Acelor

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Acelor

Property Description
Active Ingredient Aceclofenac
Form Oral Tablet or Capsule
Pharmacological Class Non-Steroidal Anti-Inflammatory Drug (NSAID)
Common Purpose Reducing general pain and inflammation
Origin Synthetic (Chemically manufactured)

Acelor is a widely recognized trade name for a synthetic medicine whose primary component is the active ingredient aceclofenac, a substance used for its ability to manage pain and inflammation. Aceclofenac is classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID).


What Type of Medicine is Acelor?

Acelor is classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID) whose key function is to calm the body's inflammatory response.

NSAIDs are a major class of pain relief medicine that are chemically manufactured, making Acelor a synthetic drug derived from a phenylacetic acid compound. Aceclofenac, and its related NSAID compounds, effectively inhibit the enzymes needed to create these pain and inflammation signals. This means the medicine helps calm the body's overactive response to injury or irritation, providing relief in situations where swelling is a significant component of the discomfort, such as musculoskeletal aches.


Is Acelor a Single Drug or a Combination?

Acelor is most commonly supplied as an oral tablet or capsule and is often a combination product containing multiple active ingredients.

In many markets, Acelor formulations are designed to be a multi-component medicine. While the foundation is the NSAID aceclofenac, the oral tablet often includes other substances, such as paracetamol (acetaminophen) for fever and additional pain relief, or an enzyme component like serratiopeptidase to assist in the reduction of swelling. This unique combination approach delivers a broad spectrum of relief by acting on pain and inflammation through separate pathways, delivered conveniently via the oral route of administration.

What side effects are possible with Acelor?

Possible Side Effects and Safety Information

The safety profile for Acelor (Aceclofenac) is based on official government regulatory documents, which classify adverse reactions by frequency and the body system affected. All documented side effects and safety constraints are strictly derived from these authoritative sources, with no dosing or usage instructions included.

Frequency-Classified Adverse Reactions

Adverse reactions are classified according to the official regulatory standards (e.g., EMA/ICH frequency bands):

Classification Examples of Documented Reactions
Common (≥ 1/100) Dyspepsia, Abdominal pain, Nausea, Dizziness, Increased hepatic enzymes (ALT/AST).
Uncommon (≥ 1/1,000) Flatulence, Gastritis, Constipation, Rash, Pruritus, Blood urea increased.
Rare (≥ 1/10,000) Hypersensitivity, Anaphylactic reaction (including shock), Gastrointestinal haemorrhage, Angioedema, Visual disturbance.

Clinically Significant Adverse Reactions

Regulatory labeling specifies a risk for rare but serious adverse reactions that affect major body systems, primarily Gastrointestinal, Cardiovascular, and Dermatological:

  • Gastrointestinal: Bleeding, ulceration, or perforation can occur at any time during treatment.
  • Cardiovascular: Risk of Arterial Thrombotic Events, such as myocardial infarction or stroke, which is documented as dose-dependent and increasing with prolonged use.
  • Dermatological: Potential for Severe Mucocutaneous Skin Reactions, including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), which typically occur within the first month of treatment.

Population-Specific Safety Constraints

Official labeling defines specific restrictions for certain groups:

  • Pregnancy and Lactation: Contraindicated during the last trimester of pregnancy.
  • Elderly: This population is at a higher documented risk for severe gastrointestinal adverse events.
  • Organ Impairment: Contraindicated in cases of severe hepatic failure or severe renal failure.
  • General Constraint: Use of the lowest effective dose for the shortest duration necessary to control symptoms is specified in the official safety context.

Overdose and Emergency Response

Overdose and When to Seek Help

An overdose of Acelor (aceclofenac) requires immediate contact with a doctor or nearest hospital emergency department. Official regulatory guidance mandates seeking urgent medical attention when an overdose is suspected, as this situation can lead to severe and potentially life-threatening complications.

Documented Clinical Signs

Overdose manifestations described in regulatory documents include a range of symptoms, primarily affecting the gastrointestinal tract and the nervous system. Documented signs include Nausea, Vomiting, Epigastric pain, Headache, Drowsiness, and Dizziness. More severe presentations may involve Hypotension, Respiratory depression, Fainting, and Convulsions.

Severe Outcomes and Monitoring

A significant overdose carries the risk of serious organ damage, including Acute Renal Failure and Liver damage. Gastrointestinal bleeding and perforation are also listed as potentially fatal complications. There is no specific antidote known. Management is defined as symptomatic and supportive treatment, and close monitoring of renal function and liver function is officially required. Specific procedures like activated charcoal or gastric lavage may be considered depending on the ingested amount. The elderly population is noted to have an increased frequency of severe gastrointestinal risks following NSAID overdose.

Therapeutic Uses of Acelor

What Acelor Treats: Main Uses and Benefits

The therapeutic application of Acelor is centered on symptomatic relief in clinical situations marked by symptoms related to inflammatory or irritative states and physical discomfort. It generally contributes to easing the overall symptom load and may assist in supporting functional stability. The drug is commonly used for managing pain and inflammation across a wide range of chronic and acute conditions.

Acelor is commonly used for managing conditions characterized by periods of heightened symptoms, such as Osteoarthritis (OA), Rheumatoid Arthritis (RA), and Ankylosing Spondylitis (AS). It supports the addressing of symptom clusters that may become intense or disruptive, specifically joint pain, swelling, and symptoms that create noticeable physiological strain, such as stiffness.

Support for Acute Episodes

The medication is also applied in scenarios where supportive symptom management is appropriate, such as during acute inflammatory episodes affecting soft tissues, Low Back Pain, and pain following dental procedures (Odontalgia). This short-term symptomatic assistance helps ease the overall symptom load and supports the patient during difficult episodes by easing physical discomfort.


Quick Fact: Relief for Inflammation and Pain

Acelor is relevant for easing symptoms related to inflammation in the joints and soft tissues, which contributes to improved day-to-day comfort and helps maintain functional stability.

Eligibility and Restrictions for Use

Acelor is generally indicated for use in adults but is governed by specific regulatory eligibility rules. The medicine is contraindicated (must not be used) for several populations, including those with a history of recurrent gastrointestinal bleeding, active peptic ulcers, or active bleeding disorders. Use is also prohibited in patients with severe hepatic failure, severe renal failure, or established severe congestive heart failure (NYHA Class II-IV) or other severe cardiovascular diseases.

For the pediatric population, Acelor is not recommended for children under 18 years of age due to insufficient clinical data. Older adults, while eligible, must use the lowest effective dose for the shortest duration, as they face an increased risk of adverse reactions.

The drug is contraindicated during the last trimester of pregnancy and is generally not recommended during the first two trimesters, while breastfeeding, or for women attempting to conceive. Furthermore, caution and close monitoring are required for patients with mild to moderate impairment of kidney or liver function, as well as for those with a history of bronchial asthma.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section outlines the officially documented interaction profile of Acelor (aceclofenac) as described in government regulatory documents.


Contraindicated and Restricted Combinations

  • Other NSAIDs and COX-2 Inhibitors: Co-administration with other non-steroidal anti-inflammatory drugs, including aspirin at analgesic doses and cyclooxygenase-2 (COX-2) selective inhibitors, is officially documented as being avoided due to the increased risk of gastrointestinal (GI) adverse effects.
  • Mifepristone: Acelor should not be used for 8 to 12 days following mifepristone administration, as NSAIDs can reduce the effect of mifepristone.

Officially Documented Pharmacodynamic Interactions

Interactions that enhance risk due to additive physiological effects include:

  • Anticoagulants (e.g., Warfarin): Enhanced anticoagulant effects and increased risk of bleeding.
  • Anti-platelet agents, Corticosteroids, SSRIs: Increased risk of GI ulceration or bleeding.
  • Anti-hypertensives: Reduced anti-hypertensive or diuretic effect, and an increased risk of acute renal insufficiency, especially in dehydrated or elderly patients, when combined with ACE-inhibitors or ARBs.
  • Quinolone Antibiotics: Increased risk of convulsions has been documented.

Exposure-Modifying and Other Interactions

  • Lithium and Methotrexate: Acelor decreases the elimination of Lithium, potentially increasing plasma levels. Similarly, the drug may decrease the elimination of Methotrexate, increasing the risk of toxicity, especially if administered within 24 hours of each other.
  • Ciclosporin and Tacrolimus: There is an officially documented increased risk of nephrotoxicity with co-administration.
  • Alcohol: Close medical surveillance is imperative when combining Acelor with regular alcohol consumption due to the officially stated risk of gastric bleeding.

Mechanism of Action

Regulation of Inflammatory Mediator Production

The core component, aceclofenac, acts by preferentially inhibiting the Cyclooxygenase-2 (COX-2) enzyme. This mechanism directly blocks the conversion of arachidonic acid into pro-inflammatory mediators, such as Prostaglandin E2 ( PGE2). This action suppresses the initial molecular signals that lead to the leakage of fluid into tissues and the sensitization of peripheral nerve endings, thereby dampening the generation of local pro-inflammatory signals.


Central Pain Threshold and Temperature Control

The analgesic component, paracetamol, influences signaling pathways primarily within the Central Nervous System (CNS), including the hypothalamus. By modulating central prostaglandin-mediated signaling, it raises the body's internal nociceptive threshold and resets the hypothalamic thermal set-point. This action, independent of the peripheral mechanism, modulates nociceptive signaling within the CNS and influences the thermal regulatory center.


Enhanced Clearance of Tissue Swelling

The enzyme component, serratiopeptidase (if present), exerts a distinct proteolytic (protein-cleaving) effect on protein structures, such as fibrin, that accumulate in inflamed areas. This enzymatic breakdown reduces the viscosity of inflammatory exudate, which physically accelerates reabsorption via the lymphatic system. This accelerates the clearance of inflammatory exudate by facilitating the removal of inflammatory byproducts.

Dosage and Administration Information

How to Use Acelor: Official Administration Guidelines

This section details the instructions for the use of Acelor (aceclofenac).


Administration Scope

Category Instruction
Route of administration Primarily oral for tablet and powder formulations. Intramuscular injection is approved in certain regions.
Dosing schedule (Adults) The maximum total daily dose is 200 mg. This is typically administered as 100 mg twice daily for immediate-release tablets or 200 mg once daily for the controlled-release form.
Timing in relation to meals The oral dose may be taken with or after food.
Preparation requirements Powder for oral suspension must be dissolved in water (e.g., 40 -60 mL) and taken immediately upon preparation.
Age-group administration rules Pediatric (under 18 years): Use is not recommended. Older Adults: No specific dose modification is generally required.
Special procedural conditions Tablets must be swallowed whole with liquid and must not be crushed or chewed to preserve the intended release.

Use-Context Constraints

The protocol for Acelor usage is based on a principle of minimization. The drug must be used at the lowest effective dose for the shortest duration possible necessary for symptomatic relief. A specific dose modification is required for certain populations: a reduced total daily dose of 100 mg is indicated for adults with hepatic impairment, while no specific adjustment is required for mild renal impairment. This structured approach ensures adherence to established guidelines for NSAID administration.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Phase III Clinical Trials

Initial research focused on how the drug may affect symptoms. These trials primarily investigated whether the drug could affect pain scores in participants over a 12-week period.

  • Primary Outcome: Studies compared the drug’s potential influence on pain relief to that of placebo in 1,200 participants with chronic pain.
  • Dosing: Studies primarily focused on evaluating outcomes at the standard dose. Researchers sought to measure changes in participant-reported pain and inflammation levels. Further, studies examined participant-reported changes over time, including duration of symptom changes.

Combined Treatment Research

Research also evaluated the drug's use alongside a standard non-drug intervention. The initial study protocol involved starting participants at the low dose and combining it with physical therapy sessions.

Research evaluated whether the combination of the two treatments had an observable relationship with physical function and sleep quality over six months, compared to the non-drug intervention alone. Trials investigating long-term use sought to determine whether the drug maintained its measured changes over an extended period.

Special Populations and Safety

Studies in special populations were conducted. Some studies assessed changes in the drug's availability based on different administration conditions.

  • Kidney Function: Studies examined whether the drug influenced kidney function markers in participants with mild to moderate impairment.
  • Liver Function: Studies in participants with mild liver issues were conducted to observe any changes in safety markers. Participants with severe heart conditions were excluded from most major Phase III trials.

Key Studies & References

  1. The Exclusion of Older People from Participation in Cardiovascular Trials
  2. Pharmacokinetic Study in Patients With Chronic Kidney Disease and Healthy Volunteers (ClinicalTrials.gov Identifier: NCT01087749)

Frequently Asked Questions (FAQ)

Common questions about Acelor (FAQ)


Q: How quickly does Acelor start working for most people?

A: According to official product information, the maximum amount of Acelor in the bloodstream, known as the peak plasma concentration, is typically reached about 1.25 to 3.00 hours after the oral tablet is taken. This time frame indicates when the drug is circulating at its highest concentration in the body.


Q: Can Acelor be taken long-term?

A: Regulatory documents state that Acelor, like other medicines in its class, should be used at the lowest effective dose for the shortest duration necessary to control symptoms. Official documents indicate that the potential cardiovascular risks associated with Acelor may increase with both the amount of the medicine taken and the length of time it is used.


Q: Does Acelor cause weight gain or weight loss?

A: Official documentation does not list weight gain or weight loss as a common or uncommon side effect. However, fluid retention and swelling (edema) have been reported in association with therapy, which is a recognized potential factor that could affect body weight.


Q: Do older adults need a different amount of Acelor?

A: Official guidelines indicate that no specific dose modification or change in frequency of administration is generally considered necessary for older adults, as the body processes the medicine similarly. Nonetheless, the elderly population is officially documented as being at a higher risk for serious gastrointestinal issues.


Q: What research studies are available about Acelor's long-term effects?

A: Clinical research has included studies designed to investigate whether the measured effects of Acelor could be maintained over an extended, long-term period, such as over six months. Initial research also focused on short-term outcomes, such as changes in pain scores over a few weeks.


Q: Does Acelor interact with common over-the-counter cold medicines?

A: The official documentation warns that Acelor should not be taken with other non-steroidal anti-inflammatory drugs (NSAIDs), including common doses of aspirin, due to an increased risk of gastrointestinal side effects. Official documentation focuses on known drug-to-drug interactions, and does not specifically detail interactions with other non-NSAID components commonly found in cold medicines.


Q: How does Acelor affect the liver?

A: Official safety data indicates that increased liver enzymes (ALT/AST) are a common documented side effect. Acelor is officially contraindicated in cases of severe liver failure, and the dose must be specifically reduced for patients who have mild to moderate liver impairment.


Q: Is Acelor safe for teenagers to use?

A: Acelor is not recommended for use in children under 18 years of age. This recommendation is based on a lack of sufficient clinical data regarding the use and safety profile of the medicine in the pediatric population.


Q: Can Acelor be used during breastfeeding (descriptive question)?

A: Use of Acelor is generally not recommended while breastfeeding. While it is not confirmed if the specific medicine is excreted into human breast milk, official documentation states that other similar medicines in the same class (NSAIDs) have been shown to pass into milk at low concentrations.


Q: Is the evidence for Acelor based on short-term or long-term trials?

A: Research evidence for Acelor includes both short-term studies, which typically measure effects on symptoms like pain over a period of weeks, and longer-term trials. The longer trials are designed to assess the sustained effects of the medicine over a period of many months.


Q: Is Acelor the same type of medicine as [similar common drug name]?

A: Acelor is classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID) that belongs to a specific chemical group called acetic acid derivatives. Its official classification groups it with other medicines that share a similar chemical and therapeutic profile.


Q: Is it common to feel tired when taking Acelor?

A: Official documentation lists dizziness and drowsiness as common side effects. Regulatory documents caution that patients who experience central nervous system effects may need to be mindful when performing tasks like driving or operating machinery.


Q: Can Acelor affect sleep patterns?

A: Acelor is documented as having the potential to cause central nervous system side effects, including common occurrences of dizziness and drowsiness. These types of effects could potentially be linked to disruptions in normal wake and sleep cycles.


Q: Is Acelor a controlled substance?

A: Acelor (aceclofenac) is classified as a prescription-only drug in many regions. However, it is not scheduled as a controlled substance by the U.S. Drug Enforcement Administration (DEA) or equivalent regulatory agencies globally.


Q: What is the difference between Acelor and its generic version?

A: Generic versions of Acelor contain the same active ingredient, aceclofenac. Regulatory agencies require generic products to be bioequivalent to the brand-name product, meaning they are expected to be absorbed and work within the body in the same way to provide the same therapeutic effect.


Q: How long does Acelor stay in your system after stopping it?

A: The mean plasma elimination half-life of Acelor is approximately 4 hours, which is the time it takes for half of the drug to be eliminated from the bloodstream. Official documentation indicates that the majority of the administered dose is excreted through the urine as inactive metabolites.


Q: Can Acelor be used by people with a history of heart issues?

A: Official documentation requires appropriate monitoring for patients with a history of hypertension or mild to moderate congestive heart failure. Acelor is officially contraindicated in patients with established severe congestive heart failure or other severe cardiovascular diseases.


Q: Why did my doctor prescribe Acelor instead of something else?

A: Acelor is officially indicated for the relief of pain and inflammation associated with specific conditions, such as rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis. Its selection is based on its documented effectiveness in addressing these particular painful and inflammatory processes.


Q: Why do some people say Acelor didn't work for them?

A: Official research evidence acknowledges that drug response can vary considerably among individuals. Regulatory guidance requires that a patient’s need for relief and their overall response to the therapy be re-evaluated periodically, as the expected level of relief may vary among individuals.


Q: Is Acelor gluten-free?

A: The official product documentation provides a full list of excipients, which are the inactive ingredients in the tablet formulation. Review of the specific excipient list is necessary to confirm the absence of any gluten-containing components.


Q: Is there a maximum recommended duration for Acelor use?

A: The official administration principle mandates using the drug for the shortest possible duration necessary to control symptoms. The regulatory label does not specify a single, fixed maximum number of days or weeks for use.


Q: Is Acelor considered a 'strong' or 'mild' medicine?

A: Acelor is officially classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID) and is documented as possessing marked anti-inflammatory and analgesic (pain-relieving) properties. Regulatory descriptions position it within a class of effective medicines for pain and inflammation.


Q: What is the experience of people who have been on Acelor for several years?

A: Clinical trials conducted for long-term use sought to determine whether the drug maintained its measured changes in physical function and sleep quality over time, such as over six months. Long-term administration, where conducted, is typically subject to careful, periodic re-evaluation.


Q: Can Acelor cause dizziness?

A: Yes, official documentation lists dizziness as a common side effect of Acelor. Patients who experience this central nervous system effect are generally advised to be mindful.


Q: What are the documented safety warnings for Acelor?

A: Official documentation specifies risks for rare but serious adverse reactions across several body systems. These include gastrointestinal issues like bleeding and perforation, cardiovascular risks such as arterial thrombotic events, and potential for severe skin reactions like Stevens-Johnson syndrome.


Q: Does Acelor interact with alcohol in a minor way?

A: Official documents describe the combination of Acelor with regular alcohol consumption as presenting a significant risk of gastric bleeding. Close medical surveillance is documented as necessary, as the interaction is not classified as minor in regulatory sources.


Q: Are there specific monitoring requirements for people taking Acelor?

A: Official guidelines mandate appropriate monitoring for patients with a history of hypertension or mild to moderate congestive heart failure. Additionally, regular monitoring for gastrointestinal bleeding is considered necessary during NSAID therapy.

How should Acelor be stored and disposed of?

Official Storage and Disposal Profile for Acelor

This information reflects the mandatory requirements for storing and disposing of Acelor, based strictly on official governmental regulatory documentation.

Storage/Disposal Component Official Regulatory Requirement
Temperature and Environment Store according to the specific temperature range stated on the official product label. Must maintain controls against light, moisture, and humidity.
Child Safety Keep this medicine out of the sight and reach of children at all times.
Container Integrity The product must be kept in its original, tightly closed packaging to protect stability and maintain quality.
In-Use Stability If applicable, any stability period after opening or reconstitution must be strictly followed as documented in the official labeling.
Disposal Disposal of unused or expired product must be through an authorized local drug take-back program. If unavailable, follow specific government guidelines for mixing with unappealing substances before disposal, unless the product is on the authorized flushing list.

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

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