Cetoprofeno

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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 Cetoprofeno

Quick Facts

Property Description
Active Ingredient Ketoprofen (INN)
Pharmacological Class Nonsteroidal Anti-Inflammatory Drug (NSAID)
Origin / Type Synthetic, Small-Molecule
Forms Available Tablet, Capsule, Solution, Topical (gel/cream), Suppository
General Purpose Analgesic, Anti-inflammatory, Antipyretic

1. Defining the Entity and Pharmacological Class

Cetoprofeno is the name for a drug product containing the active substance Ketoprofen (INN), which belongs to the specific chemical class of propionic acid derivatives. It is broadly categorized as a Nonsteroidal Anti-Inflammatory Drug (NSAID). This categorization is clinically recognized across numerous international pharmacopoeias as a standard for managing generalized pain and inflammation.

As a synthetic, small-molecule agent, Ketoprofen's primary role is determined by its ability to modulate systemic biological pathways. Ketoprofen is categorized under the Anatomical Therapeutic Chemical (ATC) code M01AE03 for systemic anti-inflammatory use.

2. Composition and Forms: A Synthetic, Single-Ingredient Medication

The core of Cetoprofeno is the chemically synthesized compound Ketoprofen, which is typically formulated as a single-ingredient product. A distinguishing feature for Ketoprofen is its comprehensive range of available forms, encompassing oral intake, parenteral delivery (injectable solutions), rectal use, and various topical preparations (gels and creams). This flexibility is a key differentiating feature within the propionic acid class, allowing for both generalized internal effect and targeted external action.

3. Primary Purpose: Analgesia, Anti-Inflammation, and Antipyresis

The established general purpose of Cetoprofeno is to act as an analgesic (pain reliever), an anti-inflammatory agent, and an antipyretic (fever reducer). It achieves these effects by inhibiting the activity of the cyclooxygenase (COX) enzymes, thereby suppressing the production of prostaglandins, which are the key chemical triggers for discomfort and swelling. Ketoprofen is used to address generalized pain and inflammation. This action allows the medication to mitigate the broad physical symptoms associated with inflammatory processes.

What side effects are possible with Cetoprofeno?

Officially Documented Side Effects and Safety Information

Cetoprofeno (Ketoprofen) is a non-steroidal anti-inflammatory drug (NSAID) whose safety profile carries known class-effects, which are summarized in official governmental regulatory documents.

Key Adverse Reactions and Serious Warnings

Cetoprofeno carries a Boxed Warning regarding two major systemic risks that can be fatal:

  • Cardiovascular Thrombotic Events: Use can increase the risk of serious events such as myocardial infarction (heart attack) and stroke. This risk may increase with higher doses and longer duration of use, and use is generally contraindicated following coronary artery bypass graft (CABG) surgery.
  • Gastrointestinal Adverse Events: NSAIDs increase the risk of serious gastrointestinal events including bleeding, ulceration, and perforation of the stomach or intestines. These events can occur without warning symptoms.

Commonly documented adverse reactions include gastrointestinal upset (e.g., nausea, dyspepsia, diarrhea, constipation) and nervous system effects (e.g., headache, dizziness, drowsiness).

Less common, but serious, adverse reactions include acute renal failure, severe liver injury (rare instances reported), and severe hypersensitivity reactions, including anaphylaxis and serious skin conditions (e.g., Stevens-Johnson syndrome).


Safety Restrictions and Population Considerations

  • Pregnancy: The drug is contraindicated from approximately 20 weeks of gestation onward due to the risk of fetal kidney problems (oligohydramnios) and premature closure of the fetal ductus arteriosus, which can lead to complications for the newborn. Its use is not generally recommended in the first two trimesters unless the expected benefit outweighs the risk.
  • Topical Formulations: These carry warnings against exposure to sunlight or UV light (including solariums) during treatment and for a period thereafter due to the risk of severe photosensitivity and photoallergic reactions.
  • High-Risk Patients: Caution is required in patients with pre-existing conditions such as heart failure, established ischemic heart disease, hypertension, or a history of gastrointestinal ulceration or bleeding. Risk is generally higher in the elderly.

Overdose and Emergency Response

Overdose and when to seek help

Official regulatory documentation identifies specific clinical manifestations and mandated emergency actions in the event of Cetoprofeno (Ketoprofen) overdose.

Documented Overdose Manifestations

Overdose presentations are frequently mild, primarily involving the Gastrointestinal (GI) and Central Nervous System (CNS). Documented signs include nausea, vomiting, epigastric pain, headache, drowsiness, and dizziness. In cases of high exposure, more severe manifestations may occur, such as convulsions (seizures), coma, gastrointestinal bleeding, and acute renal failure (kidney damage).

Required Emergency Actions

Immediate medical attention is required for any suspected overdose. Regulatory guidance mandates that individuals must seek immediate emergency help by contacting a Poison Control Center or emergency services. This is especially critical if severe symptoms—such as chest pain, difficulty breathing, slurred speech, or lack of consciousness—are present.

Management Protocol

Consistent with the NSAID pharmacological class, no specific antidote is known for Ketoprofen overdose. Therefore, management is strictly symptomatic and supportive. Supportive measures described in regulatory sources include activated charcoal, gastric lavage, and monitoring of vital signs and laboratory parameters in a healthcare setting. Official documents note that children and older adults may be at increased risk for serious complications, particularly GI and renal events.

Therapeutic Uses of Cetoprofeno

What Ketoprofen Treats: Main Uses and Benefits

Ketoprofen belongs to the class of nonsteroidal anti-inflammatory drugs (NSAIDs) and is commonly used to help with symptoms related to physical discomfort and inflammatory or irritative states. Its use is applicable within clinical settings that involve acute or disruptive symptom patterns.

This medication is indicated for the management of symptoms linked to inflammatory conditions. It is applied across domains where additional symptomatic support is needed for conditions like osteoarthritis and rheumatoid arthritis, which involve episodic or fluctuating manifestations, as well as symptoms associated with acute or episodic changes. Specifically, it may assist with general symptoms related to physical discomfort, including menstrual cramps (dysmenorrhea), and generalized aches such as muscle pain, backache, or headache. This provides supportive relief when symptoms interfere with routine activities, helping to ease the overall symptom burden.

The medication helps maintain a sense of stability when symptoms are more noticeable. It is used to support patients during episodes of heightened discomfort and is often used during phases when symptoms become more noticeable.

Quick Fact: Relief for Pain and Inflammation

Eligibility and Restrictions for Use

Who Can and Cannot Use Cetoprofeno? — Official Regulatory Information

The eligibility for Cetoprofeno (Ketoprofen) is strictly determined by official regulatory documents, primarily focusing on pre-existing health conditions, age, and physiological status. The medicine is primarily approved for use in adults; however, its safety and effectiveness are not established for prescription use in pediatric patients under 18 years of age.


Contraindicated Populations (Must Not Use)

Use is absolutely contraindicated in patients with a history of hypersensitivity to Ketoprofen, aspirin, or any other Nonsteroidal Anti-Inflammatory Drug (NSAID). The medicine must not be used by individuals with active peptic ulcer, severe heart failure, or severe renal impairment.


Restricted and Life-Stage Eligibility

Cetoprofeno is contraindicated during the third trimester of pregnancy. Its use is not recommended for nursing mothers due to a lack of data. Geriatric patients (typically ge65 years) and those with existing mild-to-moderate renal or hepatic impairment are permitted to use the medicine but require special consideration and close monitoring, often requiring a reduced initial dosage, as stated in the official labeling.

What should I know about interactions with other medicines?

The official regulatory profile for Cetoprofeno (Ketoprofen) strictly documents several types of interactions, primarily structured around its classification as an NSAID.

Contraindicated and High-Risk Combinations

Co-administration with other Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), including selective COX-2 inhibitors, and high-dose salicylates is formally restricted in regulatory labeling due to a synergistically increased risk of gastrointestinal ulceration and bleeding.

Pharmacodynamic Effects

Cetoprofeno’s interaction profile shows a heightened risk when co-administered with medications that affect hemostasis or the gastrointestinal lining. This includes anticoagulants (such as Warfarin), anti-platelet agents, oral corticosteroids, and Selective Serotonin Reuptake Inhibitors (SSRIs), all of which formally increase the risk of hemorrhage. Furthermore, a recognized interaction exists with Diuretics and ACE inhibitors/ARBs, which risks both a reduction in their intended therapeutic effect and potential deterioration of renal function.

Pharmacokinetic and Substance Interactions

Formal pharmacokinetic interactions are documented with certain medications that depend on renal clearance. This includes Lithium, which may experience increased plasma concentrations leading to toxicity, and high-dose Methotrexate, which requires that administration be separated by at least twelve hours to mitigate the risk of elevated exposure. The use of alcohol is linked in labeling to enhanced gastrointestinal and potential liver risks. Elderly patients and those with existing renal impairment are identified as populations with a formally heightened susceptibility to these interaction risks.

Mechanism of Action

Cetoprofeno, containing Ketoprofen, primarily works by altering defined physiological pathways through enzyme inhibition, leading to alterations in signaling pathways. The core of the mechanism involves the non-selective, reversible inhibition of the Cyclooxygenase ( COX) enzymes, specifically both the COX-1 and COX-2 isoforms. This molecular action blocks the conversion of Arachidonic Acid into prostaglandins ( PGE2) and other signaling mediators. This essential step initiates a chain reaction that lowers the overall level of these chemical messengers, which drive the physiological inflammatory and nociceptive responses. The mechanism influences nociception in two complementary ways: peripherally and centrally. Peripherally, the suppression of prostaglandins reduces the chemical sensitization of nociceptors at the site of tissue damage. Centrally, the molecule's ability to cross the blood-brain barrier allows it to modulate signal processing and reduce PGE2 synthesis within the hypothalamus. This dual engagement results in reduced signal generation at the periphery and diminished amplification within the central nervous system. Ketoprofen's central activity also affects thermal status: by inhibiting COX activity directly in the hypothalamus, the mechanism operates by opposing pyrogenic signals that elevate the temperature set point, which facilitates the reversal of the elevated thermal state.

Dosage and Administration Information

Cetoprofeno (Ketoprofen) is administered through multiple official routes, primarily oral (tablets, capsules, films) for systemic effect and topical (gel or cream) for localized cutaneous application. Oral dosing is highly dependent on the specific formulation. Immediate-release (IR) oral forms are typically scheduled for multiple daily administration, in divided doses ranging from 25 mg to 75 mg per single dose. Conversely, the extended-release (ER) oral formulation is administered once daily, usually at 200 mg. The total daily systemic dose should not exceed 300 mg for IR forms or 200 mg for ER forms.

Practical administration requirements dictate that oral forms may be taken with food or milk to help mitigate gastrointestinal discomfort. Extended-release tablets and capsules must be swallowed whole and never crushed, chewed, or divided. For localized treatment, the topical gel is typically applied two to four times daily; the length of this specific treatment course is often restricted and should not exceed seven days.

Usage guidelines also address specific populations. A lower initial dose should be considered for older adults or patients with known renal or hepatic impairment. General practice for the administration of this medicine is to use the lowest effective dose for the shortest possible duration of treatment.

Recent Clinical Evidence

Cetoprofeno: Recent Clinical Evidence

Summary of Findings

Research has evaluated Cetoprofeno (also known as Ketoprofen), a nonsteroidal anti-inflammatory drug (NSAID), as a treatment for acute and chronic pain conditions. Studies explored the drug's action in relation to the cyclooxygenase (COX) enzyme pathway, which is involved in inflammation and pain signaling. Research has also explored whether the use of Cetoprofeno is associated with improvements in functional outcomes and quality of life for people with conditions like osteoarthritis and rheumatoid arthritis.


Key Clinical Trials

Oral Formulations

Randomized, controlled trials have examined the effect of oral Cetoprofeno in managing various types of pain, including post-operative pain and pain associated with rheumatic conditions. Studies have evaluated whether oral Cetoprofeno may be associated with reduced pain and swelling, with some findings suggesting a favorable profile compared to other standard NSAIDs in terms of efficacy metrics. Comparative studies on acute pain have also been conducted, though specific findings regarding comparative effectiveness remain mixed, and further investigation is ongoing.

Topical and Combination Use

Research has examined the use of topical formulations (creams/gels) of Cetoprofeno for the local treatment of mild to moderate acute soft tissue injury and osteoarthritis. For knee osteoarthritis, some studies reported that topical Cetoprofeno was associated with pain reduction over 6 to 12 weeks, with benefits observed over the placebo carrier alone. Investigations have also focused on whether combining Cetoprofeno with a gastro-protective agent like Omeprazole may affect the incidence of gastrointestinal adverse effects associated with long-term NSAID use. Long-term use in adults has been a subject of investigation to establish its overall risk profile.


Special Populations and Safety Profile

Research has examined the use of Cetoprofeno in people with pre-existing liver conditions and has included subgroup analyses evaluating the safety profile in older adults (age 65+). Evidence remains limited regarding the use of Cetoprofeno in pregnant or breastfeeding individuals.

Disclaimer: This information is for educational purposes only. Before making any treatment decision, it is important to consult a healthcare professional.

Frequently Asked Questions (FAQ)

Common questions about Cetoprofeno (FAQ)

Q: What is the typical starting dose for a healthy adult using the immediate-release tablet?

A: Official regulatory documents indicate that an analgesic effect can be achieved with a low dose. However, larger single doses tend to provide a faster onset and longer duration of action. Official labeling states the fundamental principle of administration is to use the lowest effective dose for the shortest duration, with the actual dose being determined by the treating clinician.

Q: What should I do if I miss a dose of the medicine?

A: Official patient instructions typically state that if a dose is missed, it should be taken as soon as it is remembered, unless it is nearly time for the next dose. If it is close to the next scheduled dose, the missed dose should be skipped. It is generally advised not to take two doses to make up for a missed one.

Q: How long does it typically take for the oral tablet to start relieving pain?

A: Clinical studies reviewed by regulatory bodies indicate that a noticeable onset of pain relief is often reported within 30 minutes following a single oral dose. This timeframe is based on clinical trials and may vary.

Q: What are the possible signs of an overdose and what should I do?

A: Symptoms of overdose are documented in official safety information and may include severe drowsiness, lack of energy, nausea, vomiting, stomach pain, dizziness, and seizures. In the event of a suspected overdose, official safety documents recommend immediately seeking emergency medical help or contacting a poison control center.

Q: What is the recommended duration for using the topical gel?

A: Official product information, such as the Summary of Product Characteristics, states that the length of treatment for the topical gel is often restricted. For localized soft tissue treatment, the typical duration should not exceed seven days, as specified in the label.

Q: Can I cut or crush the extended-release capsules to make them easier to swallow?

A: Regulatory documents explicitly state that extended-release capsules should not be chewed, crushed, or divided. They must be swallowed whole to ensure the intended slow release of the medicine, as altering the form can cause the drug to be released all at once, increasing the risk of side effects.

Q: Is it safe to use Cetoprofeno while breastfeeding?

A: Due to a lack of complete data regarding drug levels in breast milk and the potential for adverse effects in the infant, its use is generally not recommended for nursing mothers. Decisions about using the medicine while breastfeeding should be made following a professional risk assessment.

Q: Can Cetoprofeno affect my ability to drive or operate machinery?

A: Because this medication may cause central nervous system side effects like dizziness, drowsiness, or blurred vision, official safety warnings suggest exercising caution before driving or operating machinery. This is advised until the user is aware of how the medication affects them.

Q: Where and how should I store this medication at home?

A: Official storage guidelines require the medicine to be kept in its original, tightly closed, light-resistant container. It is required to store the medicine away from excess heat and moisture. It is a mandatory safety instruction that the medicine should be kept out of the sight and reach of children.

How should Cetoprofeno be stored and disposed of?

Official Storage and Handling

Cetoprofeno (Ketoprofen) oral forms must be stored at Controlled Room Temperature, specifically 20 C to 25 C (68 F to 77 F) [3.2]. It is required that the medicine be stored away from excess heat and moisture and must not be frozen [1.4, 3.1]. The product must be kept in its original container, tightly closed, and the dispensing container must be light-resistant [3.2]. Child-safety regulations mandate that the medicine must be stored out of the sight and reach of children [1.4, 4.1].


Official Disposal Guidelines

Unused or expired product should be discarded through community drug take-back programs as the preferred method [2.5]. If a take-back option is unavailable, the medicine can be disposed of in the household trash after mixing it with an undesirable substance (like coffee grounds) and placing the mixture into a sealed bag [2.3]. Do not flush the medicine down the toilet or release it into any drains or waterways, as it is not on the specific list of flushable drugs [2.2, 4.1].

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

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