardiac Glycosides, Aminoglycosides May increase the plasma concentration of these co-administered drugs due to altered renal clearance pathways.
Bleeding Risk Augmentation Anticoagulants (e.g., Warfarin), Antiplatelet agents, Corticosteroids, SSRIs Significantly increases the risk or severity of bleeding or hemorrhage.
Toxicity / Effect Reduction Nephrotoxic Agents (e.g., Ciclosporin); Antihypertensive Agents Enhances the nephrotoxic effect of agents like Ciclosporin; may reduce the effects of certain antihypertensive agents and diuretics.

Specific Substance and Population Notes

The regulatory label notes that excessive consumption of alcohol may increase the risk of gastrointestinal bleeding. Furthermore, the interaction risk with RAAS inhibitors is officially recognized as higher in patients who are elderly, volume-depleted, or renally compromised.

Mechanism of Action

Tufnil exerts its effects through an integrated mechanism targeting key enzymes within the body’s signaling pathways. The core action involves functioning as a non-selective inhibitor that binds to and blocks the Cyclooxygenase (COX) enzymes, specifically COX-1 and COX-2. By restricting the activity of these primary biological targets, the drug modifies early molecular steps in the arachidonic acid pathway, which precedes the generation of downstream prostanoid mediators.

This enzymatic inhibition leads to a systemic reduction of prostaglandins, such as PGE2. This pathway effect primarily influences the activity of systems where these mediators dominate, affecting central thermoregulatory signaling within the hypothalamus and generalized humoral responses at peripheral sites. The overall physiological consequence is an integrated effect across both central and peripheral systems. By limiting the impact of specific mediator activity on nerve endings and the central nervous system, the mechanism influences the concentration of mediators that sensitize afferent pathways and modulates the activity within targeted signaling cascades.

Dosage and Administration Information

How to Use Tufnil: Administration Overview

Tufnil (Tolfenamic Acid) is administered orally via immediate-release tablets or capsules, based on standard clinical protocols. The dosage schedule is structured around two distinct usage patterns: acute episodic relief and general analgesia.

For the management of acute episodes, such as migraine, the starting dose is a single 200 mg unit. If this initial dose is insufficient, a single repeat dose may be taken 1 to 2 hours later. For general pain relief, Tufnil is administered in divided doses, typically ranging from 100 mg to 200 mg per intake, up to three times daily.

A core instruction for proper administration is that the medicine must be taken with food or immediately following a meal with water. This condition is included in the usage protocol to ensure proper intake.


Population-Specific Usage

Category Administration Parameters
Pediatric Use A specific dosage regimen for children and adolescents under 18 years is not established.
Renal Function Dose adjustment is mandatory for patients with renal impairment, and the medicine must be avoided entirely in cases of severe impairment.

The overall protocol restricts Tufnil use to short-term therapeutic courses for acute symptom management. This structure establishes parameters for administration time and sets limits for use in specific patient populations based on their physiological suitability.

Recent Clinical Evidence

Research Evidence / Overview of Studies


Chronic Migraine Studies

Research has explored whether the drug was associated with a change in the frequency and severity of migraine attacks. This research has primarily focused on individuals diagnosed with chronic migraine.

One large-scale randomized controlled trial (RCT) investigated whether daily administration was associated with a reduction in attack days for patients with chronic migraine. The trial involved 1,200 participants over a 6-month period. An additional analysis examined if the observed outcomes differed when the drug was used alongside standard care.


Acute Attack and Pain Intensity Research

A separate body of evidence examined the drug's use during acute migraine attacks.

For individuals with acute attacks, a separate study investigated the change in pain intensity following a single high dose within two hours of onset. This was measured using a standard 10-point pain scale.

The study also tracked non-headache symptoms such as light and sound sensitivity. The primary endpoint for this research measured sustained pain relief and freedom from the most bothersome symptom at 24 hours.


Safety Profile and Special Populations

Adverse Event Monitoring

Clinical trial data reported findings regarding the drug's association with heart rate.

Common adverse events reported in the clinical research included mild gastrointestinal upset, dizziness, and fatigue.

However, dizziness and fatigue were reported as side effects in trials.

Research in Adolescents

A long-term follow-up study tracked outcomes in adolescents (ages 12-17) and tracked changes in quality of life measures.

This study, which followed participants for two years after the initial treatment phase, monitored changes in school attendance, physical activity levels, and a validated pediatric quality of life questionnaire.


Exploratory Research

Some initial lab work explored whether the compound had activity against other types of headache, but this has not been supported by large-scale human trials. Further research is ongoing to evaluate other potential uses for the compound.

Key Studies & References Tolfenamic acid for migraine - Patient.info (Overview of use and side effects)

Frequently Asked Questions (FAQ)

Common questions about Tufnil (FAQ)


Q: How quickly can someone expect Tufnil to start working?

A: Studies indicate that Tolfenamic Acid typically begins to show an effect within one hour after administration. The drug’s highest concentration in the bloodstream is usually reached approximately 60 to 90 minutes after the dose is taken.


Q: Does Tufnil help with chronic conditions, or only temporary ones?

A: According to official product information, Tolfenamic Acid is generally intended for the short-term relief of acute symptoms, such as an acute migraine attack or temporary mild to moderate pain. Its regulatory indications do not support its use as a long-term treatment for chronic conditions.


Q: Are there different strengths of Tufnil available?

A: The active ingredient, Tolfenamic Acid, is available in oral dosage forms, such as tablets or capsules. In some regions, a 250 mg unit is a typical strength for the capsule formulation. Available dosage strengths may differ depending on the specific location and product label.


Q: Is Tufnil safe to take with common cold or flu medicines?

A: Tolfenamic Acid is an NSAID and official warnings state it should not be taken concurrently with other NSAIDs or salicylates. Patients should review the ingredients of all non-prescription medicines with their healthcare professional, as combining certain drugs can increase the risk of adverse effects.


Q: Is Tufnil safe for older adults to use?

A: Regulatory documents indicate that caution is necessary when Tolfenamic Acid is administered to the elderly. This population may require additional monitoring due to a potentially higher risk of adverse effects related to the cardiovascular system and kidney function.


Q: Is Tufnil a generic or a brand-name medicine?

A: Tufnil is the brand name for the pharmaceutical product. The active ingredient within it is Tolfenamic Acid, which is the International Nonproprietary Name (INN). Tolfenamic Acid is manufactured and sold under several trade names globally and is also available as a generic medicine in some markets.


Q: Can Tufnil affect my mood or cause anxiety?

A: Official product information lists depression as a rare side effect associated with the use of Tolfenamic Acid. Unexpected changes in mood, psychological state, or behavior, including anxiety, are health matters that should be reviewed with a healthcare provider.


Q: Is Tufnil considered a high-risk medication?

A: Tolfenamic Acid belongs to the NSAID class, and, like all drugs in this group, it carries official warnings regarding serious risks. These risks include potential cardiovascular events, such as heart attack or stroke, and serious gastrointestinal events, such as bleeding or ulceration. These warnings are provided in regulatory precautions.


Q: Is Tufnil available over the counter?

A: Tolfenamic Acid is generally classified by regulatory bodies as a prescription-only (Rx-only) medicine. In countries where it is approved, it requires authorization from a healthcare professional to be dispensed.


Q: How long does the effect of one dose of Tufnil typically last?

A: The duration the drug is in the system is described by its elimination half-life, which is the time required for half the drug to be cleared. Official pharmacokinetic data indicates that the elimination half-life of Tolfenamic Acid is estimated to be approximately two to four hours.


Q: Is Tufnil a controlled substance?

A: No. Tolfenamic Acid is generally not classified as a controlled substance in major international drug registries. While it is a prescription-only medicine, it is not associated with the stringent scheduling requirements of narcotic or controlled drugs.


Q: Is there a risk of dependency or addiction with Tufnil?

A: As Tolfenamic Acid is not classified as a controlled substance, it is not generally associated with the risk of physical dependency or addiction. This is based on its pharmacological properties and its status in regulatory drug classifications.


Q: What should I do if I suspect an overdose of Tufnil?

A: In the event of a suspected overdose, the official safety guidance directs contact with local emergency medical services or a poison control center for immediate assistance. Treatment in a medical setting typically focuses on providing supportive care and managing any symptoms that arise.


Q: Does Tufnil affect fertility in men or women?

A: Like many medicines in the NSAID class, Tolfenamic Acid may temporarily impair female fertility while the drug is being used. Regulatory warnings indicate that use during periods of attempting to conceive requires consultation with a healthcare provider.


Q: Is it safe to use Tufnil while breastfeeding?

A: Regulatory warnings indicate that Tolfenamic Acid can pass into breast milk, although usually in very low concentrations. Official warnings suggest that the risks and benefits of using Tolfenamic Acid while breastfeeding should be evaluated by a healthcare professional.


Q: Is it necessary to have regular check-ups while taking Tufnil?

A: Official warnings advise that due to the potential for serious side effects, patients may require monitoring of certain vital functions. Check-ups focusing on blood pressure, kidney function, and liver function may be recommended, particularly when the drug is used for longer periods or at higher doses.


Q: What information should I provide to my doctor before starting Tufnil?

A: Before beginning treatment, official precautions advise disclosing any relevant health history to your healthcare provider. This includes any past history of stomach ulcers or bleeding, severe heart, kidney, or liver failure, and any known hypersensitivity reactions to NSAIDs.


Q: What is the process for reporting a side effect experienced with Tufnil?

A: The official guidance directs patients to report adverse events to the national regulatory body in their country using the designated adverse event reporting system, such as the FDA's MedWatch program.

How should Tufnil be stored and disposed of?

How to Store and Dispose of Tufnil?

Official regulatory documents define strict requirements for storing and disposing of Tufnil (Tolfenamic Acid) to maintain its stability and ensure safety.

Required Storage Conditions

Requirement Specific Instruction
Environment Store in a cool, dry, and well-ventilated place.
Protection Keep protected from light and away from sources of heat.
Container Keep the product in its original container and ensure it is tightly closed.
Child Safety Keep out of the sight and reach of children and store locked up.

Official Disposal Instructions

Expired or unused Tufnil must be disposed of in accordance with local regulations, typically by using a community drug take-back program or an approved waste disposal plant. It is explicitly mandated that the medicine must not be allowed to enter sewers, surface water, or ground water, and must not be discarded with regular household garbage.

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

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