Aceclofenaco

Quick links to important sections

Aceclofenaco

Treatment option:

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 Aceclofenaco

Property Description
Active ingredient Aceclofenac
Form Tablets, Capsules, Powder for Oral Suspension
Pharmacological class Nonsteroidal Anti-Inflammatory Drug (NSAID)
Common use Relieving musculoskeletal pain and reducing inflammation
Origin Synthetic compound (Acetic acid derivative)

Identity and Pharmacological Classification

Aceclofenaco is the widely used name for a synthetic medicinal product whose active ingredient is Aceclofenac (INN). Aceclofenac is classified as a Nonsteroidal Anti-Inflammatory Drug (NSAID) and an Analgesic. The drug is often manufactured as a prescription-only medicine (POM).

Aceclofenac is chemically defined as an acetic acid derivative, placing it in the same class as Diclofenac, its primary active metabolite. Pharmacological studies have clinically recognized Aceclofenac for its ability to target inflammation effectively, noting its preferential inhibition of the COX-2 enzyme over COX-1, a feature that contributes to its anti-inflammatory effects. This substance is designed as a single active ingredient product, with its definitive grouping within the Anti-inflammatory and Antirheumatic Products, Non-Steroids class establishing its intended use for treating conditions marked by pain and inflammation.

Composition, Form, and General Purpose

The medicine consists of the active substance Aceclofenac combined with solid pharmaceutical excipients formulated for reliable systemic action. Aceclofenaco is designed for oral administration and is available in common dosage forms such as film-coated tablets, capsules, or as a powder for oral suspension (sachets). This variety in dosage forms facilitates administration.

Aceclofenac functions by acting as a Cyclooxygenase (COX) inhibitor, intervening in the body's inflammatory cascade to suppress the synthesis of prostaglandins, which are key chemical compounds that drive pain and localized swelling. The drug's mechanism effectively helps manage symptoms of pain and inflammation in adults. This action directly provides the medicine's general therapeutic purpose: to effectively relieve pain and reduce the symptoms of inflammation associated with acute or chronic musculoskeletal issues.

What side effects are possible with Aceclofenaco?

Aceclofenaco: Possible Side Effects and Safety Information

Aceclofenaco, a non-steroidal anti-inflammatory drug (NSAID), may cause side effects, typically affecting the gastrointestinal (GI) tract and the cardiovascular system. To minimize risks, the lowest effective dose for the shortest possible duration should be used.


Common Side Effects

Commonly reported side effects (occurring in 1% to 10% of patients) are primarily gastrointestinal and may include:

  • Gastrointestinal: Dyspepsia (indigestion), abdominal pain, nausea, and diarrhea.
  • Other: Dizziness and elevated liver enzymes (detected via blood tests).

Serious Warnings and Precautions

Like other NSAIDs, Aceclofenaco carries risks that require careful consideration and patient monitoring:

  • Cardiovascular Risk: Use of Aceclofenaco, particularly at high doses or for long periods, may increase the risk of serious cardiovascular thrombotic events, such as heart attack and stroke. It is generally contraindicated in patients with established congestive heart failure (NYHA Class II-IV), ischemic heart disease, peripheral arterial disease, or cerebrovascular disease.
  • Gastrointestinal Risk: Serious GI events, including bleeding, ulceration, and perforation of the stomach or intestines (which can be fatal), have been reported. This risk is higher in the elderly and in those with a history of GI issues.
  • Hypersensitivity and Skin Reactions: Rare, severe skin reactions, such as Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis, can occur. The drug should be discontinued immediately at the first sign of a rash or other hypersensitivity reaction.

Contraindications and Special Populations

Aceclofenaco is typically contraindicated in patients with a history of hypersensitivity or allergic reactions (like asthma, rhinitis, or hives) to aspirin or other NSAIDs, those with active gastrointestinal bleeding or ulcers, severe kidney or liver impairment, and during the third trimester of pregnancy due to risk of harm to the fetus. Caution is advised for the elderly and those with mild to moderate heart, liver, or kidney problems.

Overdose and Emergency Response

Aceclofenaco Overdose and When to Seek Help

The official regulatory profile for Aceclofenaco (Aceclofenac) overdose is defined by its potential to affect vital organ systems and the central nervous system. In all suspected cases of overdose, individuals are formally instructed to seek immediate medical attention. This mandate is due to the potential for severe, life-threatening outcomes that necessitate immediate medical surveillance.

Documented Manifestations Potential Severe Outcomes
Nausea, vomiting, epigastric pain Acute renal failure, hepatic failure
Headache, dizziness, somnolence Gastrointestinal bleeding, perforation
Disorientation, tinnitus Seizures and systemic compromise

The approach to management, as described in official regulatory documents, is entirely symptomatic and supportive, because no specific antidote is known for Aceclofenac toxicity. Procedural measures, such as gastric lavage or the administration of activated charcoal, may be employed if ingestion occurred recently. Following any significant exposure, close medical monitoring of key organ functions, particularly renal and hepatic function, is required. Regulatory statements also specify that the elderly population carries an officially noted greater risk for serious gastrointestinal events in NSAID overdose situations.

Therapeutic Uses of Aceclofenaco

What Aceclofenaco Treats: Main Uses and Benefits

Aceclofenaco is relevant for easing symptoms related to inflammatory musculoskeletal conditions, often used in situations where patients experience symptoms related to physical discomfort and joint stiffness. The active ingredient Aceclofenac is generally used in the management of these conditions.

It is commonly used across conditions characterized by periods of heightened symptoms, such as Osteoarthritis, Rheumatoid Arthritis, and Ankylosing Spondylitis, as well as for pain associated with soft tissue injuries or dental procedures. It helps address symptom clusters that may become intense or disruptive, and generally contributes to easing the overall symptom load.

“The medication is widely used to provide supportive relief during symptomatic periods, assisting patients in coping more steadily with difficult episodes.”

Applied in scenarios where additional management of discomfort is required, it supports patients during episodes of heightened discomfort and may assist with maintaining functional stability, which contributes to improved comfort.


Quick Fact: Symptomatic Support for Stiffness and Pain (The medication plays a role in managing symptoms that interfere with daily comfort and is relevant for easing discomfort caused by inflammatory processes.)

Eligibility and Restrictions for Use

Who Can and Cannot Use Aceclofenaco?

Aceclofenaco, a nonsteroidal anti-inflammatory drug (NSAID), is typically prescribed for pain and inflammation management, often associated with conditions like osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. It is generally suitable for most adults who do not have contraindicating medical conditions.


Contraindications (Who Cannot Use Aceclofenaco)

Aceclofenaco is contraindicated in individuals with the following conditions, as it may pose serious health risks:

Condition / Factor Reason for Contraindication
Active or History of Gastrointestinal (GI) Bleeding/Ulceration Increased risk of serious GI events.
Severe Heart Failure NSAIDs can increase the risk of cardiovascular thrombotic events.
Severe Renal (Kidney) Impairment Can worsen kidney function.
Severe Hepatic (Liver) Impairment Risk of exacerbating liver damage.
Late Stages of Pregnancy (Third Trimester) Risk of harm to the fetus and issues during delivery.
Known Hypersensitivity Previous allergic reactions to aceclofenac, aspirin, or other NSAIDs.

Patients with conditions like mild to moderate heart failure, hypertension, or those taking anticoagulants require careful monitoring and physician consultation before use. Children and adolescents are generally not prescribed aceclofenaco unless specifically advised by a specialist.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information documents essential interaction data for Aceclofenaco (Aceclofenac), guiding co-administration constraints based on pharmacodynamic and pharmacokinetic effects.

Regulatory-Defined Interaction Constraints

Classification Interacting Agents Official Regulatory Statement
Contraindicated Other NSAIDs, Analgesic Aspirin Avoid co-administration due to significantly increased risk of gastrointestinal bleeding or ulceration.
Timing Restriction Mifepristone Use must be avoided for a documented period of 8–12 days following Mifepristone administration.
Non-Medicinal Avoidance Alcohol Consumption should be avoided as it increases the risk of stomach bleeding.

Pharmacodynamic and Exposure Interactions

Aceclofenaco is officially documented to interact with several drug classes, potentially leading to altered effects or increased risk of adverse events as detailed in prescribing information:

  • Bleeding Risk: Co-administration with Anticoagulants, Antiplatelet agents, Systemic Corticosteroids, or SSRIs increases the documented risk of bleeding.
  • Exposure Modification: It may increase the plasma concentrations of certain medicines, including Lithium and Methotrexate, due to reduced excretion, requiring close professional monitoring.
  • Renal and Blood Pressure Agents: The drug reduces the anti-hypertensive and diuretic effects of ACE-inhibitors, ARBs, and Diuretics, while increasing the risk of nephrotoxicity when combined with these agents, as well as with Cyclosporine and Tacrolimus.

Population Note: The risk of acute renal insufficiency when combined with ACE-inhibitors or ARBs is documented as higher in elderly and dehydrated patients.

Mechanism of Action

The Mechanism of Cyclooxygenase Inhibition

Aceclofenac's mechanism of action is rooted in its ability to inhibit the Cyclooxygenase ( COX) enzyme system, specifically acting as a competitive, reversible inhibitor with a preference for the inducible COX-2 isoform over COX-1. This enzymatic blockade prevents the conversion of arachidonic acid into prostanoids, primarily PGE2.

This molecular inhibition initiates a downstream cascade that affects peripheral nociceptive pathways and central thermoregulation. Reduced PGE2 levels at peripheral sites lead to the physiological dampening of afferent nerve sensitivity, increasing the required stimulus intensity for signal transmission. Centrally, the mechanism involves inhibiting PGE2 production within the hypothalamus, resulting in the adjustment of the central thermoregulatory set point.

The mechanism is constrained by its non-absolute selectivity, which partially extends to the constitutive COX-1 enzyme, thereby reducing homeostatic prostaglandins necessary for maintaining the gastric mucosal barrier. The action modulates the chemical response at the mediator level but does not interfere with underlying immunological processes.

Dosage and Administration Information

How to Use Aceclofenaco: Official Administration Principles

Aceclofenaco (Aceclofenac) is intended for oral administration, typically provided as a 100 mg film-coated tablet. The administration protocol focuses on a fixed dose and frequency.


Standard Dosing and Frequency

The maximum recommended total daily intake of Aceclofenac is 200 mg. The standard regimen involves dividing this total into two 100 mg doses per day (twice daily), taken approximately 12 hours apart. The principle for duration is to use the lowest effective dose for the shortest period necessary to manage symptoms. For those taking the 200 mg controlled-release form, the usual pattern is once daily.


Administration Requirements

Aceclofenaco tablets must be swallowed whole with a sufficient quantity of liquid, such as a glass of water; they should not be crushed or chewed to preserve the intended release profile. The dose is preferably taken with or immediately after food, as this timing does not impact the overall absorption extent. If a dose is missed, the practice is to skip the forgotten dose and resume the normal schedule, avoiding the compensation of a double dose.


Population-Specific Adjustments

Specific dose adjustments are specified for certain patient groups:

  • Hepatic Impairment: A reduced daily dose is required, with an initial 100 mg per day dose recommended.
  • Pediatric Population: Use is not recommended in children and adolescents under 18 years due to a lack of sufficient clinical data.

These parameters define the methodology for using the medicine.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Research Focus

Studies investigated Aceclofenac's effects on the immune system. Researchers explored whether the drug was associated with changes in various biological markers of inflammation.


Clinical Efficacy Research

Studies investigated this treatment across several randomized, placebo-controlled trials focusing on specific populations. Research explored the duration and magnitude of reported pain reduction in participants with moderate-to-severe chronic joint pain.

Study 1: Function and Inflammation Markers

  • Objective: Researchers evaluated whether the drug was associated with a change in chronic inflammation markers and changes in joint function.
  • Outcomes: Study findings reported a difference in self-reported daily function between the drug group and the placebo group. Analysis of blood markers examined whether the drug was associated with changes in inflammatory signals.
  • Duration: The study duration was 12 weeks, followed by a 6-month open-label extension.

Study 2: Long-Term Event Rates

  • Objective: This research explored whether the drug was associated with a reduced frequency of flare-ups over a two-year period in a group of adult participants.
  • Outcomes: The trial reported a difference in the number of recorded flare-up episodes between the drug group and the control group. Some studies included comparisons between the drug and traditional NSAIDs. Findings were mixed on the extent of symptomatic differences.
  • Populations: Studies of the drug often excluded participants with severe kidney issues.

Adverse Event Reporting

Clinical trials reported on adverse events observed during long-term use in adults. Adverse events reported most often included gastrointestinal upset and headache.

Research explores the effects that were studied in clinical trials. Further studies are ongoing to investigate its full adverse event and effect profile in broader populations.

Key Studies & References

  1. Efficacy and safety of aceclofenac versus other NSAIDs in the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis: a systematic review and meta-analysis.

Frequently Asked Questions (FAQ)

Common questions about Aceclofenaco (FAQ)


Q: What kind of pain is Aceclofenaco typically used for?

A: According to official product information, Aceclofenaco is indicated for the relief of pain and inflammation associated with certain chronic conditions. These typically include joint issues like rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis. It is generally used to treat mild to moderate pain.

Q: How quickly does Aceclofenaco usually start to relieve pain or inflammation?

A: Regulatory documents often do not provide a specific time-to-onset for the pain-relieving effects. However, they indicate that the medication may remain active in the body for approximately 24 hours, suggesting a sustained effect after dosing.

Q: Why do some people compare Aceclofenaco to Diclofenac?

A: This comparison is commonly made because Aceclofenaco is structurally very similar to Diclofenac. Official drug information notes that Aceclofenaco is metabolized—or broken down—into Diclofenac within the body. This metabolic connection means the two drugs share similar effects and precautions, particularly regarding cardiovascular risk.

Q: Does Aceclofenaco cause drowsiness or dizziness that could affect driving?

A: Yes, dizziness, vertigo, and other central nervous system effects are reported side effects of Aceclofenaco. Official guidance notes that individuals experiencing these effects should exercise caution regarding activities requiring focus, such as driving or operating machinery.

Q: Can Aceclofenaco affect blood pressure levels?

A: Official warnings indicate that the medication is associated with high blood pressure (hypertension) as a possible adverse effect. It can also interact with and reduce the effectiveness of anti-hypertensive medications used to control blood pressure.

Q: Is there a risk of kidney problems with long-term use of Aceclofenaco?

A: Yes, regulatory information advises caution regarding kidney function. Prolonged use, especially at high doses, may cause or worsen kidney problems. The official principle of using the lowest effective dose for the shortest duration is advised, particularly for individuals with existing renal concerns.

Q: Is Aceclofenaco generally safe for older adults or the elderly?

A: The treatment of elderly patients requires caution, as regulatory information notes they are generally more susceptible to adverse reactions, especially serious gastrointestinal bleeding. They are also more likely to have reduced function in their kidneys, heart, or liver.

Q: Can I take Aceclofenaco if I am already taking an acid reflux medicine like a PPI?

A: Official prescribing information notes that for patients who are considered to be at a high risk of developing gastrointestinal complications, healthcare providers should consider prescribing co-administration with a gastroprotective agent, such as a proton pump inhibitor (PPI).

Q: What should I do if I forget to take a dose of Aceclofenaco?

A: Regulatory documents clearly state that if you forget a dose, you should skip the forgotten dose completely. You should then continue with your normal dosing schedule, avoiding the temptation to take a double dose to compensate for the missed one.

Q: Can Aceclofenaco cause a skin rash or increased sensitivity to sunlight?

A: Yes, common skin reactions such as a rash and dermatitis are reported adverse events. Also, sensitivity to sunlight (known as photosensitivity) has been reported with this class of medication (NSAIDs).

Q: Why is it important to take the lowest effective dose of Aceclofenaco?

A: The principle of using the lowest effective dose for the shortest possible duration is emphasized by regulatory bodies. This is done to minimize the risk of serious side effects, particularly those affecting the cardiovascular system (heart and blood vessels) and the gastrointestinal system (stomach and intestines).

Q: Does Aceclofenaco help with pain from acute injuries like sprains?

A: While the primary indications listed are chronic joint diseases, the scope of use for general mild to moderate pain may encompass acute musculoskeletal issues. The decision to use it for such issues is based on the prescribing physician's assessment.

Q: How long does the pain-relieving effect of one dose of Aceclofenaco typically last?

A: While the specific time the pain relief lasts is often not standardized, official documents indicate that the medication has a sustained action. One source suggests that Aceclofenaco may remain in the body for approximately 24 hours.

Q: Can Aceclofenaco interact with medications for diabetes?

A: Yes. Official interaction data indicates that Aceclofenaco may interact with antidiabetic drugs. This can rarely lead to unwanted changes in blood sugar levels, such as abnormally low (hypoglycemia) or abnormally high (hyperglycemia) blood sugar.

Q: Are there any specific blood tests required before or during treatment with Aceclofenaco?

A: Regulatory guidance advises that liver function, kidney function, and blood counts should be monitored with blood tests during long-term treatment. Persistently elevated hepatic enzyme levels during monitoring may necessitate withdrawal of the medication.

Q: Does Aceclofenaco have any known effect on liver function?

A: Yes. Elevated liver enzymes are listed as a common side effect detected via blood tests. Additionally, the drug is contraindicated in patients who have severe liver impairment and requires monitoring during continuous use.

Q: Is Aceclofenaco available in different forms, like gel or cream?

A: Aceclofenaco is most commonly supplied for oral use as tablets or capsules. While these are the primary forms, some regulatory labels confirm that other pharmaceutical forms, such as a gel for topical use or an injection, are also available.

Q: What is the chemical mechanism of action for Aceclofenaco?

A: The drug's action is primarily based on the inhibition of prostaglandin synthesis within the body. It achieves this by inhibiting the cyclo-oxygenase ( COX) enzyme system, with a preference for the COX-2 form over COX-1. Prostaglandins are key chemicals that drive pain and inflammation.

Q: Can I take Aceclofenaco if I have a history of heart conditions or a previous heart attack?

A: Official contraindications state that Aceclofenaco is contraindicated in individuals with established heart conditions. These include ischaemic heart disease, peripheral arterial disease, cerebrovascular disease, or congestive heart failure classified as NYHA Class II-IV.

Q: Does Aceclofenaco affect blood clotting?

A: Yes, official warnings indicate that Aceclofenaco can cause the reversible inhibition of platelet aggregation (clumping). This means it can affect the body's ability to form blood clots. Caution is advised for those who have a history of coagulation defects.

Q: Can Aceclofenaco be used for pain relief associated with menstrual cramps?

A: While not a primary indication, studies supported by regulatory guidance have explored its use for pain relief. These studies found it to be effective in treating the pain associated with primary dysmenorrhoea (menstrual cramps).

Q: Are there different brand names for the Aceclofenaco molecule?

A: Yes. The active ingredient itself is called Aceclofenac, and it is marketed and sold around the world under many different trade names. Examples include Hifenac, Preservex, and Airtal.

Q: Is it okay to crush or chew Aceclofenaco tablets?

A: Official guidance strictly states that the tablets must be swallowed whole with liquid. They should not be crushed or chewed. This is necessary to preserve the drug's intended release profile within the body.

Q: What is the typical time frame for a course of treatment with Aceclofenaco for acute pain?

A: For acute pain relief, the guiding principle is always to use the medication for the shortest period necessary. For analgesic use, one regulatory source suggests that usage for more than two days is not typically recommended, though the duration will depend on the treating physician's assessment.

Q: Does Aceclofenaco interact with selective serotonin reuptake inhibitors (SSRIs) or other antidepressants?

A: Yes. Regulatory documents specifically warn that co-administration with SSRIs, which are a class of antidepressant, increases the risk of bleeding. Interactions with other antidepressant classes are generally not explicitly listed in common sections.

Q: Are there studies supporting the use of Aceclofenaco for conditions like gout?

A: Gout is not listed as a standard indication, but the drug is indicated for inflammatory joint conditions. The specific indication for gout may vary by regional labeling, based on the treating physician's assessment of inflammatory pain.

Q: Can Aceclofenaco be used to reduce fever?

A: The mechanism of Aceclofenaco involves inhibiting the production of a chemical called PGE2 in the part of the brain that controls body temperature (the hypothalamus). This mechanism is associated with central thermoregulation, but official indications do not explicitly list it as an antipyretic (fever reducer).

Q: Can Aceclofenaco be taken with Paracetamol (Acetaminophen) for better pain relief?

A: Yes, based on regulatory allowance. Some combination products contain both Aceclofenac and Paracetamol, which implies that co-administration is permitted for certain acute inflammatory pain conditions.

Q: Is it better to take Aceclofenaco with food or on an empty stomach?

A: Official guidance recommends that the dose is preferably taken with or immediately after food. Taking it with food helps to avoid stomach irritation, and importantly, this timing does not negatively affect the overall absorption of the drug into the body.

How should Aceclofenaco be stored and disposed of?

Storage and Disposal of Aceclofenac

The storage of Aceclofenac must strictly follow the conditions specified in the official regulatory labeling. The medicine must be stored at a temperature not exceeding 30 C to maintain its stability and should be protected from light and moisture. To preserve the product for its full labeled shelf life, it must remain in its original, tight container.

Handling and Safety

Requirement Constraint
Temperature Store below 30 C (or 25 C depending on formulation)
Protection Protect from light and store in a dry place
Child Safety Keep out of the sight and reach of children

Any unused or expired Aceclofenac must be handled as pharmaceutical waste and disposed of according to local regulatory requirements. The medication should not be discarded in household trash or poured into wastewater.

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

Equivalent of Aceclofenaco found in:

A-Z Index: