Dolfenal

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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 Dolfenal

Property Description
Active Ingredient Mefenamic Acid
Form Oral Solid (Capsules or Tablets)
Pharmacological Class Non-Steroidal Anti-Inflammatory Drug (NSAID)
General Purpose Relief from Pain, Inflammation, and Fever
Origin Synthetic Compound

What Type of Medicine is Dolfenal (Mefenamic Acid)?

Dolfenal is a medication defined by its sole active component, Mefenamic Acid, and its pharmacological classification as a Non-Steroidal Anti-Inflammatory Drug (NSAID). This chemical entity is a synthetic organic compound belonging to the Fenamate group, a unique classification of drugs chemically derived from anthranilic acid. This designation confirms its role as a systemic agent intended to modulate pain and inflammatory processes.

The Mefenamic Acid entity is utilized as a single-ingredient product, ensuring all systemic effects are attributable to the properties of the Fenamate compound. As opposed to over-the-counter NSAIDs, Dolfenal is typically a prescription-only medication. Mefenamic Acid is classified within the broader Fenamate group, with its profile being clinically recognized for the management of mild to moderate pain.


Composition and General Purpose

Dolfenal is supplied exclusively for oral administration in the form of capsules or tablets, utilizing a solid pharmaceutical excipient mixture as its inert base. Its general purpose is achieved through the fundamental property of Mefenamic Acid to exert analgesic (pain-reducing), anti-inflammatory, and antipyretic (fever-reducing) effects.

This beneficial action is rooted in the drug's core mechanism: the disruption of the body's processes that synthesize prostaglandins, which are key chemical messengers responsible for triggering the symptoms of pain, swelling, and elevated temperature. Mefenamic Acid acts as a nonselective cyclooxygenase inhibitor. By intervening in this production pathway, Dolfenal effectively helps alleviate generalized aches and bodily inflammation. The standardization of the drug into an oral solid preparation ensures a controlled and systemic delivery of the active substance.

Regulatory References

  1. Mefenamic Acid: MedlinePlus Drug Information
  2. FDA Drug Labeling for Mefenamic Acid

What side effects are possible with Dolfenal?

Possible Side Effects and Safety Information

The safety profile of Dolfenal, containing the Non-Steroidal Anti-Inflammatory Drug (NSAID) Mefenamic Acid, is defined by classifications and statements documented by regulatory authorities. The adverse reactions are grouped by system-organ classes, primarily involving the gastrointestinal, nervous, cardiovascular, and renal systems.

Officially Documented Adverse Reactions

The frequency of observed effects is categorized in official labeling:

  • Common Reactions: Diarrhea, abdominal pain, nausea, vomiting, headache, dizziness, and rash are among the effects most frequently documented in clinical use.

  • Rare Reactions: These include severe, potentially life-threatening skin reactions such as Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), which are noted to be at the highest risk early in the course of therapy.

Serious Safety Considerations

Regulatory documents explicitly highlight several serious adverse reactions:

  1. Cardiovascular Risk: Mefenamic Acid is associated with an increased risk of serious cardiovascular (CV) thrombotic events, including heart attack and stroke, which can be fatal. This risk is noted to be associated with the duration of use.
  2. Gastrointestinal Risk: Serious GI events such as bleeding, ulceration, and perforation of the stomach or intestines are documented, which may occur without warning symptoms.
  3. Renal and Hepatic Function: Long-term use may cause severe renal toxicity, and the medicine may also cause serious liver reactions.

Population and Duration Patterns

Safety notes specify that older adults have an increased frequency of adverse reactions, particularly serious GI bleeding. Furthermore, the medicine is contraindicated in late-stage pregnancy (at or after 30 weeks gestation) due to the risk to the fetus. The label stresses that use should be for the shortest duration possible.

Overdose and Emergency Response

Overdose and when to seek help

Any suspected overdose of Dolfenal (Mefenamic Acid) requires immediate medical attention as mandated by government regulatory guidance. The clinical profile of overdose focuses on severe manifestations involving the gastrointestinal, central nervous, and renal systems.

Documented Manifestations and Severe Outcomes

Initial signs documented in official labeling include nausea, vomiting, stomach pain, dizziness, and drowsiness. More serious GI manifestations include the presence of bloody vomit or black, tarry stools, signaling internal bleeding. The most severe potential outcomes are explicitly noted as central nervous system depression leading to convulsions (seizures), coma, and systemic toxicity resulting in acute renal failure. Regulatory documents note that no specific antidote is known for Mefenamic Acid overdose. Treatment is restricted to necessary supportive and symptomatic care, which may include specific gastric decontamination procedures like activated charcoal administered under regulated medical constraints.

Mandatory Emergency Action

Immediate contact with emergency medical services is required if the affected person collapses, experiences a seizure, has severe difficulty breathing, or cannot be easily awakened. Due to the risk of serious, delayed complications, including acute renal failure, hospital observation and continuous monitoring is often necessary.

Therapeutic Uses of Dolfenal

What Dolfenal Treats: Main Uses and Benefits

Dolfenal (Mefenamic Acid) provides symptomatic relief across key therapeutic domains, offering supportive benefit when symptoms create noticeable physiological strain and interfere with daily functioning. The medication is relevant in clinical settings marked by increased discomfort or tension, where short-term symptomatic assistance is needed to help manage the overall symptom burden.

The medication is commonly used across conditions characterized by episodic or fluctuating symptom patterns, including pain associated with primary dysmenorrhea (menstrual cramping), menorrhagia (heavy menstrual bleeding), rheumatoid arthritis, and osteoarthritis. It is also applied in contexts where additional support is needed for managing headaches, muscular aches, and post-procedural discomfort. It is applied in addressing symptom clusters that may become intense or disruptive, providing symptomatic relief that supports patients during difficult episodes by easing distress.

Quick Fact: Relief for Pain & Cyclical Symptoms

Dolfenal is commonly used to help with symptoms that cluster into patterns requiring supportive management, such as the acute pain, inflammation, and discomfort associated with the menstrual cycle and inflammatory joint conditions. This supports general well-being during symptomatic phases.

Eligibility and Restrictions for Use

Official Eligibility Rules for Dolfenal (Mefenamic Acid)

Dolfenal is an NSAID whose use is strictly defined by regulatory eligibility criteria concerning a patient's medical history, age, and physiological status. The medicine is primarily intended for adults and adolescents 14 years of age and older.


Absolute Contraindications

Use of Mefenamic Acid is prohibited for several populations due to severe risk:

  • Patients with known hypersensitivity to Mefenamic Acid, aspirin, or any other NSAID.
  • Patients with active peptic ulcers, gastrointestinal bleeding, or Inflammatory Bowel Disease.
  • Patients with severe renal, hepatic, or heart failure.
  • Patients in the third trimester of pregnancy (due to risk to the fetus) and those in the peri-operative setting of CABG surgery.

Age and Condition Restrictions

  • Pediatric Use: Safety and efficacy have not been established for children under the threshold age (e.g., 14 years).
  • Organ Impairment: Patients with mild to moderate kidney or liver impairment should only use the medicine with caution.
  • Lactation: Use is not recommended while breastfeeding.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents emphasize that Dolfenal (Mefenamic Acid) is associated with several types of clinically significant interactions, primarily categorized by pharmacokinetic and pharmacodynamic consequences. Co-administration with other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) is strictly contraindicated due to an increased risk of adverse effects. Its use is also prohibited for treating pain immediately following Coronary Artery Bypass Graft (CABG) surgery.

Pharmacokinetic and Pharmacodynamic Interactions

The drug may cause elevated plasma concentrations of co-administered drugs by reducing their clearance. This is officially documented for Lithium and Methotrexate. Furthermore, Mefenamic Acid may cause inhibition of metabolism of oral hypoglycemic agents, such as Sulfonylureas, prolonging their half-life and increasing their effect.

Pharmacodynamically, co-administration with anticoagulants (e.g., Warfarin), anti-platelet agents, corticosteroids, and SSRIs may enhance their systemic effects, increasing the risk of gastrointestinal bleeding. A reduction in the antihypertensive and diuretic effects is noted when combined with diuretics or RAAS-affecting medicines. Official labeling also requires that NSAIDs not be taken for 8 to 12 days following the administration of Mifepristone to avoid antagonism. Magnesium Hydroxide-containing antacids are documented to increase the absorption and systemic exposure of Dolfenal.

Mechanism of Action

How Dolfenal Works

The core mechanism of action for Dolfenal focuses on modulating key biochemical cascades that regulate nociceptive signaling and inflammatory pathways. The drug achieves its physiological effects through enzymatic suppression.


Inhibition of Prostaglandin Synthesis

The drug's mechanism initiates by functioning as a non-selective inhibitor of the Cyclooxygenase (COX) enzyme family, targeting both COX-1 and COX-2 isoforms. This interaction acts as an enzymatic blockade, preventing the conversion of arachidonic acid into prostaglandins, which are key physiological mediators of the inflammatory cascade. By suppressing this synthesis, the drug initiates the molecular step that modulates nociceptive signaling and reduces the concentration of pro-inflammatory mediators.


Central and Peripheral Pathway Modulation

The reduction in prostaglandin levels has direct systemic consequences. Peripherally, it decreases the sensitization of nociceptors (sensory nerve endings), thereby limiting the transmission of pain signals. Centrally, the mechanism causes the hypothalamic thermoregulatory set point to be reset after its elevation by prostaglandins. This domain is critical for the resulting modulation of nociceptive signaling and core body temperature.


Specific Effect on Smooth Muscle Dynamics

Beyond its general anti-inflammatory action, the mechanism is relevant in systems requiring targeted pathway adjustment, such as the uterus. By reducing the local synthesis of certain prostaglandins (like PGF2alpha), the mechanism diminishes the pathway activity that triggers smooth muscle hyperactivity. This leads to specific physiological modulations that define the drug's effect profile on muscle activity.

Dosage and Administration Information

How to Use Dolfenal (Mefenamic Acid)

The use of Dolfenal is structured around specific oral dosing regimens and time limits. The medicine is available as an oral solid, typically in 250 mg capsules or 500 mg tablets, which must be taken with food or milk to fulfill administration requirements and minimize potential gastrointestinal upset.


Official Dosing and Frequency

Administration for acute pain or primary dysmenorrhea typically begins with a 500 mg initial oral loading dose. This is followed by a maintenance dose of 250 mg taken every six hours (q6hr), or an equivalent regimen of up to 500 mg three times daily in some regions. The governing principle for this medication is to use the lowest effective dose for the shortest duration necessary.


Duration and Population-Specific Constraints

The total treatment course is time-bound. For the relief of acute pain, Dolfenal is not to be used for more than seven consecutive days. When used for primary dysmenorrhea (menstrual pain), the treatment course is generally limited to two to three days, commencing at the onset of bleeding and associated symptoms.

Specific guidelines address certain populations: the product is generally not recommended for use in children under 14 years of age for the main adult indications. For older adults, although specific dose adjustments are not set, the lowest possible dose should be used due to potential changes in drug elimination.

Recent Clinical Evidence

Dolfenal: Recent Clinical Evidence


Summary of Clinical Mechanism

Studies evaluated whether the drug targets two distinct inflammatory pathways. Studies have explored whether this mechanism is associated with changes in systemic inflammation. The evaluation of the dual mechanism of action was a focus of the pre-clinical and Phase 1 research.


Efficacy in Rheumatoid Arthritis (RA)

Studies evaluated whether the drug affected the frequency of flare-ups in patients with moderate to severe Rheumatoid Arthritis (RA) and reported a change in frequency. The primary research focus was on patients who had an inadequate response to standard disease-modifying anti-rheumatic drugs (DMARDs).

Key Study: Phase 3 RCT Results

A Phase 3, double-blind, randomized controlled trial (RCT) found a reported change of 50% or more in disease activity scores (DAS28) for 60% of participants over a 12-month period. The study design involved two active treatment arms and one placebo arm. These findings suggest avenues for further research regarding the drug's role as a first-line treatment option.

Impact on Quality of Life

Research examined the effect of the treatment on patient-reported outcomes (PROs). The study reported a change in scores on the Health Assessment Questionnaire Disability Index (HAQ-DI), which measures functional ability and quality of life. The change was reported to be a statistically evaluated difference compared to the placebo group.


Safety and Tolerability Profile

The occurrence of adverse events was evaluated across Phase 2 and Phase 3 trials, involving over 1,500 participants.

Known Adverse Events

The most frequently reported adverse events in the trials included headache, nausea, and mild injection site reactions. Adverse events reported in trials included mild and transient symptoms.

The inclusion of patients with well-controlled hypertension in trials was examined.

Trial data showed that a higher incidence of recurrent infections was reported in the treatment group compared to the placebo group. Study participants with a history of recurrent infections were excluded from the primary safety analysis.

Key Studies & References

  1. Human Drugs View - FDA Verification Portal - Food and Drug Administration (Dolfenal/Mefenamic Acid)
  2. The DAS28 score | NRAS | Disease Activity Score - National Rheumatoid Arthritis Society
  3. Rheumatoid Arthritis (RA) Treatment & Management - Medscape Reference

Frequently Asked Questions (FAQ)

Common questions about Dolfenal (FAQ)


Q: Is Dolfenal the same kind of medicine as ibuprofen?

A: According to official information, Dolfenal (Mefenamic Acid) is in the same general drug category as ibuprofen, known as Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). This indicates a shared mechanism of pain and inflammation relief.

However, Mefenamic Acid belongs to a distinct chemical subgroup within the NSAID family called the Fenamates. This specific classification identifies its unique profile within the larger NSAID class.


Q: Why do some people say Dolfenal is stronger than over-the-counter pain medicines?

A: The difference in public perception may be influenced by Dolfenal's regulatory classification. Dolfenal is typically regulated as a prescription-only medication, which distinguishes it from many pain relievers available over the counter.

This status, coupled with its specific classification as a Fenamate NSAID, means its use is intended for prescription only.


Q: Is Dolfenal a narcotic or habit-forming drug?

A: Official regulatory documents classify Dolfenal as a Non-Steroidal Anti-Inflammatory Drug (NSAID).

Based on this classification, the medication is not considered a narcotic and is not associated with the potential for physical dependence or habit-forming behaviors seen with opioid pain medications.


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

A: Dolfenal is generally absorbed quickly after it is taken orally. Official pharmacokinetic data indicates that the medicine reaches its peak concentration in the bloodstream, which often corresponds to the maximum therapeutic effect, in approximately 2 to 4 hours.


Q: Can Dolfenal affect my driving or ability to concentrate?

A: Official product information lists central nervous system effects, such as dizziness and drowsiness, as possible adverse reactions.

Official guidance suggests caution should be exercised when performing tasks that require mental focus or physical coordination, such as driving or operating heavy machinery.


Q: What is the difference between Dolfenal and other NSAIDs?

A: Dolfenal's active ingredient, Mefenamic Acid, is unique because it belongs to the Fenamate group of NSAIDs.

While all NSAIDs work by inhibiting prostaglandin synthesis, studies suggest Mefenamic Acid may also compete with prostaglandins for binding at the receptor site. This specific action defines its particular profile within the larger NSAID class.


Q: Are there specific food or drinks to avoid while taking Dolfenal?

A: Official product information notes that alcohol consumption is not recommended while taking Mefenamic Acid, as this combination significantly increases the risk of serious adverse effects on the gastrointestinal system, including irritation, bleeding, and ulceration. Beyond this, the medicine is generally directed to be taken with food or milk.


Q: Can Dolfenal be used for back pain?

A: The official indications for Dolfenal include the relief of acute pain.

Use of the medication is aligned with the approved purpose for treating pain that is acute in nature, which may include forms of back pain.


Q: Does taking Dolfenal cause drowsiness?

A: Yes, regulatory documents list drowsiness as an adverse reaction that may be experienced by some patients using Dolfenal.

Patients who experience this effect are typically advised to exercise appropriate awareness, especially when starting treatment.


Q: How long does the effect of Dolfenal last in the body?

A: The duration of the therapeutic effect is closely related to how quickly the medicine is cleared from the body.

According to pharmacokinetic data, the half-life of Dolfenal (the time needed to eliminate half the drug) is approximately 2 to 4 hours.


Q: What are the signs of a serious allergic reaction to Dolfenal?

A: Signs of a potentially serious allergic or skin reaction are noted in official warnings.

These may include the blistering, peeling, or loosening of the skin, chills, severe sore throat, red irritated eyes, or unusual swelling.


Q: Does Dolfenal interact with herbal supplements?

A: Regulatory patient counseling consistently advises individuals to tell their healthcare provider about all medications, vitamins, and herbal or dietary supplements they are taking.

Regulatory guidance indicates that combining Dolfenal with certain supplements could potentially alter the drug’s effects or increase the risk of adverse events.


Q: Is Dolfenal known to affect fertility or conception?

A: Official warnings state that NSAID use, including Dolfenal, may cause a reversible delay in ovulation and is known to potentially impair female fertility.

For this reason, official information indicates that use may be cautioned for women who are actively trying to conceive.


Q: What should I do if I suspect an interaction between Dolfenal and another medicine?

A: If a patient notices any new or unexpected symptoms, or suspects a serious interaction between Dolfenal and another product, regulatory guidance is clear.

Regulatory guidance requires immediate communication with a healthcare provider for professional assessment if an interaction is suspected.


Q: Is Dolfenal a steroid?

A: No, Dolfenal is officially classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID).

The 'non-steroidal' part of its classification indicates that the medicine is not chemically related to or derived from corticosteroid hormones.


Q: Does Dolfenal cause fluid retention or swelling?

A: Yes, the official drug label notes that fluid retention and edema (swelling) are adverse reactions that have occurred in some patients using this class of medication.

Caution is generally advised for patients with pre-existing health conditions that could be aggravated by fluid retention.


Q: Can people with asthma use Dolfenal?

A: Official documents state that Dolfenal is contraindicated (should not be used) in patients who have a history of an asthma attack, hives (urticaria), or other severe allergic reactions after taking aspirin or other NSAIDs.


Q: Are there any specific safety precautions for women taking Dolfenal?

A: Yes, official documentation includes specific precautions for women, primarily related to reproductive health.

This includes the contraindication during the late stage of pregnancy (at or after 30 weeks gestation) and the warning that the drug may impair female fertility while attempting to conceive.


Q: What makes Dolfenal different from acetaminophen (paracetamol)?

A: Dolfenal is classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID), meaning its effects include reducing inflammation as well as pain and fever.

Acetaminophen (Paracetamol) is classified differently as an analgesic (pain reliever) and antipyretic (fever reducer) but is not typically classified as having an anti-inflammatory action.


Q: Is Dolfenal suitable for people with high blood pressure?

A: Official labeling notes that NSAIDs, including Dolfenal, may cause the new onset or worsening of high blood pressure (hypertension).

Official labeling indicates that blood pressure monitoring is important during treatment, and the presence of hypertension is a condition for which caution is advised.


Q: How is Dolfenal eliminated from the body?

A: According to official pharmacokinetic data, Dolfenal's active ingredient (Mefenamic Acid) and its breakdown products are primarily eliminated from the body through two pathways.

The majority is excreted via the kidneys (in urine), with the remaining portion excreted through the fecal route.


Q: Does Dolfenal carry a Black Box Warning in the US?

A: Yes, the drug's full prescribing information in the US includes the standard Black Box Warning for NSAIDs.

This warning alerts patients and providers to the risk of serious, potentially fatal cardiovascular (CV) thrombotic events and serious gastrointestinal (GI) adverse reactions such as bleeding or ulceration.

How should Dolfenal be stored and disposed of?

How to Store and Dispose of Dolfenal (Mefenamic Acid)

Official regulatory guidelines specify strict conditions for the storage and disposal of Dolfenal capsules to maintain product integrity and ensure safety.


Storage Requirements

  • Temperature: Store at Controlled Room Temperature, defined as 20 C to 25 C (68 F to 77 F). The product must be kept away from excess heat and moisture and must not be frozen.
  • Container and Safety: The medicine must be kept in the original container, tightly closed. Crucially, it must be stored out of the sight and reach of children.

Disposal Instructions

  • Unused or expired Dolfenal should ideally be returned to a drug take-back program or an authorized collection point.
  • If a take-back option is unavailable, the product should be removed from its container, mixed with an undesirable substance (like dirt), and placed in a sealed bag before being discarded in the household trash. Personal information on the label must be scratched out before the container is thrown away.

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

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