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Zerodol (Aceclofenac)

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Zerodol (Aceclofenac)

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.

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Overview of Zerodol (Aceclofenac)

Quick Facts

Property Description
Active ingredient Aceclofenac (INN)
Form Oral formulation (Tablet)
Pharmacological class Nonsteroidal Anti-inflammatory Drug (NSAID)
Common use Symptomatic relief of pain and inflammation
Origin Synthetic, Phenylacetic acid derivative

Defining Zerodol: What Type of Medicine is Aceclofenac?

Zerodol is a trade name for a prescription-only medicine whose active ingredient is Aceclofenac. It is definitively classified as a Nonsteroidal Anti-inflammatory Drug (NSAID), a high-level pharmacological class used primarily for managing pain, fever, and inflammation. The compound is chemically recognized as a phenylacetic acid derivative, demonstrating a structural relationship to the widely used analgesic diclofenac.

Aceclofenac is clinically recognized for its potent inhibitory effect on prostaglandin synthesis, which modulates the biological pathway responsible for generating inflammatory mediators. This inhibition is the core mechanism that places it within the NSAID group. Aceclofenac demonstrates strong anti-inflammatory agent and analgesic agent properties. This indicates the medicine is generally effective at reducing both the feeling of pain and the swelling that causes it.

Aceclofenac Composition: Is the Active Ingredient Synthetic or Natural?

The active ingredient, Aceclofenac (INN), is a synthetic compound manufactured through a defined chemical process, which is characteristic of most modern pharmaceutical phenylacetic acid derivatives. It is typically formulated as a single-ingredient product, containing only Aceclofenac along with the necessary solid oral excipients that aid in stability and effective delivery.

This synthetic composition guarantees a consistent pharmacological profile crucial for reliable systemic action following oral administration. The resultant consistent dosage of the active ingredient is essential for managing the chronic discomfort and limited mobility associated with various inflammatory conditions, such as stiffness and soreness related to chronic joint issues.

General Therapeutic Role: What is the Overall Purpose of Aceclofenac?

The overall therapeutic purpose of Aceclofenac is to provide symptomatic relief by acting as a triple-threat agent: an anti-inflammatory agent, an analgesic agent (pain reliever), and an antipyretic agent (fever reducer). Its core benefit is the reduction of pain, stiffness, and swelling associated with musculoskeletal pain and inflammation. By addressing these symptoms, the drug contributes to the general management of discomfort associated with various chronic inflammatory disorders.

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What side effects are possible with Zerodol (Aceclofenac)?

Possible Side Effects and Safety Information

The official safety information for Aceclofenac, a Nonsteroidal Anti-inflammatory Drug (NSAID), is structured by regulatory bodies to communicate the spectrum of possible adverse reactions and known safety constraints. Effects are typically grouped by frequency and the physiological systems affected.

Frequency-Classified Adverse Reactions

The most commonly listed adverse reactions (classified as Common, occurring in ge 1/100 to <1/10 patients) primarily involve the gastrointestinal system, including dyspepsia, abdominal pain, nausea, and increased hepatic enzyme levels. Effects classified as Uncommon (ge 1/1,000 to <1/100) include flatulence, gastritis, rash, and pruritus. Reactions categorized as Rare or Very Rare are also documented and relate to more serious systemic events.

Classification Examples of Officially Documented Effects
Common Dyspepsia, Abdominal pain, Nausea, Hepatic enzyme increased
Uncommon Flatulence, Vomiting, Rash, Pruritus

Systemic Safety Considerations

The documented adverse effects primarily involve the Gastrointestinal disorders, Nervous system disorders, Hepatobiliary disorders, and Skin and subcutaneous tissue disorders. Severe adverse reactions explicitly noted in regulatory documents include gastrointestinal haemorrhage, ulceration, and perforation, anaphylactic shock, and severe mucocutaneous skin reactions (such as Stevens-Johnson Syndrome).

Regulatory safety statements also identify specific populations requiring caution: The risk of adverse reactions, particularly fatal gastrointestinal bleeding, is noted to be higher in the elderly. Caution is also required in individuals with mild-to-moderate hepatic or renal impairment, and the medicine is officially contraindicated in cases of severe organ failure. The highest risk period for severe skin reactions is generally observed early in the course of therapy, typically within the first month.

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Overdose and Emergency Response

Immediate medical attention is required following the ingestion of a potentially toxic or potentially life-threatening amount of Aceclofenac, as defined by regulatory guidance. Overdose manifestations documented in official prescribing information primarily affect the gastrointestinal and central nervous systems.

Documented clinical signs include headache, nausea, vomiting, epigastric pain, dizziness, drowsiness, and fainting. More severe presentations may involve gastrointestinal bleeding, hypotension, and respiratory depression. In cases classified as significant poisoning, there is a documented possibility of serious organ toxicity, including acute renal failure and liver damage.

The regulatory profile notes that the elderly population carries an increased risk of severe, potentially fatal, gastrointestinal complications like bleeding and perforation.

Since no specific antidote for Aceclofenac overdose is documented in the label, treatment is defined as symptomatic and supportive. Procedural interventions described in official documents include the consideration of activated charcoal within one hour of toxic ingestion, and gastric lavage following a potentially life-threatening overdose. Close monitoring of renal and liver function is mandated. For the complication of frequent or prolonged convulsions, medical professionals are directed to treat with intravenous diazepam. The need for these procedural measures reinforces why urgent medical assessment is imperative.

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Therapeutic Uses of Zerodol (Aceclofenac)

What Zerodol (Aceclofenac) Treats: Main Uses and Benefits

Aceclofenac is generally applied across domains where additional symptomatic support is needed in situations involving certain distressing symptoms. It is commonly used across conditions presenting with acute or chronic episodes of joint inflammation. The medication is relevant in conditions characterized by periods of heightened symptoms, such as Osteoarthritis, Rheumatoid Arthritis, and Ankylosing Spondylitis. It is also applied in settings that involve acute soft-tissue inflammation like low back pain, extra-articular rheumatism, and acute dental pain.

Core Symptom Domains

Aceclofenac helps address symptom clusters that interfere with daily comfort, specifically pain, swelling, and restricted movement. It supports the patient during difficult episodes by contributing to easing the overall symptom load during periods of heightened symptoms. The role of this medication is supportive symptomatic relief:

“It provides short-term symptomatic assistance, which may help patients cope more steadily with temporary functional strain and heightened discomfort.”

It may assist with maintaining functional stability by addressing the symptoms related to inflammatory or irritative states and stiffness, providing supportive relief when symptoms interfere with daily functioning.


Quick Fact: Symptom Domains Addressed Use Case Symptom Focus
Chronic Conditions Persistent joint pain and swelling
Acute Scenarios Localized inflammation and stiffness
Primary Role Contributes to easing overall symptom burden

Regulatory References

  1. Authoritative clinical product information
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Eligibility and Restrictions for Use

Zerodol (Aceclofenac) is a non-steroidal anti-inflammatory drug (NSAID) whose use is strictly governed by authoritative regulatory documents based on a patient's pre-existing health status.

Populations for Whom Use is Forbidden (Contraindicated)

Official labeling strictly forbids use in patients with a history of hypersensitivity to aceclofenac, aspirin, or other NSAIDs (e.g., resulting in asthma, rhinitis, or urticaria). It is also contraindicated for patients with active or recurrent peptic ulcers or gastrointestinal bleeding, or a history of bleeding/perforation related to previous NSAID treatment. Use is forbidden in patients with severe hepatic failure, severe renal failure, and established severe cardiovascular disease including Congestive Heart Failure (NYHA Class II-IV), Ischaemic Heart Disease, Peripheral Arterial Disease, and Cerebrovascular Disease. Use is also contraindicated during the third trimester of pregnancy.

Populations Requiring Special Caution

Restricted use is required for elderly patients, as they are at an increased risk of serious adverse reactions, particularly gastrointestinal bleeding. Close surveillance and the lowest effective dose must be used in those with mild to moderate hepatic or renal impairment, uncontrolled hypertension, or a history of heart failure (NYHA Class I). Use is not recommended for the paediatric population (under 18 years of age) due to a lack of clinical data, and for women who are breastfeeding or attempting to conceive.

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What should I know about interactions with other medicines?

Interactions with Other Medicines and Products

The interaction profile of Aceclofenac is officially documented to be similar to that of other Nonsteroidal Anti-inflammatory Drugs (NSAIDs), characterized primarily by pharmacokinetic changes and pharmacodynamic risk amplification.

Interaction Type Interacting Agents (Examples) Official Regulatory Statement
Formal Restriction Other NSAIDs (COX-2 inhibitors) Co-administration is formally advised to be avoided due to significantly increased gastrointestinal risk.
Timing Restriction Mifepristone Use is prohibited for 8 to 12 days following administration.
Exposure Increase Lithium, Digoxin, Methotrexate Aceclofenac may increase the plasma concentrations of these medicines by reducing their elimination.
Efficacy Reduction ACE Inhibitors, Diuretics May result in a reduced anti-hypertensive or diuretic effect.
Increased Toxicity Anticoagulants, Ciclosporin Enhances the effects of anticoagulants (increased bleeding risk) and increases the risk of nephrotoxicity with immunosuppressants.

Co-administration with food officially reduces the rate of absorption but does not alter the overall bioavailability of Aceclofenac. The risk of gastrointestinal bleeding is exacerbated by concurrent alcohol consumption. Interactions that affect renal function are noted to be of heightened clinical significance in elderly patients and those with pre-existing impaired cardiac, renal, or hepatic function.

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Mechanism of Action

Targeted Inhibition of Pro-inflammatory COX-2

Aceclofenac's primary action involves the preferential inhibition of the Cyclooxygenase-2 ( COX-2) enzyme, which is responsible for synthesizing inflammatory mediators like PGE2. By blocking this enzyme, the drug limits the production of these pro-inflammatory signals, thereby initiating a cascading suppression of inflammatory mediators, nociceptive signaling, and hypothalamic thermoregulation.

Active Metabolite and Cartilage Modulation

Beyond COX inhibition, Aceclofenac's active metabolite, 4'-hydroxyaceclofenac, engages a distinct mechanism relevant to joint structures. This metabolite actively suppresses the production of destructive enzymes ( MMP-1 and MMP-3) that break down cartilage components, while also stimulating the synthesis of protective glycosaminoglycans ( GAGs). This dual action modulates the ratio of cartilage degradation to synthesis, influencing the structural integrity of joint tissue components.

Modulation of Nociceptive and Thermoregulatory Signaling

The systemic effect of reduced prostaglandin levels impacts key physiological control centers. Decreased peripheral PGE2 synthesis lowers the sensitization of nociceptors (pain-sensing nerves). Simultaneously, inhibition of PGE2 in the hypothalamus helps to normalize the body's elevated temperature set-point by influencing hypothalamic signaling, thereby modulating the thermoregulatory system.

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Dosage and Administration Information

Aceclofenac 100 mg is administered exclusively via the oral route as a film-coated tablet. The maximum recommended daily intake for adults is 200 mg, which is typically achieved by taking the medicine in two separate 100 mg doses. This constitutes the standard twice-daily frequency pattern, with one dose generally taken in the morning and the other in the evening.

Administration should occur preferably with or after food and the tablets must be swallowed whole using a sufficient quantity of liquid. The procedural instruction dictates that the tablets must not be crushed or chewed.

The overall use protocol is governed by the principle of employing the lowest effective dose for the shortest duration necessary. For certain populations, there are specific deviations from the standard regimen. For instance, initiating treatment in patients with known hepatic impairment suggests an initial daily dose reduction to 100 mg. Dose adjustment is not generally required for older adults or for individuals with mild renal impairment, provided other conditions are stable. Use in the pediatric population is not recommended due to a lack of available clinical data. This structured approach ensures administration aligns with defined parameters.

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Recent Clinical Evidence

Research Evidence / Overview of Studies for Zerodol (Aceclofenac)


Evidence Structure for Osteoarthritis (OA) and Rheumatoid Arthritis (RA)

Research examined Aceclofenac in conditions characterized by physical discomfort using controlled studies, including Randomized Controlled Trials (RCTs) and systematic evidence reviews. These studies primarily focused on adult populations experiencing functional limitations and discomfort related to conditions like Osteoarthritis (OA) and Rheumatoid Arthritis (RA). Researchers monitored outcomes related to physical discomfort, such as patient-reported pain intensity, and outcomes related to daily functioning.

The study findings describe patterns observed in these clinical settings over defined time intervals, often up to 12 weeks. For OA, for example, studies explored the outcomes measured when Aceclofenac was evaluated alongside other nonsteroidal anti-inflammatory agents. The findings help contextualize patterns observed in the studies when Aceclofenac was observed in trials alongside comparator medications.


Evidence Structure for Ankylosing Spondylitis (AS) and Acute Pain

The evidence landscape for conditions associated with acute or disruptive episodes, such as Ankylosing Spondylitis (AS) and short-term pain situations, also includes controlled trials. For AS, studies monitored patient-reported outcomes describing perceived discomfort and functional capacity, with findings providing insight into short-term changes observed across the study population.

For acute pain scenarios, such as low back pain or acute dental pain, research explored short-term symptom changes, sometimes over only a few days or weeks. These studies monitored outcomes linked to inflammatory or irritative states and the need for additional pain relief. The findings describe group patterns observed over defined time intervals, but these short durations mean the research provides limited insight into long-term outcomes.


Long-Term Study Durations and Follow-up Periods

Research has explored short-term and intermediate-term changes in symptoms when Aceclofenac was studied for chronic conditions. Most controlled trials that evaluate symptomatic changes were conducted over periods of 4 to 12 weeks. This means the studies explored measured outcomes related to periods of increased symptom activity over defined, shorter time intervals.

However, the follow-up durations were limited for many studies. The long-term effects and durability of symptomatic patterns beyond a few months are not fully established. There is limited information for long-term outcomes, meaning research provides less context on how patterns related to physical discomfort or functional capacity may evolve over six months or a year or more.


Populations Included in Clinical Research

The existing research has primarily focused on adult subjects, including cohorts of older adults, with established diagnoses of the relevant conditions. The populations studied were typically those presenting with conditions characterized by fluctuating or episodic manifestations or conditions where symptoms may vary in intensity.

Data for certain groups remain insufficient. For example, research exploring Aceclofenac in individuals under 18 years of age is scarce, meaning the results apply only to the adult populations studied. Similarly, research for populations with certain comorbidity-defined groups or those who are pregnant or breastfeeding has specific limitations, and findings for these subgroups are uncertain.


Areas of Research Uncertainty and Study Limitations

The body of evidence contributes to the broader evidence landscape but has several limitations. Many key studies were active-comparator trials, meaning they evaluated outcomes when Aceclofenac was studied alongside another NSAID, rather than being solely compared against a placebo. This structure provides context but does not determine whether an individual will respond similarly.

The sample sizes for some studies, particularly those focusing on acute conditions, were modest. Evidence quality also varies across studies. As noted, long-term effects are not fully established, and follow-up durations were limited in much of the research, providing insufficient data regarding maintenance of outcomes related to daily functioning over extended periods.

Key Studies & References Product Information: Aceclofenac 100mg Film Coated Tablet (FECK-100 Zim Laboratories Limited)

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Frequently Asked Questions (FAQ)

Common questions about Zerodol (Aceclofenac) (FAQ)

Q: Is Zerodol the same as a regular over-the-counter painkiller?

A: No, Aceclofenac, the active ingredient in Zerodol, is definitively classified as a prescription-only medicine (POM). This means that, unlike many common over-the-counter (OTC) painkillers, it must be legally obtained with a prescription from a healthcare professional.


Q: Is Zerodol safe to use for a long period of time?

A: Regulatory warnings advise that any undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms. Official documents indicate that the risks associated with this medicine, particularly cardiovascular risks, may increase with both the dose used and the total duration of exposure.


Q: How long does it usually take for Zerodol to start working?

A: Official information regarding the medicine's absorption indicates that the highest concentrations in the blood—which are generally associated with the onset of action—are typically reached around one to three hours after taking the tablet.


Q: How long does the pain relief effect of one dose typically last?

A: The medicine has a mean elimination half-life of approximately four hours, which describes how long it takes for half of the medicine to be cleared from the bloodstream. The standard recommended administration is typically twice daily, a pattern consistent with the maintenance of therapeutic levels over a 24-hour period.


Q: Is there a risk of kidney damage from taking Zerodol?

A: The use of NSAIDs like Aceclofenac may, in some cases, cause a dose-dependent reduction in certain compounds (prostaglandins) and potentially precipitate renal failure. This risk is noted to be highest in individuals who already have impaired kidney or heart function, are taking diuretics (water pills), or are elderly. Official documents often note that these effects on renal function are generally described as being reversible upon withdrawal.


Q: Does Zerodol affect liver function or require liver monitoring?

A: Official safety information lists increased hepatic enzyme levels (a marker of liver function) as a common side effect. To take a precautionary measure, regulatory bodies advise that monitoring, which includes tests for hepatic (liver) function, is considered for patients receiving long-term NSAID therapy, especially if abnormal results persist or worsen.


Q: Can Zerodol cause dizziness or make a person feel sleepy?

A: Yes, official side effect listings confirm that effects on the nervous system are possible. Dizziness and drowsiness (sleepiness) are included in the documented adverse reactions reported in official product information.


Q: Is Zerodol safe for women who are pregnant or planning to be?

A: Use is strictly forbidden during the third trimester of pregnancy. For the first and second trimesters, official guidance is that the medicine should not be administered unless it is judged to be clearly necessary. Furthermore, the use of Aceclofenac may impair female fertility and is therefore generally not recommended for women who are actively attempting to conceive.


Q: Is it safe to use Zerodol while breastfeeding?

A: There is no official information available documenting whether Aceclofenac is secreted into breast milk. Regulatory guidance suggests that use should generally be avoided during lactation unless a healthcare provider determines that the potential benefit to the mother outweighs the possible risk to the infant.


Q: Can Aceclofenac affect fertility or the ability to become pregnant?

A: Official prescribing information states that the use of Aceclofenac may impair female fertility by potentially interfering with ovulation. For this reason, regulatory bodies formally advise that it is not recommended for women who are attempting to become pregnant.


Q: Is it possible for Zerodol to worsen certain heart conditions?

A: Yes, official warnings exist regarding use in patients with heart conditions. The medicine is formally contraindicated in patients with established severe cardiovascular disease, such as certain classes of Congestive Heart Failure or Ischaemic Heart Disease. Regulatory documents also note that the medicine may cause fluid retention and is associated with an increased risk of a heart attack.


Q: What is the difference between different brand names that contain Aceclofenac?

A: Different brand names for Aceclofenac products, such as Zerodol, typically contain the same active ingredient and are expected to have a similar effect on the body. Differences between brands are usually related to the inactive ingredients (excipients), coating, or form (e.g., tablet vs. powder).


Q: Can Zerodol be used for acute pain like a sprain or muscle strain?

A: Official therapeutic indications for this medicine include the symptomatic relief of pain and inflammation associated with conditions such as Osteoarthritis and Rheumatoid Arthritis. Regulatory documents confirm the medicine's use for addressing pain due to bone and soft tissue injury, which includes many acute pain scenarios.


Q: Can I take Zerodol if I am recovering from major surgery?

A: Official documents highlight that patients recovering from major surgery are among those at a greater risk of developing certain adverse effects, such as NSAID-related kidney failure, because their bodies are under stress. Regulatory documents indicate that use in these circumstances necessitates caution and clinical monitoring.


Q: Does Zerodol make a person's body retain water or cause swelling?

A: Yes, official safety documents indicate that a possible adverse effect reported in association with NSAID treatment is the presence of fluid retention and edema (swelling). This is a known systemic effect that can occur with medicines in this class.


Q: What is the risk of a heart attack or stroke associated with Aceclofenac?

A: Available data suggests that Aceclofenac, like other NSAIDs, may be associated with a small increased risk of arterial thrombotic events such as a heart attack or stroke. Regulatory documents indicate this risk may be heightened when the medicine is used at high doses and for long periods.


Q: Do other NSAIDs, like Ibuprofen or Diclofenac, work the same way as Aceclofenac?

A: Aceclofenac is classified within the Nonsteroidal Anti-inflammatory Drug (NSAID) class. Like other NSAIDs, it functions by inhibiting prostaglandin synthesis, which is a common action within the class. Structurally and metabolically, Aceclofenac is described as being similar to diclofenac and may carry a comparable cardiovascular risk profile to some selective inhibitors.


Q: Why does my doctor need to monitor my blood levels when I take Zerodol long-term?

A: For patients undergoing long-term treatment with NSAIDs, including Aceclofenac, regulatory bodies officially recommend periodic monitoring as a precautionary measure. This monitoring typically involves checking renal (kidney) function, hepatic (liver) function, and blood counts.


Q: Is there a risk of bleeding problems when taking Aceclofenac?

A: Yes, official safety warnings indicate that severe adverse reactions can include gastrointestinal haemorrhage (bleeding). The medicine is contraindicated (forbidden) in those with active bleeding, and its use may affect the way blood clots, potentially leading to prolonged blood clotting time.


Q: Does Aceclofenac come in different strengths or forms?

A: Aceclofenac is primarily available as a 100 mg film-coated tablet for oral use. In some regions, authorized product lists also show it is available in other presentations, such as a powder for oral suspension or a topical cream (gel) formulation.


Q: Are children allowed to take Zerodol or Aceclofenac?

A: Official regulatory guidance states that use in the paediatric population (individuals under 18 years of age) is not recommended. This exclusion is due to a lack of sufficient clinical data regarding the safety and effectiveness of the medicine in this age group.


Q: What is the recommended period of time for continuous use of Zerodol?

A: Regulatory guidance dictates that to minimize the risk of undesirable effects, the medicine should be used for the shortest duration necessary to achieve control of symptoms, consistent with the principle of using the lowest effective dose.


Q: Can taking Aceclofenac cause my blood pressure to go up?

A: Caution is specifically required when this medicine is used in patients who have pre-existing uncontrolled hypertension (high blood pressure). The medicine has been reported to cause fluid retention and edema, which can affect how well blood pressure is controlled.


Q: Can Zerodol affect a person's vision or cause visual disturbances?

A: Yes, official safety documents include visual disturbances as a possible adverse reaction. This is generally classified as a rare event.


Q: What are the possible signs of the medicine not being tolerated by the body?

A: Signs of intolerance can align with the officially documented severe side effects, such as the first appearance of a skin rash or mucosal lesions (sores), signs of gastrointestinal bleeding (e.g., black stools or vomiting blood), or severe allergic reactions like swelling of the face or difficulty breathing.

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How should Zerodol (Aceclofenac) be stored and disposed of?

Official Storage and Disposal Requirements for Aceclofenac

Storage of Aceclofenac (Zerodol) must follow the conditions specified in the official labeling to maintain product stability and safety.

Storage Conditions

  • Temperature: Store the product at ambient room temperature, generally not exceeding 30 C.
  • Protection: The medicine must be protected from light and moisture by remaining in its original package.
  • Child Safety: It is mandatory to keep Aceclofenac tablets out of the sight and reach of children.
  • Stability: The medicine must not be used after the expiry date printed on the packaging, even if stored correctly.

Disposal Instructions

  • Wastewater Prohibition: Unused or expired tablets must not be disposed of via household waste or wastewater (e.g., flushing down the toilet).
  • Required Procedure: Disposal must occur in accordance with local pharmaceutical waste requirements, often by returning the product to a pharmacy or designated take-back program.

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

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