Febrofen

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Febrofen

Property Description
Active Ingredient Ketoprofen (INN)
Pharmacological Class Nonsteroidal Anti-inflammatory Drug (NSAID)
Subclass Arylpropionic Acid Derivative
Primary Forms Capsule, Tablet, Gel
Origin Synthetic
General Purpose Relief of pain, inflammation, and fever

Febrofen is a synthetic medicinal preparation containing the sole active ingredient, Ketoprofen, which is officially categorized as a Nonsteroidal Anti-inflammatory Drug (NSAID). Its fundamental purpose is to mitigate the simultaneous symptoms of pain, inflammation, and fever by targeting the underlying biological processes, functioning as a potent, non-narcotic agent within pain management.


What Type of Medicine is Febrofen (Ketoprofen)?

Febrofen is a formulation based on Ketoprofen, a compound derived from propionic acid that belongs specifically to the arylpropionic acid derivative subclass of NSAIDs. This classification establishes the substance as synthetic and non-steroidal, distinguishing it chemically from alternative analgesic agents like acetaminophen. Ketoprofen is utilized for the management of moderate pain symptoms. Unlike some other NSAIDs, Ketoprofen has been clinically recognized for a relatively rapid onset of action when taken orally.


Composition and Available Forms

The composition of Febrofen is centered on the single active substance, Ketoprofen, delivered through multiple established pharmaceutical preparations. These preparations include varieties for oral administration, such as standard immediate-release capsules and differentiated tablets (including extended-release and enteric-coated types), as well as preparations for cutaneous or topical use, typically formulated as a gel. This variety of forms ensures Ketoprofen can be administered either systemically for a broad effect or localized for targeted relief, such as managing a sprain. Both oral and topical preparations of ketoprofen are designed for the reduction of musculoskeletal pain. This confirms that the drug can be absorbed through the skin for localized action or taken by mouth for a wider effect.


The General Purpose of Ketoprofen

The general purpose of Ketoprofen is to simultaneously deliver its three principal therapeutic effects: its analgesic property (pain relief), anti-inflammatory property (swelling and redness reduction), and antipyretic property (fever reduction). These three properties stem from its core mechanism as a cyclooxygenase inhibitor, suppressing the body's internal production of prostaglandins, the chemical signals that initiate and sustain these symptoms.

Regulatory References

  1. NIH MedlinePlus: Ketoprofen Drug Information

What side effects are possible with Febrofen?

Possible Side Effects and Safety Information

Febrofen (ketoprofen) is associated with serious warnings concerning cardiovascular and gastrointestinal risks, as highlighted in official regulatory labeling.

Serious Adverse Reactions and Safety Warnings

Official regulatory documents emphasize the potential for serious adverse events. These events may occur without warning and include:

  • Serious Cardiovascular (CV) Thrombotic Events: This risk includes potentially fatal events such as myocardial infarction (heart attack) and stroke. The risk may begin early in treatment and may increase with the duration of use and at higher doses.
  • Serious Gastrointestinal (GI) Events: These include bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal.
  • Hepatotoxicity and Renal Toxicity: Serious injury to the liver or kidneys, including acute renal failure.
  • Severe Allergic/Hypersensitivity Reactions: Including anaphylaxis and severe skin reactions.

Frequency-Classified Adverse Reactions

The following are classified by regulatory authorities based on body system and frequency of occurrence:

System-Organ Class Common Adverse Reactions (e.g., >3%)
Gastrointestinal Disorders Dyspepsia (most common), nausea, abdominal pain, diarrhea, flatulence, constipation.
Nervous System Disorders Headache, dizziness, drowsiness.

Safety-Related Restrictions and Contraindications

Febrofen is strictly contraindicated (must not be used) in certain circumstances based on regulatory mandates:

  • For pain immediately before or after Coronary Artery Bypass Graft (CABG) surgery.
  • During the last trimester of pregnancy (starting at 30 weeks gestation) due to risk of harm to the fetus.
  • In patients with a known allergic reaction (e.g., asthma, hives) to ketoprofen, aspirin, or other NSAIDs.

Caution and monitoring are required for specific patient groups, including older adults (higher GI risk) and patients with pre-existing conditions like high blood pressure, heart failure, or a history of stomach ulcers.

Overdose and Emergency Response

Overdose and When to Seek Help

Immediate Action Required

If an overdose of Febrofen is suspected, immediate emergency medical attention must be sought. Contacting emergency services or a poison control center is required, even if the individual appears well or symptoms have not yet developed.

Documented Overdose Manifestations

Overdosage with products like Febrofen (a nonsteroidal anti-inflammatory drug) is officially documented to cause a range of effects, often depending on the quantity ingested. Common manifestations include gastrointestinal distress such as nausea, vomiting, and upper abdominal pain. Central Nervous System (CNS) effects may present as somnolence, confusion, or dizziness.

Serious Outcomes

Life-threatening or severe outcomes, particularly following ingestion of large quantities or in children, include profound manifestations such as metabolic acidosis, severe hypotension, coma, and seizures. In rare instances, acute renal failure and respiratory depression have been reported as serious complications.

Management and Intervention

There is officially no specific antidote available for Febrofen overdose. Clinical management focuses on supportive and symptomatic care. Measures may include efforts to reduce systemic absorption (such as activated charcoal, if appropriate) and treating complications like seizures or severe low blood pressure as they occur. Hospital monitoring of renal function, blood pressure, and acid-base status is often required to manage potential organ toxicity.

Therapeutic Uses of Febrofen

Easing Symptomatic Discomfort and Acute Episodes

Febrofen is commonly used across domains where short-term symptomatic assistance is appropriate, addressing symptom clusters that may become intense or disruptive. It may assist in addressing symptoms related to physical discomfort. It provides symptomatic support when symptoms intensify, which helps to ease the overall symptom load of acute episodes.


Supporting Stability in Fluctuating Conditions

It is commonly used across conditions characterized by periods of heightened symptoms or those involving episodic manifestations, such as pain related to arthritic diseases and symptoms of systemic imbalance (fever). It is applied across domains where additional symptomatic support is needed to manage symptoms that interfere with daily comfort. This contributes to improved day-to-day comfort during symptomatic phases.

The support provided helps the patient maintain a sense of stability when symptoms are more noticeable, assisting with functional stability.

Quick Fact: Support for Symptoms of Physical Discomfort


Temporary Assistance for Functional Strain

Febrofen is relevant in contexts marked by increased discomfort or tension, applied during phases where the patient experiences notice-able physiological strain. It is generally used when supportive symptom management is appropriate, helping to manage symptoms that cluster into patterns requiring short-term supportive management. This supports patients during difficult episodes by easing distress and is used when short-term symptom stabilization is important.

Regulatory References

  1. NIH MedlinePlus Drug Information on Ibuprofen

Eligibility and Restrictions for Use

Populations Who Must Not Use Febrofen (Contraindications)

Febrofen (Ketoprofen) use is strictly determined by official regulatory documentation, which defines specific populations who can and cannot take the medicine. Febrofen is absolutely contraindicated for patients with known hypersensitivity to Ketoprofen or any other Nonsteroidal Anti-inflammatory Drug (NSAID), including those in whom aspirin or other NSAIDs cause asthma, hives, or allergic reactions. Use is also prohibited in patients who have recently undergone Coronary Artery Bypass Graft (CABG) surgery, or those with active peptic ulcers, gastrointestinal bleeding, severe uncontrolled heart failure, or severe renal failure. Furthermore, use is strictly contraindicated during the third trimester of pregnancy.

Eligibility Restrictions and Conditional Use

The medicine’s safety and efficacy are not established for the pediatric population (under 18 years of age). Older adults (65+) are eligible but require caution and close monitoring due to increased risk of complications. Use is not recommended in women who are breastfeeding or in those attempting to conceive. Patients with compromised renal or hepatic function, a history of hypertension, or established Cardiovascular Disease must use the lowest effective dose for the shortest duration possible, as defined by official labeling.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents define the interaction profile of Febrofen (Ketoprofen) through specific pharmacokinetic and pharmacodynamic constraints. Co-administration with other Nonsteroidal Anti-inflammatory Drugs (NSAIDs) and high-dose salicylates is officially prohibited or avoided due to an additive risk of gastrointestinal ulceration and bleeding.

Pharmacodynamic and Clearance Interactions

Interacting Class/Substance Official Documented Outcome
Anticoagulants (e.g., Warfarin, Heparin) Increased risk of a haemorrhagic effect/bleeding.
Lithium and Methotrexate (high doses) Elevated blood concentrations of these substances due to reduced renal clearance.
SSRIs and Oral Corticosteroids Increased risk of gastrointestinal ulceration or bleeding.

For high-dose Methotrexate, the regulatory label specifies a mandatory timing rule: it must not be administered less than 12 hours before the start or after the end of Ketoprofen treatment. The interaction profile notes that Alcohol (Ethanol) increases the risk of stomach bleeding. Furthermore, a high-fat meal is documented to delay the peak plasma levels of extended-release formulations. In the perioperative setting of Coronary Artery Bypass Graft (CABG) surgery, Ketoprofen is formally contraindicated for pain management.

Mechanism of Action

How Febrofen Works

Febrofen (ketoprofen) functions as a nonsteroidal anti-inflammatory drug (NSAID) by primarily engaging enzyme-mediated signaling pathways to alter specific biochemical cascades. Its core action involves the non-selective inhibition of cyclooxygenase (COX-1 and COX-2) enzymes. This interaction curtails the metabolic cascade responsible for generating prostaglandins, which are potent lipid mediators derived from arachidonic acid. This molecular modification results in the suppression of pro-inflammatory eicosanoid production and subsequent alteration of nociceptive signaling at the peripheral level.

Beyond COX inhibition, the drug modulates other inflammatory processes, potentially influencing the lipoxygenase pathway and affecting systems regulated by mediators like bradykinin. Additionally, ketoprofen exhibits effects within the central nervous system (CNS), likely involving serotonergic mechanisms. This action influences nociceptive signal processing at the spinal and supraspinal levels, contributing to systemic physiological modulation.

Dosage and Administration Information

How to Use Febrofen: Official Administration Guidelines

The usage of Febrofen (Ketoprofen) is defined by its officially approved forms, administration routes, and specific dosing instructions. The general principle across all forms is to utilize the lowest effective dose for the shortest possible duration of treatment.


Administration Scope and Forms

Febrofen is administered via two primary routes: oral for systemic effect, using immediate-release (IR) capsules, extended-release (ER) tablets, or enteric-coated tablets; and topical/cutaneous via a gel for localized application.


Standard Dosing Regimens and Frequency

Usage Context Standard Adult Dosing and Frequency
Chronic Conditions (e.g., Arthritis) IR Forms: 150 to 200 mg daily, typically in 3 or 4 divided doses. Max IR dose is 300 mg per day. ER Forms: 200 mg taken once daily.
Acute Pain/Dysmenorrhea IR Forms: 25 mg to 50 mg every 6 to 8 hours as needed (PRN).
Topical Gel Applied 2 to 4 times daily to the affected area; treatment generally should not exceed one week.

Administration Requirements and Adjustments

Oral forms may be taken with food, milk, or antacids to minimize potential gastrointestinal discomfort. Extended-release tablets must be swallowed whole and should not be cut, crushed, or chewed. Dose adjustments are required for specific populations: older adults and patients with known renal or hepatic impairment should be initiated on a lower dose and have their total daily intake restricted (e.g., maximum dose potentially limited to 100 mg/day for severe renal impairment). The safety and efficacy of prescription oral forms are not established in pediatric patients.

Recent Clinical Evidence

Febrofen: Recent Clinical Evidence


Evidence for Chronic Inflammatory and Joint Conditions

The research base examining Febrofen for chronic inflammatory conditions, such as Osteoarthritis and Rheumatoid Arthritis, includes Randomized Controlled Trials (RCTs) and Systematic Reviews. These studies explored how symptoms change over time in adult populations, monitoring patient-reported outcomes related to joint stiffness, functional activity, and physical discomfort over periods lasting several weeks to a few months. Research indicates that comparative evidence directly contrasting all available Ketoprofen forms (oral vs. topical) across every chronic joint condition may be lacking in the overall body of evidence.


Evidence for Acute Pain and Traumatic Conditions

Febrofen was studied for short-term or episodic symptom patterns associated with acute conditions, such as pain following dental or orthopedic surgery or traumatic injuries. The research primarily involved single-dose RCTs in adult populations. These studies explored outcomes describing episodic changes, monitoring the time taken to observe initial changes in pain intensity and the need for supplemental pain medication. Findings indicate that outcomes related to physical discomfort were observed across these short-term trials.


Evidence for Systemic Symptom Management (Fever)

The properties of Ketoprofen relevant to outcomes related to systemic or functional imbalance (fever) were studied in comparative trials against other agents used to address high body temperature and associated systemic symptoms. Research examined the change in body temperature over defined time intervals. Compared to the extensive pain research, the volume of evidence derived from settings specifically focused solely on fever as the primary outcome is less substantial.


Evidence Gaps and Research Uncertainty

A frequently cited limitation across the research is the limited information for long-term outcomes extending across multiple years of continuous use, as follow-up durations in many key trials were limited to intermediate periods. The majority of high-quality research has been evaluated in the general adult population. Data for certain specific groups—such as pregnant individuals, children under a certain age, or patients with certain complex co-existing medical conditions—remain insufficient or are still emerging.

Key Studies & References

  1. National Institute for Health and Care Excellence (NICE) Guideline: Chronic pain (primary and secondary) in over 16s: assessment of all chronic pain and management of chronic primary pain

Frequently Asked Questions (FAQ)

Common questions about Febrofen (FAQ)

Q: What is Febrofen and how does it work?

Febrofen is the brand name for ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking the body's production of certain natural substances that cause inflammation, pain, and fever.

Q: What is Febrofen used for?

Febrofen is used to temporarily relieve pain and reduce fever caused by various conditions, including:

  • Headaches
  • Dental pain
  • Menstrual cramps
  • Muscle aches
  • Minor arthritis pain
  • The common cold or flu

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

Generally, the effects of Febrofen start to be noticeable within 20 to 30 minutes after taking the oral dose. For pain relief, the full effect is often felt within 1 to 2 hours.

Q: Can Febrofen be taken on an empty stomach?

No, it is generally recommended to take Febrofen with food or milk. This can help prevent stomach upset and reduce the risk of digestive side effects, such as stomach irritation.

Q: Can Febrofen be taken with other pain relievers?

Febrofen (ibuprofen) should not be taken at the same time as other NSAIDs, such as naproxen, celecoxib, or high-dose aspirin, because this increases the risk of serious side effects, especially stomach bleeding. You should also avoid combining it with products that already contain ibuprofen.

However, it can generally be taken with acetaminophen (a different type of pain reliever), as they work differently and do not increase the risk of bleeding in the same way. Always consult a healthcare professional or pharmacist if you are unsure.

Q: What are the common side effects of Febrofen?

Common side effects of Febrofen can include:

  • Upset stomach or nausea
  • Heartburn
  • Dizziness
  • Headache
  • Mild stomach pain or discomfort

These side effects are often mild and may decrease as your body adjusts to the medication. If they persist or worsen, contact your healthcare provider.

Q: Who should not take Febrofen?

Febrofen is not suitable for everyone. Do not take Febrofen if you have:

  • A known allergy to ibuprofen, aspirin, or other NSAIDs.
  • A history of asthma, hives, or allergic reaction after taking aspirin or other NSAIDs.
  • A history of stomach ulcers or bleeding in the stomach or intestines caused by NSAIDs.
  • Severe heart failure.
  • Are in the last three months of pregnancy.

It is essential to discuss your medical history with a healthcare provider before starting Febrofen.

How should Febrofen be stored and disposed of?

How to Store and Dispose of Febrofen (Ketoprofen)

Febrofen (Ketoprofen) must be stored according to official regulatory specifications to maintain its stability.

Storage Requirements

Requirement Condition
Temperature Store at Controlled Room Temperature, 20 C to 25 C.
Protection Keep from freezing and excessive heat. Protect from light and moisture.
Container Keep the container tightly closed and use a child-resistant closure.

Handling and Disposal

All medicinal products must be stored out of the reach of children. Do not keep outdated or unused medicine. Patients should consult a healthcare professional or pharmacist for guidance on the proper method for discarding any unused portion, ensuring disposal follows local environmental regulations.

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

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