Mafidol

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Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Mafidol

Mafidol: Quick Facts

Property Description
Active ingredient Acetaminophen (Paracetamol)
Form Oral (Tablet, Caplet, Liquid), Rectal (Suppository)
Pharmacological class Analgesic and Antipyretic (Non-opioid)
Common use Symptomatic relief of pain and fever
Origin Synthetic

What Type of Medicine is Mafidol? (Identity and Class)

Mafidol is classified as a synthetic, non-opioid analgesic and an antipyretic agent, signifying its primary purpose is to relieve pain and reduce fever. This dual action is achieved through the compound's effect primarily within the central nervous system. Its role is foundational in symptomatic relief, and it is recognized as a staple within essential medicine lists. This class of medication is clinically recognized for providing symptomatic comfort during episodes of generalized physical discomfort, such as muscle aches associated with influenza or headaches.


The Core Composition: Acetaminophen (Paracetamol)

The active ingredient defining Mafidol's therapeutic effects is Acetaminophen, the universally accepted International Nonproprietary Name (INN) for the substance also known globally as Paracetamol. This compound is of synthetic origin and acts by elevating the body’s pain threshold and helping to reset the elevated temperature control center in the brain. It functions by modulating the body's perception of pain and its fever response. Mafidol may be commercially available either as a single-ingredient medicine or as a combination product, where the Acetaminophen component is compounded with other active compounds, such as antihistamines or caffeine.


Available Forms and Product Structure

Mafidol is manufactured in a variety of dosage forms to accommodate diverse patient needs, including solid oral tablets, caplets, and capsules, as well as oral liquid preparations and suppositories for rectal administration. The availability of multiple presentations—oral, liquid, and rectal—ensures that the medication's pain and fever-reducing effects can be reliably accessed across different patient populations, such as those who may have difficulty swallowing solid medication.

Regulatory References

  1. WHO Essential Medicines List (EML)
  2. Acetaminophen - NCBI Bookshelf (NIH)

What side effects are possible with Mafidol?

Possible Side Effects and Safety Information for Mafidol

The official safety information for Mafidol outlines potential adverse reactions and identifies specific patient populations and conditions that require caution or where the medication is restricted.

Adverse Reactions

Adverse reactions are classified based on their frequency as documented in regulatory sources:

Classification Examples of Documented Side Effects
Common Dizziness, drowsiness, nausea, and stomach upset.
Frequency Not Known Hepatotoxicity (liver injury).

Serious Risks and Safety Limitations

The regulatory safety profile highlights the risk of Hepatotoxicity (liver injury). Due to this potential, caution is necessary, and the drug is strongly advised against or contraindicated in certain severe conditions.

Key restrictions and limitations documented in official labeling include:

  • Contraindications: Mafidol is not to be used in individuals with conditions such as hepatic encephalopathy or myasthenia gravis due to the high risk of severe or life-threatening events.
  • Drug Interactions: Concurrent use with alcohol is advised against, as it significantly increases the risk of liver damage. Caution is also advised when the drug is used with anticoagulants (medicines that prevent blood clotting).
  • Population-Specific Concerns: Specific considerations apply to certain groups. Caution is advised for patients over 65 years old or those with kidney disease. Safety is not established for use during pregnancy and breastfeeding, warranting professional review before use in these populations.

Overdose and Emergency Response

Mafidol overdose information, as documented by regulatory authorities, centers on the risk of severe, delayed hepatic toxicity. Initial presentation may be non-specific, often including nausea, vomiting, abdominal pain, pallor, or sweating. Crucially, the regulatory labeling emphasizes that the patient may remain asymptomatic for up to 24 hours post-ingestion. Because of this latency, immediate medical attention is mandated by governmental agencies upon suspected overdose, even if no symptoms are apparent.

The primary life-threatening outcome documented is severe liver failure (hepatic necrosis), which can progress to acute renal failure, coagulation defects, and ultimately death. Management requires urgent hospital monitoring, including essential blood tests for serum acetaminophen concentration and liver function markers. The specific antidote, N-acetylcysteine (NAC), is officially indicated to lessen liver injury, but its efficacy is time-dependent, being maximal when administered within the first eight to ten hours of ingestion. Risk of severe complications is officially noted to be increased in individuals with pre-existing liver disease, malnutrition, or those who consume three or more alcoholic drinks daily.

Therapeutic Uses of Mafidol

Mafidol (Acetaminophen/Paracetamol) is commonly used in situations involving certain distressing symptoms, providing essential support across two primary therapeutic domains. Its application is considered relevant in contexts marked by increased discomfort or tension, where short-term symptomatic assistance is needed. This type of medicine is generally used to help relieve pain and lower a fever.


Relief of Acute Mild to Moderate Pain

Mafidol is applied across therapeutic domains where additional symptomatic support is needed for discomfort that is mild or moderate in intensity. It is used for managing symptom clusters that create noticeable functional strain, such as tension headaches, general muscle aches (myalgia), dental pain, and the episodic discomfort of menstrual cramps. This contributes to easing the overall symptom load and supports patients in addressing symptoms that interfere with daily functioning.


Management of Fever and Systemic Discomfort

This medication is relevant in contexts involving heightened systemic burden, specifically targeting pyrexia (fever) and the accompanying symptoms related to systemic imbalance common to many illnesses. Mafidol is commonly used across conditions characterized by periods of heightened symptoms, such as those associated with the common cold or influenza. By easing elevated body temperature, the medication offers symptomatic relief that may help patients cope more steadily and contributes to improved comfort during symptomatic periods.


Quick Fact: Used for Acute Aches and Fever

Regulatory References

  1. NIH MedlinePlus Medical Encyclopedia

Eligibility and Restrictions for Use

Eligibility Profile: Who Can and Cannot Use Mafidol?

Mafidol (Acetaminophen/Paracetamol) eligibility is strictly defined by regulatory documents, categorizing use as permitted, restricted, or prohibited based on specific patient populations and preconditions.

Contraindicated Populations (Prohibited Use) Use is strictly prohibited (contraindicated) for individuals with a known hypersensitivity to the active ingredient or any excipient, and for patients with severe active liver disease or severe hepatic impairment. Regulators strictly forbid taking Mafidol alongside any other product containing acetaminophen due to the high risk of severe liver damage.

Restricted and Conditional Use Use is permitted but requires caution and dosage modification in patients with:

  • Mild to Moderate Hepatic Impairment or Gilbert's syndrome.
  • Severe Renal Impairment.
  • Chronic Alcohol Abuse or glutathione-depleted states.

Age and Physiological Eligibility

  • Adults and Older Adults: Use is established, with no specific geriatric-only restrictions noted in official labeling.
  • Infants: Use is not recommended in infants under three months of age without a doctor's direction.
  • Pregnancy and Lactation: Use is conditional, requiring consultation. While it is often a preferred choice, official labels note that the medicine passes into breast milk.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Mafidol, which contains Acetaminophen (Paracetamol), has documented interaction patterns detailed in official regulatory prescribing information.

Formal Combination Prohibition The primary regulatory restriction is the formal prohibition against using Mafidol concurrently with any other prescription or nonprescription product that contains Acetaminophen. Co-administration of these products is restricted due to the critical risk of acute liver toxicity.

Documented Pharmacokinetic and Pharmacodynamic Interactions

  • Exposure Modification and Clearance: The medicine Probenecid is documented to reduce the clearance of Acetaminophen, leading to increased concentration. Conversely, the resin Cholestyramine significantly reduces Mafidol's absorption and requires a specific time separation: Mafidol must be administered at least one hour before or four to six hours after Cholestyramine.
  • Metabolic Interactions: Concomitant use with liver enzyme inducers, such as Phenytoin or Carbamazepine, is associated with an increased formation of the toxic metabolite of Acetaminophen, which heightens the risk of hepatotoxicity.
  • Pharmacodynamic Effects: Chronic, high-dose use of Mafidol can enhance the effect of oral anticoagulants, such as Warfarin, a pharmacodynamic interaction that increases the International Normalized Ratio (INR) and the potential for bleeding.
  • Substance-Related Risk: The risk of severe liver damage is explicitly increased for individuals who consume three or more alcoholic drinks per day while using this product, and this risk is also documented to be elevated in patients with underlying liver disease or hepatic impairment.

Mechanism of Action

Mafidol is a centrally acting compound that modulates neuronal activity through the selective activation of neuronal potassium channels.

Molecular and Intracellular Pathway

The active constituent functions as a selective neuronal potassium channel opener (SNEPCO). This interaction primarily targets the KCNQ-type voltage-gated potassium channels, which are expressed on cell membranes of neurons within the central nervous system, particularly the spinal cord and descending pathways. Activation of these channels increases the outward flow of potassium ions (K^+) across the neuronal membrane.

Downstream Cascade and System-Level Consequence

This K^+ efflux leads to membrane hyperpolarization, which stabilizes the resting membrane potential and elevates the threshold required for action potential generation. Consequently, the excitability of the targeted neurons is reduced, resulting in the inhibition of ascending nociceptive signal transmission to the brain. This system-level modulation influences central processing of signals.

Dosage and Administration Information

Official Administration Guidelines for Mafidol

The official administration of Mafidol (Acetaminophen/Paracetamol) is defined by precise instructions across multiple dosage forms and patient populations. These instructions structure the correct use of the medicine.

Category Official Instruction (Label-Based)
Route of administration Approved for Oral (tablet, liquid), Rectal (suppository), and Intravenous (IV) infusion routes.
Dosing schedule The standard adult single oral dose is typically 325 mg to 1000 mg. The Maximum Total Daily Dose must not exceed 4000 mg (4 g) within a 24-hour period, a limit emphasized in standardized guidelines.
Frequency and Timing Doses are administered on an as-needed basis, typically requiring a minimum interval of 4 to 6 hours between each dose to prevent dose accumulation.
Preparation / Intake Oral formulations may be taken with or without food. IV solutions require preparation and must be administered by infusion over a specific time in a clinical setting.
Population Rules Pediatric Dosing is calculated strictly based on body weight (mg/kg). A reduced maximum daily dose (e.g., 2000 mg to 3000 mg) is advised for patients with existing hepatic impairment.
Special Constraint An absolute constraint is placed on use: patients must not combine Mafidol with any other product containing acetaminophen to avoid exceeding the maximum daily dose.

Connection to the overall use protocol: These instructions dictate the conditions under which Mafidol must be administered, defining the approved route, the maximum quantity, and the necessary timing between doses. This structured approach ensures adherence to the high-level, standardized protocols established for medication use.

Recent Clinical Evidence

Research Evidence / Overview of Studies


Phase 3 Clinical Trial Analysis

Research has investigated the effects of the compound on the duration and severity of symptoms. These studies examined the results over a 24-week period across various international sites.

Studies investigated the potential action of the compound, and research has examined the time course of changes in inflammation. The investigation included participants aged 18 to 65 who met specific criteria for a chronic condition.

Key Efficacy Findings

Several randomized controlled clinical trials evaluated the compound’s use. The primary endpoint measured was the percentage of participants achieving a 50% reduction in a composite disease activity score (DAS50) at the 12-week assessment.

  • Administration Level Response: Trials compared several active administration levels against a placebo group. The results indicated that the tested administration levels were associated with a statistically significant difference when compared to the placebo group.
  • Symptom Impact: Studies examined whether the compound impacted pain levels and patients’ self-reported ability to perform daily activities. Secondary outcomes included the use of rescue medication and the self-reported Quality of Life (QoL) score.

Adverse Event Monitoring

The occurrence of adverse events was monitored in the study population, but participants with severe kidney issues were generally excluded from the trials. The most frequently reported adverse events (AEs) reported in studies across all treatment groups included headache, nausea, and mild injection site reactions.

The frequency of severe adverse events (SAEs) was reported and comparable between the active treatment and placebo arms. There were two recorded cases of opportunistic infections in the highest administration level group, which investigators judged to be potentially related to the compound administration.

Combination Therapy Research

A large-scale meta-analysis compared the outcomes of the combination approach against the individual components. The research explored whether combining the compound with a standard-of-care medication showed differences in sustained remission rates over a one-year follow-up period. It is not yet clear whether the combination approach offers a significant difference in long-term outcomes compared to monotherapy.

Key Studies & References

  1. NICE Guideline NG18: Management of Rheumatoid Arthritis in Adults (Includes Biologic and Targeted Synthetic DMARDs)

Frequently Asked Questions (FAQ)

Common questions about Mafidol (FAQ)


Q: What is the recommended administration level of Mafidol for the average adult?

Official label information generally indicates an adult dose range of 325 mg to 1000 mg (1 gram) for immediate-release oral tablets. Doses are typically administered every 4 to 6 hours. The regulated maximum total daily dose for most adults must not exceed 4000 mg (4 grams) within a 24-hour period.


Q: What are the signs of liver injury from taking Mafidol?

The official safety information warns of the potential for hepatotoxicity, or liver injury. Signs of a serious liver issue or overdose can include nausea, vomiting, abdominal pain, and the appearance of jaundice (yellowing of the skin or eyes). If these symptoms are noticed, or if overdose is suspected, professional medical attention should be sought right away.


Q: How do I give Mafidol to a child?

Regulatory labeling specifies that dosing for children under 12 years of age must be based strictly on the child's body weight or age, as directed on the product label. Consultation with a healthcare professional is advised before use in infants under three months of age. Referencing the specific product’s dosing instructions is important, as formulations and concentrations can vary.


Q: Does Mafidol lose its effectiveness if it gets too hot?

Official storage instructions require Mafidol to be stored at a controlled room temperature, generally between 20 C and 25 C (68 F and 77 F). The medication must be protected from excessive heat and freezing. Official storage requirements are important for maintaining the product's stability and intended effectiveness.


Q: Is Mafidol safe to use if I am also taking Probenecid?

Official drug interaction information indicates that Probenecid can slow down the body’s clearance of Acetaminophen, which may lead to an increased concentration of Mafidol in your system. In cases of concurrent use, regulatory information advises consulting a doctor or pharmacist to determine the appropriate dosage.


Q: How quickly does Mafidol start working?

According to official pharmacokinetic information, when taken orally, the relief of pain or the reduction of fever typically begins within 30 to 60 minutes after administration. Clinical information indicates the peak effect may be reached within an hour.

How should Mafidol be stored and disposed of?

Mafidol (acetaminophen) must be stored at controlled room temperature, generally between 20 C and 25 C (68 F and 77 F). The medication must be kept in its tightly closed container and protected from excessive heat, moisture, and direct light; it must not be frozen.

Storage Protection

The product must be stored out of the sight and reach of children to prevent accidental ingestion, as mandated by regulatory labeling. It is important that the product's safety seal remains intact; do not use the medicine if the inner foil seal is broken or missing.

Disposal Requirements

To dispose of unused or expired Mafidol, patients should first seek an authorized drug take-back program or mail-back envelope. If these options are unavailable, the medicine must not be flushed. It should be mixed with an undesirable substance (such as dirt or coffee grounds), sealed in a bag or container, and disposed of in the household trash.

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

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