Clofenac

Quick links to important sections

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 Clofenac

Quick Facts

Property Description
Active ingredient Diclofenac (Sodium or Potassium salt)
Common Forms Tablets, Capsules, Gels, Injectable Solutions
Pharmacological Class Nonsteroidal Anti-inflammatory Drug (NSAID)
General Purpose Relief of Pain, Inflammation, and Fever
Origin Synthetic Compound

What Type of Medicine is Clofenac (Diclofenac)?

Clofenac is a trade name for a medication whose core component is the active ingredient Diclofenac, which is globally classified as a Nonsteroidal Anti-inflammatory Drug (NSAID). As an NSAID, the drug is designed to reduce inflammation, providing a distinction from simple analgesic medications. The Diclofenac compound is a synthetic chemical entity derived from phenylacetic acid, positioning it within a group of agents that all share a similar, targeted biological action against swelling and discomfort. Unlike less selective NSAIDs, Diclofenac is recognized for its relatively potent anti-inflammatory action, making it relevant for managing symptoms related to musculoskeletal discomfort.

Compositional Identity: Forms and Origin of the Active Ingredient

The medication is a single-active-ingredient product, leveraging Diclofenac which is utilized in pharmaceutical preparations primarily as a mineral salt, such as Diclofenac sodium or Diclofenac potassium, to improve its stability and systemic absorption. The physical form of the preparation dictates its intended route of administration, as Diclofenac is formulated into a range of dosage forms, including traditional oral solid forms like tablets and capsules, as well as specialized applications like topical gels, suppositories, and injectable solutions. The availability across these diverse forms allows the medication to be specifically targeted, such as providing localized action via a topical gel, or systemic relief via an oral tablet.

Primary Purpose and High-Level Action

The overall general purpose of Clofenac is to provide simultaneous relief from both pain and the physical signs of inflammation, including swelling and redness. The therapeutic effects of Diclofenac are achieved through its ability to inhibit the chemical pathways of inflammation. This mechanism ensures the drug acts to suppress the bodily processes that lead to swelling and discomfort. By moderating the body's response at this point, the drug provides a combined analgesic, anti-inflammatory, and antipyretic (fever-reducing) benefit, establishing its role in scenarios requiring symptom management.

Regulatory References

  1. MedlinePlus
  2. National Institutes of Health (NIH)
  3. NIH Review

What side effects are possible with Clofenac?

Possible Side Effects and Safety Information

The safety profile of Clofenac, as documented in official regulatory sources, includes a range of potential adverse reactions, some of which are serious and clinically significant. Regulatory bodies often highlight risks associated with the cardiovascular and gastrointestinal systems.

Serious Adverse Event Warnings

Official safety information contains warnings regarding an increased risk of serious, potentially fatal cardiovascular thrombotic events (such as myocardial infarction or stroke), particularly with high doses and long-term use. Warnings also exist for serious, life-threatening gastrointestinal events, including bleeding, ulceration, and perforation of the stomach or intestines, which may occur without warning symptoms.

Common and Uncommon Adverse Reactions

Adverse reactions are officially classified by frequency. Common reactions (occurring in 1 to 10 out of 100 people) include headache, dizziness, nausea, vomiting, dyspepsia, abdominal pain, flatulence, anorexia, and elevations in liver transaminase levels. Uncommon reactions include somnolence and fatigue. Additionally, risks of hepatotoxicity (liver damage) and renal toxicity (kidney problems) are documented.

Safety Restrictions and Contraindications

Regulatory documents specify conditions under which this medicine should not be used (contraindications). These include established congestive heart failure (NYHA Class II-IV), ischaemic heart disease, peripheral arterial disease, cerebrovascular disease, and the setting of coronary artery bypass graft (CABG) surgery. Use is also contraindicated during the third trimester of pregnancy due to the risk of fetal harm. Official guidelines emphasize that the lowest effective dose should be used for the shortest possible duration to minimize the potential for serious adverse events.

Overdose and Emergency Response

Overdose and When to Seek Help — Official Regulatory Information for Clofenac

Official regulatory documents emphasize that while minor symptoms may occur, a suspected overdose of Clofenac (Diclofenac) requires immediate action.

When to Seek Urgent Medical Help (Mandatory Action)

Seek emergency medical help right away if overdose is suspected or if severe manifestations occur, such as:

  • Signs of internal bleeding: bloody, black, or tarry stools (melaena), or vomiting a substance that looks like coffee grounds.
  • Severe respiratory depression (trouble breathing), coma, or convulsions (seizures).
  • Chest pain or sudden weakness on one side of the body.

Documented Overdose Manifestations

The following are regulatory-documented signs and symptoms of overdose, reflecting impacts on the central nervous system (CNS), gastrointestinal (GI), and renal systems:

System Documented Manifestations
Common Nausea, vomiting, epigastric pain, headache, drowsiness, lethargy, tinnitus (ringing in the ears).
Severe Gastrointestinal haemorrhage, acute renal failure, hypertension (or hypotension).

Official Management and Antidote Status

  • No specific antidote is documented as known for Diclofenac (NSAID) toxicity.
  • Management is strictly symptomatic and supportive, focusing on treating complications like low blood pressure, renal failure, and respiratory issues.
  • Decontamination procedures, such as gastric lavage or administering activated charcoal, may be considered by medical professionals if the overdose occurred within a few hours of presentation.
  • Elderly patients are noted to be at greater risk for serious gastrointestinal consequences following NSAID toxicity.

Therapeutic Uses of Clofenac

What Clofenac Treats: Main Uses and Benefits

The primary therapeutic benefit of Clofenac (Diclofenac) may be part of symptomatic management across conditions marked by both pain and inflammation, supporting general well-being during symptomatic phases and assisting with maintaining functional stability. The medication is relevant in clinical settings requiring short-term symptomatic assistance when discomfort becomes more noticeable or overwhelming.

Clofenac is commonly used across conditions characterized by episodic or fluctuating symptom patterns. It is generally applied in addressing symptoms related to chronic inflammatory disorders, such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. It is also relevant in acute therapeutic contexts involving traumatic injuries like sprains or strains, post-operative discomfort, and for managing intense recurring pain, including acute migraine attacks and primary dysmenorrhea. The supportive relief provided may help patients cope more steadily with symptom fluctuations.


Quick Fact: Relief for Symptomatic Discomfort

Category Symptom Management Contexts
Symptom Axes Symptoms related to physical discomfort and inflammatory states
Condition Frames Conditions involving episodic or fluctuating manifestations
Patient Benefit Supports comfort; assists with functional stability

Eligibility and Restrictions for Use

Eligibility Scope

Populations for whom use is allowed (as stated in label): Adults without any documented contraindications, severe organ impairment, or critical cardiovascular conditions listed in the product labeling.

Populations for whom use is contraindicated:

  • Patients with known hypersensitivity to diclofenac or a history of allergic reactions (e.g., asthma, urticaria) after taking aspirin or other NSAIDs.
  • Individuals with active gastrointestinal ulceration, bleeding, or perforation, or a history of recurrent peptic ulcer disease.
  • Patients with severe hepatic failure or severe renal failure (advanced renal disease).
  • Use is prohibited in the setting of Coronary Artery Bypass Graft (CABG) surgery and during the third trimester of pregnancy (30 weeks gestation and later).
  • Patients with established congestive heart failure (NYHA Class II–IV) or established ischemic heart disease.

Age-related eligibility rules: Systemic use is not established or not recommended for most pediatric patients. Older adults (typically 65 years) require caution and monitoring due to increased risk of cardiovascular and gastrointestinal events.

Pregnancy and lactation eligibility status (if explicitly documented): Use is contraindicated in the third trimester of pregnancy and is not recommended during breastfeeding. Use during the first and second trimesters is also not generally recommended.

Eligibility Classifications (High-Level)

Eligibility severity classification (as defined in official documents): Contraindicated (absolute prohibition), Not Recommended/Caution Required (restricted or conditional use), and Use Not Established (insufficient data, primarily pediatric).

Connection to the overall eligibility profile: Regulatory documents define eligibility by establishing formal contraindications based on critical systemic risks (GI, CV, renal/hepatic) and mandatory exclusions for certain physiological states (late-stage pregnancy, post-CABG surgery). Only populations outside these prohibited or restricted categories are officially eligible for systemic use.

What should I know about interactions with other medicines?

The official regulatory profile for Clofenac details pharmacokinetic, pharmacodynamic, and administrative constraints. The medication is formally contraindicated for the treatment of perioperative pain following coronary artery bypass graft (CABG) surgery and must be avoided with other systemic NSAIDs or COX-2 inhibitors due to additive risks.

Interaction Category Documented Outcome
Pharmacodynamic Risk Increased risk of gastrointestinal bleeding when co-administered with Anticoagulants (e.g., Warfarin), Anti-platelet Agents, or SSRIs.
Pharmacokinetic Exposure Co-administration with the CYP2C9 inhibitor Voriconazole significantly increases Diclofenac plasma exposure, raising C max by 114% and AUC by 78%.
Antihypertensive Efficacy May diminish the antihypertensive or diuretic effects of drugs like ACE Inhibitors and ARBs, increasing the risk of renal injury.

Regulatory Restrictions and Conditions:

The serum concentration and half-life of Digoxin may be increased when used concomitantly. The official label restricts co-administration with Alcohol or the herbal product Ginkgo Biloba due to an increased risk of bleeding or serious gastrointestinal events. Additionally, the Diclofenac oral solution requires administration on an empty stomach to prevent a documented reduction in effectiveness due to food. Elderly patients are documented to be at a greater risk for serious gastrointestinal events when interacting substances are co-administered.

Mechanism of Action

Dual Mechanism of Inflammation and Pain Control

The primary mechanism involves the competitive inhibition of the Cyclooxygenase (COX) enzymes, particularly the inducible COX-2 enzyme, which significantly reduces the synthesis of pro-inflammatory Prostaglandin E2 ( PGE2). This action interrupts the Arachidonic Acid Cascade, suppressing the production of biochemical mediators of inflammation. The antinociceptive mechanism is complemented by a non-COX mechanism involving the activation of ATP-sensitive potassium channels in peripheral tissue, which modulates the excitability of pain-sensing neurons.

Central Modulation of Fever

The mechanism that leads to antipyresis occurs centrally within the hypothalamus of the brain. During a febrile state, PGE2 acts on the hypothalamus to elevate the body's core temperature set point. By inhibiting PGE2 production in this region, the drug prevents the signal that causes temperature elevation, allowing the body's internal thermoregulatory system to reset the elevated core temperature set point.

Dosage and Administration Information

Administration Routes and Dosage Principles

Clofenac (Diclofenac) is administered via multiple routes, including oral (tablets, capsules, powder), topical (gel, solution), rectal (suppository), and parenteral (intramuscular and intravenous injections). Systemic adult dosing generally ranges from 100 mg to 200 mg total daily dose. This quantity is distributed into divided doses (e.g., two to four times daily) for immediate-release formulations or administered once daily for extended-release tablets.

Administration Conditions and Duration

Oral preparations are typically consumed on an empty stomach; specifically, delayed-release and enteric-coated forms are preferred to be taken before meals to ensure proper systemic availability. To maintain the drug's intended action, formulations such as extended-release tablets must be swallowed whole and not crushed, chewed, or split. Intravenous forms require immediate dilution with specific buffered solutions prior to administration.

Standard practice involves the use of the lowest effective dosage for the shortest duration necessary. Specific limitations exist for certain uses; for instance, intramuscular injection is generally restricted to a maximum course of two days. The use of the lowest effective dose is a standard consideration when treating older adults. If a dose is missed, it is recommended to take the next dose at the regularly scheduled time, rather than taking a double dose.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Clofenac

Clofenac (Diclofenac) was studied for managing symptoms across a range of conditions characterized by fluctuating or episodic manifestations. The available research explored how patients reported their experience during clinical evaluations, but research does not determine whether an individual will respond similarly.


Evidence for Use in Chronic Inflammatory Conditions

Research exploring how symptoms change over time in chronic conditions like osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis primarily involved numerous Randomized Controlled Trials (RCTs) relevant in studies examining the use of Clofenac for managing symptoms. These trials were applied in studies examining patient-reported experiences related to outcomes linked to inflammatory or irritative states. Studies monitored outcomes reflecting daily functioning or activity level, such as pain intensity scores and measures of physical mobility. The study populations were mainly adults with confirmed diagnoses, with some attention given to older adults in separate research.

Comparative Evidence Against Placebo and Other Treatments

Studies conducted during periods of increased symptom activity were evaluated in comparative studies against inactive treatments (placebo) or other standard anti-inflammatory medications in chronic disease trials. Research explored how patients reported their experience in these comparative scenarios.


Evidence for Use in Acute Pain Syndromes

Clofenac was also evaluated in research relevant in trials assessing short-term or episodic symptom patterns, such as acute migraine attacks and primary dysmenorrhea (menstrual pain). This research involved short-term, placebo-controlled RCTs focusing on episodes characterized by noticeable symptom changes. Study outcomes examined were time-sensitive, including measures of changes in symptom duration and intensity. The focus of this research is primarily on short-term symptom changes.


Long-Term Data and Follow-up in Clinical Studies

The majority of definitive efficacy research has follow-up durations that were limited, typically ranging from a few weeks up to 12 weeks. While some observational settings evaluating daily-life functioning extend over longer periods, the long-term outcomes are not fully established by the primary controlled trials.

Evidence in Special Populations

Research monitored adults, including older adults, in studies exploring symptom patterns within these specific groups. However, data for certain groups remain insufficient, particularly for pediatric populations. Additionally, the results apply only to the populations studied, and research is limited for patients with certain specific co-existing medical conditions.

What is Still Uncertain About the Research Evidence

Despite the existence of large trials and reviews, long-term outcomes are not fully established by the primary controlled research. Furthermore, comparative evidence is lacking for certain scenarios, and evidence quality varies across studies when analyzing specific sub-measures, such as joint stiffness.

Key Studies & References

  1. National Institute for Health and Care Excellence (NICE) Guideline: Osteoarthritis: care and management (Guideline context for NSAID use)

Frequently Asked Questions (FAQ)

Common questions about Clofenac (FAQ)

Q: What is Clofenac and how does it work?

Clofenac is a type of non-steroidal anti-inflammatory drug (NSAID). It works by blocking certain natural substances in the body that contribute to inflammation, pain, and fever.


Q: What is Clofenac used to treat?

Clofenac is prescribed to treat mild to moderate pain, signs, and symptoms of certain inflammatory conditions, such as:

  • Osteoarthritis (a type of arthritis that affects joints)
  • Rheumatoid arthritis (a chronic inflammatory disorder)
  • Ankylosing Spondylitis (a type of arthritis that affects the spine)
  • Menstrual cramps (period pain)
  • Other forms of inflammation and pain caused by injuries or surgery

Q: What are the potential side effects of Clofenac?

Like all medicines, Clofenac can cause side effects. Common side effects often include:

  • Stomach pain, indigestion, or upset stomach
  • Nausea and vomiting
  • Constipation or diarrhea
  • Headache, dizziness, or drowsiness

Serious side effects can include an increased risk of serious cardiovascular events (like heart attack or stroke), and serious gastrointestinal issues (like stomach or intestinal bleeding/ulcers). You should seek immediate medical attention if you experience severe chest pain, sudden weakness, shortness of breath, or vomit that looks like coffee grounds.


Q: Can I take Clofenac with other medications?

Clofenac can interact with many other medications, which can increase the risk of serious side effects. It's especially important to inform your doctor or pharmacist if you are taking:

  • Other NSAIDs or aspirin
  • Blood thinners (anticoagulants), such as warfarin
  • Medications for high blood pressure (e.g., ACE inhibitors, diuretics)
  • Certain medications for depression or mood disorders

Always provide your healthcare professional with a complete list of all prescriptions, over-the-counter medicines, and herbal supplements you are taking.


Q: Who should avoid taking Clofenac?

Clofenac is generally not recommended for individuals with:

  • A history of allergic reaction to Clofenac, aspirin, or other NSAIDs
  • Active or recent stomach or intestinal bleeding/ulcers
  • Recent heart attack or those undergoing a coronary artery bypass graft (CABG) surgery
  • Established heart failure, certain types of heart disease, or cerebrovascular disease
  • Severe kidney or liver disease

It should be used with caution in older adults and individuals with risk factors for heart disease (e.g., high blood pressure, high cholesterol, diabetes, or smoking).

How should Clofenac be stored and disposed of?

How to Store and Dispose of Clofenac (Diclofenac)

The storage and disposal of Diclofenac must strictly follow the conditions defined in official regulatory labeling to ensure product stability and safety.

Storage Requirements

Requirement Official Condition
Temperature Store at controlled room temperature, typically 20 C to 25 C (68 F to 77 F), with limited excursions permitted.
Protection Must be kept in the original container, tightly closed, and protected from light, moisture, and excessive heat.
Handling Note Do not allow topical solutions or patches to freeze.
Safety Keep the medicine out of the reach and sight of children.

Disposal

Unused or expired Diclofenac must be managed as pharmaceutical waste. Official instructions require disposal according to local regulations and explicitly state that the product should not be disposed of via household trash or wastewater due to the potential risk to the aquatic environment.

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

Available in countries:

Equivalent of Clofenac found in:

A-Z Index: