Kefen

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Medically reviewed

Rosario Oropesa

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 Kefen

Property Description
Active ingredient Ketoprofen
Pharmacological class Nonsteroidal Anti-inflammatory Drug (NSAID)
Origin Synthetic compound
Common forms Capsules, Gel, Suppositories, Solution for injection
General purpose Relief of pain, inflammation, and fever

Kefen is a medicinal preparation whose active component is Ketoprofen, a substance clinically recognized for its robust triple action. It is classified as a Nonsteroidal Anti-inflammatory Drug (NSAID). This drug is fundamentally a synthetic compound known for its ability to provide pain relief, reduce inflammation, and lower fever. Ketoprofen is recognized as an essential medicine, highlighting its global importance for managing core symptoms.

What Type of Medicine is Ketoprofen?

Ketoprofen is an NSAID that belongs to the propionic acid derivative chemical class. The substance is used for the general purpose of symptomatic control, providing a powerful, multimodal effect that combines analgesic, anti-inflammatory, and antipyretic actions. This classification signals that the agent works by interfering with the body's production of inflammatory mediators, a mechanism associated with its therapeutic efficacy. The versatility of its action makes it a suitable choice for managing acute discomfort, such as the pain and inflammation associated with musculoskeletal strain.

Composition and Available Forms of Ketoprofen

The active ingredient in Kefen is Ketoprofen, which is a single-component product derived through chemical synthesis. This composition is identical to the active ingredient found in other major brands like Orudis and Profenid, positioning it as a highly adaptable formulation. The medicine is manufactured in multiple dosage forms—such as capsules or tablets for oral intake, suppositories for rectal application, and gel for topical use—with sterile solution for injection also being available. This range ensures the agent can be administered through various routes of administration, enabling localized or systemic action as required for the management of discomfort.

What side effects are possible with Kefen?

Possible Side Effects and Safety Information

The safety profile of Kefen, as documented by government regulatory bodies, outlines adverse reactions categorized by frequency and severity, focusing primarily on central nervous system effects and rare, but life-threatening hypersensitivity reactions.

Serious Adverse Reactions

The most serious documented safety concerns include rare, severe, and potentially fatal hypersensitivity reactions. These include Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), Stevens-Johnson Syndrome (SJS), and Toxic Epidermal Necrolysis (TEN).

  • DRESS: This reaction can cause internal organ injury affecting the liver, kidney, lung, heart, or pancreas. It typically develops between two to eight weeks after starting the medicine. Official safety information notes that early symptoms, such as fever or swollen lymph nodes, may occur without the presence of a skin rash.

Common Adverse Reactions

Adverse reactions classified as common (occurring in 1% to 10% of patients) often involve the central nervous system and psychiatric disorders. These may include, but are not limited to, unusual irritability, aggression, confusion, extreme drowsiness, and loss of balance or coordination.

Safety-Related Restrictions

Kefen is designated as a Schedule IV controlled substance due to the risk of developing physical dependence with use. The regulatory safety information emphasizes the need for close monitoring to detect signs of serious reactions, even when symptoms are subtle or delayed. The range of potential side effects extends across multiple system-organ classes, including nervous system, psychiatric, skin, immune system, and gastrointestinal disorders.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory documents define the overdose profile of Kefen (Ketoprofen) based on documented clinical manifestations and mandated emergency actions. Overdose presentations are commonly noted in regulatory labeling to include gastrointestinal symptoms like nausea, vomiting, abdominal pain, and diarrhea, along with central nervous system effects such as drowsiness, dizziness, confusion, and headache.


Serious Outcomes and Immediate Actions

Classification Official Regulatory Statement
Severe Outcomes Life-threatening risks include internal Gastrointestinal Bleeding or Perforation, Acute Renal Failure (Kidney Damage), and severe CNS depression leading to seizures or coma.
Antidote No specific antidote is known for acute nonsteroidal anti-inflammatory drug (NSAID) toxicity.

When to Seek Urgent Help

Regulators require individuals to seek immediate medical attention right away for any suspected overdose. Urgent action is specifically mandated when symptoms include chest pain, slurred speech, weakness on one side of the body, or vomit that is bloody or looks like coffee grounds. Management is officially described as symptomatic and supportive treatment, potentially involving activated charcoal, gastric lavage, and continuous monitoring of vital signs, blood tests, and cardiac function.

Therapeutic Uses of Kefen

What Kefen Treats — Main Uses and Benefits

Kefen provides targeted symptomatic relief by addressing the cluster of pain, inflammation, and fever across several clinical contexts. The medication is utilized to relieve symptoms related to physical discomfort, stiffness, and swelling caused by various conditions. Its primary benefit involves symptomatic relief, which may assist with maintaining a sense of stability when symptoms are more noticeable.


The agent is commonly used to help with conditions characterized by periods of heightened symptoms, including chronic disorders like rheumatoid arthritis and osteoarthritis, as well as acute manifestations such as sprains, strains, dental pain, and primary dysmenorrhea (menstrual cramps).

“Kefen is applied in scenarios where additional management of discomfort is required, providing support that may help patients cope more steadily with symptom fluctuations.”

This symptomatic assistance is relevant in contexts marked by increased discomfort or tension, such as post-traumatic recovery or during phases when symptoms of systemic imbalance, like fever, become more noticeable.


Quick Fact: Relief for Pain and Inflammation

Kefen is commonly used for managing symptoms that interfere with daily comfort across therapeutic domains, including musculoskeletal stiffness, acute episodic headaches, and inflammatory swelling in soft tissues.

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Who can and cannot use Kefen?

Kefen (Ketoprofen) eligibility is strictly defined by regulatory bodies to protect patient safety. The medicine is contraindicated (must not be used) in individuals with a known hypersensitivity to Ketoprofen, aspirin, or other Nonsteroidal Anti-inflammatory Drugs (NSAIDs).


Absolute Prohibitions (Contraindications)

An absolute ban applies to patients with active gastrointestinal ulceration, a history of bleeding, or severe heart, liver, or renal failure. Use is also prohibited for treating pain following coronary artery bypass graft (CABG) surgery.


Age and Physiological Restrictions

Kefen is not recommended for children and adolescents under 18 years for systemic forms, as safety and efficacy are not established in this population. It is strictly contraindicated during the third trimester of pregnancy and is generally not recommended while breastfeeding.


Conditional Use

For older adults and for those with mild to moderate hepatic or renal impairment, use is permitted but requires caution and close monitoring. Regulatory documents specify that these populations may require a lower starting dose due to reduced clearance, defining a crucial condition-specific eligibility limit.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The regulatory interaction profile for Kefen (Ketoprofen) is structured by documented patterns that affect co-administered drugs or impose specific restrictions, as stated in official labeling.

Formal Restrictions and Interaction Classes

Classification Constraint or Interaction Pattern
Contraindicated Combinations Co-administration with other NSAIDs (including COX-2 inhibitors) and high-dose Salicylates is strictly prohibited due to an increased risk of gastrointestinal haemorrhage and ulceration.
Surgical Restriction The drug is formally restricted, and thus contraindicated, for the management of peri-operative pain in the setting of Coronary Artery Bypass Graft (CABG) surgery.

Documented Pharmacokinetic and Pharmacodynamic Effects

Ketoprofen exhibits a pharmacokinetic interaction by reducing the renal clearance of certain co-administered drugs. This effect increases the systemic exposure of substances like Lithium and high-dose Methotrexate, leading to elevated plasma concentrations. For high-dose Methotrexate, a mandatory timing rule is enforced, requiring administration to be separated by at least 12 hours before or after Ketoprofen treatment.

Pharmacodynamic interactions increase the risk of bleeding. Combining Ketoprofen with Oral Anticoagulants (e.g., Warfarin), Heparins, Oral Corticosteroids, or SSRIs may result in an increased risk of haemorrhagic events. Co-administration with Diuretics, ACE Inhibitors, or ARBs carries a documented risk of acute renal failure and a reduction of the expected antihypertensive effect. Furthermore, interactions with alcohol and tobacco are documented to enhance the risk of serious gastrointestinal adverse effects.

Mechanism of Action

Inhibition of Cyclooxygenase Enzymes

Kefen's primary action involves acting as a non-selective inhibitor of the cyclooxygenase (COX) enzymes, targeting both the COX-1 and COX-2 isoforms. By blocking these enzymes, the drug interferes with the initial steps of the arachidonic acid cascade, which is the fundamental process required to synthesize key signaling molecules in the body.


Modulation of Mediator Signaling

This enzymatic blockade leads to a significant reduction in the body's local production of prostaglandins. This decrease in mediator signaling affects the sensitivity of peripheral nerve endings and alters the central nervous system's thermal regulation set point, resulting in a reduction of heightened physiological signaling.


️ Integrated Central and Peripheral Action

The drug's complete mechanistic activity results from its engagement with both peripheral and central biological systems. This dual action results in the modulation of the thermal set point and nerve excitability within targeted pathways, influencing systemic processes such as heightened nerve excitability and elevated thermal regulation.

Dosage and Administration Information

Kefen (ketoprofen) is a nonsteroidal anti-inflammatory drug (NSAID) used to manage the signs and symptoms of conditions such as rheumatoid arthritis, osteoarthritis, and for the relief of mild to moderate pain and dysmenorrhea (menstrual cramps).

General Administration Instructions

  • Take Exactly as Prescribed: Use this medication exactly as directed by your healthcare provider. The dosage and duration of treatment are determined by your medical condition and response to therapy.
  • Lowest Effective Dose: To minimize the risk of serious side effects, including gastrointestinal and cardiovascular events, it is essential to use the lowest effective dose for the shortest duration necessary to achieve treatment goals.
  • With Food or Milk: To help reduce the potential for stomach upset or irritation, you may take Kefen with food, milk, or an antacid, unless your doctor instructs otherwise. While food may slightly delay absorption, it does not alter the total amount of drug absorbed by the body.
  • Do Not Alter Capsules: Immediate-release and extended-release capsules should be swallowed whole. They should not be crushed, chewed, or opened.

Dosage for Immediate-Release Capsules

Condition Typical Starting Dose Maximum Total Daily Dose
Osteoarthritis / Rheumatoid Arthritis 75 mg three times daily OR 50 mg four times daily 300 mg
Mild to Moderate Pain / Dysmenorrhea 25 mg to 50 mg every 6 to 8 hours as needed 300 mg

Missed Dose

If you miss a dose of Kefen, take it as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not double your dose to catch up.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Kefen


Evidence for Acute Pain and Soft Tissue Injuries

Kefen (Ketoprofen) was studied for examining short-term outcomes related to physical discomfort associated with acute episodes like sprains, strains, and dental or postoperative pain. Research for these conditions primarily consists of short-term Randomized Controlled Trials (RCTs) and Systematic Reviews. These studies included adults and monitored outcomes such as changes in pain intensity scores and functional measures over short periods.

Findings describe patterns observed in the studies where data showing patterns related to subjective pain scores were reported compared to placebo groups. Studies exploring short-term symptom changes involving the topical gel formulation also examined patient-reported outcomes describing perceived discomfort. Long-term effects are not fully established because follow-up durations were limited; the research was designed for examining temporary, acute episodes.


Evidence for Chronic Inflammatory Conditions

Research was studied for exploring outcomes in long-term conditions such as Osteoarthritis (OA) and Rheumatoid Arthritis (RA). Intermediate-term RCTs contribute to the broader evidence landscape for these conditions, which often involved adults and older adults over periods ranging from six to twelve weeks. These studies examined outcomes reflecting daily functioning and joint mobility.

Findings describe patterns observed in the studies where changes in patient-reported scores for outcomes related to physical discomfort were reported. Evidence is limited in determining how these patterns might continue or change over periods longer than 12 weeks. Comparative evidence is lacking for direct head-to-head trials against the full range of newer treatments, meaning subgroup findings are uncertain in patients with specific comorbidity profiles.


What is Still Uncertain About Kefen's Research Profile

The existing research presents several research limitation frames. The research generally explores short-term symptom changes, leaving long-term effects not fully established regarding sustained symptomatic management. Data for certain groups remain limited, and evidence is limited regarding the systematic study of Ketoprofen in children or adolescents.

Key Studies & References

  1. Ketoprofen Compounding Powder - FDA-approved indications for oral formulation (2025)

Frequently Asked Questions (FAQ)

Common questions about Kefen (FAQ)

Q: What is the main difference between Kefen and Tylenol (acetaminophen)?

A: Kefen (ketoprofen) is classified in official documents as a Nonsteroidal Anti-inflammatory Drug (NSAID). This classification means it is used to help reduce pain, fever, and inflammation.

Acetaminophen, commonly known as Tylenol, is a different type of analgesic generally used for pain and fever relief, but it does not have the same anti-inflammatory properties as NSAIDs.

Q: Is Kefen considered a type of narcotic or opioid painkiller?

A: No, Kefen (ketoprofen) is classified as a Nonsteroidal Anti-inflammatory Drug (NSAID) and is not an opioid or narcotic painkiller.

However, regulatory documents note that it is designated as a Schedule IV controlled substance due to the risk of developing physical dependence with use. This status indicates the need for careful review of use conditions.

Q: How quickly does Kefen start to provide pain relief after taking it?

A: Information from regulatory sources indicates that for the oral dosage form, the time until the start of activity can vary, with effects observed within two hours in studies involving similar forms.

It is described that the maximal effect has been reported to occur after approximately 12 hours, but the individual response may differ.

Q: How long does the effect of one dose of Kefen usually last?

A: The length of time the effect lasts is often linked to the prescribed dosing schedule.

Clinical data related to the injectable form indicates that effects have been measurable up to 24 hours after a dose, and for oral doses, the duration of effect is typically related to the prescribed dosing interval (e.g., every 6 to 8 hours) needed to maintain symptom control.

Q: Can Kefen be taken by people who have high blood pressure?

A: Regulatory warnings indicate that the use of this drug requires caution in patients with high blood pressure (hypertension) or heart failure.

This is because it can cause the body to hold onto water and salt, leading to fluid retention and swelling (edema), which may worsen these existing conditions. Regulatory guidance describes patient monitoring as a necessary condition for use.

Q: Can Kefen be used by patients who have a history of asthma?

A: Official labeling advises that Kefen (ketoprofen) should not generally be used in patients with aspirin-sensitive asthma.

This is due to the documented risk of severe, possibly fatal, allergic-type reactions. Official documentation describes a need for caution in patients with a history of asthma.

Q: Does Kefen cause drowsiness or affect my ability to concentrate during the day?

A: Reported side effects in regulatory documents include common central nervous system effects such as drowsiness, sleepiness, confusion, and dizziness.

These effects, if experienced, may influence performance of activities that require mental alertness.

Q: Is Kefen safe to use for people who have kidney issues?

A: Official documents state that the drug is contraindicated (must not be used) in patients with severe kidney failure.

For older adults or individuals with existing mild to moderate kidney problems, caution is advised and a dose adjustment may be necessary according to prescribing information due to the risk of worsening kidney issues.

Q: What are the most commonly reported stomach-related side effects of Kefen?

A: The most frequently reported gastrointestinal side effects according to regulatory information include indigestion (dyspepsia), abdominal pain, nausea, and flatulence.

Patients should be aware that serious, though less common, gastrointestinal events like bleeding and ulcers can also occur.

Q: Is it normal to feel dizzy or lightheaded when starting to use Kefen?

A: Dizziness and lightheadedness are noted in regulatory documents as less common, but possible, side effects.

Regulatory materials advise discussing any new or unusual symptoms with a healthcare professional.

Q: Is Kefen the same drug as Ketotifen? What is the difference?

A: Kefen (ketoprofen) and Ketotifen are two distinctly different medications.

Ketoprofen is an NSAID used for pain and inflammation. Ketotifen, however, works as an antihistamine and mast cell stabilizer, often used for treating conditions like allergies or asthma.

Q: Does Kefen contain aspirin or similar ingredients?

A: The active ingredient in Kefen is Ketoprofen.

It does not contain aspirin, but because it belongs to the same class of drugs (NSAIDs), it is contraindicated (must not be used) in people who are hypersensitive to aspirin or other NSAIDs.

Q: What information is available regarding Kefen use during pregnancy or breastfeeding?

A: Official labeling states that Kefen is strictly contraindicated during the third trimester of pregnancy due to documented risks to the fetus.

For the first and second trimesters and while breastfeeding, use is generally not recommended and should only occur after careful medical consideration, as safety is not fully established and fetal toxicity is a documented concern.

Q: What are the symptoms of overdose related to Kefen?

A: Regulatory information indicates that signs following an acute NSAID overdose are often limited to symptoms like lethargy, drowsiness, nausea, vomiting, and upper abdominal pain.

These effects are generally reversible, though more severe reactions like respiratory depression, coma, or convulsions may occur after ingesting very large amounts.

Q: Is Kefen safe for older adults, and are there special considerations for them?

A: Official documents describe that older adults may be more likely to experience age-related kidney problems, which may require caution.

NSAIDs, including Kefen, carry an increased risk of serious gastrointestinal events (like bleeding and ulcers) in older or debilitated patients, and a dose adjustment may be necessary due to reduced clearance.

Q: Does Kefen interact with common medications for depression or anxiety?

A: Yes, official drug interaction warnings indicate that combining Kefen with Selective Serotonin Reuptake Inhibitors (SSRIs), a common class of medication for depression and anxiety, is documented to increase the risk of haemorrhagic (bleeding) events.

Q: Can Kefen affect blood sugar levels for people with diabetes?

A: Regulatory documents state that the condition of diabetes mellitus may be aggravated by this medication.

In addition, an interaction with the common diabetes medication metformin is documented, which can increase the risk of a serious condition called lactic acidosis.

Q: What are the signs of a serious skin reaction related to Kefen that I should look for?

A: Serious skin reactions, such as Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and DRESS, are rare but possible and are described in official safety information.

Regulatory information describes signs of serious skin reactions, such as new rashes, skin peeling, blistering, or fever. The official documents note that early DRESS symptoms can include fever or swollen lymph nodes even without a rash.

Q: Is there a maximum time frame that Kefen is recommended to be used?

A: While regulatory guidance does not set a specific maximum duration for all uses, it emphasizes that the lowest effective dose should be used for the shortest duration necessary to achieve treatment goals.

This instruction is given to help minimize the risk of serious side effects, including cardiovascular and gastrointestinal events.

Q: Are there any known interactions between Kefen and alcohol?

A: Official drug labeling documents state that alcohol use can enhance the risk of serious gastrointestinal adverse effects, including stomach bleeding and ulceration, when taken with this drug.

Official documentation describes a restriction on alcohol use while using this medicine.

Q: Is it normal if Kefen causes a slight change in the color of my urine?

A: Adverse events related to the urinary system, such as bladder pain, cloudy urine, and difficult urination, have been reported as less common side effects in regulatory documents.

Dark urine is also a symptom associated with rare but serious liver problems, which patients may wish to discuss with a healthcare professional.

Q: What are the potential effects of Kefen on liver function?

A: Kefen is contraindicated in patients with severe liver failure. Official warnings also note that serious, possibly fatal, liver disease has been reported rarely.

The official documentation describes signs associated with liver issues, which may include yellowing of the skin or eyes (jaundice), dark urine, or upper right abdominal pain.

Q: Why is it recommended to take Kefen with food sometimes?

A: Administration instructions from official sources note that taking Kefen with food, milk, or an antacid may help to reduce the potential for stomach upset or irritation.

Although food may slightly delay the absorption of the drug, it does not change the total amount absorbed by the body.

Q: Does Kefen help reduce fever as well as pain and inflammation?

A: Yes, regulatory and pharmacological classification confirms that Ketoprofen, the active ingredient in Kefen, is an NSAID with a triple action.

This means it has documented analgesic (pain-relieving), anti-inflammatory, and antipyretic (fever-reducing) actions.

Q: Is Kefen suitable for children, and is the dosage adjusted for them?

A: Official documents state that Kefen is generally not recommended for children and adolescents under 18 years for systemic (oral) forms.

This is because the safety and efficacy of the medication have not been established in this younger population.

Q: Does Kefen have a potential for misuse or dependence?

A: Official United States regulatory bodies have designated Kefen as a Schedule IV controlled substance.

This classification is due to the documented risk of developing physical dependence with its use.

Q: Is Kefen available in different forms, like a gel, patch, or injection?

A: Yes, in addition to capsules or tablets for oral intake, the active ingredient Ketoprofen is described as being available in other forms in regulatory documents.

These forms include topical gels, suppositories, and solutions for injection.

Q: What are the research findings about Kefen's effectiveness for menstrual cramps?

A: Clinical studies have examined the use of Ketoprofen for addressing the symptoms of primary dysmenorrhea (menstrual cramps).

Findings reported in the literature indicate patterns related to pain relief and an improvement in associated symptoms, such as headache, when compared to a placebo group.

Q: Can Kefen be used for pain after dental surgery?

A: Yes, regulatory overviews and clinical studies mention the use of Ketoprofen for managing acute pain.

This includes addressing discomfort associated with short-term episodes such as dental pain and pain after postoperative procedures.

How should Kefen be stored and disposed of?

How to Store and Dispose of Kefen (Ketoprofen)

Storage & Disposal Scope Requirements
Labeled Storage Temperature Controlled Room Temperature (CRT), typically 20 C to 25 C (68 F to 77 F).
Light/Moisture Protection Must be protected from light, excess heat, and moisture [1.1]. Avoid storing in moist areas like a bathroom [1.2].
Packaging Requirements Keep the medicine in the container it came in, tightly closed [1.6].
Child-Protection Storage A mandatory instruction is to keep the medication out of the reach of children [1.6].
Official Disposal Rules Drug take-back programs or mail-back envelopes are the best option for unused or expired product [2.1].
Environmental Disposal Do not flush down the toilet or pour into a drain unless specifically instructed to do so [3.1].

These storage requirements strictly define the environmental conditions—such as the permitted temperature range and protection from light and moisture—that must be maintained to ensure the product’s integrity. The disposal instructions mandate the use of authorized take-back programs or, as an alternative, safe household disposal by mixing the medicine with an unappealing substance and placing it in a sealed container.

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

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