Kafenac

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Medically reviewed

Laura Arias

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 Kafenac

Property Description
Active Ingredient Aceclofenac (INN)
Form Oral Tablet (various coatings/releases)
Pharmacological Class Non-Steroidal Anti-Inflammatory Drug (NSAID)
Common Use Relief from pain and inflammation
Origin Synthetic Phenylacetic Acid Derivative

What Type of Medicine is Kafenac?

Kafenac is a systemic pharmaceutical product classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID), belonging to the chemical group of acetic acid derivatives. The ATC classification places Aceclofenac in the anti-inflammatory and antirheumatic products group. This classification is widely accepted and confirms its role as a systemic agent used to manage discomfort.

The drug's primary therapeutic purpose is to alleviate symptoms associated with inflammatory and painful processes, functioning as both an anti-inflammatory and analgesic compound intended for the adult target audience. Aceclofenac is clinically recognized for its ability to effectively reduce discomfort and swelling associated with musculoskeletal conditions. This demonstrates the medicine's core ability to provide comprehensive relief for painful physical issues. Kafenac, with its active component Aceclofenac (INN), functions as a preferential COX-2 inhibitor, a chemical characteristic that guides its action towards the mediators of inflammation.

Composition and Form: Aceclofenac as a Single-Ingredient Product

The core identity of Kafenac lies in its single active component, Aceclofenac, a synthetic substance derived as a phenylacetic acid derivative. This medicine is consistently presented as a single-ingredient product, which is a key differentiating factor from treatments that utilize combined analgesic formulations.

Kafenac is predominantly supplied for oral administration as a tablet (including film-coated or sustained-release variants). The solid tablet represents the medicine's standardized dosage form, which is specifically designed for effective systemic absorption of Aceclofenac. This preparation, intended for the management of chronic and acute pain episodes, confirms its status as a prescribed agent focusing solely on anti-inflammatory and pain-relieving effects.

What side effects are possible with Kafenac?

Possible Side Effects and Safety Information: Kafenac

The safety profile of Kafenac (Aceclofenac) is classified according to the likelihood of adverse reactions documented in official regulatory sources. These effects are grouped by the affected organ system, with the Gastrointestinal disorders being the most frequently reported System-Organ Class.

Frequency Classification

Adverse reactions are classified into several frequency bands in official documents:

  • Common (1/100 to < 1/10): Includes effects such as dyspepsia, abdominal pain, nausea, and diarrhea, along with officially noted elevations in liver enzymes (transaminases).
  • Uncommon (1/1,000 to < 1/100): Covers events like flatulence, gastritis, rash, and increased levels of serum creatinine or blood urea.
  • Rare and Very Rare: Documented reactions include anemia, visual disturbances, hypertension, cardiac failure, and serious events like gastrointestinal bleeding and perforation, as well as severe skin reactions such as Stevens-Johnson syndrome and Toxic Epidermal Necrolysis.

Safety-Related Constraints and Patterns

Official labeling defines specific constraints and time-related patterns regarding the drug's use:

  • Dose and Duration: The risk of cardiovascular thrombotic events is officially noted to increase with higher doses and longer duration of exposure.
  • Special Populations: Older adults are specified as having an increased frequency of adverse reactions, particularly severe gastrointestinal effects. The medicine is generally contraindicated in individuals with severe heart failure or active gastrointestinal bleeding/ulceration.

Overdose and Emergency Response

Overdose and When to Seek Help

Kafenac (Aceclofenac) overdose requires immediate medical attention. All individuals who suspect an overdose must contact emergency medical services promptly.

Documented Manifestations and Severe Outcomes

Official regulatory sources document that overdose may present with signs related to the gastrointestinal system and the Central Nervous System (CNS). Documented manifestations include nausea, vomiting, epigastric pain, abdominal pain, and potentially gastrointestinal haemorrhage. CNS effects may include headache, dizziness, drowsiness, tremor, and, in cases of massive overdosage, convulsions.

Severe poisoning carries the official risk of life-threatening outcomes, including acute renal failure, liver damage, and coma. Continuous hospital monitoring may be required, particularly for observation of gastrointestinal complications.

Required Emergency Actions

No specific antidote is known for Aceclofenac overdose. Therefore, the management strategy is defined as symptomatic and supportive treatment. Procedural steps officially documented may include gastric lavage or administration of activated charcoal if the ingestion occurred within approximately one hour.

The regulatory information notes that the severity of overdose may be increased in patients who have pre-existing renal impairment, hepatic impairment, or who are elderly.

Therapeutic Uses of Kafenac

Main Uses and Benefits of Kafenac

Kafenac contains nepafenac, a non-steroidal anti-inflammatory drug (NSAID) specifically formulated as an ophthalmic prodrug. It is primarily used to manage inflammation and pain associated with eye surgery.

Prevention and Treatment of Postoperative Inflammation

The primary application of Kafenac is the prevention and treatment of pain and inflammation following cataract surgery. When applied to the eye, the medication penetrates the cornea and is converted by ocular tissues into amfenac, an active metabolite that inhibits the production of prostaglandins. Prostaglandins are naturally occurring substances in the body that mediate the inflammatory response, causing redness, swelling, and discomfort.

Reduction of Macular Edema Risk

In certain patient populations, particularly those with diabetes, there is an increased risk of developing cystoid macular edema (swelling of the central part of the retina) after cataract surgery. Kafenac is indicated to reduce the risk of this complication, helping to maintain visual acuity during the postoperative recovery period.

Key Benefits

  • Targeted Action: The prodrug formulation allows for effective penetration into the anterior and posterior segments of the eye.
  • Management of Ocular Pain: It effectively reduces the physical discomfort and Foreign Body Sensation often experienced by patients immediately following surgical procedures.
  • Control of Inflammation: By suppressing inflammatory mediators, the medication helps the eye recover its normal function and appearance more efficiently.

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Kafenac

The eligibility for Kafenac (Aceclofenac) is strictly defined by regulatory documents, primarily restricting its use based on pre-existing health conditions and age.

Category Official Regulatory Statement
Populations for whom use is allowed Adults without any of the absolute contraindications listed below.
Populations for whom use is not recommended Children and adolescents under 18 years of age due to insufficient clinical data.
Women who are pregnant (first or second trimester) or are breastfeeding
Populations for whom use is contraindicated Patients with known hypersensitivity to the drug or other NSAIDs/Aspirin.
Patients with active or recurrent gastrointestinal bleeding/ulcers, severe heart failure (NYHA II-IV), or severe hepatic/renal failure.

Age-Related Eligibility Rules

The medicine is not recommended for use in children under 18. Use in older adults is permitted but requires caution due to a higher risk of adverse reactions, particularly GI bleeding.

Condition-Specific Eligibility Rules

Conditions leading to absolute prohibition include severe organ failure, established ischaemic heart disease, and certain cerebrovascular diseases. Patients with mild to moderate hepatic or renal impairment may be eligible but require close medical surveillance.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory documents for Kafenac (Aceclofenac) detail specific interactions, primarily involving pharmacokinetic clearance modifications and pharmacodynamic risk reinforcement.

Interaction Classifications

Contraindicated Combinations: Co-administration with other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including COX-2 selective inhibitors and high-dose Aspirin, is classified as strictly avoided due to the documented increase in the risk of serious gastrointestinal events.

Pharmacokinetic/Exposure Effects: Kafenac may decrease the renal elimination of certain medicines, resulting in increased plasma concentrations. This is a primary concern for Lithium and Cardiac Glycosides (Digoxin), requiring monitoring if co-administered. For Methotrexate, caution is advised if the two medicines are taken within a 24-hour period, due to the potential for increased Methotrexate exposure.

Pharmacodynamic Risk: An increased risk of bleeding is documented when Kafenac is combined with Anticoagulants, Corticosteroids, Anti-platelet agents, or SSRIs. Additionally, co-administration with Diuretics and Anti-hypertensives may reduce the blood pressure-lowering effect and carries a labeled, enhanced risk of acute renal insufficiency, particularly noted in elderly or volume-depleted patients.

Timing and Food: Kafenac must not be used for 8–12 days following administration of Mifepristone. Food intake affects only the rate, but not the overall extent, of Aceclofenac absorption.

Mechanism of Action

Targeted Modulation of COX-2 and Prostaglandin Signaling

Kafenac (Aceclofenac) operates primarily through the preferential inhibition of the inducible enzyme Cyclooxygenase-2 ( COX-2), which increases its activity in response to inflammatory stimuli. By blocking COX-2, Kafenac modifies the early molecular steps in the Arachidonic Acid Pathway, significantly reducing the cellular production of Prostaglandin E2 ( PGE2) . This mechanism is relevant in systems where PGE2 dominates the physiological response, and its suppression leads to a direct decrease in nociceptive signal transmission and a limitation of local fluid extravasation and vascular permeability.

Non-Prostanoid Modulation of Tissue and Cytokine Activity

Beyond the primary COX cascade, the drug engages secondary mechanisms that regulate structural and chronic inflammatory processes. Kafenac modulates activity within the cartilage metabolic pathway by influencing the synthesis of glycosaminoglycans (GAGs), which influences tissue structural integrity. Simultaneously, it influences the scope of excessive mediator activity by suppressing the expression of key inflammatory cytokines ( IL-1beta, TNFalpha), contributing to alterations within systemic inflammatory pathways.

Dosage and Administration Information

How Kafenac is Used

Kafenac is a medication containing Aceclofenac, administered through the oral route as a 100 mg tablet. Its application follows established usage patterns and dosage guidelines for clinical practice.

Dosage and Administration Principles

The standard adult daily dose is 200 mg total, which is typically administered in a divided regimen of two separate 100 mg tablets per day. This standard dosing establishes the maximum recommended daily intake at 200 mg.

The overarching principle for its administration is to use the lowest effective dose for the shortest duration necessary to achieve the desired outcome.


Key Administration Instructions

Instruction Detail
Timing Relative to Food Taken preferably with or immediately after food.
Tablet Handling Tablets must be swallowed whole with a sufficient quantity of liquid. They must not be crushed or chewed.
Missed Dose If a dose is missed, the standard protocol is to skip the missed dose and resume the regular schedule. A double dose should not be taken.

Population-Specific Use Patterns

Dosage modification is generally not required for older adults. However, for patients with mild hepatic impairment, a reduced initial daily dose of 100 mg is the standard approach. The medicine is not recommended for use in children and adolescents under 18 years of age due to insufficient data.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Kafenac


Evidence for Use in Chronic Inflammatory Joint Conditions

Research examined how Kafenac was studied for use in conditions characterized by symptoms associated with Osteoarthritis (OA) and Rheumatoid Arthritis (RA). These conditions are typically marked by fluctuating or episodic manifestations of pain, swelling, and stiffness. The evidence gathered primarily comes from Randomized Controlled Trials (RCTs) and meta-analyses, which explored Kafenac against an inactive substance (placebo) or against other medicines already used for these conditions. These trials focused on collecting patient-reported outcomes describing perceived discomfort and measuring changes in functional ability over defined time intervals. For OA and RA, the findings describe patterns observed in the studies over follow-up durations that often lasted several weeks to a few months.

Research for Other Musculoskeletal and Acute Pain Relief

Kafenac was studied for use in other conditions marked by functional limitations, such as Ankylosing Spondylitis (AS), and in research exploring short-term symptom changes during acute pain episodes following injuries or procedures. For AS, trials focused on specific measures of spinal mobility and monitored how morning stiffness changed in the studied adult populations. The evidence was evaluated in settings exploring short-term symptom changes in conditions associated with acute or disruptive episodes, such as pain following dental surgery or acute low back pain. Researchers monitored outcomes describing the tracking of symptom evolution and change in pain measurement over periods of just a few days or hours. The data show patterns related to symptom tracking during the phases of heightened symptom activity.

What Is Still Uncertain About Kafenac Research

A major limitation is the short-term duration of most major RCTs, which primarily examined outcomes related to physical discomfort rather than long-term health outcomes. Comparative evidence is lacking for many direct, head-to-head comparisons against the newest classes of anti-inflammatory medicines. Long-term effects are not fully established because the primary efficacy trials were not designed to monitor outcomes over many years. Furthermore, data for certain groups remain insufficient, particularly for vulnerable populations such as children and adolescents. The results apply only to the populations studied, and certainty remains low in areas where long-term or specific population data are sparse.

Key Studies & References

  1. Efficacy and safety of aceclofenac in osteoarthritis: A meta-analysis of randomized controlled trials
  2. Aceclofenac vs paracetamol in the management of symptomatic osteoarthritis of the knee: a double-blind 6-week randomized controlled trial

Frequently Asked Questions (FAQ)

Common questions about Kafenac (FAQ)

Q: Is Kafenac the same as ibuprofen?

A: Kafenac and ibuprofen are both nonsteroidal anti-inflammatory drugs (NSAIDs) used to manage pain and inflammation. However, they contain different active ingredients. Kafenac typically contains diclofenac sodium or a related salt, while ibuprofen is its own distinct chemical compound. The choice between them may depend on a variety of factors related to the specific condition, individual response, and medical history, and should be discussed with a healthcare professional.


Q: Can I take Kafenac for a headache?

A: The official product labeling indicates that Kafenac is approved for treating certain types of pain, which may include some headaches, depending on the specific formulation and regulatory approval. It is important to only use Kafenac as directed by a healthcare provider for the diagnosed condition.


Q: How quickly does Kafenac start working?

A: The onset of action for Kafenac can vary among individuals and depends on the specific formulation (e.g., tablet, gel, or injection). Generally, for oral formulations, some pain relief may be noticeable within 30 minutes to an hour, but this timeline is not guaranteed and can differ widely.


Q: What are the most common side effects?

A: As with all medicines, Kafenac may be associated with side effects. Common ones reported in clinical studies include stomach pain, nausea, diarrhea, constipation, headache, and dizziness. Individuals who experience side effects should speak with their healthcare provider.


Q: Does Kafenac interact with blood pressure medicine?

A: Kafenac, like other NSAIDs, may interact with certain medications, including some used to manage blood pressure (antihypertensives). Using Kafenac with these medicines may potentially reduce the blood pressure-lowering effect or increase the risk of kidney-related side effects. A healthcare provider should be informed of all current medications to assess potential interactions.

How should Kafenac be stored and disposed of?

How to Store and Dispose of Kafenac?

The storage and disposal of Kafenac (Aceclofenac) must adhere strictly to official regulatory requirements to ensure product integrity and safety.

Storage Conditions

Kafenac is required to be stored at controlled room temperature, which is typically defined as not exceeding 30 C, though some labels specify below 25 C. The medicine must be preserved in tight containers and kept in the original packaging to protect it from both light and moisture.

Child Safety and Disposal

It is a mandatory labeling instruction to keep this medicine out of the sight and reach of children. Unused or expired Kafenac must be managed as pharmaceutical waste; disposal should be done in accordance with local requirements and must avoid release to the environment due to the active substance's toxicity to aquatic life.

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

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