Febrectal

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Febrectal

Medically reviewed

Marina Burgos

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 Febrectal

Property Description
Active ingredient Acetaminophen (Paracetamol)
Form Suppository
Pharmacological class Analgesic and Antipyretic
Common use Relief of pain and fever
Origin Synthetic compound

What Type of Medicine is Febrectal?

Febrectal is a dedicated mono-substance pharmaceutical preparation primarily classified as both an analgesic (pain reliever) and an antipyretic (fever reducer). The active substance, Acetaminophen, places it within the broad class of non-opioid analgesics. It is distinctly presented in a suppository format for systemic absorption via rectal administration, which is recognized as an alternative route when oral dosing is unsuitable, such as when a patient is experiencing nausea or is unable to swallow.

The Composition: Is Febrectal the Same as Paracetamol?

Yes, the sole active ingredient in Febrectal is Acetaminophen, which is the identical chemical substance known across many regions as Paracetamol. This ingredient is a synthetic compound, chemically derived rather than naturally sourced. The suppository itself is a combination of this active substance and an inert fatty vehicle, known as the suppository base. The simple, single-active-ingredient formulation contains Acetaminophen for its indicated purposes.

Core Function: What General Symptom Does Febrectal Address?

The core function of Febrectal is the symptomatic relief of mild to moderate discomfort and the active reduction of elevated body temperature, which are the defining effects of its analgesic and antipyretic classification. For instance, it provides a typical, neutral use scenario for children or adults who require fever reduction when standard oral routes are not tolerated. The Acetaminophen component works centrally to regulate temperature and pain perception, a mechanism that contributes to thermal stability and improved comfort.

Regulatory References

  1. MedlinePlus Drug Information

What side effects are possible with Febrectal?

Possible Side Effects and Safety Information

This section summarizes the officially documented adverse reactions and safety information for Febrectal (paracetamol/acetaminophen suppositories) as regulated by government health authorities.

Frequency-Classified Adverse Reactions

Adverse effects are generally documented as rare and typically mild. However, certain serious reactions are noted for surveillance. Adverse events are officially categorized based on their estimated frequency:

  • Rare: Adverse effects associated with the active substance, paracetamol, generally.
  • Occasionally (Uncommon): Skin rashes and other forms of hypersensitivity reactions.
  • Very Rare: Serious, potentially life-threatening skin reactions, including Fixed Drug Eruption (FDE).

System-Organ-Class Safety Grouping

The following are examples of body systems (System-Organ-Classes) where adverse reactions have been reported:

  • Haematological Reactions: Blood disorders such as thrombocytopenia, leucopenia, and neutropenia.
  • Skin and Subcutaneous Tissue Disorders: Includes exanthema (skin eruption), urticaria (hives), and angioedema (swelling).
  • Hepatobiliary Disorders: Liver damage and hepatic necrosis, particularly following dose exceedance.
  • Gastrointestinal Disorders: Localized soreness or redness of the rectal mucous membrane has been reported with suppository use.

Serious Safety Considerations and Restrictions

Government regulatory documents identify specific circumstances and populations requiring caution or presenting higher risk:

  • Serious Skin Reactions: Due to the very rare occurrence of severe skin reactions, immediate reporting and evaluation are mandated upon suspicion.
  • Concomitant Use: It is strictly restricted from use alongside other products containing paracetamol to prevent exceeding the maximum safe daily dose.
  • High-Risk Populations: Caution is advised, and administration should be undertaken with care, in patients with pre-existing impaired liver function (including non-cirrhotic liver disease, chronic malnutrition, and chronic alcoholism), severe renal impairment, or conditions like dehydration and sepsis.
  • Specific Drug Interactions: A risk of high anion gap metabolic acidosis (HAGMA) is associated with concomitant administration with flucloxacillin, especially in patients with pre-existing risk factors.

Overdose and Emergency Response

Overdose: When to Seek Help

Febrectal contains paracetamol (acetaminophen), and overdose carries a significant risk of severe, delayed organ damage. Immediate medical attention is essential and is required urgently for all suspected overdoses, regardless of the presence or severity of early symptoms.

Documented Overdose Manifestations

The initial symptoms of a paracetamol overdose are often mild, non-specific, and do not correlate with the final outcome. These may include pallor, nausea, vomiting, anorexia, and abdominal pain within the first 24 hours. However, the most severe outcome is delayed hepatic failure (liver damage), which may lead to encephalopathy, coma, and be life-threatening. Acute renal failure and coagulopathy are also documented severe outcomes.

Emergency Response and Treatment

Urgent medical attention must be sought immediately, even if the patient feels well. This is critical because liver toxicity progresses silently. Treatment should align with established national guidelines and focuses on the timely administration of the specific antidote, N-acetylcysteine (NAC), ideally within eight hours of ingestion to maximize protective effect. Hospital monitoring of blood plasma levels and liver function tests is required to assess severity and guide management.

Population-Specific Notes

The risk of severe overdose is greater for individuals with pre-existing hepatic impairment or those with factors leading to glutathione depletion, such as chronic alcoholism.

Therapeutic Uses of Febrectal

Febrectal is commonly used to help manage symptoms related to systemic imbalance and physical discomfort. The medication is primarily applied across domains where short-term symptom management is appropriate.

Supportive Relief for Fever and Pain

Febrectal is commonly used to address elevated body temperature (fever) during conditions involving episodic or fluctuating manifestations, such as the common cold or flu. Furthermore, it is relevant for easing mild to moderate pain that may interfere with daily functioning, including headaches, temporary muscular aches, and discomfort associated with menstrual periods. This symptomatic support contributes to easing the overall symptom load, may assist with easing distress, and helps patients cope more steadily with difficult episodes.

Situational Symptom Management

This suppository form is considered relevant in situations requiring additional symptomatic assistance, specifically when patients cannot tolerate or retain oral medication due to vomiting or severe nausea. This alternative route assists with maintaining functional stability by helping to provide essential fever and pain support.

Quick Fact: Relief for Acute Discomfort Febrectal is typically used for the temporary management of fever and mild to moderate pain, applicable in scenarios where additional management of discomfort is required.

Regulatory References

  1. MedlinePlus Medical Encyclopedia

Eligibility and Restrictions for Use

Febrectal, a medicine containing paracetamol, is intended for specific populations based on weight, age, and pre-existing medical conditions.

Populations Who Must Not Use Febrectal (Contraindications)

Use of Febrectal is strictly prohibited if a patient has:

  • Hypersensitivity or Allergy: A known allergy to paracetamol (acetaminophen) or any other component listed in the medicine's formulation.
  • Severe Hepatic Dysfunction: Any diagnosis of severe liver failure or severe active liver disease.

Eligibility Restrictions and Special Considerations

Patient Group Eligibility Status & Restriction
Infants/Children Eligible only for certain formulations (e.g., 150 mg suppository is for those weighing ge 10 kg; the 300 mg suppository is typically for those ge 20 kg). Not recommended for children under the minimum specified weight/age for the specific product strength.
Liver/Kidney Impairment Use requires caution and medical supervision due to increased risk of toxicity. Contraindicated in severe hepatic dysfunction.
Glutathione Depletion Patients with conditions like chronic alcoholism, severe malnutrition, or sepsis are at higher risk of overdose; maximum doses and continuous use are not recommended.
Pregnancy/Lactation Paracetamol may be used during pregnancy if clinically necessary, and is compatible with breastfeeding when used at therapeutic doses.
Other Medications Must not be used concurrently with any other product containing paracetamol to prevent exceeding the safe daily limit.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile for Febrectal, which contains Acetaminophen (Paracetamol), is based on officially documented pharmacokinetic and pharmacodynamic outcomes as stated in government regulatory documents. The information focuses strictly on documented interaction patterns and associated label restrictions.

Prohibited Combinations and Substance Interactions

  • Other Acetaminophen Products: Official regulatory information establishes an absolute prohibition on co-administering Febrectal with any other prescription or nonprescription medicine containing acetaminophen due to the documented, severe risk of hepatotoxicity.
  • Alcohol (Ethanol): Severe liver damage is an officially documented risk for adults consuming three or more alcoholic drinks daily while using this product. This risk is noted to be greater in populations with chronic alcoholism or who are glutathione deplete.

Pharmacokinetic and Pharmacodynamic Effects

Interacting Substance/Class Officially Documented Interaction Outcome
Oral Anticoagulants (e.g., Warfarin) Enhanced anticoagulant effect and increased risk of bleeding, particularly with prolonged regular use.
Hepatic Enzyme Inducers (e.g., Phenytoin, Carbamazepine) Reduced Acetaminophen exposure and an officially documented increased risk of severe liver damage due to altered metabolism.
Colestyramine Reduced absorption of Acetaminophen. A minimum of one hour separation in administration time is required to mitigate this effect.
Metoclopramide / Probenecid Increased rate of absorption (Metoclopramide); reduced clearance leading to higher plasma levels (Probenecid).

The drug's official interaction structure mandates strict adherence to these regulatory constraints to manage documented risks associated with metabolic change, altered clearance, and potentiation of bleeding risk.

Mechanism of Action

Pharmacodynamic Mechanism

Febrectal's active compound, X-101, functions as a cyclooxygenase (COX) inhibitor. This interaction establishes its core biological target and pharmacologic effect. The compound operates by blocking the enzyme-mediated conversion of arachidonic acid into various prostaglandins and related autocoids. This key inhibition of prostaglandin synthesis occurs locally at peripheral sites and centrally within the nervous system.

The resultant molecular effect is a systemic pathway modulation that influences local cellular activity. This leads to a mechanistic cascade: a measurable decrease in the activation threshold of peripheral nociceptors and a simultaneous blunting of central afferent signal transmission. This physiological modulation constitutes the drug's mechanism without reference to clinical outcomes.

Dosage and Administration Information

Administration and Dosing of Febrectal Suppositories

Febrectal, which contains the active ingredient acetaminophen (paracetamol), is a pharmaceutical preparation with established instructions for its administration and dosing. The usage guidelines below follow established prescribing parameters for this medication.

Administration Scope and Route

Feature Standard Instruction
Route Rectal Use Only (Suppository)
Frequency Every 4 to 6 hours as needed
Minimum Interval 4 hours between doses
Preparation Remove wrapper; may cool or wet the tip for easier insertion
Dose Form Only whole suppositories should be administered

Dosing Principles

Dosage is determined by weight for children and adolescents under 50 kg. The general principle is to use the lowest effective dose for the shortest duration necessary. Dosing adheres to specific limits to prevent exceeding established thresholds:

  • Pediatric Dosing: Standard dose is typically 10 to 15 mg of acetaminophen per kilogram of body weight (mg/kg) per dose.
  • Adult Dosing: The unit dose is generally 325 to 650 mg up to 1000 mg, depending on weight and specific guidance.
  • Maximum Daily Dose: Total intake must not exceed 4000 mg (4 g) in 24 hours for standard adult use, or 60 mg/kg for children.

Adjustments for Specific Populations

Standard prescribing parameters include modifications to the schedule for specific conditions. For patients with severe renal impairment, the dosing interval is prolonged to 6 or 8 hours. The dose may also require reduction or interval prolongation in cases of hepatic impairment (liver problems).

Recent Clinical Evidence

Research evidence for the suppository formulation of Acetaminophen focuses primarily on its evaluation for two core areas: antipyretic action (fever reduction) and analgesic action (mild to moderate pain relief). This body of work includes randomized controlled trials (RCTs), systematic reviews, and comparative studies.

For antipyretic action, studies were conducted in pediatric and adult populations during episodes of elevated body temperature, monitoring temperature change over acute observation periods, typically up to six hours. For analgesic action, research explored its use in acute pain settings, such as multi-modal analgesia protocols for post-operative patients, monitoring changes in pain intensity scores and the need for supplemental analgesic medication. Findings across trials indicate that these outcomes were measured in the observed populations.

A key area of research uncertainty involves the comparison between the rectal and oral routes of administration. Studies describe patterns suggesting the rectal formulation's absorption rate was measured as slower and less predictable, achieving lower peak concentrations in the bloodstream than the oral route. This inconsistent absorption introduces variability into the study findings, and results regarding the true comparative speed of action for fever reduction have been mixed.

Overall, the evidence base is limited to short-term studies, and there is insufficient information for long-term outcomes or the durability of observed symptom patterns. Data for certain groups, such as older adults or individuals with multiple comorbidities, remain insufficient in the core regulatory evidence base, and findings generally apply only to the populations studied.

Key Studies & References

  1. Acetaminophen (Paracetamol) Drug Information: Clinical Indications, Absorption Kinetics, and Dosing Uncertainty

Frequently Asked Questions (FAQ)

Common questions about Febrectal (FAQ)


Q: How quickly does Febrectal usually start working?

Pharmacokinetic data from studies on the active ingredient indicate that the time to reach the highest level in the bloodstream is typically measured around 2 to 3 hours after rectal administration. Therapeutic concentrations for fever reduction have been observed within 1 to 2 hours according to official information.


Q: How long can the effects of Febrectal typically last?

Regulatory guidance for Febrectal specifies that the medicine should not be repeated more frequently than every four hours. This recommended minimum interval implies that the duration of symptomatic relief is expected to typically last within the range of four to six hours.


Q: Can Febrectal cause stomach upset?

Adverse event reporting for the active ingredient indicates that general gastrointestinal effects, such as nausea or abdominal pain, are considered extremely uncommon when the medicine is used at recommended doses. Localized soreness or redness of the rectal mucous membrane has been reported in association with suppository use.


Q: What are the signs of an allergic reaction to Febrectal?

Official patient safety information describes the signs of a serious allergic reaction to the active ingredient. These can include a rash, itching or swelling, especially of the face, tongue, or throat. Severe dizziness and difficulty breathing are also noted, indicating the serious nature of the reaction.


Q: Can people with liver issues use Febrectal?

Official guidelines strictly prohibit the use of Febrectal in cases of severe liver failure or severe active liver disease, which is classified as a contraindication. For other pre-existing liver issues or impaired function, regulatory documents advise caution, and administration should only be undertaken with medical supervision.


Q: Is it normal to have mild discomfort at the application site?

Official safety information notes that localized soreness or redness of the rectal mucous membrane has been reported as a gastrointestinal event associated with suppository use. Patients may experience this mild discomfort at the site of administration.


Q: What evidence exists for using Febrectal in fever reduction?

The official regulatory evidence base includes specific clinical studies, such as randomized controlled trials. These trials have examined the antipyretic action (fever reduction) of the active ingredient, primarily monitoring changes in elevated body temperature over acute observation periods.


Q: Is there a maximum period of time Febrectal is typically used?

Official regulatory guidance advises that Febrectal should typically not be used for fever for more than three days without first consulting a medical professional. This limitation aligns with the general principle of using the lowest effective dose for the shortest duration necessary.


Q: Are there different strengths of Febrectal available?

According to the official product information, Febrectal suppositories are described as being available in multiple strengths. These different strengths are available to accommodate various individual dosing requirements, typically based on age and body weight.


Q: Is Febrectal considered a non-steroidal anti-inflammatory drug (NSAID)?

Official documentation classifies the active ingredient in Febrectal as an analgesic (pain reliever) and an antipyretic (fever reducer). It is structurally and pharmacologically distinct from Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) because it exhibits only minimal anti-inflammatory activity.


Q: Can Febrectal be used for a common cold?

The official indicated uses for Febrectal are the relief of pain and the reduction of fever. These are effects that address symptoms often associated with conditions such as the common cold.


Q: Why is Febrectal sometimes used for children?

The suppository route of administration is officially recognized as a way to deliver the active ingredient when a patient, such as a child, is unable to take oral forms. This may be due to factors like vomiting, nausea, or a recent surgical procedure.


Q: Is it common to feel sleepy after taking Febrectal?

Drowsiness or sleepiness is not typically listed among the common adverse effects described in regulatory documents. Official patient safety information does, however, note extreme tiredness as a potential symptom associated with an overdose.


Q: How is Febrectal classified by major health agencies?

Febrectal is formally classified by regulatory authorities based on its core functions. It is considered an analgesic, meaning it provides pain relief, and an antipyretic, meaning it helps reduce fever.


Q: Are there long-term studies available for Febrectal use?

The available regulatory evidence base for the active ingredient is limited to short-term studies and observation periods. Official labels explicitly note that there is insufficient information regarding long-term outcomes or the durability of effect beyond acute use.


Q: Does Febrectal work differently depending on the age of the person?

Official dosing instructions are dependent on the body weight of children and adolescents. Furthermore, regulatory guidance recommends caution and potential dosing adjustments for patients with impaired kidney or liver function, conditions which can be more prevalent in older patients.


Q: Can Febrectal be used by people with asthma?

Official product information notes that the active ingredient is generally well tolerated by individuals with a known hypersensitivity to acetylsalicylic acid (aspirin). This is a consideration for some patients with asthma who may have related sensitivities.


Q: Is there a possibility of becoming dependent on Febrectal?

Febrectal is classified as a non-opioid analgesic. Official documentation for the active ingredient does not describe a potential for physical dependence associated with its use at the recommended therapeutic doses.


Q: How long after using Febrectal can I take another medicine?

The official regulatory minimum interval between separate doses of Febrectal itself is four hours. For co-administration with other medicines, such as colestyramine, specific one-hour separation requirements are noted in the product information to avoid reduced absorption.


Q: Is there a specific mechanism mentioned in official documents for how Febrectal reduces discomfort?

Official documents describe the mechanism as a systemic pathway modulation. This modulation is described as influencing the activation threshold of peripheral pain receptors (nociceptors) and having an effect on central pain signal transmission.


Q: What official documents describe the ingredients of Febrectal?

The exact chemical substance and composition of Febrectal are described in official regulatory documents. These include the FDA-approved label, often available via DailyMed, and the EMA Summary of Product Characteristics (SmPC).


Q: Is it necessary to avoid driving while using Febrectal?

Official regulatory information typically addresses the product's effect on the ability to drive and use machines. The official product information does not contain a specific warning advising users to avoid driving or operating machinery.


Q: What are the main topics discussed in clinical trials for Febrectal?

Official documentation states that the clinical research focuses primarily on evaluating two core areas. These areas are the drug's antipyretic action (the reduction of fever) and its analgesic action (the relief of mild to moderate pain).

How should Febrectal be stored and disposed of?

Febrectal suppositories must be stored in accordance with specific regulatory requirements to ensure product integrity.

Storage Conditions

The required storage temperature must not exceed 25 C. The medicine must be kept in the original package, and the suppository should only be removed from the blister packaging immediately before use.

Mandatory safety instructions require that the product be kept out of the reach and sight of children.

Disposal Requirements

Official instructions specify that any unused product or waste material must be disposed of in accordance with local requirements. It is essential for environmental protection that Febrectal should not be disposed of via wastewater or regular household trash.

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

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