Profenid 2.5%

Quick links to important sections

Medically reviewed

Marina Burgos

Last updated on 22/12/2025

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

Overview of Profenid 2.5%

Property Description
Active ingredient Ketoprofen
Form Gel (Semisolid dosage form)
Pharmacological class Nonsteroidal Anti-inflammatory Drug (NSAID)
Common use Localized pain relief and inflammation reduction
Origin Synthetic compound

What Type of Medicine is Profenid 2.5%? (Identity and Classification)

Profenid 2.5% is a synthetic compound that is classified as a Nonsteroidal Anti-inflammatory Drug (NSAID), intended for Cutaneous application as a Gel. This classification confirms the preparation is an Anti-inflammatory agent that works peripherally to address localized pain and swelling.

The Active ingredient is Ketoprofen, a Propionic acid derivative and the key chemical entity, which has been clinically recognized for its reliable anti-inflammatory and analgesic properties. Ketoprofen is utilized for its analgesic and anti-inflammatory action in topical preparations, serving a role in managing localized musculoskeletal discomfort. This unique formulation is often positioned for adult use, offering a localized treatment option distinct from oral NSAIDs.

Composition and Physical Form of Profenid 2.5%

The medicine is formulated as a Gel, representing a Semisolid dosage form designed for direct application onto the skin. This preparation is a Single-ingredient product, containing Ketoprofen as the sole pharmacologically active substance.

The 2.5% concentration denotes the precise amount of the Active ingredient that is uniformly dispersed within the Aqueous-alcoholic gel base. This specific Base/vehicle is critical, as its composition enables the drug to penetrate the skin barrier effectively, allowing the Ketoprofen to reach the underlying soft tissues and fulfill its targeted purpose of Peripheral anti-inflammatory action.

General Purpose and Action of Profenid 2.5%

The general purpose of this Ketoprofen preparation is to provide a Local analgesic effect and Peripheral anti-inflammatory action for the Inflammation reduction and Pain relief of localized symptoms. A typical use scenario involves applying the gel to ease discomfort associated with common soft tissue injuries.

Its Physiological action is achieved because Ketoprofen functions as a Cyclooxygenase inhibitor, modulating the body's inflammatory response at the site of concern. By locally acting on the chemical pathway that mediates discomfort and swelling, the gel fulfills its core Therapeutic uses by directly targeting the inflammatory component of the localized symptoms, minimizing systemic exposure.

What side effects are possible with Profenid 2.5%?

Possible Side Effects and Safety Information

The official regulatory safety profile for Profenid 2.5% Gel (Topical Ketoprofen) is predominantly characterized by adverse reactions affecting the Skin and Subcutaneous Tissue due to its localized application, with systemic effects being rare.


Adverse Reaction Frequencies and Systems

Adverse reactions are classified by frequency according to regulatory standards:

  • Uncommon (1/100 to <1/10): Localized skin reactions at the application site, including erythema (redness), pruritus (itching), eczema, and a burning sensation. These are the most frequently reported effects.
  • Rare (1/10,000 to <1/1,000): Photosensitisation reactions and urticaria (hives).
  • Very Rare (<1/10,000): Severe dermatological events like bullous dermatitis, and systemic effects such as acute renal failure or aggravation of existing renal insufficiency.

Serious Adverse Reactions and Safety Constraints

The regulatory label specifies the possibility of severe photosensitivity reactions, which may persist even after treatment cessation. The official safety documentation also lists rare but serious systemic reactions, including anaphylactic reactions (shock) and angioedema, which fall under Immune System Disorders.

Safety considerations emphasize that the risk of both contact dermatitis and photosensitivity increases with the duration of treatment. The medicine is contraindicated in individuals with a known history of photosensitivity to Ketoprofen, Fenofibrate, or UV blockers, and should not be applied to pathological skin changes like open wounds, eczema, or infected lesions.

Special population cautions exist for older adults and those with impaired renal or hepatic function, who may be more susceptible to the systemic risks associated with the NSAID class, although absorption is typically low.

Overdose and Emergency Response

Overdose and when to seek help

The regulatory profile for Profenid 2.5% overdose emphasizes that a clinical overdose is officially deemed unlikely to occur through the intended route of topical administration. This is based on the low systemic absorption when the gel is applied to the skin. The official concern detailed in government documents focuses entirely on the event of accidental ingestion of the preparation.

If accidental ingestion occurs, the regulatory guidance states that the resulting systemic adverse effects are formally classified to be treated in accordance with established overdosage protocols for oral anti-inflammatory drugs (NSAIDs). The severity of these outcomes is documented as being dependent on the amount ingested. Urgent medical assistance must be sought immediately if the gel is accidentally ingested.

Overdose Risk & Action Official Regulatory Statement
Primary Scenario Accidental ingestion of the gel.
Overdose Classification Treated as overdosage of oral anti-inflammatories.
Urgent Help Required Seek immediate medical assistance if ingestion occurs.
Management Treatment is mandated to be symptomatic and supportive.
Antidote Status No specific antidote is known or documented.

Regulatory documents mandate that management must be symptomatic and supportive, as there is no specific antidote available for the systemic effects associated with this type of NSAID overdosage.

Therapeutic Uses of Profenid 2.5%

What Profenid 2.5% Treats: Main Uses and Benefits

Profenid 2.5% Gel is relevant in situations involving certain distressing symptoms.

Focused Relief for Localized Discomfort

This domain covers the symptomatic management of pain, swelling, and tenderness associated with sudden, non-severe soft tissue injuries. Topical formulations of the active ingredient may be part of symptomatic management for symptoms related to pain and inflammation, such as those associated with minor trauma, tendinitis, and localized joint discomfort. This support helps moderate the distressing symptoms and contributes to improved comfort during the initial acute phase.

The medication is commonly used across domains where short-term symptomatic assistance is appropriate, helping to ease the pain and tenderness that create noticeable interference with daily comfort and movement. It is relevant in conditions characterized by episodic or fluctuating symptom patterns.

“The gel may assist with symptomatic management in episodes where localized muscle or joint discomfort is heightened.”

Quick Fact: Support for Symptoms of Pain and Swelling

The gel provides support that helps ease the overall symptom burden and supports patients during episodes of heightened discomfort.

Eligibility and Restrictions for Use

Who can and cannot use Profenid 2.5% Gel

Official regulatory information strictly defines the eligible populations for Profenid 2.5% Gel (Topical Ketoprofen) through specific contraindications and age-based restrictions.


Contraindicated Populations (Must Not Use)

Individuals are contraindicated from using this medicine if they have a known hypersensitivity to Ketoprofen, other non-steroidal anti-inflammatory drugs (NSAIDs), or aspirin. Use is absolutely prohibited in patients with a history of any photosensitivity reaction, on damaged or open skin (such as eczema or burns), and for women in the third trimester of pregnancy. Furthermore, the treated skin area must avoid direct sun or UV light exposure during treatment and for two weeks following discontinuation.


Age and Physiological Restrictions

This gel is generally indicated for adults. Its use is not recommended in children under the minimum age specified on the regional label (typically 12 or 15 years), as safety and efficacy have not been formally established. For older adults, the regulatory documents advise using the lowest effective dose. Use during the first and second trimesters of pregnancy should be avoided, and the gel is not recommended in nursing mothers.


Conditional Use (Caution)

Use requires caution in patients with reduced cardiac, hepatic, or severe renal function, as well as those with a history of peptic ulceration or specific respiratory conditions like asthma.

What should I know about interactions with other medicines?

Profenid 2.5% (ketoprofen) gel, as a non-steroidal anti-inflammatory drug (NSAID), has the potential for interactions, even with topical application, although the risk of systemic effects is lower than with oral formulations. It is important to inform your healthcare provider about all medicines you are taking, including over-the-counter (OTC) products, supplements, and herbal remedies.

Increased Risk of Bleeding or Gastrointestinal Issues

The simultaneous use of Profenid 2.5% on large skin areas or for prolonged periods with other medicines that increase the risk of bleeding may require caution. These include:

  • Other NSAIDs (e.g., oral ibuprofen, naproxen, or aspirin for pain/fever) and high-dose aspirin. Combining NSAIDs, even topical, increases the risk of gastrointestinal side effects like ulceration or bleeding.
  • Anticoagulants (e.g., warfarin, heparin) and Anti-platelet agents (e.g., clopidogrel).

Potential for Reduced Effectiveness or Toxicity

Ketoprofen can interact with medicines affecting blood pressure and kidney function. Exercise caution with:

  • Diuretics (e.g., furosemide) and certain blood pressure medications (e.g., ACE inhibitors, Angiotensin II Antagonists), as the combination may increase the risk of renal function impairment, especially in dehydrated or elderly patients.
  • Methotrexate (at doses greater than 15 mg/week) due to a potential increase in toxicity.
  • Lithium, as NSAIDs can increase lithium plasma levels.

Other Products

Alcohol and tobacco use may increase the risk of gastrointestinal bleeding when combined with NSAIDs. While the systemic absorption of the gel is low, caution is still advisable.

Mechanism of Action

Mechanism of Action: Prostaglandin Synthesis Inhibition

The mechanism of Profenid 2.5% (Ketoprofen) is a localized pharmacological action focused on the peripheral soft tissues. Its primary action is the non-selective inhibition of the Cyclooxygenase (COX) enzymes, targeting both COX-1 and COX-2. By occupying the active sites of these enzymes, Ketoprofen suppresses the enzymatic conversion of Arachidonic acid into prostaglandins, specifically reducing the formation of Prostaglandin PGE2 at the application site.

This molecular effect initiates a physiological cascade that modulates nociceptive and inflammatory responses. The reduction in prostaglandin concentration, coupled with secondary interference of bradykinin activity, lowers the chemical sensitization threshold of peripheral nociceptors (sensory afferents). Consequently, the mechanism modifies signaling patterns and restricts fluid extravasation (edema) in the local soft tissue. The drug's activity is strictly peripheral and dependent on dermal penetration, concentrating the anti-inflammatory and nociceptive-modulating effects at the site of application.

Dosage and Administration Information

How to Use Profenid 2.5%

This section outlines the official administration instructions for Profenid 2.5% Gel.


Administration Scope

Feature Official Labeled Instruction
Route of Administration The medicine is approved strictly for cutaneous use, meaning it is applied topically to the skin surface.
Dosing Schedule A single application typically involves using a strip of gel 5 cm to 10 cm long, corresponding to approximately 2 g to 4 g of gel. The maximum total amount applied in a 24-hour period must not exceed 15 g of the gel.
Dosing Frequency The gel is applied to the affected area two to four times daily.
Age-Group Rules Use is not recommended in children and adolescents under 15 years of age. No specific dosage adjustment is stipulated for older adults.

Procedural Instructions and Use Constraints

Procedural Requirement Labeled Condition
Application Method The gel should be rubbed into the skin using a gentle and prolonged massage to aid absorption.
Post-Application Hygiene Hands must be washed thoroughly immediately after applying the gel, unless the hands are the area being treated.
Occlusion Restriction The treated area must not be covered with occlusive dressings (e.g., airtight bandages).
Treatment Duration The medication is intended for short-term use only, with the course of treatment generally not exceeding 7 to 10 days.

These official instructions define the standardized external-use protocol for the gel, detailing precise administration limits, frequency, and mandatory physical application techniques.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Profenid 2.5%

Evidence from Studies for Acute Soft Tissue Injuries

Research exploring research patterns for acute soft tissue injuries—such as sprains, strains, and contusions—has been conducted primarily through short-term Randomized Controlled Trials (RCTs) and systematic reviews. The research examined patient-reported outcomes describing perceived discomfort, specifically focusing on measured differences in reported pain intensity while resting and during movement, often over an initial study period of one to two weeks. The trials documented measurements of differences in pain reports when the gel was compared against an inactive placebo vehicle. The evidence contributes to the broader evidence landscape regarding symptom patterns during the initial acute phase. Long-term evidence is not fully established for these conditions, and changes measured after the initial two-week study period are limited.


Evidence from Studies for Localized Joint and Tendon Discomfort

For conditions characterized by fluctuating or episodic manifestations like localized joint discomfort and tendinitis, studies explored outcomes related to physical discomfort and measures of functional ability in adult populations. Trials documented measured differences in patient pain scores over periods up to twelve weeks, with reports describing a focus on symptom measurement. Researchers noted that findings varied depending on the joint studied and the comparator used. Data for deep-seated joints or conditions requiring long-term management are still emerging, and certainty remains low regarding observations from extended use.


What is Still Uncertain About the Research Evidence

The existing research provides context but not individual predictions. Findings describe group patterns, not personal outcomes. Sample sizes were modest in some specific indication trials, and the evidence quality varies across studies. Comparative evidence is lacking to definitively contrast the 2.5% concentration against every other available topical or oral analgesic. Areas such as chronic pain management and long-term physiological effects are still subjects where more research is needed to provide a full characterization.

Frequently Asked Questions (FAQ)

Common questions about Profenid 2.5% (FAQ)


Q: Is Profenid 2.5% the same type of medicine as Ibuprofen or Naproxen?

Profenid 2.5% contains the active ingredient Ketoprofen, which is part of the propionic acid class of non-steroidal anti-inflammatory drugs (NSAIDs). Regulatory documents confirm this classification, meaning it belongs to the same chemical group that includes common medicines like Ibuprofen and Naproxen.


Q: Can Profenid 2.5% be used for internal joint pain like deep arthritis?

Official documents state that the gel is approved for the localized treatment of rheumatic or traumatic pain affecting the osteo-articular and muscular system. The mechanism relies on dermal penetration to concentrate the anti-inflammatory effects in the peripheral soft tissues. For deeper-seated conditions, the drug's action is strictly localized and may not be effective in reaching deep joint structures.


Q: What should I do if my skin turns red or itchy after applying the gel?

Redness (erythema) and itching (pruritus) are listed as common localized skin reactions at the application site. Official guidance states that if these skin reactions become bothersome, worsen, or persist, the product label requires discontinuation of the medicine. Consultation with a healthcare professional is needed for evaluation and further guidance on the reaction.


Q: Is there a concern about Profenid 2.5% affecting my heart like oral NSAIDs?

Profenid belongs to the NSAID class, which carries a systemic risk, including the potential for cardiovascular issues, that may increase with the duration of use. However, the topical gel is formulated for low systemic absorption. Due to this localized action, systemic effects are rarely experienced.


Q: Why is Profenid 2.5% not recommended for use in the later stages of pregnancy?

Regulatory information strictly prohibits the use of the gel during the last trimester of pregnancy. This prohibition exists because the active ingredient, as a prostaglandin-synthesis inhibitor, may cause serious problems for the fetus. These risks include potential cardiopulmonary and renal toxicity, specifically the premature closure of the fetal ductus arteriosus.


Q: Can I use Profenid 2.5% if I have high blood pressure?

Official precautions indicate that NSAID medications may cause or worsen existing high blood pressure in some patients. For this reason, use of the gel carries a caution for patients with high blood pressure or those taking blood pressure-controlling medications. Consultation with a physician prior to use is a common requirement to evaluate individual risk.


Q: How does the low 'systemic absorption' of Profenid 2.5% affect safety?

The formulation is designed to minimize the amount of drug that passes into the bloodstream, a process called systemic absorption. This low systemic exposure is the reason why serious side effects often associated with oral NSAIDs, such as gastrointestinal toxicity (stomach bleeding or ulcers), are rarely experienced with the topical gel.


Q: How quickly should I expect Profenid 2.5% gel to start providing relief?

While official labels do not always provide a specific time, clinical studies have examined the onset of pain relief. Evidence indicates that pain suppression with the gel may be relatively rapid, often reaching a maximum effect within approximately one hour after application.


Q: How long does the pain relief from one application of Profenid 2.5% typically last?

Clinical data suggests that the localized analgesic effect provided by a single application can be transient. The analgesic effect has been observed to last for up to three hours in certain studies. This observation supports the rationale for the recommended dosing frequency.


Q: What does the term 'photosensitivity' mean in relation to Profenid 2.5%?

Photosensitivity is a listed rare but potentially serious side effect, describing a reaction where the skin develops a rash, redness, or blistering in areas exposed to sunlight or UV light. Official instructions state that direct sun exposure is prohibited during treatment and for a period afterward to prevent this photoallergic reaction.


Q: Can Profenid 2.5% cause dizziness or drowsiness even though it is applied topically?

The active ingredient, Ketoprofen, has the potential for effects on the central nervous system. Regulatory documents note that, although rare with topical application due to low absorption, systemic effects like dizziness or drowsiness are possible.


Q: Is it safe to apply other creams or lotions over Profenid 2.5% gel?

Official product information contains a precaution against the simultaneous use of the gel with other topical products on the same area. This includes applying cosmetics, sunscreens, lotions, or moisturizers.


Q: Is Profenid 2.5% safe to apply near my face or on my neck?

The gel is approved for use on the neck (e.g., for a stiff neck), provided it is applied to the prescribed area. However, its use is prohibited near the eyes, mouth, nostrils, anal, or genital regions due to the risk of irritation and increased absorption through mucous membranes.


Q: Is Profenid 2.5% a drug that requires a prescription?

Following a regulatory review of its safety profile, major health authorities, such as the European Medicines Agency (EMA), have often recommended that topical ketoprofen be classified as a prescription-only medicine. This requirement helps ensure proper patient screening and risk management.


Q: Why is the total daily amount of Profenid 2.5% limited?

The total daily amount of the gel is strictly limited in the official instructions. This measure is a key regulatory control to ensure the lowest effective dose is used and to minimize the risk of the active ingredient being absorbed systemically, thereby reducing the potential for dose-dependent adverse effects.


Q: What should I do if I accidentally ingest a small amount of the gel?

Official safety guidelines specify contacting a Poison Control Center if any amount of the gel is accidentally swallowed. Medical attention is advised immediately following accidental ingestion, even if no immediate symptoms are present.

How should Profenid 2.5% be stored and disposed of?

How to Store and Dispose of Profenid 2.5%

The official requirements for storing Profenid 2.5% Gel are designed to preserve the product's quality and stability. The medicine must be kept out of the sight and reach of children.

Storage and Handling

Condition Requirement
Temperature Limit Do not store above 25°C.
Environment Store away from excess heat and moisture (e.g., not in the bathroom).
Container Keep in the container it came in and replace the cap after use.
Special Handling Keep away from naked flames due to the alcohol content in the gel base.
Shelf Life The unopened product has a shelf life of 30 months.

Disposal Instructions

Disposal of any unused or expired Profenid 2.5% Gel must be carried out according to local requirements. If a drug take-back program is unavailable, non-controlled medication can typically be discarded in the household trash. This requires mixing the gel with an undesirable substance, such as dirt or used coffee grounds, before placing it in a sealed bag or container and disposing of it.

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

Available in countries:

Equivalent of Profenid 2.5% found in:

A-Z Index: