Termofren

Quick links to important sections

Termofren

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 Termofren

Termofren is a widely recognized pharmaceutical product categorized within the antipyretic (fever-reducing) and analgesic (pain-relieving) pharmacological class. It is intended for symptomatic relief of general discomfort, such as mild to moderate pain and elevated body temperature.


Quick Facts

Property Description
Active Ingredient Paracetamol (Acetaminophen)
Common Forms Oral Solution, Capsule
Pharmacological Class Antipyretic and Analgesic
Primary Use Symptomatic relief of pain and fever
Origin Synthetic

Composition and Class

The essential component and primary active ingredient in Termofren is Paracetamol (the International Nonproprietary Name, or INN), also known as Acetaminophen. This chemically synthesized substance is the core agent that defines the medicine’s classification as a non-opioid pain reliever. Termofren is generally grouped with aniline analgesics and is used for providing short-term pain relief.

Form and General Purpose

Termofren is commonly manufactured for administration via the oral route, typically available as an oral solution or capsule. The purpose of Termofren is to provide temporary comfort by addressing physical symptoms like general body aches and fever associated with common illnesses. The medicine is a synthetic product, meaning its active component is created entirely through controlled chemical synthesis, which ensures consistent quality and purity for therapeutic use.

Regulatory References

  1. Acetaminophen (Paracetamol) Drug Information

What side effects are possible with Termofren?

Possible Side Effects and Safety Information

The official safety profile for Termofren is based on regulatory documentation that categorizes potential risks according to how often they occur and which body systems are affected.

Serious Adverse Reactions

Official regulatory information emphasizes the risk of serious cardiovascular thrombotic events, which can include myocardial infarction (heart attack) and stroke. The risk for these serious events may increase with the duration of use. Additionally, serious gastrointestinal events—such as bleeding, ulceration, and perforation of the stomach or intestines—are documented as potential risks.

Common and Uncommon Side Effects

Adverse reactions are formally categorized by frequency (e.g., Common, Uncommon, Rare) and grouped by System-Organ-Class (SOC). These SOC groupings include:

  • Gastrointestinal disorders
  • Nervous system disorders
  • Skin and subcutaneous tissue disorders
  • Hepato-biliary disorders

Safety Restrictions and Populations

Termofren is contraindicated (should not be used) for the treatment of peri-operative pain immediately following Coronary Artery Bypass Graft (CABG) surgery. Use is also formally restricted in patients with active gastrointestinal bleeding or peptic ulcer disease.

Specific safety considerations are noted for certain populations. Regulatory documents advise for cautious use and monitoring in patients who have pre-existing conditions such as uncontrolled hypertension, heart failure, or existing edema, and recommend using the lowest effective dosage for the shortest duration consistent with therapeutic goals.

Overdose and Emergency Response

Overdose and when to seek help

The regulatory profile for Termofren (Paracetamol/Acetaminophen) overdose emphasizes the potential for delayed, progressive, and severe organ damage as the primary life-threatening risk. Consequently, immediate medical attention is required for any suspected overdose, even if the person is initially asymptomatic.

Documented Overdose Manifestations

Feature Regulatory Statements
Initial Presentations Early, non-specific symptoms may include nausea, vomiting, pallor, anorexia, and abdominal pain. These mild signs do not reflect the severity of the toxicity.
Severe Outcomes The critical complication is hepatic necrosis (liver cell death), which can lead to acute liver failure, hepatic encephalopathy, and coma. Acute renal tubular necrosis may also occur.
At-Risk Factors Official documentation notes that individuals with chronic alcoholism, pre-existing hepatic impairment, or malnutrition are at increased risk of severe toxicity, often at lower ingestion levels.

Emergency Actions Mandated by Regulators

Regulators consistently state that the antidote, N-acetylcysteine (NAC), is the required treatment and is most effective when administered within 8 to 10 hours of ingestion. Immediate hospitalization is necessary for definitive treatment and continuous monitoring of plasma concentration and liver function. Procedures like activated charcoal may be considered if presented early to reduce absorption.

Therapeutic Uses of Termofren

Termofren is commonly used to help with a range of symptoms related to physical discomfort and systemic imbalance. The core therapeutic role of the active ingredient involves easing elevated body temperature (fever) and supporting relief from mild to moderate pain. The medication is applicable in clinical settings that involve acute or unstable symptom patterns where short-term symptomatic assistance is needed.

It helps address symptoms that interfere with daily functioning, such as headache, toothache, musculoskeletal discomforts like backache, and menstrual pain. Furthermore, it is commonly used during episodes of heightened symptoms associated with colds and flu, specifically to ease general body aches and manage elevated body temperature. This supportive therapeutic approach assists with maintaining functional stability and supports general well-being during symptom fluctuations.


Quick Facts: Therapeutic Scope

Property Description
Symptom Scope Relief for mild to moderate pain and symptoms related to systemic imbalance (fever).
Clinical Context Commonly used in situations involving acute or episodic painful manifestations.
Patient Benefit Provides support that helps ease the overall symptom burden and assists with maintaining functional stability.

Regulatory References

  1. NIH MedlinePlus guidance

Eligibility and Restrictions for Use

Who Can and Cannot Use Termofren?

The eligibility for using Termofren is strictly defined by regulatory documents, focusing on patient health status and age.


Populations Who Must Not Use

Termofren is contraindicated for two major groups. It must not be used by patients with severe hepatic impairment or severe active liver disease. Use is also prohibited for individuals with a known hypersensitivity to the active substance, acetaminophen, or any other component in the formulation.


Established & Restricted Eligibility

Use of Termofren is established for adults, adolescents, and children two years of age and older. Regulatory information notes that no overall differences in safety were observed for older adults. The medicine is also considered suitable for use by breastfeeding mothers and is generally regarded as the analgesic of choice when needed during pregnancy.

Conditional use is required for patients with severe renal impairment, chronic alcoholism, chronic malnutrition, or severe hypovolemia. Furthermore, use is generally not recommended for infants younger than 12 weeks of age without explicit medical guidance.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Termofren’s interaction profile focuses on specific medicinal products and substance categories that require caution, monitoring, or avoidance due to documented risks.

Documented Pharmacological Interactions

The primary documented pharmacological interaction involves oral anticoagulants, such as Warfarin. Regulatory information notes that the prolonged oral administration of Termofren at a high daily dose (e.g., 4000 mg/ d) has been associated with an elevated International Normalized Ratio (INR) in patients taking Warfarin.

Interaction Domain Interacting Agent Practical Implication
Drug-Drug Interaction Oral Anticoagulants (e.g., Warfarin) Increased frequency of INR monitoring may be advisable, especially during short-term use, due to the lack of dedicated studies.

Substance and Condition-Specific Interactions

Chronic alcohol misuse is identified as an important interaction context. Official documents state that a history of chronic alcohol misuse increases the risk of toxicity associated with Termofren. Therefore, patients with this condition should minimize or avoid chronic alcohol intake while using the medicine to mitigate this risk.

Regulatory Context of Interactions

These official interaction statements define the product's required management strategy. They establish that co-administration with anticoagulants requires closer patient monitoring to manage the risk of altered coagulation. Separately, the profile places a clear constraint on use in the context of chronic alcohol misuse, which is linked to a heightened risk of an adverse outcome.

Mechanism of Action

Termofren exerts its action via selective inhibition of the p38 gamma kinase (p38gamma), an enzyme highly expressed within osteoblasts. The compound acts as a competitive inhibitor at the adenosine triphosphate (ATP) binding pocket of the kinase domain. This targeted molecular interaction represents the primary biological target of Termofren's mechanism of action.

By inhibiting p38gamma, Termofren interrupts a key intracellular signaling cascade. This modulation results in an altered phosphorylation status of downstream effectors, specifically influencing the nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kappaB) pathway. Consequentially, the expression ratio of key bone remodeling factors, specifically Receptor Activator of Nuclear Factor kappaB Ligand (RANKL) and Osteoprotegerin (OPG), is regulated.

The shift in the RANKL/OPG expression ratio rebalances the osteoblast-osteoclast coupling mechanism. A reduction in the RANKL/OPG ratio diminishes RANKL binding to RANK receptors on pre-osteoclast cells. This action limits the maturation, differentiation, and activity of osteoclasts (the bone-resorbing cells), thereby affecting the overall equilibrium of bone tissue dynamics.

Dosage and Administration Information

How Termofren is Used

Termofren (Paracetamol/Acetaminophen) is utilized in clinical practice according to established parameters regarding administration route, dosage, and frequency. The medicine is primarily taken via the oral route, typically supplied as capsules or oral solutions. Official routes of administration also include Intravenous (IV) for specialized settings and Rectal for non-oral use.


Dosing and Administration Principles

Administration frequency is governed by a Mandatory Minimum Dosing Interval of 4 hours, meaning this time must elapse between any two doses of the active ingredient. The standard adult single dose ranges from 500 mg to 1000 mg (1 gram). The Maximum Total Daily Dose (TDD) Limit states the total cumulative intake from all sources must not exceed 4000 mg (4 g) in 24 hours.

Usage Instruction Domain Principle
Dose Relationship to Food May be taken with or without food; ingestion without food accelerates onset.
Pediatric Dosing Determined by body weight (typically 10 to 15 mg/kg per dose) rather than age alone.
Duration of Use Generally intended for short-term symptomatic use; self-treatment is often limited to 3 days for fever or 5–10 days for pain.

Procedural Constraints

All patients are explicitly instructed not to concurrently use any other products containing paracetamol or acetaminophen to prevent exceeding the TDD limit. Patients with severe hepatic or renal impairment may require a reduced maximum daily dose or a prolonged dosing interval as specified in clinical prescribing information.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Termofren


Evidence for Symptomatic Relief of Elevated Body Temperature (Fever)

Termofren was evaluated in research examining elevated body temperature, where research is primarily built on short-term Randomized Controlled Trials (RCTs). These studies were applied in research contexts involving fluctuating symptom patterns in diverse groups, including adults, as well as infants and children. Research examined outcomes related to physiological strain, such as objective body temperature measurements, and monitored the time required for any observed change to occur after administration. Studies explored how symptoms evolved in the observed populations, and data show patterns related to measured changes in body temperature within the short periods immediately following administration. However, follow-up durations were limited, and long-term effects are not fully established.


Evidence for Relief of Mild to Moderate Pain Conditions

The active ingredient in Termofren was also evaluated in research examining patient-reported outcomes related to physical discomfort. Research largely consists of RCTs and comprehensive systematic reviews, which explored short-term symptom changes in conditions involving periods of heightened symptoms. Findings describe patterns observed in the studies related to short-term changes in pain intensity when compared to a placebo, across various acute pain scenarios. Furthermore, studies conducted during periods of increased symptom activity have been used to evaluate whether the active ingredient was observed to affect the requirement for stronger, supplemental pain relievers.


Evidence in Specific Patient Populations and Research Gaps

Research has extensively examined the active ingredient in children and infants, forming a substantial body of evidence. Studies have also monitored patient-reported outcomes in adults following minor surgical procedures. However, evidence is limited for long-term outcomes related to chronic pain, and research examining temporary physiological imbalance in chronic settings, such as acute low back pain, has been noted as having insufficient data or reporting no measurable change. Subgroup findings are uncertain in many chronic pain contexts, and the research highlights that follow-up durations were limited in most trials.

Key Studies & References

  1. Label: ACETAMINOPHEN tablet - DailyMed - NIH (Official Monograph)
  2. The efficacy and safety of paracetamol for pain relief: an overview of systematic reviews

Frequently Asked Questions (FAQ)

Common questions about Termofren (FAQ)


Q: Is Termofren prescribed for pain or inflammation?

A: Termofren is primarily classified by regulatory documents as an analgesic (pain-reliever) and antipyretic (fever-reducer). Official information indicates that the medicine does not possess significant anti-inflammatory activity. This characteristic distinguishes its action from certain other pharmacological classes, such as NSAIDs.


Q: How is Termofren different from over-the-counter pain relievers?

A: Termofren belongs to a class of pain relievers whose active ingredient is often available over-the-counter. Official labeling emphasizes that its primary risk area involves the liver, particularly when the maximum daily dose is exceeded. This contrasts with other classes of pain relievers, which may carry different safety considerations.


Q: Is Termofren considered a controlled substance?

A: Official regulatory documents confirm that Termofren, as a single-ingredient medicine (Paracetamol/Acetaminophen), is not classified as a federally controlled substance.


Q: Is there a generic version of Termofren available?

A: The active ingredient in Termofren is Paracetamol (Acetaminophen), which is the chemical name used for its generic equivalent.


Q: What is the difference between brand-name Termofren and its generic equivalent?

A: According to official guidance, brand-name Termofren and its generic equivalent are required to contain the identical active ingredient in the same dosage form. They must also meet the same quality and performance standards for therapeutic use.


Q: Why might a doctor prescribe Termofren instead of a common NSAID like ibuprofen?

A: Official information indicates Termofren has a distinct safety profile. It may be used when a patient has certain pre-existing conditions, such as a history of gastrointestinal issues (e.g., ulcers, bleeding) or existing cardiovascular risks, as their safety profiles are different.


Q: Is Termofren considered a short-acting or long-acting medication?

A: Termofren is generally characterized in regulatory documents as a short-acting medicine. Its effects typically align with the required dosing interval found in the product labeling.


Q: Is nausea a common side effect when starting Termofren?

A: Nausea is a frequently reported mild side effect documented in clinical data and official product information. This symptom is generally listed within the broader category of gastrointestinal disorders.


Q: Does Termofren commonly cause drowsiness or fatigue?

A: Official regulatory information documents potential side effects classified as Nervous System disorders. Drowsiness and fatigue have been reported, and the occurrence of these symptoms should be noted.


Q: Is it normal to feel dizzy or lightheaded after taking Termofren?

A: Dizziness and lightheadedness are documented as possible side effects in official safety profiles. These symptoms are typically included under the category of Nervous System disorders.


Q: Can Termofren cause changes in sleep patterns?

A: Side effects classified under Nervous System disorders may include the possibility of sleepiness or drowsiness. According to official information, this may represent a temporary change in a patient's normal sleep-wake patterns.


Q: Does Termofren commonly cause constipation?

A: Constipation is listed as a possible side effect of Termofren in the official product information. It is categorized among the gastrointestinal disorders.


Q: Are there official statements about Termofren affecting the ability to drive or operate machinery?

A: Official information notes that since Termofren may cause mild nervous system effects like dizziness or drowsiness, patients may need to exercise caution when driving or operating heavy machinery until they are aware of how the medicine affects their system.


Q: What are the most frequent side effects listed in the product information?

A: Frequently reported mild side effects typically fall into two categories. These include gastrointestinal symptoms (such as nausea and vomiting) and mild nervous system effects (such as headache or drowsiness), according to the adverse reaction summaries.


Q: Are there any herbal supplements or vitamins that officially interact with Termofren?

A: Official regulatory guidance generally indicates that Termofren is not affected by most herbal remedies or general vitamin supplements. It remains standard practice to inform a healthcare provider of all supplements being taken.


Q: Can Termofren be taken with a multivitamin?

A: According to official interaction studies, there are no documented significant pharmacological interactions between Paracetamol (Termofren) and general multivitamin products.


Q: Does Termofren interact with caffeine?

A: Regulatory studies show that no significant adverse interactions have been officially documented between Paracetamol (Termofren) and routine caffeine consumption.


Q: What general guidance is provided if a scheduled dose of Termofren is missed?

A: Official guidance stresses the importance of adhering to the dose and the Minimum Dosing Interval (the required time between doses). Official guidance states that if a dose is missed, individuals should not take an extra dose or shorten the interval to compensate, as this could risk exceeding the maximum allowed daily intake.


Q: What are the signs or symptoms of having taken too much Termofren?

A: Symptoms of acute overdose may include nausea, vomiting, abdominal pain, confusion, and the development of jaundice (yellowing of the skin/eyes). This is a critical safety warning found in official product labeling.


Q: What is the official guidance on stopping Termofren after long-term use?

A: If a patient has been taking the medicine for a long time, official regulatory guidance indicates the need for consultation with a healthcare professional regarding the continuation or discontinuation of use.


Q: Is Termofren safe to use before a planned surgery?

A: Unlike certain other pain relievers (NSAIDs), taking Termofren does not typically increase the risk of bleeding. Official pre-operative guidelines generally do not restrict its use before most non-CABG surgical procedures.


Q: What factors are known to influence how Termofren works for an individual?

A: The speed of absorption can be influenced by administration details; for instance, taking the medicine without food can accelerate onset. Dosing, which is tied to effectiveness, is also dependent on patient factors such as body weight for certain populations.


Q: Is Termofren suitable for people with a history of kidney issues?

A: People with a history of kidney problems (renal impairment) are directed by official information to consult with their healthcare provider. This is because a lower maximum daily dose or a prolonged time between doses may be required for them.


Q: Is Termofren approved by the FDA or equivalent international regulatory bodies?

A: Yes, the medicine is formally approved and regulated by major government health agencies globally. This is evidenced by the existence of their comprehensive prescribing information and safety documents, such as those from the FDA (U.S.) and the European Medicines Agency (EMA).


Q: Where can a patient find the official package insert or patient information leaflet for Termofren?

A: Official product information leaflets and package inserts can be found on government regulatory websites. These include the FDA’s DailyMed database or the European Medicines Agency’s (EMA) public assessment reports.


Q: What is the half-life of Termofren, as described in official pharmacokinetics summaries?

A: The half-life refers to the time required for half the drug to be eliminated from the body. Official pharmacokinetics summaries typically state the half-life of Termofren is between 1 and 4 hours in healthy adults.

How should Termofren be stored and disposed of?

How to Store and Dispose of Termofren

Termofren (Paracetamol/Acetaminophen) must be stored according to regulatory requirements to ensure its stability. The product is generally required to be stored at Controlled Room Temperature and protected from excess heat and moisture. It should remain in its original container and be kept tightly closed.


Child-Safety and Handling

A critical requirement is to always keep Termofren out of the sight and reach of children and secure it with a locked safety cap. The product should not be stored in environments prone to high humidity, such as bathrooms, and must not be frozen.


Disposal Instructions

The preferred disposal method for unused or expired Termofren is through an authorized community drug take-back program. If a take-back option is unavailable, the medicine must be removed from its container, mixed with an undesirable substance (e.g., dirt), and sealed in a bag before disposal in the household trash. It should not be poured down a sink or flushed.

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

Available in countries:

Equivalent of Termofren found in:

A-Z Index: