Biprofenid

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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 Biprofenid

Property Description
Active Ingredient Ketoprofen (INN)
Pharmacological Class Nonsteroidal Anti-inflammatory Drug (NSAID)
Chemical Group Propionic Acid Derivative
Primary Forms Capsule, Tablet, Topical Gel, Injectable Solution
Origin Synthetic (Chemically synthesized)
General Purpose Analgesic, Anti-inflammatory, and Antipyretic

What Type of Medicine Is Biprofenid?

Biprofenid is a medicinal product containing the active ingredient Ketoprofen, which is officially classified as a Nonsteroidal Anti-inflammatory Drug (NSAID). This classification defines the drug's action as primarily anti-inflammatory and pain-relieving without the inclusion of opioid components.

Ketoprofen is a chemically synthetic compound belonging to the propionic acid derivative group, a structure it shares with other established NSAIDs. The molecule itself is formally known as 2-(3-benzoylphenyl)propanoic acid. Biprofenid is formulated as a single-ingredient product, and is recognized for its specific oral formulations, including extended-release tablets or capsules designed to maintain therapeutic levels over a prolonged period.


Ketoprofen: Forms and General Purpose

The general purpose of Biprofenid is to provide symptomatic relief through its triple action as an analgesic (pain reliever), an anti-inflammatory agent, and an antipyretic (fever reducer). The mechanism of action involves inhibiting the production of chemical messengers, specifically prostaglandins, that signal injury and mediate the body's response to discomfort.

The medicine is manufactured in several dosage forms to accommodate various patient needs. These forms include oral preparations like tablets and extended-release capsules for systemic absorption via the oral route, as well as specialized topical gels and injectable solutions for administration via topical or parenteral routes. Ketoprofen functions through the inhibition of cyclooxygenase (COX) enzymes, which ultimately blocks the formation of proinflammatory prostaglandins. This variety in delivery options allows for a flexible approach to managing discomfort through systemic or localized action.

Regulatory References

  1. LiverTox - NIH

What side effects are possible with Biprofenid?

The official safety documentation for Biprofenid (Ketoprofen), an NSAID, details adverse reactions classified by both frequency and the body system affected, consistent with regulatory standards.

Frequency and System-Organ Effects

Adverse reactions are grouped by how often they appear. Dyspepsia (indigestion) is typically classified as a Very Common effect. Other Common effects, reported in 1% to 10% of users in clinical trials, include gastrointestinal issues such as abdominal pain, nausea, and diarrhea, as well as central nervous system effects like headache, dizziness, and drowsiness. Less common effects include gastritis and fatigue.

Serious Adverse Reactions and Safety Constraints

The regulatory labels contain explicit warnings for potentially fatal Serious Adverse Reactions. These include major Gastrointestinal Adverse Events, such as bleeding, ulceration, and perforation of the stomach or intestines. There is also a documented risk of serious Cardiovascular Thrombotic Events, including Myocardial Infarction (Heart Attack) and Stroke. The risk for both GI and CV events may increase with the duration of use.

Specific Safety Constraints are documented. The medication is contraindicated for pain following Coronary Artery Bypass Graft (CABG) surgery and during the third trimester of pregnancy. Older adults and individuals with pre-existing severe heart failure or severe renal or hepatic impairment are identified in the official documents as populations requiring increased caution due to heightened risk.

Overdose and Emergency Response

Overdose and When to Seek Help

Biprofenid (which is based on the NSAID Ketoprofen profile) overdose typically results in mild symptoms, although serious reactions are possible after substantial ingestion. The signs of an overdose are primarily related to the gastrointestinal and central nervous systems.


Documented Overdose Symptoms

Symptoms frequently reported in cases of overdose include drowsiness, vomiting, and abdominal pain. While most cases are benign, massive ingestions, often occurring in adult suicide attempts, may lead to more severe outcomes. These serious manifestations can include seizures, coma, respiratory depression, and renal failure (kidney damage).


Emergency Action and Medical Attention

Seek immediate medical help if you or someone else has taken more Biprofenid than recommended, even if no symptoms are immediately apparent. If symptoms such as persistent vomiting, severe abdominal pain, excessive drowsiness, or seizures are present, urgent medical assessment is required.

Treatment for overdose is entirely supportive. Your doctor may consider methods to reduce the absorption of the drug, such as administering activated charcoal, and will manage any severe symptoms that develop. In rare instances of oliguric renal failure, specialised procedures like haemodialysis may be necessary.

Never attempt to treat an overdose at home. Call emergency services or a poison control center right away.

Therapeutic Uses of Biprofenid

What Biprofenid Treats: Main Uses and Benefits

Biprofenid is a medication containing ketoprofen, a non-steroidal anti-inflammatory drug (NSAID) from the propionic acid group. It is formulated as a bi-layered prolonged-release tablet designed to provide both rapid and sustained management of symptoms related to inflammation and pain.

Primary Indications

This medication is primarily used for the long-term symptomatic treatment of chronic inflammatory conditions and certain painful joint disorders. Its application is generally centered on the following areas:

  • Chronic Inflammatory Rheumatism: This includes conditions such as rheumatoid arthritis and ankylosing spondylitis, or related syndromes like Fiessinger-Leroy-Reiter syndrome and psoriatic arthritis.
  • Degenerative Joint Disease: It is utilized for the management of painful symptoms associated with various forms of osteoarthritis.
  • Extra-Articular Disorders: It may be used to treat painful conditions affecting the tissues around the joints, such as certain types of tendinitis or scapulohumeral periarthritis.

Therapeutic Benefits

The dual-action formulation of Biprofenid aims to address clinical symptoms through several mechanisms:

  • Reduction of Inflammation: By inhibiting the synthesis of prostaglandins—chemical messengers involved in the inflammatory response—it helps reduce swelling and localized heat in affected joints and tissues.
  • Analgesic Effect: It acts to alleviate pain associated with both chronic inflammatory states and mechanical wear of the joints.
  • Improvement in Mobility: By reducing pain and stiffness, particularly morning stiffness common in rheumatic conditions, the medication helps maintain or improve functional movement in the affected areas.
  • Prolonged Action: The specific structure of the tablet allows for a controlled release of the active ingredient, which helps maintain a therapeutic effect over an extended period, often allowing for simplified daily management of chronic symptoms.

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Who Can and Cannot Use Biprofenid?

Eligibility for Biprofenid (Ketoprofen) is strictly determined by official regulatory labeling, focusing on patient status rather than therapeutic benefit. The medicine is primarily approved for adults 18 years and older; its safety and efficacy are not established for use in the pediatric population. Certain patient groups are formally contraindicated and must not use the medicine.


Absolute Contraindications

Biprofenid is strictly prohibited for patients with a known hypersensitivity to Ketoprofen or other NSAIDs (including aspirin-induced asthma, rhinitis, or urticaria). It is also contraindicated in those with active peptic ulcers or GI bleeding, severe hepatic or renal failure, or severe uncontrolled heart failure. Furthermore, use is forbidden during the third trimester of pregnancy and for treating pain related to Coronary Artery Bypass Graft (CABG) surgery.


Restricted or Not Recommended Use

Use is not recommended for women who are actively breastfeeding or those attempting to conceive. Elderly patients and individuals with non-severe hepatic or renal impairment require close medical monitoring and often a dose reduction due to increased risk, as explicitly outlined in regulatory guidelines.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The regulatory profile for Biprofenid identifies two primary interaction mechanisms: pharmacodynamic risk reinforcement and altered plasma drug concentrations via reduced clearance. This framework establishes specific constraints for co-administration.

Interaction Classifications and Constraints

Classification Interaction Entity / Substance Official Interaction Description / Restriction
Contraindicated Use CABG Surgery Formally prohibited for treating peri-operative pain in the context of Coronary Artery Bypass Graft surgery.
Aspirin or Other NSAIDs Contraindicated in patients with a history of hypersensitivity (allergic-type reactions, asthma, or urticaria) to these substances.
Pharmacodynamic Risk Anticoagulants (e.g., Warfarin) May enhance the anticoagulant effect, increasing the risk of bleeding and hemorrhage.
SSRIs, Corticosteroids, Antiplatelet Agents Co-administration increases the risk of serious gastrointestinal bleeding and ulceration.
Exposure Modification Lithium, Methotrexate Co-administration elevates serum levels and prolongs exposure of these drugs by decreasing their renal clearance.
Diuretics, ACE Inhibitors, ARBs Risk of renal function impairment is increased; the antihypertensive or diuretic effect may be diminished.
Substance & Timing Note Alcohol (Ethanol) Ingestion is documented to increase the risk of stomach bleeding. Administration of the extended-release form with a high-fat meal results in a delayed peak plasma concentration.

Mechanism of Action

Biprofenid, containing ketoprofen, functions primarily as a non-selective inhibitor of the cyclooxygenase (COX) enzymes, COX-1 and COX-2. Its biological targets are these integral membrane enzymes which catalyze the conversion of arachidonic acid to prostaglandin G2 ( PGG2) and subsequently to prostaglandin H2 ( PGH2).

The drug molecule competitively binds to the hydrophobic channel of the active site on both COX isoforms, obstructing the access of the arachidonic acid substrate. This molecular interaction results in the downstream cascade of reduced prostaglandin synthesis within various tissues, particularly those exhibiting an induced inflammatory response.

At the cellular level, this suppression of prostanoid generation modulates processes such as vasodilation, capillary permeability, and leukocyte chemotaxis. The system-level physiological consequence of this generalized decrease in prostanoid mediators is the modulation of thermoregulation in the hypothalamus and a reduction in peripheral vascular responses, resulting in altered physiological temperature and microcirculatory dynamics.

Dosage and Administration Information

How to Use Biprofenid: Official Administration Guidelines

The usage of Biprofenid (Ketoprofen) is defined by its approved forms and routes, with specific dosing regimens established for different therapeutic needs. The primary routes of administration are oral (capsules/tablets) and topical (gel), with systemic use emphasizing the lowest effective dose for the shortest duration possible.

Administration Scope

Category Official Instructions
Route of Administration Oral (IR/ER capsules/tablets) and Topical (gel) for human use. Parenteral (injectable) is also recognized in some jurisdictions.
Dosing Schedule & Frequency Oral Immediate-Release: 25 mg to 50 mg every six to eight hours for acute needs, or 50 mg three to four times daily for chronic conditions. The total dose must not exceed 300 mg daily. Oral Extended-Release: Administered 200 mg once daily.
Contextual Intake Oral formulations may be taken with food, milk, or an antacid to assist with intake conditions. Extended-Release capsules must be swallowed whole and cannot be crushed or chewed.
Population-Specific Rules Treatment for older adults or small individuals must be initiated at lower doses. Mandatory dose adjustments (e.g., maximum 100 mg to 150 mg daily) are required for patients with renal or hepatic impairment.
Special Procedural Conditions Topical gel requires gentle and prolonged massage into the affected area. The treated skin must be protected from sunlight and UV light during treatment and for two weeks following discontinuation.

Resulting Procedural Structure

Official guidelines establish that the administration route and formulation determine the use frequency, with the total duration restricted to the shortest time required. The Extended-Release form is not recommended for acute pain, aligning with its once-daily schedule for maintenance. The protocol mandates that topical application courses are generally limited, adhering to the principle of using the lowest dose for the shortest duration.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Biprofenid


Evidence for use in Reducing Inflammation from Minor Injuries

This section will summarize available research findings used in research exploring whether Biprofenid affects outcomes linked to inflammatory or irritative states associated with common, non-severe soft tissue injuries. The summary will detail the types of studies conducted and what their findings generally describe regarding outcomes related to physical discomfort over defined time intervals.

Evidence for use in Managing Pain Associated with Arthritis

This section will present an overview of research that has evaluated Biprofenid in studies involving conditions associated with acute or disruptive episodes, such as various forms of arthritis. It will outline the scale and design of these trials and how studies monitored outcomes related to physical discomfort.


Long-term Studies and Follow-up

This area will describe the scope of research that has tracked patients taking Biprofenid over extended periods to understand patterns observed over extended periods and to describe data related to sustained change beyond the initial study periods. It will summarize what is known about long-term patterns observed in patients and describe where there is limited information for long-term outcomes.


Evidence in Special Populations

This section will outline research findings from studies that specifically evaluated Biprofenid in patient groups where data are often insufficient, such as older adults or those with specific coexisting health conditions. It will outline research limitations regarding data for certain groups.


What is Still Uncertain About Biprofenid

This concluding section will synthesize and articulate the main evidence gaps, inconsistent findings, and areas where certainty remains low in the current body of research on Biprofenid.

Key Studies & References

  1. NCT00810121 | Study of Non Inferiority Bi-Profenid® 200mg Versus Bi-Profenid® 300mg Among Patients Presenting of the Post-traumatic or Rheumatologic Acute Affections of the Locomotor Apparatus (BIPROPAIN) | ClinicalTrials.gov
  2. [Long-term study of 150 mg. Bi-Profenid in patients followed at the Department of Rheumatology of Cochin Hospital] - PubMed
  3. Systematic Review: Is the Use of NSAIDs Effective and Safe in the Elderly? (Relevant for Evidence in Special Populations)
  4. [Double-blind comparative study of Bi-Profenid tablets and Profenid capsules in inflammatory rheumatism] - PubMed

Frequently Asked Questions (FAQ)

Common questions about Biprofenid (FAQ)


Q: How does Biprofenid compare generally to over-the-counter anti-inflammatory medicines?

According to official product information, Biprofenid, which contains the active ingredient ketoprofen, is classified as a Nonsteroidal Anti-inflammatory Drug (NSAID). It belongs to the propionic acid derivative chemical group, the same category as several other common over-the-counter pain and inflammation medicines.

Q: What is the typical timeframe for a person to notice the effects of Biprofenid?

Pharmacokinetic data from regulatory documents indicate that the immediate-release form of Biprofenid is absorbed quickly. The drug's peak concentration in the bloodstream has been reported to occur within 0.5 to 2 hours in studies.

Q: Is a mild headache considered a normal or expected side effect of Biprofenid?

Regulatory safety documents list headache as a Common adverse reaction, meaning it was reported by 1% to 10% of users in clinical trials. This indicates it is one of the more frequently observed effects in clinical trials.

Q: Does Biprofenid have interactions with common vitamins or supplements?

While regulatory warnings focus on interactions with prescription medications, official documents specifically note that products containing willow bark should be avoided. This is due to a reported complex interaction with components of Biprofenid.

Q: Are there different strengths or forms of Biprofenid available?

Yes, Biprofenid's active ingredient is manufactured in multiple forms. These forms include immediate-release capsules, extended-release capsules, and a topical gel. Strengths vary depending on the form, such as 25 mg, 50 mg, and 200 mg for extended-release versions.

Q: Can Biprofenid be taken with other over-the-counter pain medications?

Biprofenid is described as contraindicated (prohibited) for use with other NSAIDs, including aspirin, due to an increased risk of side effects. Regulatory documents state this caution, but official sources do not typically list acetaminophen (paracetamol) in the same contraindicated category.

Q: Has Biprofenid been studied in children?

Official labeling states that the safety and effectiveness of Biprofenid in the pediatric population (individuals under 18 years old) have not been established. The labeling reflects that the safety and effectiveness are not established for this age group.

Q: Are there any specific lifestyle factors (like sun exposure or exercise) that official sources mention regarding Biprofenid use?

Official documents specify that skin treated with the topical gel formulation must be protected from sunlight and UV light during treatment. The regulatory guidelines specify this caution should be followed for two weeks after stopping the use of the gel.

Q: Is Biprofenid considered a new medication, or has it been available for a long time?

Based on its history, Biprofenid's active ingredient, ketoprofen, was first approved for use in the United States and has been available since 1986.

Q: Is it normal to feel dizzy or drowsy after starting Biprofenid?

Dizziness and drowsiness are listed in regulatory safety documents as Common adverse reactions, meaning they were reported by 1% to 10% of users in clinical trials. This indicates they are among the effects frequently observed in clinical trials.

Q: Does Biprofenid have the potential to cause fluid retention?

Regulatory documents indicate that NSAIDs like Biprofenid can lead to fluid retention and peripheral edema (swelling). This was observed in approximately 2% of patients in clinical trials.

Q: Is Biprofenid described as treating the underlying condition or just the symptoms?

Official regulatory information describes Biprofenid as providing symptomatic relief. This means it helps with symptoms such as pain, inflammation, and fever but is not intended to treat or resolve the underlying medical condition.

Q: Are there any reports about Biprofenid and sleep issues (insomnia)?

Insomnia (trouble sleeping) is documented in regulatory safety labels as a Common psychiatric adverse reaction. This was reported in 1% to 10% of clinical trial users.

Q: Can Biprofenid be used by people with a history of asthma?

Official documents describe Biprofenid as contraindicated for patients with a history of aspirin-induced asthma. For individuals with non-aspirin-sensitive asthma, regulatory guidelines suggest using the drug with caution and monitoring.

Q: Is there an established maximum time a person should use Biprofenid continuously?

The guiding principle established in regulatory documents is to use the lowest effective dose for the shortest duration possible. However, the overall duration of use is restricted to the shortest time possible, based on the principle established in regulatory documents.

Q: Does Biprofenid interact with specific foods or juices?

Official documents note that when the extended-release form is taken with a high-fat meal, the time it takes for the drug to reach its peak concentration can be delayed. There are no specific warnings against common juices or other food categories.

Q: Can Biprofenid cause a person to feel bloated or gassy?

Flatulence (passing gas) is listed in regulatory safety documents as a Common adverse reaction (reported in up to 9% of clinical trial users). A feeling of being bloated is also noted as a potential side effect.

Q: What is the official stance on using Biprofenid for a dental procedure-related pain?

The regulatory indication for Biprofenid is established as the management of mild-to-moderate acute pain. The official label does not specifically address dental pain but broadly covers acute discomfort.

Q: Are there published results from Phase III trials for Biprofenid?

As part of the drug approval process, the regulatory body reviews comprehensive research evidence. This includes data gathered from extensive Phase III clinical trials, to review the safety and effectiveness data related to the drug's approved indications.

Q: Can Biprofenid cause changes in hearing like ringing in the ears?

Regulatory documents list tinnitus (ringing in the ears) as a Common adverse reaction. Hearing loss is also noted as a less frequent adverse event that may occur.

Q: Are there reports of Biprofenid affecting mental clarity or concentration?

Official safety documents include reports of effects on the central nervous system. These possible adverse reactions include general CNS inhibition or excitation, as well as reports of trouble concentrating.

Q: What is the official information regarding Biprofenid's use in older adults (over 65)?

Regulatory documents specify that older adults require increased caution and often a lower initial dose. The regulatory guidance requires close medical monitoring for this population due to the potentially heightened risk of serious adverse events.

Q: Does the time of day a person takes Biprofenid matter?

The regulatory label establishes the dosing frequency (e.g., every 6 to 8 hours for immediate-release or once daily for extended-release). However, it does not specify morning versus night intake, as long as the prescribed schedule is followed.

How should Biprofenid be stored and disposed of?

How to Store and Dispose of Biprofenid?

The storage and disposal of Biprofenid (Ketoprofen) must follow official regulatory requirements to maintain product stability and safety.

Storage Conditions

Biprofenid must be stored at controlled room temperature, typically below 25°C or 30°C, and must be protected from light and moisture. Keep the medicine in its original, tightly closed container and do not freeze it. A mandatory requirement for all formulations is to keep the product out of the sight and reach of children.

Disposal Instructions

Unused or expired Biprofenid must be disposed of according to local regulations and through established drug take-back programs. The product should not be flushed down a toilet or disposed of in wastewater. If a take-back program is unavailable, mix the medicine with an undesirable substance and seal it before discarding in household trash.

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

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