Rofenid

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Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Rofenid

Property Description
Active Ingredient Ketoprofen (INN)
Pharmacological Class Non-steroidal Anti-inflammatory Drug (NSAID)
Common Purpose Analgesic, Anti-inflammatory, Antipyretic effects
Origin Synthetic Propionic Acid Derivative
Common Forms Tablets, Capsules, Gels, Patches

What Type of Medicine is Rofenid?

Rofenid is a medicinal product containing the active substance Ketoprofen, a synthetic Propionic acid derivative that belongs to the pharmacological class of Non-steroidal Anti-inflammatory Drugs (NSAIDs). This classification identifies Rofenid as a systemic agent and an anti-rheumatic agent developed to modulate the body's response to pain and inflammation.

Ketoprofen's specific chemical structure distinguishes it within the NSAID class. Its identity is that of a single-ingredient compound primarily designed to act simultaneously as an analgesic and an effective anti-inflammatory compound, offering symptomatic relief in scenarios where both pain and inflammatory swelling are present.

Composition and General Therapeutic Purpose

The fundamental action of Rofenid is achieved by inhibiting cyclooxygenase (COX) enzymes, which are instrumental in generating prostaglandins—the biological mediators of pain and the swelling response. By suppressing prostaglandin production, Rofenid alleviates discomfort. This molecular function translates directly into the drug's general triple therapeutic purpose: providing pain relief, reducing inflammation, and lowering fever.

Ketoprofen addresses inflammation and pain and is used for symptomatic management. The compound is effective at relieving symptoms both when taken systemically and when applied locally.

Common Forms and Differentiation

As a synthetic compound, Rofenid is precisely manufactured. The brand is typically associated with the marketing of specific dosage forms for varied applications, such as both systemic preparations (tablets, capsules) and forms intended for topical administration (gels, patches). This availability across multiple routes of administration—including oral and topical—provides flexibility for its application. Regardless of the form, the final composition always features the active Ketoprofen combined with the necessary base or excipients for stable delivery.

Regulatory References

  1. Ketoprofen: MedlinePlus Drug Information

What side effects are possible with Rofenid?

Adverse Reaction Scope

Rofenid is a nonsteroidal anti-inflammatory drug (NSAID), typically containing the active substance Ketoprofen. Its safety profile is defined by class-wide risks, primarily involving the Gastrointestinal and Cardiovascular systems.

Key adverse reactions include gastrointestinal disturbances (common), such as nausea and dyspepsia. More serious, clinically significant events—which can occur without warning—are ulceration, bleeding, or perforation of the stomach or intestines, which may be fatal.

Serious Safety Considerations

Governmental regulatory warnings emphasize an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke. This risk may be greater with higher doses or prolonged use and is a major safety restriction. The drug is contraindicated for the treatment of pain right before or after coronary artery bypass graft (CABG) surgery.

System-Organ Class Serious Adverse Reaction Examples (Regulatory Basis)
Cardiovascular Myocardial infarction, stroke, new or worsening hypertension
Gastrointestinal Bleeding, ulceration, or perforation (potentially fatal)
Immunologic Serious allergic reactions (e.g., anaphylaxis, severe skin reactions)

Population-Specific Safety

Elderly patients are at significantly increased risk for serious gastrointestinal adverse events. Use is generally restricted in the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus. Caution is required in patients with pre-existing heart failure, unmanaged hypertension, kidney impairment, or liver disease, as NSAIDs can worsen these conditions and require close monitoring.

Overdose and Emergency Response

An overdose of Rofenid (Ketoprofen) is defined in regulatory documents by a cluster of documented clinical manifestations that require immediate attention. These typically involve the gastrointestinal (GI) tract, presenting as nausea, vomiting, and epigastric pain. Central nervous system (CNS) effects are also common and include headache, dizziness, drowsiness, or disorientation.

The presence of a suspected overdose demands that an individual seek emergency medical help right away, contacting a Poison Control Center or emergency services. This urgent action is mandated due to the risk of progression to severe, life-threatening systemic outcomes. Official labeling specifies potential complications such as significant gastrointestinal bleeding, acute renal failure, hepatic dysfunction, and, in severe cases, convulsions or coma.

Management relies strictly on symptomatic and supportive care, as there is no specific antidote known for Ketoprofen overdose. Depending on the dosage suspected and the time since ingestion, decontamination procedures like gastric lavage or the administration of activated charcoal may be considered by medical professionals. Hospital monitoring may be required to observe vital signs, correct imbalances like dehydration or acidosis, and perform diagnostic tests. Special consideration is noted for patients with pre-existing renal or hepatic impairment, who may face an increased risk of severe outcomes.

Therapeutic Uses of Rofenid

Rofenid is used in situations involving certain distressing symptoms related to inflammatory or irritative states. This medicine is commonly used for various conditions presenting with acute episodes or chronic discomfort. It is applicable for conditions like rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, as well as for managing acute painful manifestations such as primary dysmenorrhea (menstrual pain), tendinitis, bursitis, and gout attacks.

The medication is relevant for easing symptoms related to physical discomfort and stiffness, applied when symptoms create noticeable physiological strain. This symptomatic support is often used when symptoms intensify, assisting with maintaining functional stability during periods of heightened distress.

“The medication may be part of symptomatic management, offering supportive relief when symptoms interfere with routine activities. This supports general well-being during symptomatic phases.”

Quick Fact: Symptomatic Support Focus

Focus Area Symptom Domain Benefit Provided
Musculoskeletal Symptoms related to inflammatory or irritative states Assists with maintaining functional stability
Episodic Symptoms that create noticeable physiological strain May help patients cope more steadily with symptom fluctuations

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Eligibility Profile for Rofenid (Ketoprofen)

Official regulatory documents define strict criteria for who can and cannot use Rofenid, based on age, organ function, clinical history, and physiological status. Eligibility is primarily established for adults seeking symptomatic management for conditions like rheumatoid arthritis or osteoarthritis.


Absolute Contraindications

Rofenid is absolutely contraindicated for specific populations where use poses severe risk. Individuals must not use Rofenid if they have a known hypersensitivity to Ketoprofen, have a history of allergic-type reactions (e.g., asthma) induced by Aspirin or other NSAIDs, or have active gastrointestinal ulceration, bleeding, or perforation. Use is prohibited in patients with severe hepatic or severe renal impairment, severe heart failure, and in the third trimester of pregnancy. It is also contraindicated for peri-operative pain management in the setting of CABG surgery.


Restricted and Age-Based Use

Use is not recommended for breastfeeding women and must be avoided in pregnant individuals at or after 20 weeks of gestation. Safety and effectiveness have not been established for all prescription uses in the pediatric population. While older adults (65 years and older) may use the medicine, close monitoring is mandatory due to the increased risk of serious adverse events.

What should I know about interactions with other medicines?

Rofenid Interactions with other medicines and products

This section outlines the officially documented interaction patterns for Rofenid (Ketoprofen), based strictly on government regulatory documents such as those from the FDA and EMA. This information describes how Rofenid's effects may change when combined with certain medicines or products.

Formally Prohibited Combinations

Co-administration is officially contraindicated for the following:

  • Other NSAIDs or High-Dose Aspirin: Prohibited due to a significantly increased risk of serious gastrointestinal adverse events, including bleeding and ulceration.
  • Octocrylene-containing Products: For topical forms, co-application is contraindicated due to the risk of severe photoallergic contact dermatitis.

Significant Pharmacodynamic and Exposure-Altering Interactions

Interacting Substance Documented Interaction Pattern
Anticoagulants (e.g., Warfarin) Increased risk of bleeding and hemorrhage (additive effect).
Lithium Increased plasma Lithium levels due to reduced renal clearance.
Methotrexate (high-dose) Increased plasma Methotrexate levels due to reduced renal clearance.
Diuretics / Antihypertensives Reduced efficacy of the blood pressure agent and increased risk of renal impairment.

Other Documented Constraints

Official regulatory sources note warnings for consumption habits and specific populations:

  • Alcohol: Increases the risk of serious gastrointestinal adverse events.
  • High-Fat Meals: May reduce the total absorption of certain extended-release formulations.
  • Population Notes: Patients who are elderly, have renal impairment, or chronic liver disease may experience altered drug clearance, leading to a higher risk of accumulation or interaction consequences.

Mechanism of Action

Targeting Eicosanoid Synthesis via COX Inhibition

The fundamental mechanism of Rofenid (Ketoprofen) involves the non-selective, reversible inhibition of the Cyclooxygenase (COX) enzymes (COX-1 and COX-2). This molecular blockade prevents the conversion of arachidonic acid into prostaglandins, which are key biological mediators. This action modulates pathways associated with heightened physiological responses and contributes to suppressing excessive signaling.

️ Dual Action: Peripheral Nociception and Central Thermoregulation

The functional consequence of COX inhibition is dual. Peripherally, the reduction in prostaglandins diminishes the sensitization of nociceptive nerve endings and lowers local vascular permeability, contributing to a reduced level of signaling within the nociceptive and inflammatory pathways. Centrally, the mechanism acts in the hypothalamus to reset the pyrogen-elevated thermoregulatory setpoint, resulting in physiological adjustments that govern the molecule's activity profile concerning core temperature.

Enantiomeric Complexity and Secondary Cellular Effects

Ketoprofen is administered as a racemic mixture, with the less active R(-)-enantiomer undergoing unidirectional chiral inversion to the pharmacologically active S(+)-enantiomer, which supports the continued presence of the active inhibitory molecule. The drug also engages secondary mechanisms, including the stabilization of lysosomal membranes in inflammatory cells, which restricts the release of hydrolytic enzymes into the surrounding cellular environment.

Dosage and Administration Information

How to Use Rofenid: Official Administration Guidelines

Rofenid (Ketoprofen) must be used strictly according to established procedures and dosage limits. The usage depends on the form and the intended site of action.


Administration Routes and Standard Dosing

Administration Route Standard Adult Dosing (Examples) Maximum Daily Dose
Oral (Immediate-Release) 25 mg to 50 mg every 6 to 8 hours (PRN for pain) 300 mg
Oral (Extended-Release) 200 mg once daily (QD) 200 mg
Topical (Gel) Apply 2 to 4 grams, two to four times daily 15 grams

Oral therapy is initiated at lower doses, and adjustments are made based on the individual's response, but must not exceed the stated maximums.


Conditions for Proper Use

Procedural Instructions

  • Oral Capsules: Should be taken with a full glass of water. They may be taken with food or milk to help reduce gastric upset, though this may slow absorption.
  • Posture: Patients must not lie down for at least 10 minutes after taking the oral dose.
  • Extended-Release Forms: Must not be crushed, chewed, or opened to preserve the controlled-release mechanism.
  • Topical Gel: Must be applied via gentle and prolonged massage and should not be used with occlusive or airtight dressings. The gel must not be applied to mucous membranes, eyes, or broken skin.

Dosing Adjustments

  • Duration: Use must be for the shortest duration necessary to achieve the intended result. Topical treatment duration is typically limited (e.g., up to seven days).
  • Specific Populations: Lower doses are required for older adults and those with severe renal or hepatic impairment. For example, in severe renal impairment, the maximum daily oral dose is typically reduced to 100 mg/day.

Recent Clinical Evidence

Rofenid: Recent Clinical Evidence

Rofenid is a trade name for ketoprofen, a nonsteroidal anti-inflammatory drug (NSAID) of the propionic acid class. Clinical research confirms its established role in managing pain and inflammation related to various conditions.


Efficacy in Acute and Chronic Pain

Clinical trials have investigated ketoprofen's utility across several pain and inflammatory states, including rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis. Studies show that ketoprofen may support the symptomatic treatment of both acute and chronic pain. Research in acute, non-infectious rheumatologic conditions and closed, benign, acute post-traumatic motor system conditions has been a focus. In some randomized controlled trials, ketoprofen demonstrated effectiveness in reducing pain intensity and was comparable to other non-opioid analgesics in managing post-operative pain.


Comparative and Formulation Studies

Comparative clinical data does not definitively establish a superior efficacy profile for ketoprofen over all other individual NSAIDs in all indications. However, non-inferiority trials have evaluated different formulations and dosing regimens of ketoprofen. For instance, some studies compared a 200 mg daily dose of a sustained-release formulation (Bi-Profenid) to a 300 mg daily dose in patients with acute post-traumatic and rheumatologic pain. The results suggested that the lower daily dose was non-inferior to the higher dose based on primary criteria such as changes in pain intensity at rest. These findings are limited to the specific trial populations and endpoints measured.


Consideration of Safety Profiles

Like all NSAIDs, ketoprofen use is associated with potential risks, particularly concerning the gastrointestinal and cardiovascular systems. Observational studies emphasize the necessity of monitoring blood pressure and being aware of risks like gastrointestinal bleeding and ulceration. When evaluating clinical evidence, the reported tolerability, often described as 'good' or 'well-tolerated' within the context of specific study populations, should be considered alongside established safety warnings and contraindications.

Frequently Asked Questions (FAQ)

Common questions about Rofenid (FAQ)

Q: Can Rofenid be taken on an empty stomach?

A: Regulatory pharmacokinetic data shows that if the oral capsule form of Rofenid is taken on an empty stomach, it may be absorbed more quickly. Official administration guidelines note that taking the medicine with food or milk is a condition that may reduce the risk of experiencing stomach upset.

Q: Does Rofenid affect blood pressure readings?

A: Official warnings state that medicines like Rofenid may lead to the development of new high blood pressure, known as hypertension. It may also cause existing high blood pressure to worsen. These effects would be reflected in blood pressure measurements.

Q: Can Rofenid affect liver function tests?

A: Studies and official information have indicated that Rofenid use is associated with a low rate of temporary elevation in certain serum liver enzymes (aminotransferases) in some patients. These changes in liver enzymes are the components that are typically assessed during a liver function test.

Q: Can Rofenid be taken with antacids?

A: Official regulatory documents indicate that the co-administration of certain antacids, specifically those containing magnesium hydroxide and aluminum hydroxide, does not interfere with how the capsule form of Rofenid is absorbed by the body.

Q: Does Rofenid interact with medicines used for diabetes?

A: Yes, official warnings note a potential interaction between Rofenid and certain medications used to treat diabetes, such as metformin. This combination is officially associated with an increased risk of lactic acidosis, which is a rare but serious condition.

Q: How quickly does Rofenid start working after taking it?

A: Regulatory documents based on clinical studies indicate that the onset of pain relief following a single oral dose of Rofenid has been reported within 30 minutes for a proportion of patients assessed.

Q: How long does the effect of Rofenid usually last?

A: Regulatory pharmacokinetic data for the immediate-release capsule form of the medicine indicates it has a half-life of approximately 2.1 hours. The half-life is the time it takes for the concentration of the medicine in the body to be reduced by half.

Q: Does Rofenid make you feel drowsy or sleepy?

A: Adverse event reporting indicates that central nervous system effects such as sleepiness (somnolence) are common side effects reported in clinical studies (1% to 10% of patients).

Q: What are the most commonly reported side effects of Rofenid?

A: The most commonly reported side effects according to official documents are gastrointestinal issues. These include indigestion, nausea, stomach pain, diarrhea, and constipation.

Q: Do I need a prescription from a doctor to get Rofenid?

A: The official labeling for the oral capsule and extended-release forms of the active ingredient (Ketoprofen) in the United States indicates that it is a prescription-only (Rx only) medicine.

Q: What happens if I miss a scheduled time to take Rofenid?

A: Official drug labels contain procedural information for missed doses. This guidance typically describes that if a dose is missed, it should be taken when remembered, unless it is close to the next scheduled dose, in which case the missed dose is skipped. Regulatory documents state that double doses should be avoided.

Q: Is there a risk of becoming dependent on Rofenid?

A: As a non-steroidal anti-inflammatory drug (NSAID), Rofenid is not classified as a controlled substance with abuse potential. Regulatory documents focus warnings on serious gastrointestinal and cardiovascular events; dependence risk is not listed as a primary safety concern.

Q: Are there any specific foods to avoid while taking Rofenid?

A: Official documents specifically note that a high-fat meal may cause a delay in reaching the medicine's peak concentration in the blood. Official documents also warn that consuming alcohol concurrently with Rofenid significantly increases the established risk of serious gastrointestinal events.

Q: Is Rofenid commonly used for muscle pain or tension?

A: Official documents recognize the medicine’s use in managing pain and inflammation related to various conditions. These indications include acute, non-infectious rheumatologic conditions and closed, benign, acute post-traumatic motor system conditions.

Q: Why is Rofenid sometimes prescribed for conditions that aren't painful?

A: The medicine is described as having a triple therapeutic purpose. Beyond providing pain relief (analgesic) and reducing inflammation (anti-inflammatory), Rofenid also has the ability to reduce fever (antipyretic effect).

Q: Can Rofenid cause stomach irritation or heartburn?

A: Common adverse reactions reported in official documents include gastrointestinal issues such as indigestion and heartburn.

Q: Is it normal to feel a bit dizzy after taking Rofenid?

A: Dizziness is one of the central nervous system effects that has been reported in clinical studies. Official information indicates that this effect has been reported as common, affecting 1% to 10% of patients.

Q: Is the feeling of lightheadedness a common side effect of Rofenid?

A: Central nervous system effects, including lightheadedness and dizziness, are reported side effects. Dizziness, specifically, is noted in the product information as a common side effect.

Q: Does Rofenid cause changes in appetite?

A: Loss of appetite is listed in the official documents among the reported adverse reactions associated with Rofenid use.

Q: How does Rofenid compare to a generic version of the same medicine?

A: Regulatory standards require that any generic version of a medicine must contain the identical active ingredient, which is Ketoprofen. Generics must also demonstrate bioequivalence, meaning they perform the same way as the original brand formulation.

Q: Does taking Rofenid affect how well I can drive or operate machinery?

A: Because Rofenid may cause central nervous system effects such as dizziness, somnolence (sleepiness), and confusion, official warnings recommend caution regarding activities like driving or operating machinery.

How should Rofenid be stored and disposed of?

How to Store and Dispose of Rofenid (Ketoprofen)

Official regulatory labeling dictates that Rofenid must be stored under specific conditions to maintain its effectiveness. The medicine requires storage at Controlled Room Temperature, defined as 20 C to 25 C (68 F to 77 F), with permitted excursions up to 30 C.

Key Storage Rules

Condition Requirement
Temperature Restriction Keep the product from freezing and away from excess heat.
Environmental Protection Protect from moisture and direct light; do not store in areas like bathrooms.
Packaging Store in the tightly closed, light-resistant container it was dispensed in.
Safety The medicine must be stored out of the reach of children.

Disposal

Unused or expired Rofenid should be discarded via a drug take-back program. If this is unavailable, mix the medicine with an undesirable substance, seal it in a container, and dispose of it in the household trash, following official guidelines.

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

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