Clofenac SR

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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 Clofenac SR

What is Clofenac SR? Defining the Core Medication and Purpose

Property Description
Active ingredient Diclofenac (typically Diclofenac Sodium)
Form Sustained-Release (SR) Tablet
Pharmacological class Non-Steroidal Anti-Inflammatory Drug (NSAID)
Common use Symptomatic relief of pain and inflammation
Origin Synthetic, Phenylacetic acid derivative

Clofenac SR is a specific pharmaceutical product containing the active ingredient Diclofenac, which belongs to the major pharmacological class of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). This classification is clinically recognized for addressing both inflammatory processes and the pain they cause. Diclofenac is a synthetic compound classified chemically as a phenylacetic acid derivative. It serves as an anti-inflammatory and analgesic agent for various conditions. This means the medication helps reduce both the severity of pain and the underlying body reaction that causes swelling, a key benefit when managing conditions requiring sustained comfort.


Sustained-Release Formulation: Identity and Distinction

The designation "SR" in Clofenac SR defines its unique dosage form as a sustained-release (prolonged-release) tablet, designed for oral administration. This is a single-ingredient product where the diclofenac is gradually released over an extended period. This design distinguishes it from conventional, immediate-release tablets, and is particularly suited for individuals needing steady management of persistent symptoms. The sustained-release characteristic ensures more consistent blood plasma levels of the active substance over time. The controlled-release mechanism offers a practical benefit, providing prolonged symptomatic relief and potentially allowing less frequent dosing for the continuous management of chronic pain or inflammation.

What side effects are possible with Clofenac SR?

Clofenac SR: Possible Side Effects and Safety Information

Clofenac SR (an extended-release form of diclofenac) is a nonsteroidal anti-inflammatory drug (NSAID) and carries Boxed Warnings regarding serious risks. Patients should be treated with the lowest effective dose for the shortest duration possible to minimize potential adverse effects.


Serious and Clinically Significant Risks

This medication is associated with an increased risk of serious cardiovascular thrombotic events, including myocardial infarction (heart attack) and stroke, which can be fatal. This risk may increase with the duration of use and higher doses. Clofenac SR is contraindicated for the treatment of pain immediately before or after Coronary Artery Bypass Graft (CABG) surgery, and is generally not recommended in patients with established cardiovascular disease (e.g., heart failure NYHA Class II-IV, ischemic heart disease).

NSAIDs also cause an increased risk of serious gastrointestinal (GI) adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These GI events can occur at any time, often without warning symptoms, and the risk is higher in elderly patients.

Other serious risks include hepatotoxicity (severe liver injury), serious skin reactions (such as Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis), and new onset or worsening hypertension (high blood pressure) or congestive heart failure. Renal toxicity, including acute renal failure, may also occur, necessitating caution in patients with pre-existing kidney or fluid retention issues.


Contraindications and Population Safety

Clofenac SR is contraindicated in individuals with a known hypersensitivity to diclofenac or a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Use during the third trimester of pregnancy (starting at 30 weeks gestation) must be avoided due to the risk of premature closure of the fetal ductus arteriosus.

Commonly reported adverse reactions (occurring in 1% to 10% of patients) may include edema (swelling), headache, dizziness, and nausea. Patients should be monitored for signs of fluid retention, elevated blood pressure, and liver enzyme changes throughout the course of therapy.

Overdose and Emergency Response

Clofenac SR Overdose and when to seek help

Overdose Scope

Domain Official Regulatory Statements (Diclofenac SR)
Documented Overdose Presentations Overdose may be asymptomatic or present with symptoms such as nausea, vomiting (sometimes with blood), diarrhea, stomach pain, lethargy, drowsiness, headache, dizziness, tinnitus, and blurred vision.
Physiological Systems Affected (as stated in label) The Gastrointestinal tract, Central Nervous System, Cardiovascular system, and Renal system are affected. Severe outcomes include seizures, coma, and potential acute renal failure.
Dose-related or Exposure-related Factors (if applicable) A large overdose can be very harmful to children and adults.
Population-specific Overdose Notes (if applicable) Elderly patients are at greater risk for serious gastrointestinal adverse events. Those with pre-existing asthma or lung conditions may be at increased risk for respiratory distress.
Emergency-response statements (as written in official documents) Seek emergency medical attention right away. Call the local emergency number (e.g., 911) and contact the Poison Help line or local poison control center immediately.
When immediate medical help is required (label-derived phrasing only) Urgent medical attention is required upon suspicion of an overdose or when life-threatening symptoms such as seizures, coma, significant gastrointestinal bleeding, or acute renal failure are manifested.

Overdose Classifications (High-Level)

Classification Official Regulatory Statement
Severity classification (as defined in official documents) Overdose events range from asymptomatic or self-limiting minor symptoms to severe or life-threatening outcomes.
Regulatory basis (EMA / FDA / etc.) Information is based on government-authorized prescribing information, including FDA, EMA, and NIH documents.
Overdose-context constraints (as defined in official documents) No specific antidote is documented for Diclofenac overdose. Management is limited to symptomatic and supportive treatment.

Resulting Overdose Structure

Official overdose statements:

  • In cases of suspected overdose, immediate contact with emergency medical services or a poison control center is mandated.
  • Documented overdose presentations include epigastric pain, nausea, vomiting, drowsiness, dizziness, and tinnitus.
  • Management procedures described in regulatory labeling include considering gastric decontamination, administering activated charcoal, and providing symptomatic and supportive care.
  • Severe outcomes listed include coma, seizures, Gastrointestinal bleeding/perforation, and the potential for acute renal damage.

Connection to the overall overdose profile (2–4 sentences): Regulatory documents explicitly define the overdose profile by listing the spectrum of documented clinical manifestations, ranging from minor symptoms to severe neurological or gastrointestinal complications. This leads directly to the core requirement that individuals seek immediate medical attention and contact a poison control center upon suspicion of an overdose, thereby ensuring timely initiation of the officially described supportive and symptomatic management procedures.

Therapeutic Uses of Clofenac SR

What Clofenac SR Treats: Main Uses and Benefits

The extended-release form of this medication is used for symptomatic relief in conditions characterized by periods of heightened symptoms, such as rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis. The sustained-release characteristic is applied across domains where additional symptomatic support is needed to address the symptom clusters of persistent pain, stiffness, and joint swelling. This supports the patient during difficult episodes by easing distress and assisting with maintaining functional stability over time.

The medication is relevant in situations involving symptoms related to inflammatory or irritative states, supporting the patient during difficult episodes by easing distress.

The medication is also used for easing the heightened pain and inflammation that occur in acute clinical scenarios, such as localized soft tissue injuries (strains, sprains), post-traumatic inflammation, and intense, sudden episodes like acute gouty arthritis. It is applied in situations involving recurrent or episodic manifestations to help manage symptom intensity, such as the cramping associated with primary dysmenorrhoea. This use contributes to easing the overall symptom load during phases where acute or recurrent manifestations might otherwise create noticeable physiological strain.

Quick Fact: Relief for Persistent Discomfort

Clofenac SR's sustained action supports continuous symptomatic relief, helping to manage symptoms that interfere with daily functioning and require steady, long-term support.

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Clofenac SR

Official regulatory documents define strict eligibility criteria and contraindications for the use of Clofenac SR (Diclofenac Sustained-Release).

Category Official Regulatory Statement
Populations for whom use is allowed Adults are the primary population for established use, generally for conditions like osteoarthritis and rheumatoid arthritis.
Populations for whom use is contraindicated Patients with known hypersensitivity to diclofenac, aspirin, or any NSAID. The drug is prohibited for pain management after coronary artery bypass graft (CABG) surgery.
Conditions in which use is prohibited Active gastrointestinal (GI) bleeding, ulceration, or perforation. Use is also contraindicated in severe uncontrolled heart failure and severe hepatic or renal failure.
Age-related eligibility rules The sustained-release form is not generally recommended for children or adolescents (typically under 18), as safety and efficacy have not been established for this age group. Older adults require particular caution due to increased susceptibility to risks.
Pregnancy and lactation eligibility status Contraindicated during the third trimester of pregnancy (after 30 weeks' gestation). Use between 20 and 30 weeks is restricted. The drug is not recommended while breastfeeding as it passes into breast milk.
Eligibility-related restrictions Patients with significant cardiovascular risk factors (e.g., hypertension) or a history of GI toxicity should be treated only after careful consideration. Use should also be reviewed for women attempting conception.

Official eligibility statements strictly define prohibitions based on severe pre-existing disease and allergic history. The sustained-release formulation is limited to patients where risks related to these severe conditions and sensitivities are absent.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile for Clofenac SR is structured around documented risks involving pharmacodynamic toxicity reinforcement and pharmacokinetic exposure modification, as outlined in regulatory documents.

Formal Restrictions and Contraindications

Co-administration with other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), such as aspirin, is formally contraindicated due to the documented significantly increased risk of serious gastrointestinal (GI) adverse events and bleeding. The medication is also restricted for treating perioperative pain following Coronary Artery Bypass Graft (CABG) surgery.

Clinically Significant Pharmacodynamic Risks

Combinations with agents that affect clotting, such as Anticoagulants, Antiplatelets, Oral Corticosteroids, or SSRIs/SNRIs, are documented to result in a synergistic risk of serious bleeding. Further, co-administration with Diuretics or Antihypertensives (ACE Inhibitors/ARBs) is noted to diminish the therapeutic effect of these agents while increasing the risk of renal toxicity. Immunosuppressants such as Cyclosporine also increase the risk of nephrotoxicity.

Exposure Modification and Substance Interactions

The strong inhibitor Voriconazole is documented to cause a significant increase in Diclofenac plasma concentration (AUC and Cmax). Conversely, Diclofenac can increase the plasma levels and associated toxicity risk of drugs like Methotrexate and Lithium. Furthermore, regulatory warnings state that alcohol consumption significantly enhances the risk of serious GI bleeding. The interaction profile also notes that patients with Alcoholic Cirrhosis show substantially higher systemic exposure to Diclofenac.

Mechanism of Action

Enzyme Inhibition: Prostaglandin Synthesis Blockade

The primary mechanism involves the non-selective competitive inhibition of Cyclooxygenase (COX) enzymes. By blocking the active site, the drug prevents the conversion of arachidonic acid into prostaglandins ( PGs) at both peripheral and central sites. This targets the core biochemical production of mediators involved in the signaling of inflammation and fever. This mechanism results in reduced vascular permeability and decreased sensitization of nociceptors.

️ Non-COX Modulation of Neural Signaling

A secondary domain focuses on the direct interaction with certain voltage-gated ion channels on peripheral nerve cells, independent of prostaglandin synthesis. This modulation influences the nerve membrane's electrical activity, reducing the capacity of sensory neurons to transmit nociceptive signals. This mechanism results in an altered profile of nociceptive modulation that acts in addition to the COX-inhibition pathway.

️ Central COX Inhibition and Thermoregulation

Within the central nervous system, particularly the hypothalamus, COX inhibition reduces the PGE2 that dictates the body's temperature set-point, resulting in the modulation of the thermal set-point. This central action also modulates nociceptive signal throughput at the spinal level.

Dosage and Administration Information

How to use Clofenac SR: Administration Guidelines

Clofenac SR (Diclofenac Sustained-Release) is administered under specific instructions that govern its use. The prolonged-release characteristic dictates the pattern of usage, focusing on consistent dosing over time for the conditions such as osteoarthritis and rheumatoid arthritis.


Administration Protocol

The approved route of administration is oral. The primary dosing schedule for adults is once daily, typically at a dose of 100 mg. Treatment adheres to the fundamental clinical principle of utilizing the lowest effective dose for the shortest duration possible.

Feature Official Labeled Instruction
Route of Administration Oral only.
Dosing Frequency Once daily.
Adult Dose Range Typically 100 mg once daily (absolute maximum daily dose of all forms is 150 mg).
Administration Timing Preferably taken with or immediately after food.
Tablet Integrity Must be swallowed whole with liquid; do not crush, break, or chew.

Procedural and Population Rules

To maintain the sustained-release mechanism, the tablet integrity is mandatory, meaning it must be swallowed whole and must not be divided. For older adults or frail patients, guidelines require the use of the lowest effective dosage for the shortest time. This formulation is not suitable for the pediatric population.

Use Pattern over Time

While the drug is suitable for the long-term management of chronic conditions, the need for continued symptomatic treatment must be re-evaluated periodically as part of the established protocol, ensuring the treatment continues to align with safety directives.

Recent Clinical Evidence

Clofenac SR: Recent Clinical Evidence

Clofenac is a nonsteroidal anti-inflammatory drug (NSAID) whose sustained-release (SR) formulation is researched for its potential in managing chronic pain and inflammatory conditions. The SR formulation is designed to provide a slower release of the active compound compared to immediate-release versions.

Clinical Efficacy and Indications

Research evidence suggests that Clofenac SR may be beneficial in the treatment of chronic conditions such as osteoarthritis (OA) and rheumatoid arthritis (RA). Randomized controlled trials involving patients with OA have indicated that the drug can contribute to pain management and may result in observed improvements in physical function and joint stiffness over a 4-to-12-week treatment period. Similar findings have been reported for patients with RA, where the medication has been associated with a reduction in inflammation markers and reported pain intensity.

Extended Use and Tolerability

Studies focused on the extended use of Clofenac SR suggest that its therapeutic effects are generally maintained in individuals with chronic pain. When compared with certain other analgesic treatments in some trials, Clofenac SR was found to achieve comparable outcomes in pain control.

Regarding patient experience, certain large-scale studies have reported that Clofenac SR was generally well tolerated by the majority of trial participants. As with all NSAIDs, the potential for gastrointestinal and cardiovascular considerations is an important area of ongoing research, and evidence related to these specific risk profiles continues to be evaluated by researchers.

Frequently Asked Questions (FAQ)

Common questions about Clofenac SR (FAQ)


Q: How quickly does Clofenac SR start providing relief after the first dose?

This medication is designed as a sustained-release (SR) tablet, which means the active ingredient is released slowly over time. According to official product information, the time to reach its maximum concentration in the blood is typically around 2 hours after being taken orally. This sustained-release characteristic is designed to help maintain consistent levels of the active substance over an extended period.


Q: Does Clofenac SR affect blood pressure?

Official regulatory information states that Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), the class this medicine belongs to, have been associated with effects on blood pressure. These effects can include the onset of new high blood pressure (hypertension) or the worsening of high blood pressure that a person already has. Regulatory warnings mention that monitoring for signs of fluid retention and blood pressure changes is part of the established protocol.


Q: What are the official recommendations for Clofenac SR use in people with liver issues?

Use of this medicine is strictly contraindicted in patients who have severe hepatic (liver) failure. For other patients, official warnings advise that liver function should be monitored, especially during long-term therapy. In the event that abnormal liver function tests persist or worsen, official safety protocol outlines that the medication may be discontinued.


Q: Is Clofenac SR known to interact with common antidepressants?

Official drug interaction profiles note that the co-administration of this medication with certain antidepressants, specifically Selective Serotonin Reuptake Inhibitors (SSRIs), may lead to an increased risk of bleeding. This is because both types of medicines can affect the body’s ability to clot. Official documentation describes this interaction as a key consideration for healthcare providers when reviewing treatment plans.


Q: What does the term 'serious adverse event' mean for this medication?

Regulatory guidance defines a 'serious adverse event' based on the resulting patient outcome. For any medicine, a reaction is considered serious if it results in death, is life-threatening, requires or prolongs hospitalization, or results in disability or permanent damage. The official safety information for this drug includes boxed warnings detailing some of these serious risks.


Q: What is the longest period of time a person is expected to take this medicine?

Regulatory documents do not set a specific maximum duration of use for this medication. However, official warnings consistently emphasize that to minimize potential risks, the lowest effective dose should always be used for the shortest duration possible. Official documents require that the need for continued treatment for chronic conditions be re-evaluated periodically as part of the established protocol.


Q: Does Clofenac SR have a risk of dependence or addiction?

This medication is classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID). This class of medicine is generally not associated with the risk of dependence or addiction, unlike substances such as opioids. The safety monitoring protocols described in official documentation do not list risks related to physical dependence or addiction.


Q: How does the SR formulation change the schedule compared to immediate-release versions?

The sustained-release (SR) designation means the tablet is formulated to release the active drug slowly over many hours. This design allows the drug to be used for once-daily dosing. In contrast, standard immediate-release versions of the same active ingredient typically require being taken multiple times throughout the day.


Q: Does Clofenac SR affect a person's ability to drive or operate machinery?

Official product documents advise patients to use caution when performing skilled tasks. This is because adverse reactions such as dizziness, drowsiness, vertigo, or other central nervous system effects are reported. The official documents advise that if these effects occur, activities requiring mental alertness, such as driving or operating machinery, should be avoided.


Q: What are the official recommendations about Clofenac SR use in the elderly population?

Official recommendations state that older adults require particular caution, as they may be more susceptible to adverse reactions, especially serious gastrointestinal events. Regulatory guidelines specify that treatment protocols for elderly patients emphasize using the lowest effective dose for the shortest duration possible, particularly for frail individuals.


Q: Is there a higher risk of side effects if Clofenac SR is taken at the maximum dose?

Regulatory warnings consistently indicate that the risk of serious adverse events, including cardiovascular thrombotic events (like heart attack or stroke) and gastrointestinal complications, may increase with higher doses of the medication. This statement aligns with the general regulatory principle of using the lowest effective dose for the shortest possible duration to minimize risk.


Q: Does taking Clofenac SR for a long time affect fertility?

Official information states that the use of this medicine may impair female fertility due to its effect on ovulation. Official documents note that the medicine is generally not recommended for women attempting conception.


Q: Is there an increased risk of bleeding while taking Clofenac SR?

Yes, regulatory safety warnings are in place regarding the potential for bleeding. The medication is associated with an increased risk of serious gastrointestinal adverse events, including bleeding and perforation. Furthermore, taking it concurrently with anti-clotting agents can increase the overall risk of bleeding complications.


Q: Why is the drug sometimes prescribed for post-operative pain?

The drug is officially indicated for the symptomatic relief of pain and inflammation. While the medicine is explicitly contraindicated for pain following coronary artery bypass graft (CABG) surgery, its properties as an anti-inflammatory agent and official indications may align with the symptomatic management of certain other post-operative conditions.


Q: Is it common for people to gain or lose weight while taking Clofenac SR?

Official adverse reaction listings for this medication include weight changes as a reported event. Official documents note that edema (swelling/fluid retention) is a commonly reported adverse reaction. This reaction can sometimes be a factor in unexplained weight changes.


Q: What are the official recommendations for Clofenac SR use in people with kidney issues?

The medication is contraindicated in patients with severe renal (kidney) failure. For patients with existing kidney issues that are not severe, official warnings advise that caution is needed, and monitoring of renal function is required during prolonged treatment.

How should Clofenac SR be stored and disposed of?

Official Storage and Handling Requirements

Clofenac SR (diclofenac sodium extended-release) must be stored strictly according to regulatory guidelines to ensure product stability. The required storage environment is Controlled Room Temperature (CRT), defined as 20°C to 25°C (68°F to 77°F). Storage temperatures must not exceed 25 C, though short excursions between 15 C and 30 C are permitted.

Storage Constraint Requirement
Temperature mathbf20 C to mathbf25 C (CRT)
Container Keep in original container, tightly sealed
Child Safety Keep out of the sight and reach of children

Disposal Instructions

Disposal must adhere to specific environmental and pharmaceutical waste regulations. Unused or expired Clofenac SR should be disposed of to an approved waste disposal plant or according to local requirements. The product must not be allowed to enter sewers, surface water, or ground water, and release to the environment must be avoided.

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

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