Fastum

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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 Fastum

Quick Facts

Property Description
Active ingredient Ketoprofen (2.5% w/w)
Form Gel (Non-greasy, colorless)
Pharmacological class Non-steroidal Anti-inflammatory Drug (NSAID)
Common use Localized relief of pain and swelling (e.g., sprains or strains)
Origin Synthetic (Propionic acid derivative)

What Type of Medicine is Fastum Gel?

Fastum Gel is a proprietary pharmaceutical preparation and topical analgesic agent designed exclusively for cutaneous use, which means it is applied directly to the skin. It is classified within the Non-steroidal Anti-inflammatory Drug (NSAID) pharmacological class, a category used in managing inflammatory conditions. The active component is Ketoprofen, a synthetic propionic acid derivative. The preparation is engineered as a localized relief option, contrasting with oral NSAIDs intended for systemic absorption.

Ketoprofen: Composition and Origin

The medication utilizes Ketoprofen as its single active ingredient, typically at a concentration of 2.5% w/w, formulated into an easily applicable gel. This dosage form is non-greasy and non-staining. The formulation relies on a hydroalcoholic base to optimize the penetration of Ketoprofen through the skin. This composition allows for the delivery of the active substance directly to the tissues beneath the application site. This targeted approach is intended to allow the medication to work primarily where the discomfort is felt.

What is the General Purpose of Fastum?

The primary purpose of Fastum Gel is to provide targeted reduction of discomfort and associated swelling, often in cases of soft tissue injury, such as a localized sprain or strain. Ketoprofen operates by inhibiting cyclooxygenase (COX) enzymes, thereby blocking the synthesis of prostaglandins, the chemical mediators involved in both pain and inflammation. This mechanism provides a dual analgesic effect and anti-inflammatory effect. As a topical NSAID for localized acute pain relief, it is used for addressing inflammation and pain.

Regulatory References

  1. Fastum Gel - SAHPRA OTC Directory

What side effects are possible with Fastum?

Possible Side Effects and Safety Information

The safety profile for Fastum Gel (topical ketoprofen) is primarily characterized by localized reactions at the application site, reflecting its cutaneous route of administration. Adverse reactions are formally classified by frequency and System-Organ Class (SOC) in regulatory documents.


Adverse Reactions and Frequency

Frequency Classification Examples of Documented Adverse Reactions
Uncommon (1/1,000 to <1/100) Local skin reactions such as erythema, pruritus (itching), rash, and a burning sensation.
Rare (1/10,000 to <1/1,000) Photosensitisation (increased sun sensitivity), urticaria, and various forms of dermatitis (e.g., bullous, contact).
Very Rare (<1/10,000) Systemic effects such as acute renal failure or aggravation of existing renal insufficiency.
Not Known Severe systemic events including anaphylactic shock, peptic ulcer, gastrointestinal bleeding, Stevens-Johnson syndrome (SJS), and Toxic Epidermal Necrolysis (TEN).

Safety Considerations and Restrictions

The most prominent safety constraint is the potential for photosensitivity reactions, which regulatory labeling states may be linked to the duration of treatment and UV light exposure. The risk of both photosensitisation and contact dermatitis is explicitly noted to increase over time of use.

Official documents advise caution when using the medication in specific populations, including older adults and individuals with pre-existing renal, hepatic, or cardiac impairment, which reflects the systemic precautions associated with the entire non-steroidal anti-inflammatory drug (NSAID) class. The medication is restricted in individuals with a known history of photosensitivity or hypersensitivity to aspirin or other NSAIDs.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose with Fastum Gel is unlikely during normal topical application due to the active ingredient, Ketoprofen, having very low systemic absorption through the skin. The official regulatory guidance addresses the potential for systemic overdose primarily in the event of accidental ingestion.

Documented Manifestations and Complications

Manifestations following accidental ingestion are consistent with an oral Non-steroidal Anti-inflammatory Drug (NSAID) overdose. Common, generally reversible symptoms include lethargy, drowsiness, nausea, vomiting, and epigastric (upper stomach) pain.

Regulatory documentation also lists potential severe outcomes, although rare, which include convulsions (seizures), gastrointestinal bleeding, acute renal failure (kidney failure), and respiratory depression.

Required Emergency Actions

In the event of accidental ingestion, regulatory information requires that the patient contact a doctor immediately or visit the nearest hospital. Treatment is symptomatic and supportive, as there is no specific antidote for Ketoprofen overdose.

Supportive measures such as gastrointestinal decontamination using activated charcoal may be considered by medical professionals, particularly if a large overdose is suspected. Procedural steps like hemodialysis are generally not considered useful due to the drug’s high protein binding.

Therapeutic Uses of Fastum

Quick Facts

  • Targeted Relief: Used for temporary relief of localized discomfort.
  • Primary Indications: Manages pain and inflammation associated with injuries and musculoskeletal issues.
  • Therapeutic Area: Soft tissue injuries, such as strains, sprains, and tendonitis.

Fastum is a topical medication used for the temporary relief of discomfort and swelling in the muscles and joints. As a non-steroidal anti-inflammatory drug (NSAID) applied to the skin, its primary therapeutic domain is the management of localized pain and inflammation in the osteo-articular and muscular system.

This medication is appropriate for use in conditions resulting from acute musculoskeletal injuries, including strains, sprains, contusions, and soft tissue rheumatism. It is an option considered for localized traumatic pain and is applied to the affected area to support recovery and alleviate symptoms. The active ingredient, ketoprofen, is used to provide a measure of relief for these conditions when applied externally.

The use of Fastum is intended to address the symptoms of acute, non-life-threatening conditions. Its efficacy profile supports its role in short-term management. This treatment should be applied only as directed by a healthcare professional to ensure proper usage.

Eligibility and Restrictions for Use

Population Eligibility and Contraindications

Official regulatory documentation establishes specific populations who must avoid using Fastum Gel, and groups for whom use is restricted or requires caution.

Absolute Contraindications

Use of this medicine is absolutely prohibited (contraindicated) in patients with a known hypersensitivity to Ketoprofen or cross-reacting NSAIDs, such as aspirin or fenofibrate. It must not be applied to pathological skin changes, open wounds, or infected skin. Furthermore, the gel is contraindicated for women in the third trimester of pregnancy.

Conditional Use and Restrictions

Individuals must strictly avoid sunlight (including hazy sun) or solarium UV light exposure on the treated area during the treatment period and for two weeks after discontinuation. Caution is required for patients with reduced cardiac, hepatic, or renal function, as well as those with a history of peptic ulceration or complex respiratory conditions like asthma combined with nasal polyposis. Use in the first and second trimesters of pregnancy is restricted and should be avoided unless clearly necessary.

Age and Lactation Rules

Fastum Gel is not recommended for children under 12 years of age, as the safety and efficacy profile has not been established in this pediatric population. It is also not recommended for nursing mothers due to a lack of data regarding its excretion in human milk.

This regulatory framework dictates that eligibility is primarily determined by the absence of absolute contraindicating conditions and the careful consideration of co-existing health limitations.

What should I know about interactions with other medicines?

The official regulatory profile for Fastum Gel (Ketoprofen topical) is primarily shaped by its extremely low systemic absorption. This key factor means that typical systemic drug-drug interactions, such as those involving CYP enzymes, are officially documented as unlikely to occur.


Interaction Scope

Category Official Regulatory Statement
Medicinal product categories with documented interactions: Oral Anticoagulants (coumarin-like substances).
Mechanistic basis of interactions (only if stated in label): Pharmacodynamic interaction: Potential for an additive effect on bleeding risk; requires monitoring.
Interaction-related restrictions: Octocrylene-containing products: Co-application is restricted; immediate discontinuation is required upon any skin reaction following co-use with cosmetics or sunscreens containing this substance.
Timing-based interaction rules (if applicable): None. Regulatory documents do not mandate any specific time separation between application and other medicines.

Interaction Classifications (High-Level)

Classification Official Regulatory Status
Interaction severity classification (as defined in official documents): Use with Caution / Monitor Closely (for Oral Anticoagulants); Prohibited Co-application (for Octocrylene substances upon reaction).

Resulting Interaction Structure

The regulatory documents explicitly structure the interaction profile based on the drug's minimal systemic absorption, stating that most systemic drug interactions are unlikely. The profile is confined to cautions regarding the low-risk pharmacodynamic effect with coumarin-like anticoagulants and a specific co-application restriction involving non-medicinal substances containing octocrylene, as mandated in the Summary of Product Characteristics.

Mechanism of Action

How Ketoprofen Modulates Physiological Processes

The active component, Ketoprofen, functions exclusively through a pharmacodynamic mechanism at the site of application. Its primary action is as a reversible non-selective inhibitor of the Cyclooxygenase ( COX) enzyme system, specifically targeting the COX-1 and COX-2 isoforms.

By blocking the COX enzymes, Ketoprofen interrupts the conversion of Arachidonic Acid, thereby suppressing the synthesis of local prostanoids, such as PGE2. This suppression initiates the downstream mechanistic cascade.

Reduced prostanoid concentration directly results in a modulation of local tissue hemodynamics, restricting the pathological increase in blood vessel permeability and dilation in the affected area. Furthermore, the decrease in these mediators removes a key chemical sensitizing factor that acts on peripheral nociceptors. This action supports a change in nerve activity by increasing the activation threshold of these nerves, thereby altering the transmission of nociceptive signals from the tissue.

Dosage and Administration Information

The administration of Fastum Gel, a 2.5% w/w Ketoprofen topical preparation, is characterized by a specific administration pattern.

Administration Protocol Overview

Instruction Detail
Route of Administration The preparation is for cutaneous use only, meaning it must be applied externally to the skin.
Standard Dosing Schedule Adults should apply a length of gel measuring approximately 5 to 10 cm (2 to 4 grams) per application. The total amount used daily must not exceed 15 grams.
Frequency Pattern The gel is applied to the affected area one to three times daily, and the treatment is designated for brief treatment periods only.
Administration Steps The medicine must be gently massaged into the skin until it is fully absorbed, and hands must be washed thoroughly following each use.
Age-Group Rules The medication is not recommended for use in children under 12 years of age, as the safety and efficacy profile has not been established for this population.

Special Use Constraints

There are specific procedural constraints associated with the use of this preparation. The gel is not to be used under occlusive dressings (air-tight or water-tight bandages). Furthermore, the treated skin area requires protection by clothing when outdoors, during the entire course of treatment and for a period of two weeks after discontinuation, to manage light exposure. The maximum duration of use is generally restricted to 7 to 10 days.

Recent Clinical Evidence

The Research Basis for Fastum Gel

The scientific understanding of Fastum gel, which contains the active ingredient ketoprofen, comes from controlled clinical evaluations cited by health regulators. The research primarily was studied for localized conditions involving pain and inflammation. The available evidence landscape consists mainly of randomized controlled trials (RCTs) and systematic reviews that gather and analyze data across these individual trials.


Evidence for Use in Acute Soft Tissue Injuries

The largest body of evidence was studied for acute injuries, such as sprains, strains, and contusions. Research exploring short-term changes in these conditions has used short-term, randomized controlled trials. In these trials, the active gel was evaluated in comparison against a non-medicated topical placebo (the carrier gel without the drug).

Researchers monitored outcomes related to physical discomfort by measuring changes in pain intensity. They also assessed outcomes reflecting daily functioning to see how patients reported movement and use of the injured area. Data show patterns related to a difference in pain reduction measurements between the active group and the placebo group in some systematic reviews.


Evidence for Use in Musculoskeletal Conditions Beyond Acute Injury

Research has also explored the use of topical ketoprofen in conditions associated with acute or disruptive episodes. This includes studies relevant in trials assessing short-term symptom patterns in tendinitis and localized pain associated with small-joint osteoarthritis. For these chronic conditions, the trials typically lasted 6 to 12 weeks.

Findings described that the non-medicated topical placebo group often reported changes in their symptoms, which is observed in some studies exploring chronic pain. Evidence quality varies across studies regarding the magnitude of the difference between the active gel and the placebo in some reviews. Long-term effects are not fully established beyond the observation periods of the original clinical trials.


Research in Specific Patient Groups

The majority of the research that was evaluated in major clinical trials focused on general populations of healthy adults. Data for certain groups remain insufficient. For instance, there is limited clinical evidence on the use of topical ketoprofen specifically in children or adolescents. Results apply only to the populations studied, meaning findings describe group patterns, not personal outcomes for individuals who differ significantly from the general study populations.

Key Studies & References

  1. Topical ketoprofen patch in the treatment of tendinitis: a randomized, double blind, placebo controlled study

Frequently Asked Questions (FAQ)

Common questions about Fastum (FAQ)


Q: Can Fastum be used for chronic muscle pain?

A: Official documents indicate that Fastum is generally indicated for the localized relief of pain and inflammation associated with acute musculoskeletal disorders and injuries. Its intended use is for brief periods of treatment. The regulatory profile does not include an indication for use in generalized or long-term chronic pain conditions.

Q: Is Fastum safe to use every day?

A: According to official product information, Fastum is intended for topical application up to three times daily. However, regulatory instructions generally restrict the maximum duration of use to 7 to 10 days. The duration of treatment is advised by regulatory guidance to be kept as brief as possible, as the risk of certain skin reactions may increase with prolonged use.

Q: What happens if I apply Fastum more often than recommended?

A: Applying amounts larger than those specified in the instructions may increase the risk of systemic effects, which means the drug could affect parts of the body other than the application site. Exceeding the recommended total dose is associated with a risk of effects such as hypersensitivity reactions, asthma, or kidney-related issues.

Q: Are there any long-term effects of using Fastum for many months?

A: Official regulatory guidance states that the treatment duration should be kept as short as possible. The risk of developing localized skin reactions, including contact dermatitis and photosensitivity reactions (a sensitivity to sunlight), is increased when the product is used for extended periods beyond the recommended duration.

Q: Can Fastum be used on any part of the body, like the face or open wounds?

A: Fastum is for use only on the skin (cutaneous use). Regulatory instructions state that it must not be applied to mucous membranes, the eyes, open wounds, or any pathological skin changes such as eczema, acne, or lesions.

Q: Can Fastum be used alongside heat or cold packs?

A: Official instructions state that the gel must not be used under occlusive dressings, which are air-tight or water-tight bandages, as this can increase drug absorption. There is no specific regulatory instruction regarding the use of non-occlusive heat or cold packs.

Q: What does 'topical anti-inflammatory' mean in simple terms?

A: The term "topical anti-inflammatory" indicates that the medicine works primarily at the site of application, on the surface of the skin. The active ingredient functions by blocking the action of chemical messengers that cause both pain and the typical signs of inflammation, such as swelling and redness, in the local area.

Q: Why are some people not allowed to use Fastum, according to the official documents?

A: Official documents state that Fastum is contraindicated for certain groups of people. This includes individuals with a known allergy or hypersensitivity to the drug or to other non-steroidal anti-inflammatory drugs (NSAIDs), a history of photosensitivity reactions, or those who are in the third trimester of pregnancy.

Q: Can Fastum be applied while taking an oral NSAID?

A: Regulatory guidance indicates that caution is necessary if using Fastum alongside other topical non-steroidal anti-inflammatory drugs (NSAIDs) due to a possible increased risk of side effects. While the drug has very low systemic absorption, official documents acknowledge the potential for additive effects when combining multiple NSAID products.

Q: Is it true that Fastum can cause stomach problems if used too much?

A: Topical application is associated with low systemic exposure and generally results in fewer gastrointestinal problems compared to oral NSAID forms. However, official information indicates that if the recommended amount is exceeded, the amount of drug absorbed may result in systemic side effects, which could include gastrointestinal issues.

Q: What kind of skin reactions or side effects are most common with Fastum?

A: Official documents list the most common side effects as localized reactions at the application site. These include a sensation of burning or tingling, skin rash, redness, itching, or minor blistering.

Q: Do you need a prescription to get Fastum?

A: Depending on the regulatory jurisdiction, Fastum may be available over-the-counter (without a prescription) for temporary use in treating mild conditions. Regulatory status may vary by country.

Q: Is it normal to feel a burning or tingling sensation after applying Fastum?

A: Official product information lists a burning or tingling sensation on the skin as one of the possible localized side effects of applying the gel.

Q: What should I do if I accidentally swallow a small amount of Fastum?

A: Since Fastum is intended for external skin use only, regulatory instructions state that accidental swallowing requires immediate contact with a doctor or the nearest hospital casualty department.

Q: Is Fastum approved for use during pregnancy or while breastfeeding?

A: Official documents state that use is prohibited during the third trimester of pregnancy. For the first six months of pregnancy, it is generally not recommended unless the potential benefit outweighs the potential risk. Use while breastfeeding is generally considered unsafe according to regulatory information.

Q: Are there any known issues with Fastum and alcohol consumption?

A: Regulatory documents for the topical gel formulation generally state that there are no known interactions with food, drink, or alcohol.

Q: Does Fastum have an odor or stain clothing?

A: Fastum Gel is officially described as a colourless, non-greasy product that is non-staining. The formulation does contain an aromatic fragrance.

Q: What medical conditions prevent a person from using Fastum?

A: Official guidance states that caution is necessary for individuals with severe kidney, heart, or liver impairment, a history of peptic ulceration, or bleeding disorders. Contraindications include a history of photosensitivity or known allergy to NSAIDs.

Q: What are the ingredients listed in Fastum besides the active one?

A: Besides the active ingredient, ketoprofen, Fastum Gel contains several inactive ingredients, or excipients. These include ethyl alcohol, triethanolamine, carbomer 940, purified water, and various components that contribute to the aromatic fragrance.

Q: Are allergic reactions to Fastum common?

A: Allergic reactions, including skin rash, itching, and swelling, are listed as possible side effects. Official documents note that the risk of developing these reactions may increase the longer the product is used.

Q: Can older adults use Fastum without special precautions?

A: Regulatory guidance indicates that caution is necessary when using the gel in older adults. It also states that the lowest effective dose for the shortest possible duration should be employed, as this population may be more susceptible to experiencing adverse events.

Q: Does using more Fastum increase the chance of side effects?

A: Regulatory information indicates that using more than the recommended amount or using excessively large quantities may increase the chance of systemic effects. This means the drug could be absorbed in sufficient amounts to cause effects throughout the body, such as hypersensitivity reactions.

Q: What is the best way to clean Fastum off the skin if too much is applied?

A: If the gel is accidentally applied to a sensitive area like the eyes or mouth, or if too much is applied to the skin, regulatory instructions indicate that the affected area is to be washed thoroughly with plenty of water.

Q: Why do some people use Fastum for headaches, even though it's a topical gel?

A: The product is officially indicated for the local relief of pain and inflammation associated with specific soft tissue injuries and musculoskeletal disorders. The regulatory profile does not support or provide information on the use of the topical gel for conditions such as headaches.

Q: What happens if Fastum is applied to irritated skin?

A: Official instructions state that the gel should not be applied to irritated or damaged skin. This includes areas with pathological skin changes such as eczema, acne, or infected lesions, as this may increase the risk of irritation or worsen the existing condition.

How should Fastum be stored and disposed of?

Storage and Disposal of Fastum Gel

Official regulatory documents define strict conditions for storing and disposing of Fastum Gel (ketoprofen 2.5% w/w) to maintain its stability and ensure environmental safety.

Item Official Regulatory Statement
Storage Temperature Store at or below 25 C or below 30 C (varies by region).
Prohibited Environments Do not freeze the product; keep it away from naked flames.
Child Protection Keep out of the sight and reach of children.
Packaging Rule The cap or closure must be replaced immediately after use.
Disposal Instructions Do not throw away unused medicine via household waste or wastewater.
Waste Protocol Patients must ask their pharmacist for guidance on how to properly discard expired or unused product.

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

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