Ketonal

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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 Ketonal

Property Description
Active ingredient Ketoprofen
Form Tablet, Capsule, Gel, Solution for Injection, Suppository
Pharmacological class Non-Steroidal Anti-Inflammatory Drug (NSAID)
Common purpose Symptomatic relief of pain, inflammation, and fever
Origin Synthetic, Propionic Acid Derivative

What Type of Medicine is Ketonal (Ketoprofen)?

The medicinal entity known by the trade name Ketonal derives its activity from the chemical substance Ketoprofen. This compound is classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID), a class known for its analgesic, anti-inflammatory, and antipyretic capabilities. Chemically, Ketoprofen is a synthetic compound, specifically identified as a Propionic acid derivative. This classification is clinically recognized for its capacity to address the three primary symptoms of inflammation simultaneously.

The medicine's function is to directly intervene in the body's inflammatory response, setting it apart from simple analgesics. Its primary pharmacological activity is the inhibition of prostaglandin synthesis. This demonstrates the medicine's fundamental role in controlling the internal processes that cause swelling and pain. While sharing the NSAID class with ibuprofen and naproxen, Ketoprofen is often differentiated by its diverse range of dosage forms, including the availability of solutions for parenteral administration, indicating a recognized versatility in clinical application.

Composition and General Purpose of this NSAID

Ketonal is defined as a single-ingredient product, with the alpha-methyl-3-benzoylphenylacetic acid molecule being the sole source of its therapeutic effect. The medicine is available in various Dosage form(s), including oral preparations (Capsule, Tablet) for systemic use and forms like Gel or Cream for Topical (cutaneous) application, providing versatility in its delivery.

The general purpose of using this NSAID is to achieve efficient symptomatic relief, such as easing the discomfort associated with soft tissue injuries. Ketoprofen is recognized for providing relief from various inflammatory conditions. The conclusion drawn is that the drug provides significant mitigation of discomfort and swelling associated with inflammation. This action is the fundamental benefit, positioning it as a key agent in managing the physical signs of inflammatory states across multiple administration routes.

Regulatory References

  1. Ketoprofen - LiverTox - NCBI Bookshelf - NIH

What side effects are possible with Ketonal?

Possible Side Effects and Safety Information

The safety profile of Ketoprofen, the active ingredient in Ketonal, is formally documented by government regulatory agencies and reflects patterns typical of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).

Adverse reactions are classified by frequency and grouped into System-Organ Classes (SOC) as defined in regulatory documents. Common reactions (occurring in up to 1 in 10 patients) often involve the Gastrointestinal System (e.g., dyspepsia, nausea, abdominal pain) and the Nervous System (e.g., headache, dizziness, somnolence).

Serious adverse reactions are explicitly listed due to their potential clinical significance. These include the risk of potentially fatal Gastrointestinal Adverse Events, such as bleeding, ulceration, and perforation, which may occur without warning. Regulatory labels also highlight an increased risk of serious Cardiovascular Thrombotic Events, such as myocardial infarction (MI) and stroke, which may increase with high doses and long-term use.

Population-specific safety considerations are noted in official prescribing information. Older adults are documented as having a greater risk for serious gastrointestinal adverse events. Use of Ketoprofen during the third trimester of pregnancy is constrained due to potential toxicity to the fetus.

Furthermore, official documentation defines specific limitations. Ketoprofen is contraindicated in patients with pre-existing severe hepatic, renal, or cardiac impairment and in the setting of peri-operative pain for coronary artery bypass graft (CABG) surgery.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documents for Ketoprofen (Ketonal) outline specific manifestations and mandated actions in the event of an overdose. Overdose presentations commonly documented include gastrointestinal signs such as nausea, vomiting (potentially with blood), stomach pain, and diarrhea. Central Nervous System (CNS) effects like headache, dizziness, confusion, and drowsiness are also documented.

Severe manifestations involving systemic organ toxicity are listed. These include gastrointestinal bleeding and perforation, acute renal failure, and cardiovascular complications such as hypotension and congestive heart failure. In severe cases, seizures and coma are officially noted as potential outcomes.

The regulator mandates that individuals seek immediate medical attention or contact the local emergency number upon suspected overdose. This urgent action is required if any signs of severe events, such as heavy GI bleeding or difficulty breathing, are observed.

Management is focused on symptomatic and supportive care, as the official labeling confirms no specific antidote is known. Procedures like gastric lavage or the administration of activated charcoal may be indicated to achieve gastrointestinal decontamination. Regulatory information also notes that elderly patients and those with existing renal or hepatic impairment face a greater risk of severe outcomes. Hospital monitoring to track vital signs and organ function is a requirement that may be necessary.

Therapeutic Uses of Ketonal

What Ketonal Treats: Main Uses and Benefits

The fundamental purpose of Ketonal (Ketoprofen) is to provide symptomatic relief in contexts where symptoms related to inflammatory or irritative states are more noticeable. This medication is commonly used when short-term symptomatic assistance is needed. It provides support that helps ease the overall symptom burden of acute and chronic discomfort.

Ketonal is commonly used to help with symptomatic discomfort associated with chronic inflammatory conditions such as Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis. It is also relevant in scenarios involving acute pain from soft tissue injuries (sprains and strains), as well as intense, recurrent manifestations like the discomfort of primary dysmenorrhea and acute gout. This support contributes to easing the overall symptom load.

“The medication helps address symptom clusters that may become intense or disruptive, specifically joint stiffness, swelling, and persistent tenderness.”

Applied across various domains, the drug supports the patient during difficult episodes by easing distress and may assist with maintaining functional stability when symptoms become more noticeable. This is relevant when supportive symptom management is appropriate to ease challenging symptoms that create noticeable functional strain.

Quick Fact: Helps manage symptoms related to Inflammation and Pain

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

The eligibility profile for Ketonal (Ketoprofen) is strictly defined by regulatory authorities and is based on mandatory exclusions related to the Non-Steroidal Anti-Inflammatory Drug (NSAID) class.

Contraindicated Populations

Use of Ketonal is absolutely contraindicated for patients with a known hypersensitivity or a history of allergic reactions, such as asthma, to aspirin or other NSAIDs. It is also prohibited for individuals with active gastrointestinal bleeding or peptic ulcers, and those with severe hepatic, renal, or heart failure. Regulatory documents prohibit its use throughout the third trimester of pregnancy and for perioperative pain management in the setting of coronary artery bypass graft (CABG) surgery.


Restricted and Age-Related Eligibility

Safety and effectiveness have not been established in the pediatric population (e.g., typically children under 12 or 16 years of age, depending on formulation and region). For older adults (geriatric patients), use requires caution due to increased susceptibility to adverse effects. The medicine is generally not recommended for women who are breastfeeding or those in the first and second trimesters of pregnancy unless the benefit is strictly justified.

What should I know about interactions with other medicines?

Ketonal (Ketoprofen) is an NSAID with a documented profile of interactions based on government regulatory labeling, primarily involving pharmacodynamic risk reinforcement and altered pharmacokinetics.

Regulatory Interaction Classifications

Classification Interacting Agents
Avoid/Contraindicated Other NSAIDs (including COX-2 inhibitors) and high-dose Aspirin (due to increased risk of severe adverse effects).
Clinically Significant Anticoagulants (e.g., Warfarin), Lithium, Methotrexate, ACE Inhibitors, ARBs, and Diuretics.

Officially Documented Interaction Patterns

  • Bleeding and GI Risk: The use of Ketoprofen with Anticoagulants, Antiplatelet agents, Oral Corticosteroids, or SSRIs carries a documented synergistic effect that increases the risk of serious gastrointestinal bleeding. Daily use of Alcohol also enhances this risk.
  • Renal and Blood Pressure: Co-administration with ACE Inhibitors or Diuretics may diminish their intended therapeutic effect and increase the documented risk of acute renal failure and hyperkalemia.
  • Exposure Modification: Probenecid significantly reduces the clearance of Ketoprofen, resulting in elevated plasma concentrations of the NSAID. Conversely, Ketoprofen may elevate plasma levels of co-administered Lithium and Methotrexate by reducing their clearance.
  • Food and Timing: While Antacids (magnesium/aluminum hydroxide) do not interfere with the absorption of immediate-release forms, Food is officially documented to alter absorption kinetics, specifically by delaying the time to maximum concentration (Tmax).

Mechanism of Action

How Ketonal (Ketoprofen) Works

Ketoprofen's action is rooted in a multi-modal pharmacodynamic mechanism that targets key signaling molecules involved in the eicosanoid cascade and thermoregulatory pathways.

Non-Selective Inhibition of Prostaglandin Synthesis

The primary function involves the non-selective, competitive inhibition of the cyclooxygenase (COX-1 and COX-2) enzymes. This interaction suppresses the arachidonic acid cascade, limiting the synthesis of Prostaglandin E2 ( PGE2) and other eicosanoid mediators. This molecular suppression initiates an alteration of local vascular permeability and diminished eicosanoid-mediated tissue signaling.

Modulation of Nociceptive and Thermoregulatory Signals

The mechanism extends to systemic responses by reducing the sensitization threshold of peripheral nociceptors (pain fibers) and involving central serotoninergic mechanisms, resulting in an altered transmission of pain signals. Furthermore, inhibition of PGE2 synthesis within the hypothalamus affects the thermoregulatory set-point, facilitating the body's heat loss mechanisms.

Secondary Anti-Inflammatory Pathway Influence

Ketoprofen's mechanism is complemented by an influence on the lipoxygenase (LOX) pathway and a stabilizing effect on lysosomal membranes in inflammatory cells. These mechanisms modulate cellular enzyme release and mediator activity, contributing to the overall modulation of the inflammatory cascade.

Dosage and Administration Information

Official Administration Guidelines

Ketoprofen administration is dictated by the formulation, with distinct instructions for systemic (oral, parenteral, rectal) and local (topical) routes. The method of use is strictly tied to the dosage form being utilized.

Administration Route Standard Regimen Maximum Daily Dose
Oral Immediate-Release 50 mg four times daily or 75 mg three times daily. 300 mg
Oral Extended-Release 200 mg once daily. 200 mg
Topical Gel (2.5%) 2 to 4 applications daily. 15 g

Oral forms are typically taken at divided intervals based on the formulation's release properties. These forms are permitted to be taken with food, milk, or an antacid to assist with intake conditions. Extended-release capsules are specifically intended for chronic management and are not included in the administration guidelines for acute, on-demand pain relief.

Population-Specific Adjustments

Lower initial doses are required for older adults and individuals with impaired renal or hepatic function. For patients with severe renal dysfunction, the maximum daily oral intake is restricted to 100 mg. Prescription use is not established for patients under 18 years of age.

Special Administration Constraints

For topical gel, the maximum duration of continuous treatment should not exceed seven days. Treated skin must be protected by clothing and direct sun exposure avoided during treatment and for two weeks following discontinuation. The gel must not be used beneath occlusive dressings. If a dose is missed, patients are instructed to skip the dose if it is almost time for the next scheduled dose, and not to double doses.

Recent Clinical Evidence

Research Evidence / Overview of studies for Ketonal

The clinical evaluation of Ketonal (Ketoprofen) is based on formal scientific research, primarily involving randomized controlled trials (RCTs) and systematic reviews, which was studied for specific conditions. Research describes how the medicine was evaluated in populations experiencing different types of physical discomfort and functional limitations.


Research Evidence for Osteoarthritis and Rheumatoid Arthritis

Research examining Ketoprofen was evaluated in conditions characterized by fluctuating or episodic manifestations, such as Osteoarthritis (OA) and Rheumatoid Arthritis (RA). Studies monitored outcomes related to physical discomfort in the observed populations during periods of increased symptom activity.

For OA, studies focused on both oral and topical formulations (like gels), often comparing the drug against a placebo or other standard medications. Researchers monitored outcomes related to physical discomfort, such as pain scores, and outcomes reflecting daily functioning or activity level. Findings describe patterns observed in these short-to-intermediate-term studies, which typically lasted between 6 and 12 weeks. Studies report how symptoms evolved in the observed populations of adults with diagnosed OA.

Similarly, in RA, Ketoprofen was evaluated in comparative clinical trials. Studies reported how symptoms evolved in the observed populations over defined time intervals. However, much of this evidence contributes to the broader evidence landscape for the entire NSAID class, and long-term effects are not fully established, as the focus was on short-term symptomatic changes and not on outcomes related to long-term disease courses.

Research Evidence for Acute Pain and Injury

Ketoprofen was studied for several conditions associated with acute or disruptive episodes, including Primary Dysmenorrhea and common Soft Tissue Injuries (such as sprains and strains).

For primary dysmenorrhea, research explored short-term symptom changes, utilizing single-dose or very short-term (1–3 day cycle treatment) randomized trials. Studies monitored outcomes describing episodic or acute changes, like the time until patients reported a change in perceived discomfort and the reported use of rescue analgesic medication.

In the case of soft tissue injuries, research explored the use of topical formulations in conditions associated with acute or disruptive episodes. Studies monitored outcomes related to local physical discomfort and functional outcomes reflecting daily functioning. The research highlights changes measured during the study period, which was typically very short (around one to two weeks).


Evidence Gaps and Areas of Uncertainty

The research contributes to the broader evidence landscape but also highlights what is known — and what is still uncertain. Data for certain groups remain insufficient, particularly regarding long-term outcomes and the durability of the response beyond the trial period. Findings were mixed in some trials involving the application of topical formulations compared to their non-medicated base. This means findings describe group patterns, not personal outcomes over extended periods, and for certain populations, comparative evidence is lacking.

Key Studies & References

  1. Efficacy and safety of over-the-counter analgesics for primary dysmenorrhea - A network meta-analysis
  2. Ketoprofen 2.5% gel: a clinical overview (European Review for Medical and Pharmacological Sciences)

Frequently Asked Questions (FAQ)

Common questions about Ketonal (FAQ)


Q: Is Ketonal the same type of medicine as ibuprofen or aspirin?

Official documents classify the active ingredient in Ketonal (ketoprofen) as a Non-Steroidal Anti-Inflammatory Drug (NSAID), placing it in the same class as medicines like ibuprofen and aspirin. Regulatory information specifically addresses the co-administration of ketoprofen with high-dose aspirin due to an increased risk of severe adverse effects.


Q: Why is Ketonal prescribed for different kinds of pain?

Regulatory documents state that ketoprofen has analgesic (pain-relieving), anti-inflammatory, and antipyretic (fever-reducing) properties. These actions are consistent with why it has been studied for and is indicated to treat various types of pain and inflammatory conditions.


Q: Does Ketonal help with inflammation or just pain relief?

Official information confirms that the active ingredient in Ketonal is classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID). This classification indicates that its purpose is to provide symptomatic relief for pain, inflammation, and also fever.


Q: Can Ketonal affect blood pressure?

Regulatory documents note that NSAIDs, including ketoprofen, have been associated with new onset or worsening of pre-existing hypertension (high blood pressure). Fluid retention has also been observed in some patients using the medication.


Q: Can Ketonal cause sensitivity to sunlight?

Official labeling, particularly for the topical gel formulation, includes warnings about a risk of photosensitivity reactions (increased sensitivity to light). Regulatory labeling states that treated skin requires protection from direct sunlight during treatment and for a specified period after discontinuation.


Q: What does the research evidence say about the effectiveness of Ketonal for muscle aches?

Research evidence includes studies of ketoprofen for pain associated with Soft Tissue Injuries, such as sprains and strains, which often involve muscle discomfort. These studies monitored outcomes related to local physical discomfort experienced by the observed populations.


Q: What is the difference between Ketonal and a regular painkiller I can buy over-the-counter?

Ketoprofen, the active ingredient, has been made available in different strengths under various regulatory classifications. This means that while higher-strength forms of ketoprofen are typically available only by prescription, lower strengths may be available as non-prescription (OTC) painkillers in some regions.


Q: Is Ketonal only available by prescription?

Ketoprofen is available in various forms and strengths globally. While the higher doses are typically prescription-only, in some regions, lower-strength forms of ketoprofen are available as non-prescription over-the-counter (OTC) medicines.


Q: What conditions besides pain is Ketonal used for?

Ketonal is officially indicated for the symptomatic relief of pain and inflammation. Additionally, regulatory documents classify the active ingredient as possessing antipyretic properties, meaning it can be used to reduce fever.


Q: Is there a maximum time someone is generally advised to take Ketonal?

Regulatory documents emphasize the importance of using the lowest effective dose for the shortest duration possible to minimize the potential risk of serious adverse cardiovascular events associated with NSAIDs. The topical gel formulation has a specific maximum treatment duration of seven days.


Q: Can Ketonal be used for dental pain?

Official regulatory-approved formulations of ketoprofen have listed the temporary relief of minor aches and pains due to conditions like toothache as an indication.


Q: How quickly does Ketonal usually start working after taking it?

Pharmacokinetic data for the immediate-release oral form indicates that the medicine reaches its peak plasma concentration within approximately 0.5 to 2 hours after administration.


Q: How long does the effect of Ketonal typically last?

Official pharmacokinetic information for the immediate-release oral form indicates the drug's half-life (the time it takes for half of the substance to be eliminated from the body) is approximately 2 hours. Studies have shown that the duration of action may be longer with higher doses.


Q: Are there any signs of a serious side effect from Ketonal that people should know about?

Official regulatory documents list specific symptoms that have been observed in association with serious adverse effects. These include signs related to gastrointestinal bleeding (such as black, tarry stools or vomiting blood) or cardiac events (such as sudden chest pain or unexplained shortness of breath).


Q: Is Ketonal known to cause drowsiness?

Official documentation lists somnolence (drowsiness) as a common adverse reaction, meaning it is reported by up to 1 in 10 patients. This is listed under the Nervous System class of side effects.


Q: Can Ketonal be taken by someone who has asthma?

Official regulatory documents state that Ketoprofen is contraindicated (prohibited) for patients who have a known history of allergic reactions, such as asthma, to aspirin or any other Non-Steroidal Anti-Inflammatory Drug (NSAID).


Q: Are there different brand names for the medicine that is in Ketonal?

The active ingredient in Ketonal, ketoprofen, is sold under various brand names globally. These include brand names like Orudis and Oruvail, and others, depending on the country and the specific formulation.


Q: Are there any studies comparing the long-term effects of Ketonal to similar drugs?

Regulatory reviews state that while ketoprofen has been evaluated in comparative clinical trials, much of this evidence contributes to the broader NSAID class. Official summaries note that comparative evidence regarding long-term effects is often lacking across the NSAID class.


Q: Is it normal to feel a slight headache after taking Ketonal?

Official documentation lists headache as a common adverse reaction, meaning it is reported in up to 1 in 10 patients in clinical data. It is categorized under Nervous System side effects.


Q: Does Ketonal have the potential for dependence or addiction?

The active ingredient in Ketonal is classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID). It is not classified as a controlled substance or a narcotic drug that causes physical or psychological dependence.


Q: Is Ketonal available in a low-dose option?

Official regulatory documents list various capsule and tablet strengths for ketoprofen. These options typically include a 25 mg capsule, which is often listed as the lowest standard dose for the immediate-release oral form.


Q: Is Ketonal a steroid?

No. The active ingredient in Ketonal is classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID). The 'Non-Steroidal' part of the classification confirms that this medicine is not a steroid compound.


Q: Is Ketonal used for fever reduction?

The active ingredient in Ketonal is classified in regulatory documents as possessing antipyretic (fever-reducing) properties, in addition to its capabilities for relieving pain and inflammation.


Q: Does Ketonal have an effect on blood sugar levels?

Official safety documents do not list blood sugar level changes as a common effect. However, they recommend special consideration for patients with risk factors for cardiovascular events, including diabetes mellitus.


Q: Is Ketonal used worldwide, or is it specific to certain regions?

The active ingredient, ketoprofen, is registered and regulated by a wide range of government health authorities across the globe. This includes the US FDA, European EMA, Health Canada, and others, indicating its widespread use internationally.


Q: What evidence exists regarding Ketonal's use for period pain?

Research evidence provided in regulatory documents includes studies of ketoprofen for conditions associated with period pain, specifically Primary Dysmenorrhea. The research explored short-term symptom changes in women experiencing this condition.


Q: Do studies suggest Ketonal works differently for acute versus chronic pain?

While the core therapeutic action is shared, regulatory documents indicate different formulations are typically used for the management of these conditions: immediate-release forms are often used for acute pain, and extended-release forms are intended for chronic management.

How should Ketonal be stored and disposed of?

The storage and disposal of Ketonal (Ketoprofen) must strictly adhere to regulatory labeling to maintain stability and ensure safety.

Official Storage Conditions

Ketoprofen is required to be stored at Controlled Room Temperature, defined as 20 C to 25 C (68 F to 77 F), with permitted excursions. It must be stored away from excess heat and moisture and requires protection from light in a tightly closed, light-resistant container.

Do not freeze this medication, as this can compromise product integrity.

Child Safety and Disposal

It is a mandatory safety requirement to store the medicine out of the sight and reach of children and to keep it locked up.

For disposal, the product must not be thrown into household garbage or flushed down the toilet (wastewater). Unused or expired medication, including the container, must be disposed of according to local regulations via an approved pharmaceutical waste take-back program.

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

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