Biofenac

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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 Biofenac

This section provides a factual overview of the medicinal entity Biofenac, detailing its chemical composition, pharmacological classification, and general therapeutic function.

Property Description
Active ingredient Aceclofenac
Form Tablet, Gel, Capsule, Injection
Pharmacological class Non-Steroidal Anti-Inflammatory Drug (NSAID)
General purpose Relief of pain, inflammation, and fever
Origin Synthetic (Phenylacetic acid derivative)

Aceclofenac: Classification and Definition of Biofenac

Biofenac is a medicinal product containing the active ingredient Aceclofenac, a substance formally classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID). It is utilized for its properties in reducing pain and inflammation. It is categorized among the acetic acid derivatives, placing it within the group of compounds structurally related to diclofenac, from which it is derived. Within standard classification, Aceclofenac is designated with the code M01AB16.

Composition and General Therapeutic Purpose

The product is a single active ingredient preparation, relying solely on the synthetic compound Aceclofenac for its therapeutic effect. The general therapeutic purpose of this drug is to deliver analgesic and anti-inflammatory relief, often utilized in cases such as managing discomfort associated with chronic joint conditions. The availability of Aceclofenac in multiple forms, including oral tablets and topical gels, allows for application that is either systemic or localized. The pharmacological mechanism involves the inhibition of the enzyme cyclooxygenase-2 (COX-2) to reduce the production of inflammatory mediators. This process helps to reduce the discomfort and swelling resulting from inflammation.

What side effects are possible with Biofenac?

Possible Side Effects and Safety Information

The safety profile for Biofenac (Aceclofenac), an NSAID, is structured according to regulatory classifications of adverse reactions based on frequency and affected body systems. These classifications distinguish between expected reactions and rare, serious events as documented by official government health authorities.


Adverse Reaction Classifications

Side effects are categorized by frequency, including Common (occurring in 1 in 100 to 1 in 10 patients), Uncommon, Rare, and Very Rare events. The most frequently documented reactions involve the Gastrointestinal disorders (such as dyspepsia, abdominal pain, and nausea) and the Nervous system disorders (including dizziness).

Classification Examples of Documented Effects
Common Dyspepsia, Abdominal pain, Nausea, Increased hepatic enzymes
Uncommon Flatulence, Gastritis, Constipation, Rash, Pruritus

Serious Safety Considerations

The official labeling documents potential for Serious Adverse Reactions (SARs), which include gastrointestinal hemorrhage, ulceration, or perforation and anaphylactic reaction. Furthermore, the medicine is associated with a risk of arterial thrombotic events, such as myocardial infarction or stroke, which may increase with the dose and duration of use. Severe mucocutaneous reactions, such as Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), are also documented.

Safety Constraints and Special Populations

The product is contraindicated in patients with conditions such as severe heart failure, severe hepatic failure, or active peptic ulcer/haemorrhage. Regulatory documents note an increased frequency and risk of serious gastrointestinal events in the elderly. For women attempting conception, the use of Aceclofenac may potentially impair female fertility.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory profile for Aceclofenac overdose is structured around documented manifestations and specific emergency actions. Overdose presentations are generally categorized by the systems they affect, and the core management principle is supportive care, as no specific antidote is known.

Overdose Domain Officially Documented Manifestations
Gastrointestinal Effects Nausea, vomiting, epigastric pain, and in severe cases, gastrointestinal bleeding.
Central Nervous System (CNS) Effects Headache, drowsiness, dizziness, disorientation, and the potential for convulsions (seizures).

In situations of severe overexposure, the risk of life-threatening outcomes is officially documented, including acute renal failure, hepatic damage, and cardiovascular issues such as hypotension.

When to Seek Immediate Medical Help

Any suspicion of overdosage with Biofenac requires immediate medical attention. Regulators mandate this urgent action due to the potential for severe systemic toxicity and the need for immediate, professional support.

Treatment is strictly symptomatic and supportive. For large, recent ingestions, interventions such as gastric lavage or the administration of activated charcoal may be considered by medical professionals. Close hospital monitoring is required to surveil for, and manage, the progression of severe complications.

Therapeutic Uses of Biofenac

Main Therapeutic Uses

Biofenac is primarily used for the management of pain and inflammation associated with various musculoskeletal and joint disorders. It belongs to the class of medications known as non-steroidal anti-inflammatory drugs (NSAIDs). Its main applications include:

  • Osteoarthritis: Relief of pain and inflammation in chronic degenerative joint disease.
  • Rheumatoid Arthritis: Management of symptoms in autoimmune inflammatory joint conditions.
  • Ankylosing Spondylitis: Treatment of pain and stiffness affecting the spine and large joints.
  • Acute Pain Management: Relief of discomfort resulting from dental pain, post-surgical recovery, or primary dysmenorrhea (menstrual pain).
  • Soft Tissue Injuries: Treatment of inflammation following trauma to tendons, ligaments, and muscles, such as sprains or strains.

Benefits and Mechanism

The active ingredient in Biofenac works by inhibiting the production of prostaglandins, which are chemicals in the body that signal pain and promote inflammation. By reducing these substances, the medication provides several therapeutic benefits:

Reduction of Inflammation

It helps decrease swelling and redness in affected tissues, which is particularly beneficial for chronic inflammatory conditions where persistent swelling can lead to tissue damage.

Pain Relief

By targeting the chemical triggers of pain, it helps restore comfort and improve the ability to perform daily activities. It is effective for both continuous dull aches and sharp, acute pain.

Improvement in Mobility

By addressing both pain and stiffness, Biofenac can help improve joint function. In conditions like arthritis, this reduction in symptoms allows for a better range of motion and physical functionality.

Eligibility and Restrictions for Use

Biofenac (Aceclofenac) is approved for use in adults for conditions such as Osteoarthritis, Rheumatoid Arthritis, and Ankylosing Spondylitis. Use in older adults is permitted, but regulatory guidance mandates caution and the use of the lowest effective dose for the shortest duration. The medicine is not recommended for children and adolescents under 18 due to insufficient clinical data to establish its safety and efficacy in this age group.

The medicine is strictly contraindicated for several populations. These absolute prohibitions include patients with known hypersensitivity to Aceclofenac or other NSAIDs, and those with a history of recurrent peptic ulceration, gastrointestinal hemorrhage, or perforation related to previous NSAID use. It must not be used by patients with severe heart failure, severe renal impairment, or severe hepatic impairment. Use during the third trimester of pregnancy is also absolutely contraindicated, as is use in patients with established ischaemic heart disease or cerebrovascular disease.

For patients with mild to moderate hepatic impairment, use is restricted, requiring a reduced starting dose. For patients with mild to moderate renal impairment, caution and monitoring are necessary. Use during the first and second trimesters of pregnancy is to be avoided unless medically essential, and it is not recommended for breastfeeding mothers.

What should I know about interactions with other medicines?

Interaction Map: Official Regulatory Information for Biofenac

Interaction Scope

Classification Interacting Agents or Condition
Avoided Combinations Other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including Aspirin and selective COX-2 inhibitors.
Transporter/Clearance Lithium, Digoxin, Methotrexate
Pharmacodynamic Risk Anticoagulants (e.g., Warfarin), Systemic Corticosteroids, SSRIs, Ciclosporin
Reduced Efficacy Risk Diuretics, ACE Inhibitors, ARBs, Oral Hypoglycaemic Agents

Official Interaction Statements

  • Co-administration with other NSAIDs is officially avoided due to the documented, increased risk of gastrointestinal adverse effects.
  • Biofenac may decrease the elimination and increase the plasma concentrations of Lithium, Digoxin, and Methotrexate through a documented effect on renal clearance.
  • The product may enhance the effects of Anticoagulants, increasing the documented risk of bleeding, and cause a reduced anti-hypertensive or diuretic effect when co-administered with Diuretics or ACE Inhibitors/ARBs.
  • A timing restriction mandates that Aceclofenac not be administered for 8–12 days following Mifepristone administration to prevent documented reduction in Mifepristone's effect.
  • The risk of acute renal insufficiency is specifically noted to be higher in the elderly, volume depleted, or those with compromised renal function when co-administered with diuretics or ACE Inhibitors/ARBs.

Connection to the Overall Interaction Profile

The regulatory documents define this product's interaction structure by classifying risks into domains focusing on additive pharmacodynamic effects that increase organ-specific toxicity (e.g., GI and renal risk) and pharmacokinetic alterations that reduce clearance of co-administered medicines. The profile imposes specific constraints, including formal avoidance rules for certain combinations and timing restrictions for others, reflecting officially recognized limits on co-administration.

Mechanism of Action

Biofenac (aceclofenac or diclofenac) is a non-steroidal anti-inflammatory drug (NSAID) that modulates signaling sequences within multiple biochemical pathways.


Cyclooxygenase Enzyme Inhibition

This represents the primary mechanistic domain. The compound functions as an inhibitor of cyclooxygenase (COX) enzymes, specifically targeting COX-2. COX-2 is responsible for the conversion of arachidonic acid into pro-inflammatory mediators. This enzymatic blockade modifies the early molecular steps within the arachidonic acid cascade, leading to a reduction in prostaglandin synthesis.


Modulation of Inflammatory Mediators

Beyond the primary target, the drug engages mechanisms that influence inflammatory cascades. It modifies signaling sequences involving specific pro-inflammatory cytokines (such as IL-1β and TNF-α) and influences the chemotaxis of leukocytes. This effect modulates the concentration and activity of specific mediator compounds at the target site.


Regulation of Cartilage Metabolism

Its active metabolite is relevant in systems requiring pathway adjustment for tissue maintenance. It has been demonstrated to modulate the synthesis of glycosaminoglycans and interfere with the release of matrix metalloproteinases. This mechanistic effect modulates the molecular processes associated with joint tissue composition.

Dosage and Administration Information

How to Use Biofenac

This section outlines the general principles for the administration of Biofenac (Aceclofenac). Usage follows established parameters regarding route, dosage, frequency, and duration.


Official Usage Patterns

Biofenac is intended for oral administration. The general principle mandates that the medicine be used at the lowest effective dose for the shortest duration necessary to control symptoms, consistent with guidelines for Non-Steroidal Anti-Inflammatory Drugs.

Administration Component General Guideline
Standard Oral Dose The maximum recommended total daily intake is 200 mg. This is typically divided into 100 mg doses taken twice daily, or administered as a single 200 mg prolonged-release tablet once daily.
Timing and Intake Tablets should be swallowed whole with sufficient liquid. It is preferable to take the medicine with or immediately after food. The tablets must not be crushed or chewed.
Frequency Dosing is typically scheduled twice daily for the immediate-release tablet or once daily for the prolonged-release tablet.

Population-Specific Adjustments

Dosing modifications are utilized for certain patient groups. For instance, in individuals with moderate hepatic impairment, the initial total daily dose is reduced to 100 mg once daily.

While no routine adjustment is mandated for older adults, the use of the lowest possible effective dose for the shortest duration is emphasized. Use in pediatric patients (under 18 years) is not recommended due to insufficient clinical data in this population.

Recent Clinical Evidence

Research evidence / Overview of studies for Biofenac


️ Evidence for Use in Chronic Inflammatory Joint Diseases

Biofenac was studied in Randomized Controlled Trials (RCTs) for conditions characterized by fluctuating or episodic manifestations, including Osteoarthritis (OA), Rheumatoid Arthritis (RA), and Ankylosing Spondylitis (AS) in adults and older adults. Researchers examined outcomes related to physical discomfort and daily functioning. Systematic reviews contribute to the broader evidence landscape by examining patient-reported outcomes compared against similar pharmacological interventions. Uncertainty remains regarding sustained changes; follow-up durations were often limited to 4-12 weeks, and long-term effects are not fully established. Results apply only to the populations studied.

️ Evidence for Use in Acute Pain and Inflammation

Studies observed Biofenac in research contexts involving acute conditions, such as short-term low back pain and dental discomfort. Research examined outcomes describing episodic changes in physical discomfort. Comparative studies were used to compare measured outcomes against those reported for other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and analgesics. Due to short-term follow-up (a few weeks), data for sustained relief or prevention of recurrence remains insufficient.

️ Long-Term Follow-up and Durability of Response

Clinical research has focused predominantly on initial symptom changes over time intervals of up to three months. There is limited information for long-term outcomes regarding Biofenac extending beyond 12 weeks in high-quality RCTs. The durability of measured changes over many months is not well characterized, though research is ongoing in post-marketing settings.

️ Research in Special Population Groups

Biofenac was studied for chronic joint conditions in research focusing on older adults. However, data for certain groups remain insufficient. Evidence is limited regarding its application in research contexts involving children, pregnant populations, or individuals with specific complex comorbidities.

️ Research Gaps and Areas of Uncertainty

The research provides context but not individual predictions. Evidence quality varies across studies, leading to mixed findings when data is combined in meta-analyses, due in part to high heterogeneity and varying symptom burdens. Furthermore, comparative evidence is lacking in some areas, such as large-scale studies directly comparing Biofenac to all non-pharmacological interventions.

Key Studies & References

  1. WHO Anatomical Therapeutic Chemical (ATC) Classification System - Aceclofenac (M01AB16)

Frequently Asked Questions (FAQ)

Common questions about Biofenac (FAQ)


Q: How long do the effects of Biofenac last in the body?

A: Information from official pharmacokinetic data describes the mean elimination half-life of the active ingredient as approximately four hours. The half-life refers to the time it takes for the concentration of the substance in the bloodstream to be reduced by half. This measurement helps characterize the time the medicine remains in the system.

Q: Do I need to take Biofenac with food?

A: Official regulatory information advises that it is preferable to take the tablets either with food or immediately after eating. This instruction is consistent with guidelines often provided for this class of medicine.

Q: Is Biofenac the same type of medicine as ibuprofen or naproxen?

A: Yes, Biofenac (Aceclofenac) belongs to the Non-Steroidal Anti-Inflammatory Drug (NSAID) class of medicines. This is the same pharmacological category that includes both ibuprofen and naproxen.

Q: Can Biofenac cause stomach problems, even if I take it correctly?

A: Gastrointestinal issues such as dyspepsia (indigestion), abdominal pain, and nausea are documented as common side effects that may occur during use, even when administration instructions are followed.

Q: What are the most common side effects listed for Biofenac?

A: The most commonly documented reactions in regulatory materials involve the gastrointestinal system (such as nausea and abdominal pain) and the nervous system (including dizziness).

Q: Can taking Biofenac affect my blood pressure?

A: Official regulatory documents note that fluid retention and swelling (oedema) have been reported in association with NSAID therapy. For individuals with a history of hypertension (high blood pressure), caution is advised.

Q: What kind of research has been done on Biofenac's long-term effects?

A: Clinical research has focused predominantly on measuring symptom changes over short time frames, typically up to 12 weeks. The durability of measured changes over many months and long-term effects are not fully established in high-quality randomized controlled trials.

Q: Why does the packaging list so many warnings about liver function?

A: Regulatory documents list warnings regarding liver function due to the possibility of increased levels of hepatic enzymes (a common side effect). Furthermore, the medicine is contraindicated for patients with severe hepatic impairment (severe liver failure).

Q: What kind of foods or drinks should be avoided while taking Biofenac?

A: Official sources do not typically list specific foods to avoid, but consuming alcohol while using Non-Steroidal Anti-Inflammatory Drugs may increase the documented risk of gastrointestinal adverse effects, such as bleeding and ulcers.

Q: Does Biofenac affect how blood clots?

A: Biofenac is associated with a documented risk of arterial thrombotic events, such as heart attack or stroke. It may also enhance the effects of anticoagulant (blood-thinning) medicines, increasing the documented risk of bleeding.

Q: Why do official warnings mention risks to the heart with Biofenac?

A: Warnings exist because the drug is associated with a documented risk of arterial thrombotic events, such as myocardial infarction or stroke. Official documents indicate this risk may increase with the dose and duration of use.

Q: Is Biofenac known to cause drowsiness?

A: Drowsiness (somnolence) is documented in regulatory information as a possible side effect affecting the central nervous system, though it is reported as rare.

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

A: Signs of a severe allergic reaction (anaphylaxis) documented in official patient leaflets may include fever, difficulty breathing or wheezing, abdominal pain, vomiting, and swelling of the face and throat.

Q: Can Biofenac be split or crushed to make it easier to swallow?

A: Official regulatory guidelines state that Biofenac tablets should be swallowed whole with liquid. They should not be crushed, split, or chewed before swallowing.

Q: What is the role of Biofenac in treating chronic pain?

A: The medicine is approved for use in the treatment of pain and inflammation associated with chronic inflammatory joint diseases. This includes conditions such as Osteoarthritis, Rheumatoid Arthritis, and Ankylosing Spondylitis.

Q: What does the term 'half-life' mean regarding Biofenac?

A: Half-life, in the context of medication, refers to the time it takes for the concentration of the active substance in the bloodstream to be reduced by half. For Biofenac, the mean elimination half-life is approximately four hours, according to pharmacokinetic data.

Q: Do studies suggest Biofenac can affect fertility?

A: Official regulatory documents state that the use of Biofenac may potentially impair female fertility. For this reason, it is generally not recommended for women who are actively attempting to conceive.

Q: Why are people often confused about the difference between Biofenac and a steroid?

A: Biofenac is classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID), indicating that its chemical structure and therapeutic action mean it is not a steroid medication.

Q: Is Biofenac available in other countries under different names?

A: The active ingredient, Aceclofenac, has been approved for use in numerous countries worldwide. It is marketed under various brand names depending on the regulatory jurisdiction.

Q: Can Biofenac cause insomnia or affect sleep patterns?

A: Rare cases of insomnia (difficulty sleeping) are documented as a possible side effect listed under the product's psychiatric adverse reactions in official information.

Q: Is Biofenac used in combination with other pain relievers?

A: In some regions, combined formulations of Biofenac (Aceclofenac) with other non-NSAID pain relievers, such as Paracetamol, have been approved and made available.

Q: How is the safety profile of Biofenac generally described in regulatory documents?

A: The product's safety profile is defined by officially documented adverse reactions that are classified by frequency. The most common reactions involve the gastrointestinal system and the nervous system, while certain severe risks are also documented and highlighted in warnings.

Q: What are the official recommendations for stopping Biofenac if side effects occur?

A: Official regulatory information describes certain serious signs, such as a skin rash, mucosal lesions, or signs of severe hypersensitivity, as reasons for immediate discontinuation.

Q: Is there a maximum time frame for how long Biofenac can be used?

A: Official regulatory guidelines mandate that the medicine be used for the shortest duration necessary to control symptoms. This is consistent with guidelines for Non-Steroidal Anti-Inflammatory Drugs, which focus on minimizing the duration of exposure.

Q: Can Biofenac be used for general back pain?

A: Some official documents include conditions such as low back pain within the scope of conditions Biofenac is indicated for. However, its primary indicated uses are chronic inflammatory joint diseases like Osteoarthritis and Rheumatoid Arthritis.

Q: Can Biofenac be taken by people who are generally healthy?

A: The medicine is generally indicated for use in adults who do not have documented contraindications such as severe organ impairment or a history of recurrent ulceration. Official product labeling focuses on these specific prohibitions and warnings.

Q: What does 'Biofenac should be used at the lowest effective dose' officially mean?

A: This official mandate means that the smallest amount of medicine that successfully controls symptoms should be used for the briefest time necessary. This is a strategy used to minimize the possibility of adverse effects.

Q: If I have mild asthma, can I still use Biofenac?

A: Official documents state that the medicine is contraindicated for individuals who have a known history of aspirin or other NSAIDs precipitating attacks of asthma, acute rhinitis, or urticaria.

Q: Why is it important to check for drug interactions before starting Biofenac?

A: Official regulatory documents describe how Biofenac can alter the effects of other essential medicines, potentially affecting their risk profile or efficacy. This check is necessary because of the documented risks of co-administration.

How should Biofenac be stored and disposed of?

Storage and Disposal Conditions for Biofenac (Aceclofenac)

Biofenac must be stored and handled according to specific regulatory requirements to maintain its integrity and ensure safety.

Storage Requirements

The product must be stored below 25 C and kept in the original package. It must be protected from direct sunlight and moisture. As a standard safety measure, the medicine must be stored out of the sight and reach of children.

Disposal Requirements

To protect the environment, unused or expired Biofenac must not be disposed of via household waste or wastewater. The official instruction is to return the unused medicine to the pharmacist or follow local regulatory procedures for pharmaceutical waste disposal.

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

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