Fastufrem

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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 Fastufrem

Property Description
Active Ingredient Ketoprofen (INN)
Form Topical Gel (Water-alcohol-based hydrogel)
Pharmacological Class Nonsteroidal Anti-inflammatory Drug (NSAID)
Common Use Symptomatic relief of localized pain and inflammation
Origin Synthetic (Propionic acid derivative)

What Type of Medicine is Fastufrem and its Core Identity?

Fastufrem is a pharmaceutical preparation distinguished by its single active substance, the International Nonproprietary Name (INN) of which is Ketoprofen. This molecule is defined as a Nonsteroidal Anti-inflammatory Drug (NSAID), a pharmacological class used for its anti-inflammatory and analgesic activities. The inherent identity of Ketoprofen as an NSAID means its action is based on a specific, chemically characterized pathway, establishing an established mechanism of effect.

Ketoprofen is a synthetic compound, chemically classified as a propionic acid derivative. This classification ensures that the preparation functions via the same mechanism of action as other established propionic acid derivatives used in managing inflammation.

Composition and Pharmaceutical Form

The medicine is supplied as a topical gel, a specific pharmaceutical form intended strictly for cutaneous application onto the affected area. This is a single-ingredient product, where Ketoprofen is the only substance responsible for the therapeutic effect. It is provided in a specialized water-alcohol-based hydrogel vehicle, a formulation distinctive for its focus on skin penetration.

This hydrogel base is engineered to serve as a volatile vehicle that supports the release and penetration of Ketoprofen through the skin barrier to the underlying painful tissues. Pharmacokinetic data indicate that systemic exposure from the topical formulation is minimal, providing focused therapeutic concentration at the site of discomfort.

General Function and Purpose

The primary function of this preparation is to deliver symptomatic relief by locally managing acute pain and inflammation. A typical use scenario involves the temporary relief of tenderness and swelling in a localized musculoskeletal area. It achieves this by the mechanism of its active ingredient, which acts as a cyclooxygenase (COX) inhibitor to reduce the body’s synthesis of prostaglandins, the chemical messengers that mediate both pain and inflammation.

The resulting therapeutic purpose is to mitigate the external signs of inflammation, such as swelling, and simultaneously reduce the sensation of discomfort. This localized analgesic and anti-inflammatory action offers a targeted means of easing symptoms associated with musculoskeletal issues.

Regulatory References

  1. Ketoprofen - LiverTox - NIH

What side effects are possible with Fastufrem?

Possible Side Effects and Safety Information

Adverse effects documented in regulatory labeling for topical ketoprofen gel primarily involve reactions at the application site. The medicine's safety profile is formally categorized by the frequency and type of reaction.

Frequency-Classified Adverse Reactions

The most frequent effects, classified as Uncommon (affecting up to 1 in 100 people), are localized skin reactions such as rash, redness (erythema), itching (pruritus), eczema, and a burning sensation. Severe skin reactions, notably photosensitization—an increased sensitivity to sunlight or UV light—are classified as Rare (affecting up to 1 in 1,000 people). Severe, life-threatening systemic allergic reactions, such as anaphylactic shock or angioedema, are officially classified as Not Known or Very Rare.

Systemic and Serious Safety Considerations

The label notes that systemic effects typical of NSAIDs, including gastrointestinal disorders (e.g., peptic ulcer) and renal dysfunction (e.g., aggravation of previous renal insufficiency), are Very Rare but possible if the gel is applied in large amounts, over extensive areas, or under occlusive dressings. Treatment must be immediately discontinued upon the development of any skin reaction, and this includes reactions following exposure to sunlight.

Time- and Population-Related Restrictions

The risk of developing photosensitivity officially increases over time. Therefore, treated skin areas must not be exposed to direct sunlight or UV light (including solariums) during the entire treatment period and for a mandatory two-week period following discontinuation. Furthermore, official regulatory documents state the medicine is contraindicated for use during the third trimester of pregnancy due to potential risks to the fetus. Caution is also advised for use in patients with pre-existing heart, liver, or renal impairment.

Overdose and Emergency Response

The official regulatory documents define the overdose profile for the Ketoprofen topical gel primarily based on the risk associated with accidental oral ingestion, as systemic absorption from cutaneous application is generally minimal.

Overdose Scope

Classification Documented Official Information
Documented Manifestations Symptoms of systemic overdose include Nausea, Vomiting, Abdominal pain, Headache, Drowsiness, Dizziness, and Diarrhoea.
Physiological Systems Affected Severe, life-threatening complications primarily involve the Gastrointestinal system (risk of bleeding and ulceration) and the Renal system (risk of acute renal failure). Convulsions are also cited as potential severe CNS manifestations.
Population-Specific Note Patients with pre-existing renal impairment may face an increased risk of severe systemic effects following an overdose exposure.

Emergency-Response Statements

Immediate medical attention must be sought upon suspicion of overdose or accidental ingestion. Contact emergency services immediately if severe or life-threatening symptoms occur, such as convulsions or signs of gastrointestinal bleeding.

Management is strictly symptomatic and supportive treatment, as no specific antidote is known. Healthcare professionals may administer activated charcoal or perform gastric lavage for recent oral ingestion to mitigate absorption, and continuous hospital monitoring of vital signs and renal function is required.

Therapeutic Uses of Fastufrem

The medication is commonly used for symptomatic relief in situations involving certain distressing symptoms related to the musculoskeletal system, concentrating on local discomfort felt directly in the affected area.

Symptom Relief for Soft Tissue Discomfort

This medication is primarily used to help manage the symptoms of pain and tenderness as well as local inflammation (swelling and redness) that arise from soft tissue issues.

Easing the intensity of the discomfort may provide supportive relief that helps patients cope more steadily with symptom fluctuations and assists with maintaining functional stability.

It is relevant for managing symptoms associated with common conditions such as minor sprains, strains, localized contusions (bruises), and acute episodes of tendinitis.

“This medication is applied across domains where additional symptomatic support is needed for localized physical discomfort.”

Quick Fact: Relief for Localized Pain and Inflammation

The medication is commonly used across conditions presenting with acute episodes and localized symptoms, offering short-term symptomatic assistance that helps improve day-to-day comfort during symptomatic periods.

Eligibility and Restrictions for Use

The eligibility for using Fastufrem (topical Ketoprofen) is strictly determined by official regulatory criteria, focusing on age, allergic history, and specific physiological states.

Eligibility Classification Population Restriction
Approved Use Generally for Adults and adolescents aged 15 years and over who have no contraindications.
Contraindicated Individuals with a history of photosensitivity reactions or allergy to Ketoprofen, other NSAIDs, or aspirin.
Contraindicated Women in the third trimester of pregnancy.
Contraindicated Application to open wounds or pathological skin changes (e.g., eczema, infected skin).
Not Recommended Children and adolescents under 15 years (safety/efficacy not established).
Not Recommended Women who are breastfeeding.

Use is also prohibited on areas exposed to direct sunlight or UV radiation during treatment and for a mandatory period of two weeks after stopping the medicine. Caution is required for older adults and patients with pre-existing severe renal, cardiac, or hepatic insufficiency, as described in the product's official labeling.

What should I know about interactions with other medicines?

Fastufrem Interactions with other medicines and products

The official regulatory profile for Ketoprofen topical gel is structured by the medicine's limited systemic exposure. Because the active substance reaches low serum concentrations following cutaneous application, systemic pharmacokinetic interactions, including those involving drug-metabolizing enzymes or transporters, are formally classified as unlikely to occur.


Despite the minimal systemic risk, the profile contains two specific constraints.

A Pharmacodynamic Interaction Caution is documented regarding the concurrent use of the gel with coumarinic substances (oral anticoagulants). While the overall risk is minimal due to the topical route, regulatory authorities advise that patients receiving these blood thinners should be monitored. This addresses the potential for a general NSAID-related additive effect on factors influencing bleeding time.

A strict Product-Substance Interaction Restriction applies to the use of the gel with octocrylene-containing products, which are chemical components found in various cosmetics and sunscreens. Regulatory guidance notes a risk of cutaneous co-sensitisation at the application site. The interaction constraint dictates that the treatment must be immediately discontinued if any skin reaction develops following co-application with a product containing octocrylene.

Mechanism of Action

How Fastufrem Works

Fastufrem exerts its primary action by functioning as a non-selective inhibitor of the cyclooxygenase (COX) enzymes, targeting both the COX-1 and COX-2 isoforms. This interaction blocks the enzyme active site, thereby preventing the conversion of arachidonic acid into prostaglandins.

This molecular suppression of prostaglandin synthesis leads to a reduction in the concentration of these key local mediators in peripheral tissues. Prostaglandins normally enhance tissue changes and increase the sensitivity of pain-sensing nociceptors. By limiting their supply, the drug limits the degree of vascular changes and reduces the activation of nerve endings, leading to a lower degree of tissue response and reduced sensitization of peripheral nociceptors.

Additionally, the drug engages a mechanism in the central nervous system, specifically influencing the hypothalamus, which acts as the body's internal thermostat. This action alters the signaling of the body's temperature set point, resulting in enhanced heat dissipation. This central influence contributes to the overall effect on the hypothalamic thermoregulation center.

Dosage and Administration Information

How to Use Fastufrem — Administration Guidelines

Fastufrem, which contains the active ingredient Ketoprofen in a 2.5% w/w gel formulation, is intended exclusively for cutaneous use (topical application) onto the affected area.


Administration Protocol

The gel is intended for divided daily use on the skin, following specific quantity and timing guidelines:

Feature Instruction
Dosing Schedule (Adults) Apply a length of gel measuring 5 to 10 cm (approximately 2–4 g) per application. The maximum total daily dose should not exceed 15 g of gel.
Frequency and Timing Apply the gel two to four times daily (2–4 applications every 24 hours).
Course Duration Limit Treatment should be limited to the shortest duration necessary for relief, typically not exceeding 7 to 10 days of continuous use.

Procedural and Population-Specific Rules

The following steps and rules apply to the application of the medicine and specific patient groups:

Step Sequence:

  • Apply a thin layer of the measured amount of gel to the skin.
  • Gently and thoroughly massage the gel into the affected area to ensure absorption.
  • Hands must be washed thoroughly immediately after each application (unless the hands are the area being treated).

Age-Group Rules:

  • Older Adults: The lowest dose compatible with clinical control should be employed.
  • Pediatric Population: Use is not recommended in children under 12 or 15 years as safety and efficacy have not been established.

Use-Context Constraints: The product must not be used with occlusive dressings (e.g., airtight bandages) and contact with mucous membranes, eyes, or open wounds must be avoided.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Fastufrem

The clinical understanding of topical ketoprofen (Fastufrem) is built upon evidence from controlled clinical trials and large-scale reviews reported by authoritative governmental and intergovernmental sources. Research explored the structure of studies for topical ketoprofen in specific, localized conditions characterized by outcomes related to physical discomfort and acute changes.


Evidence for Use in Acute Soft Tissue Injuries

Research has explored the use of the gel in conditions associated with acute or disruptive episodes, such as minor sprains, strains, and contusions (bruising). This evidence is primarily based on short-term Randomized Controlled Trials (RCTs) and subsequent meta-analyses. These studies monitored short-term changes in adults over defined time intervals, usually up to 14 days.

The research examined patient-reported scores for Pain Intensity and objective measures of local swelling and tenderness. Findings describe patterns observed in the studies where researchers recorded differences in Pain Intensity scores between participants using the active gel and those using the carrier alone. Studies also reported patterns related to the time interval to reach a defined change in symptom levels.

Evidence for Localized Chronic Joint Pain (Osteoarthritis)

The medicine was studied for its use in managing symptoms of chronic conditions, specifically localized osteoarthritis affecting superficial joints, such as the knee or hand. Studies exploring this use were typically intermediate-term RCTs, with observation periods lasting up to 12 weeks. Research describes measured outcomes when comparing the active gel group and the inactive carrier gel group.

A specific pattern observed in these studies relates to the carrier itself: the inactive gel base was associated with a symptomatic response in a portion of participants (known as the placebo or carrier effect). Research does not determine whether an individual will respond similarly, as study results reflect the specific conditions under which they were conducted.

Study Duration, Long-Term Follow-up, and Research Gaps

The majority of pivotal evidence was relevant in trials assessing short-term or episodic symptom patterns. Data for chronic conditions are primarily limited to the intermediate-term intervals (up to 12 weeks). Long-term effects are not fully established beyond these observation periods. There is limited information for long-term outcomes that describe the durability of observed changes or the need for sustained application over many months or years.

Evidence in Specific Populations and Conditions

The results apply only to the populations studied, which primarily consists of non-comorbid adults with acute or localized conditions. Data for certain groups remain insufficient regarding specific anatomical areas. Research has primarily examined superficial joints like the knee and hand, and there is limited information for long-term outcomes or comparative evidence for deeper joints, such as the hip or spine.

Frequently Asked Questions (FAQ)

Common questions about Fastufrem (FAQ)

Q: How is Fastufrem different from common over-the-counter options for the same condition?

Official product information describes the topical gel as delivering the active ingredient (Ketoprofen) for a localized anti-inflammatory effect. Because the gel is applied to the skin, its absorption into the bloodstream is significantly lower compared to oral non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen. Regulatory information indicates this low systemic exposure is generally associated with lower potential for typical systemic NSAID side effects.

Q: Is it true that Fastufrem works by affecting the immune system?

The drug’s main function, as an NSAID, is to inhibit specific enzymes (COX-1 and COX-2) that produce prostaglandins. Prostaglandins are chemical messengers that drive pain and inflammation in the body. While the drug affects this key part of the body's inflammatory response, the mechanism is described as a chemical blockade rather than a direct action on the broader immune system itself.

Q: What kind of side effects require immediate attention from a doctor?

Regulatory documents stress that immediate medical attention is required for signs of a severe allergic reaction, such as swelling of the face, tongue, or throat (angioedema), or anaphylactic shock. Official labeling describes that treatment must be immediately discontinued and a physician contacted if any skin reaction develops, including severe blistering or widespread rash.

Q: Is there a problem if I take Fastufrem and also use an anti-inflammatory cream?

Official guidance generally advises caution against combining topical non-steroidal anti-inflammatory drugs (NSAIDs) with other NSAIDs, whether they are oral or topical. This is due to the potential for increased absorption of the active ingredient into the bloodstream, which could lead to an increased risk of adverse effects from the combined exposure.

Q: How long does it usually take for people to start feeling the effect of Fastufrem?

Official documents for the topical gel focus on its local anti-inflammatory effect, and therefore do not provide a specific systemic onset time. For the orally taken formulation of the active ingredient, studies have described an onset of pain relief in some patients within 30 minutes. The active ingredient is known to be absorbed gradually when applied to the skin.

Q: How long does the active ingredient of Fastufrem stay in the body after a dose?

The systemic passage of the gel through the skin is described as very low. After application, peak plasma levels of the active ingredient are typically seen approximately five to eight hours later. The active ingredient itself has a relatively short elimination half-life, ranging from one to three hours.

Q: If I accidentally miss a dose, does that completely stop the medication from working?

Official documentation describes that if an application is missed, it may be applied as soon as the patient remembers, unless it is nearly time for the next scheduled application. Official product information states that a double quantity of gel must not be applied to compensate for a forgotten dose.

Q: Are headaches a common side effect when first starting Fastufrem?

Headaches are not classified among the common or frequent side effects following the standard topical use of the gel. Official product information lists headaches and confusion as possible systemic symptoms that may occur only in cases of accidental ingestion or overdose.

Q: Does Fastufrem affect sleep patterns or cause insomnia?

Drowsiness or fatigue is listed in regulatory documents as a potential systemic effect that could occur in cases of accidental ingestion or overdose. Insomnia or other changes to sleep patterns are not commonly cited among the adverse effects reported from normal topical use.

Q: I've read that some people feel tired on Fastufrem; is that a normal reaction?

Official product information indicates that drowsiness or fatigue is listed as a potential systemic effect that may occur in cases of accidental ingestion or overdose. This reaction is not classified among the frequent adverse effects associated with standard topical application.

Q: Does Fastufrem interact with common blood pressure medications?

Regulatory documents note that interactions are unlikely due to the minimal systemic absorption of the gel. However, caution is advised for patients taking blood pressure medications, such as certain antihypertensives or diuretics, because the active ingredient is an NSAID. NSAIDs may reduce the efficacy of these medications or increase the risk of renal effects.

Q: Is Fastufrem a medication that requires regular blood tests or monitoring?

Regulatory documents do not mandate routine blood tests for all patients using the topical gel. However, caution is advised for patients with existing heart, liver, or kidney impairment. Monitoring is recommended for patients who may be at risk of systemic effects, such as those concurrently taking certain blood pressure medications.

Q: When was Fastufrem first approved by major regulatory bodies like the FDA or EMA?

The active ingredient, Ketoprofen, was first patented in 1967. The earliest topical formulations of the active ingredient were available in most European Member States as far back as 1978. The oral formulation of the active ingredient was later approved by the FDA in 1986.

Q: Is there any ongoing research on Fastufrem for other conditions?

Studies and official information indicate that research into new uses of the active ingredient is ongoing. This includes investigations registered in official clinical trial databases for new topical formulations and potential applications in conditions such as chronic wounds or specific soft tissue injuries.

Q: What happens if someone accidentally takes too much Fastufrem?

Official product information states that overdose is unlikely to occur from correctly applying the gel to the skin. If the gel is accidentally ingested, systemic adverse effects are possible depending on the quantity. Official guidance describes that management involves supportive and symptomatic care, consistent with general protocols for oral NSAID overdose.

How should Fastufrem be stored and disposed of?

The official regulatory documentation for Fastufrem provides strict requirements for storage and disposal to ensure safety and maintain product integrity.

Storage Requirements

Classification Required Statement
Temperature Store at Controlled Room Temperature (20 C to 25 C). Do not refrigerate or freeze.
Protection Keep in the original container, tightly closed. Protect from moisture and strong direct light.
Stability Discard any unused portion 6 months after the initial opening of the container.
Child Safety Keep Fastufrem and all medicines out of the sight and reach of children.

Disposal Instructions

Expired or unused Fastufrem must be disposed of via a formal drug take-back program or specialized collection site. Do not dispose of the medicine by flushing it down a toilet or pouring it down a drain, as this prevents the active substance from entering the aquatic environment.

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

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