Dexofen  

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Dexofen  

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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 Dexofen  

Property Description
Active ingredient Dexketoprofen (as the trometamol salt)
Forms Tablets, Granules for oral solution, Solution for injection
Pharmacological class Non-Steroidal Anti-Inflammatory Drug (NSAID)
Common use Relief from pain and inflammation
Origin Synthetic (Enantiopure compound)

What is Dexofen and What Type of Medicine is It?

Dexofen is a pharmaceutical preparation whose active component is Dexketoprofen. It is classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID) and functions as a non-opioid analgesic, placing it among medicines used to mitigate pain, inflammation, and fever. As a potent short-term agent for pain relief, the drug is categorized among the anti-inflammatory and antirheumatic products, non-steroids (ATC code M01AE17). This distinguishes it from opioid-based alternatives by managing discomfort through action on inflammatory pathways rather than central narcotic mechanisms.

Composition, Forms, and Chemical Origin of Dexketoprofen

The core medicinal substance in Dexofen is Dexketoprofen, a synthetic compound that is a propionic acid derivative. It is chemically notable as an enantiopure substance, specifically the S(+)-enantiomer, which represents the biologically active portion isolated from the racemic precursor, ketoprofen. This focus on the single active molecule differentiates it from older, mixed-component NSAIDs. The active substance is commonly formulated as the highly soluble trometamol salt for improved absorption, which is designed to provide rapid action. As a single-ingredient product, the medicine is available for administration by both the oral route, such as tablets and granules for oral solution, and the parenteral route as a solution for injection.

The General Purpose of Dexofen

The primary purpose of Dexofen is to rapidly and efficiently interrupt the processes that lead to physical discomfort. It achieves this by functioning as a potent cyclooxygenase inhibitor, thereby reducing the body's synthesis of prostaglandins, which are chemical mediators responsible for transmitting pain and initiating inflammation. This mechanism of action allows the medication to mitigate the physical symptoms associated with acute discomfort, providing relief and contributing to the resolution of underlying inflammatory responses.

What side effects are possible with Dexofen  ?

Possible Side Effects and Safety Information

Dexofen is a Non-Steroidal Anti-Inflammatory Drug (NSAID) and carries the class risks associated with this category of medicines. Factual safety information derived from regulatory documents includes serious warnings regarding cardiovascular, gastrointestinal, and hypersensitivity reactions.

Adverse Reaction Categories

Commonly reported adverse reactions involve Gastrointestinal Disorders, such as nausea, vomiting, stomach pain, and indigestion. More serious, but less common, adverse events include effects on the Cardiovascular System and Skin and Subcutaneous Tissue.

System-Organ Class Serious Adverse Reactions (Regulatory Warnings)
Cardiovascular/Vascular Increased risk of serious thrombotic events, including myocardial infarction (heart attack) and stroke, which can be fatal. This risk is greater with higher doses or long-term use.
Gastrointestinal Risk of serious stomach bleeding, ulceration, and perforation (often without warning), which can be fatal.
Immune/Skin Severe allergic reactions, including anaphylaxis, angioedema, and serious skin reactions (e.g., severe rash, blistering).
Hepatobiliary/Renal Serious liver or kidney problems, especially in patients with pre-existing impairment or dehydration.

Safety-Related Restrictions and Considerations

Contraindications include severe heart failure, moderate to severe renal or hepatic impairment, active gastrointestinal bleeding or ulceration, and a history of asthma or allergic reactions after taking aspirin or other NSAIDs. Use is also contraindicated during the third trimester of pregnancy and during breastfeeding.

Population-Specific Warnings: Elderly patients are at a higher risk for adverse effects, particularly gastrointestinal bleeding. Women who are trying to conceive should be aware that the drug may temporarily impair reproductive capacity. Patients with existing cardiovascular disease, hypertension, or associated risk factors (e.g., diabetes, high cholesterol, smoking) require careful assessment, and the lowest effective dose for the shortest duration possible should be used.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for Dexketoprofen overdose details specific documented manifestations that primarily affect the gastrointestinal (GI) and central nervous systems (CNS). Common presentations include gastrointestinal discomfort, such as nausea, vomiting, and epigastric pain, alongside CNS effects like lethargy, drowsiness, and dizziness. Severe over-ingestion is documented to carry the risk of life-threatening complications, including acute renal failure, coma, seizures, and serious GI events such as bleeding or perforation. These serious outcomes are officially noted to be of increased frequency and severity in the elderly population.

Regulatory guidance mandates that immediate medical attention be sought for any suspected overdose. Urgent contact with emergency services is required for the development of severe symptoms, specifically seizures, loss of consciousness, or difficulties with breathing.

Due to the official statement that no specific antidote is known for Dexketoprofen, clinical management is strictly defined as symptomatic and supportive care. Procedures such as the administration of activated charcoal and gastric lavage are documented as appropriate supportive measures following a large ingestion. Continuous hospital monitoring, including ECG and extensive blood/urine testing, is required to manage documented systemic effects.

Therapeutic Uses of Dexofen  

What Dexofen Treats: Main Uses and Benefits

Dexofen is an analgesic medication that helps manage a range of acute or disruptive symptom patterns, and is often used during phases when symptoms become more noticeable. It is applied across domains involving episodic or acute manifestations where symptomatic support is needed, primarily for managing physical discomfort. The medication is relevant for conditions characterized by short-term symptomatic discomfort in areas such as acute pain from injuries and procedures, musculoskeletal and joint discomfort, and symptoms related to fever and painful periods. By easing distress, it provides support that helps ease the overall symptom burden and may assist with maintaining comfort during routine activities.

“It provides support that helps ease the overall symptom burden.”

This support is relevant when symptoms create noticeable physiological strain, such as temporary backache, pain from dental extractions, or discomfort from strains and sprains. The medication is applicable in clinical settings that involve systemic or episodic changes, providing supportive relief when symptoms become temporarily overwhelming.


Quick Fact: Support for Acute Symptom Clusters Dexofen is commonly used across conditions presenting with localized or systemic discomfort where short-term symptomatic assistance is needed.

Regulatory References

  1. NIH MedlinePlus guidance

Eligibility and Restrictions for Use

Official Eligibility Profile: Who Can and Cannot Use Dexofen?

This information is based strictly on authoritative governmental regulatory documents (e.g., Summary of Product Characteristics, Prescribing Information).

Populations for Whom Use is Contraindicated

Dexofen (dexketoprofen trometamol) must not be used by individuals with the following conditions or characteristics:

  • Hypersensitivity to the drug or any other Non-Steroidal Anti-Inflammatory Drug (NSAID), including those who experience asthma, acute rhinitis, or urticaria upon taking NSAIDs.
  • Active gastrointestinal (GI) disease, such as peptic ulcer/haemorrhage, a history of recurrent GI bleeding/perforation related to prior NSAID use, Crohn's disease, or ulcerative colitis.
  • Severe organ dysfunction, including severe heart failure, severe hepatic impairment, or moderate to severe renal impairment (creatinine clearance leq 59 mL/min).
  • Active bleeding or bleeding disorders, or severe dehydration.
  • Third trimester of pregnancy and during lactation (breastfeeding).

Age and Life Stage Eligibility

Category Regulatory Status
Children and Adolescents (under 18) Use Not Established. Safety and efficacy have not been established; use is not permitted.
Elderly Use requires caution, monitoring, and generally a lower starting dose due to increased risk of adverse reactions.
First/Second Trimester of Pregnancy Not recommended unless clearly necessary; must be used at the lowest possible dose for the shortest duration.

Restricted or Conditional Use

Use is restricted and requires careful consideration and monitoring for patients with mild renal or hepatic impairment, a history of GI disease, uncontrolled hypertension, or other cardiovascular risk factors.

What should I know about interactions with other medicines?

Dexofen’s interaction profile is strictly defined by regulatory documentation, identifying risks primarily related to pharmacodynamic effects and altered substance clearance.

Documented Pharmacodynamic Interactions

The co-administration of Dexofen with other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including COX-2 selective inhibitors, must be avoided due to the officially documented increased risk of gastrointestinal adverse effects. Interactions with Anticoagulants (e.g., Warfarin, Heparins), Oral Corticosteroids, and Selective Serotonin Re-uptake Inhibitors (SSRIs) carry a heightened risk of bleeding or ulceration.

Clearance and Exposure Modulation

Regulatory documents highlight pharmacokinetic interactions that alter plasma levels. Co-administration may increase plasma levels of Lithium and high-dose Methotrexate (ge 15 mg/week) due to reduced renal clearance. Conversely, Probenecid may increase the plasma concentration of Dexketoprofen itself.

Substance and Timing Restrictions

Interaction with food is documented to delay absorption; therefore, for acute pain management, administration is regulated to be taken at least 30 minutes before meals. Consumption of Alcohol is officially noted to increase the risk of both gastrointestinal bleeding and central nervous system effects such as dizziness. The interaction profile notes that elderly patients face increased frequency and severity of GI risks, which heightens the relevance of these interactions.

Mechanism of Action

The action of Dexofen® (Dexketoprofen) is defined by its ability to act upon specific enzyme-driven biochemical processes, thereby affecting physiological signaling cascades. This mechanism involves modulation of responses characterized by heightened activity associated with inflammation and fever pathways.

Enzyme Inhibition and Prostaglandin Suppression

The fundamental mechanism involves the non-selective inhibition of Cyclooxygenase ( COX-1 and COX-2) enzymes. By blocking the catalytic sites, Dexketoprofen prevents the conversion of arachidonic acid into prostaglandins ( PGs), which are the main chemical mediators in this pathway. This suppression of PG synthesis is the molecular step that underlies the drug's physiological responses.

Attenuation of Nociceptive and Thermoregulatory Signals

This mechanism acts to alter physiological signaling dynamics across multiple systems. Reducing peripheral PG concentration leads to a decrease in the excitability of nociceptors. Simultaneously, the central action on PG synthesis in the hypothalamus alters the body's core temperature set-point mechanism.

Dosage and Administration Information

Dexofen (dexketoprofen) is administered via the oral route, using tablets or granules, or the parenteral route, using a solution for intramuscular (IM) or intravenous (IV) injection/infusion.

Standard Dosing and Duration

The standard oral dose is typically 12.5 mg every 4 to 6 hours or 25 mg every 8 hours, with the total daily intake not exceeding 75 mg. For parenteral use, the dose is generally 50 mg every 8 to 12 hours, with a maximum daily limit of 150 mg. Treatment with Dexofen is intended for short-term use only, and the parenteral route is limited to a maximum of two consecutive days before transitioning to oral therapy.

Administration Conditions and Adjustments

Oral tablets should be swallowed with fluid and are recommended for administration at least 30 minutes before meals to optimize the rate of absorption. The injection solution, when administered intravenously, must be given as a slow infusion lasting 10 to 30 minutes or as a slow bolus over no less than 15 seconds, and the prepared solution must be protected from natural daylight.

Dosage adjustments apply to certain patient populations:

Population Initial Total Daily Dose
Older Adults (Elderly) Reduced to a total of 50 mg
Mild Renal Impairment Reduced to a total of 50 mg
Mild to Moderate Hepatic Impairment Reduced to a total of 50 mg

Use in the pediatric population (children and adolescents) is not recommended, as safety and efficacy have not been established.

Recent Clinical Evidence

Research evidence / Overview of studies

Pharmacological Profile and Mechanism

Research examined the findings of studies that explored two key pathways, and investigation explored whether the drug was associated with a reduction in pain. Studies investigated the effects on function and explored observed changes in inflammation levels. The research protocol examined administration at the onset of symptoms.


Primary Clinical Trials (Acute Pain Relief)

A combination of two molecules (Component A and Component B) evaluated whether the intervention was associated with a reduction in the duration of acute flare-ups compared to a placebo group. Research focused on time to meaningful pain relief (MPR) as a primary endpoint.

While some studies reported positive findings, research has explored potential drug interactions. A meta-analysis of randomized controlled trials (RCTs) reported a statistically significant difference in pain scores compared to placebo.


Long-term and Safety Studies

Research from long-term studies explored the relationship between use and changes in disease progression markers, and studies have continued to investigate the profile of the drug for managing chronic conditions.

Studies have included participants with mild liver impairment. Participants with severe kidney issues were generally excluded from the research. The long-term safety profile continues to be a subject of ongoing research.

Key Studies & References

  1. Systematic Review of Dexketoprofen in Acute and Chronic Pain
  2. Chronic pain (primary and secondary) in over 16s: assessment of all chronic pain and management of chronic primary pain - NICE Guideline [NG193]

Frequently Asked Questions (FAQ)

Common questions about Dexofen (FAQ)


Q: What is the active component or main ingredient in Dexofen?

The active component in the medication is the non-steroidal anti-inflammatory drug (NSAID) known as dexketoprofen. This active ingredient works by modulating the body's physiological signaling cascades related to pain and inflammation.

Q: What is the official definition of the condition that Dexofen is used for?

Official regulatory labeling describes the drug's use for the symptomatic short-term treatment of mild to moderate acute pain. This indication includes conditions such as musculoskeletal pain, painful periods (dysmenorrhea), and toothache.

Q: Is Dexofen a long-term treatment or is it usually for short courses?

Regulatory documents state that treatment with the drug is intended for short-term use only. The treatment duration must be strictly limited to the symptomatic period for which the drug is required.

Q: How long after starting Dexofen do people usually notice a change?

The onset of pain relief is described in official documents as being relatively rapid. The time to onset of effects is typically noted within about 30 minutes after the oral dose is taken.

Q: Is it safe to stop taking Dexofen suddenly?

As treatment is intended for short-term use for acute pain, official documents generally do not detail a tapering schedule for discontinuation. Official patient information notes that stopping the medication abruptly may be associated with the return of painful symptoms.

Q: Can I crush or split my Dexofen tablet?

Official patient instructions advise that the tablets should be swallowed whole with fluid. Regulatory directions for use generally specify that the tablets should not be crushed, chewed, or broken, unless the specific product is formulated as granules or powder intended for solution.

Q: What are the most commonly reported less-serious side effects of Dexofen?

The most commonly reported, less-serious effects typically involve the gastrointestinal system. These effects are categorized as common (occurring in more than 1 in 100 people) and can include nausea, vomiting, abdominal pain, diarrhea, and indigestion (dyspepsia).

Q: Do studies suggest that Dexofen is well-tolerated by most people?

Clinical data indicates that the drug is generally tolerated in its approved short-term use. The adverse effects reported were typically described as mild and transient, with an incidence similar to that observed with placebo in some clinical trials.

Q: Is Dexofen only available by prescription?

Dexofen is cited extensively in regulatory documents that contain specific prescribing information, such as the Summary of Product Characteristics (SmPC). These documents indicate that the drug is formally classified as a prescription-only medicine (POM) for the approved formulations.

Q: What is the safety class or category that Dexofen belongs to?

Medical authorities classify the drug as a Non-Steroidal Anti-Inflammatory Drug (NSAID). For use during pregnancy, official documents state that it is generally contraindicated (should not be used) during the third trimester due to potential fetal risks.

Q: How do regulatory bodies classify the potential for Dexofen to cause serious side effects?

Regulatory warnings classify the drug, like other NSAIDs, as carrying an increased potential for serious cardiovascular (CV) thrombotic events (such as heart attack and stroke) and serious gastrointestinal (GI) adverse events (such as bleeding and ulceration). These warnings are noted in official labeling and are of particular concern with long-term use.

Q: Can Dexofen be used during pregnancy or breastfeeding?

Official documents state that the drug is contraindicated (should not be used) during the third trimester of pregnancy and during the lactation period (breastfeeding). Use during the first and second trimesters is described in official documents as being permitted only when the potential benefit is judged to outweigh the potential risk.

Q: Why is Dexofen sometimes mentioned with a different drug name?

The name Dexofen is a brand name. The drug may be mentioned by other trade names (like Keral or Ketesse, which are cited in regulatory documents) because different pharmaceutical companies market the same active ingredient, dexketoprofen, in various regions.

Q: Is there a generic version of Dexofen available?

The active ingredient is dexketoprofen. Products containing this ingredient are marketed under various brand names, and generic versions of the drug (dexketoprofen) may be available depending on the specific country’s regulatory approvals and market status.

Q: What does the research say about Dexofen use in younger adults?

While use in the pediatric population is not recommended, studies establishing the drug's pharmacokinetic properties (how the body handles the drug), such as absorption time and maximum plasma levels, were typically conducted in healthy adult volunteers.

Q: How quickly does Dexofen leave the body after the last use?

Scientific literature indicates that the drug has a relatively short elimination half-life. This time period is reported to be approximately 1.65 to 2.5 hours.

Q: What is the purpose of the inactive ingredients found in Dexofen tablets?

Inactive ingredients, also known as excipients, are substances included in the formulation for various purposes. These can include ensuring stability, aiding in the manufacturing process, and helping with stability, taste-masking, or the proper release of the active ingredient in the body.

Q: Is Dexofen considered a common treatment for its main approved condition?

Regulatory and medical literature confirms the drug's use for the symptomatic short-term management of acute pain, consistent with its approval.


How should Dexofen   be stored and disposed of?

How to Store and Dispose of Dexofen

Official regulatory documents define specific storage and disposal requirements for Dexofen (dexketoprofen trometamol) to maintain the drug's stability and ensure safety.

Storage Conditions

Item Requirement
Temperature (Tablets) Do not store PVC-Aluminum blisters above 30 C. Other blister types may not require special temperature conditions.
Light Protection Store all formulations (tablets and injection) in the original outer carton to protect the contents from light.
Child Safety Keep this medicine out of the sight and reach of children.
Shelf Life Do not use after the expiry date stated on the carton. The diluted injectable solution must be used within 24 hours at 25 C and protected from light.

Disposal Instructions

Unused or expired Dexofen must not be thrown away in household waste or wastewater. Disposal should be carried out in accordance with local regulations, and the patient must consult a pharmacist for proper disposal methods to protect the environment.

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

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