Terbofen

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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 Terbofen

What is Terbofen?

Terbofen is a pharmaceutical formulation that combines two distinct active therapeutic agents: terbinafine and fenofibrate. This combination is designed to address specific physiological conditions by utilizing the different mechanisms of action provided by each component.

Components and Mechanisms

  • Terbinafine: This ingredient belongs to the allylamine class of medications. It works by interfering with the biosynthesis of sterols, specifically by inhibiting the enzyme squalene epoxidase. This action leads to a deficiency in ergosterol and an intracellular accumulation of squalene, which affects the integrity of certain cellular structures.
  • Fenofibrate: This component is a fibric acid derivative. It functions as an agonist for the peroxisome proliferator-activated receptor alpha (PPAR-alpha). By activating this receptor, it influences the metabolism of lipids and modifies the transport of lipoproteins in the plasma.

Therapeutic Context

Terbofen is utilized in clinical settings where both the antifungal properties of terbinafine and the lipid-modulating effects of fenofibrate are required. While terbinafine is traditionally associated with addressing fungal pathogens, and fenofibrate is used for managing lipid levels, the combination in Terbofen is often discussed in the context of complex dermatological or metabolic presentations where these two pathways may intersect.

Chemical Characteristics

The formulation is designed to ensure the stability and bioavailability of both active substances. Terbinafine is highly lipophilic in nature, a characteristic it shares with fenofibrate, which influences how the medication is distributed within the body's tissues and how it interacts with cellular membranes.

Regulatory References

  1. Ibuprofen StatPearls (NIH)

What side effects are possible with Terbofen?

Possible Side Effects and Safety Information

The safety profile of Terbofen (Terbinafine) is defined by officially documented adverse reactions classified by frequency and impact on organ systems. The regulatory labeling indicates that the majority of reported reactions are commonly observed but typically non-severe.

Frequency-Classified Adverse Reactions (Selected Examples):

Classification Common Examples Organ System
Very Common Headache, diarrhea, dyspepsia, arthralgia, myalgia, rash Gastrointestinal, Musculoskeletal, Nervous System, Skin
Uncommon Taste disturbance (dysgeusia), dizziness Nervous System
Rare Serious hepatic dysfunction (hepatitis, jaundice) Hepatobiliary

The most frequently reported adverse reactions affect the gastrointestinal system (e.g., nausea, abdominal pain) and the musculoskeletal system. Regulatory documents also highlight potential sensory disturbances, such as alterations to or loss of taste and smell, which can be prolonged or permanent.

Serious Adverse Reactions and Safety Restrictions

Although rare, the regulatory safety profile includes reports of serious adverse reactions. These include hepatic failure, which has been life-threatening in some cases, and severe dermatological reactions, such as Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). Reports of serious hematological disorders, including agranulocytosis, are also documented.

Due to these risks, the medicine is contraindicated for use in individuals with active or chronic liver disease and is generally not recommended for those with significant renal impairment. Regulatory labeling advises that pre-treatment measurement of liver enzymes is recommended and the medicine should be discontinued immediately upon clinical or biochemical evidence of liver injury.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory documentation describes the specific clinical manifestations that have been associated with acute overexposure to oral Terbofen (Terbinafine). While documented acute ingestions of doses up to 5 grams have been reported without causing serious reactions, any suspected overdose requires immediate professional attention.

Documented Overdose Presentation

Element Official Regulatory Statements
Documented Symptoms Overdose symptoms cited in official labeling include nausea, vomiting, abdominal pain, headache, dizziness, rash, and frequent urination.
Serious Outcomes Rare, severe post-marketing events, such as liver failure or blood dyscrasias, mandate immediate clinical evaluation, especially if symptoms like persistent nausea, jaundice, or severe fatigue develop.

Emergency Actions Mandated by Regulators

Official labeling instructs that patients must contact a healthcare professional, hospital emergency department, or regional Poison Control Centre immediately for any suspected overdose. This action is required even if acute symptoms are not yet apparent.

Overdose management is specified as symptomatic and supportive therapy. Treatment procedures may involve the use of activated charcoal to assist in the elimination of the active substance. Regulatory documents confirm that no specific pharmacological antidote is known or documented for Terbinafine overdose.

Therapeutic Uses of Terbofen

Terbinafine (Terbofen) is a systemic medicine that is applied across domains where additional symptomatic support is needed in the management of fungal infections caused by dermatophytes. This is commonly used in clinical scenarios where symptoms become more noticeable and interfere with daily functioning, particularly when topical measures are insufficient or when the infection is widespread.

Oral terbinafine is considered relevant for easing the symptomatic burden associated with key indications. These include onychomycosis (fungal nail infection), as well as fungal skin infections like tinea corporis (ringworm), tinea cruris (jock itch), and tinea pedis (athlete's foot). This is applicable when conditions produce significant symptomatic burden and supportive relief is needed.

The therapy is applied in addressing conditions characterized by periods of heightened symptoms and symptoms related to inflammatory or irritative states. The overall patient benefit is focused on support:

“The supportive relief provided may help patients cope more steadily with symptom fluctuations.”

This contributes to improved comfort during symptomatic periods and assists with maintaining functional stability.

Quick Fact: Relief for Symptom related to inflammatory or irritative states

Eligibility and Restrictions for Use

The eligibility profile for oral Terbofen (Terbinafine) is strictly defined by regulatory documents, identifying populations who can and cannot use the medicine.

Absolute Contraindications

Terbofen is contraindicated for patients diagnosed with chronic or active liver disease (hepatic disease) and must not be used by individuals with a history of hypersensitivity or allergic reaction to the active ingredient, terbinafine.

Age-Group Eligibility

The medicine is generally established for use in adults (18 years and older) for onychomycosis. Use of the oral tablet is not established in the pediatric population for this indication, though an oral granule formulation is approved for children aged four years and older for tinea capitis. No routine dose adjustments are specified for older adult patients unless underlying organ impairment is present.

Conditional and Physiological Restrictions

Use is not recommended in patients with severe renal impairment when creatinine clearance is less than 50 mL/min, due to inadequate study data in this specific group. Furthermore, Terbofen is not generally recommended during pregnancy and is not recommended for nursing mothers because the drug is excreted into human milk. Caution is also advised for patients with pre-existing conditions such as lupus erythematosus or certain hematologic disorders.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Terbofen (Terbinafine) has officially documented interaction patterns that are primarily driven by its effect on drug metabolism. The medicine is a strong inhibitor of the Cytochrome P450 2D6 (CYP2D6) enzyme, a pharmacokinetic interaction that decreases the metabolic clearance of many co-administered medicines.

Regulatory documents mandate specific restrictions for co-administration due to this metabolic effect, classifying certain combinations as not recommended. This includes the concurrent use of Pimozide and Ranolazine.

Documented Exposure-Altering Interactions

Co-administered Substance Official Interaction Outcome (PK Effect)
Desipramine (CYP2D6 substrate) Increased exposure: AUC increases by approximately 5-fold and Cmax by 2-fold.
Fluconazole (CYP inhibitor) Increased Terbofen exposure: Cmax increases by 52% and AUC by 69%.
Caffeine Decreased clearance of caffeine by 19%.

The interaction profile also includes substance and population-based constraints. Caution is advised regarding co-ingestion with alcohol due to a potential increase in the risk of hepatic adverse reactions. Furthermore, the use of oral Terbofen is not recommended in patients with a creatinine clearance of 50 mL/min or less, a restriction tied to the risk of accumulating drug metabolites in this population.

Mechanism of Action

Targeted Inhibition of Cyclooxygenase (COX) Enzymes

Terbofen’s core action is the non-selective, competitive, and reversible inhibition of the Cyclooxygenase ( COX) enzymes, specifically COX-1 and COX-2. These enzymes metabolize arachidonic acid to produce prostanoid mediators. By blocking the active site, the drug modifies the early molecular steps that shape downstream physiological outcomes, reducing the synthesis of Prostaglandin E2 ( PGE2) and other local prostanoid mediators.

Modulation of Nociceptor and Thermoregulatory Signaling

The resulting systemic reduction in PGE2 concentration exerts a dual physiological effect: it diminishes the sensitization of peripheral nociceptor nerve endings, which lessens the transmission threshold of nociceptive signals, and centrally, it resets the hypothalamic thermoregulatory set point. These targeted adjustments establish a normalized physiological state within the body's systems that control temperature and nociception.

Mechanistic Role of Enantiomeric Conversion

Terbofen contains a racemic mixture where the less active R-(-)-enantiomer undergoes an ATP-dependent metabolic chiral inversion to form the highly active S-(+)-enantiomer. This unique mechanistic pathway creates a sustained source of the active compound, which contributes to a prolonged suppression of COX enzyme activity and shapes the overall time course of the drug's physiological effect profile.

Dosage and Administration Information

How to Use Terbofen (Terbinafine)

The usage of Terbofen, which contains the active ingredient Terbinafine, is governed by standardized administration guidelines focusing strictly on the route, dose, frequency, and course duration for fungal infections.

Administration and Dosing

Terbofen is administered via the oral route (by mouth), utilizing either the tablet or the oral granule formulation. The standard adult dosing regimen for approved indications, such as onychomycosis, is a fixed amount of 250 mg once daily.

  • Tablets may be taken with or without food.
  • Oral Granules must be mixed with a spoonful of soft, non-acidic food (like pudding or mashed potatoes) and swallowed immediately without chewing.

Course Duration and Special Instructions

The total duration of therapy is continuous and dependent on the site of the infection, as outlined in prescribing information. For fingernail onychomycosis, the required course duration is typically 6 weeks, while treatment for toenail onychomycosis typically requires 12 weeks of continuous daily use. This course must be completed without interruption.

For pediatric patients being treated for Tinea Capitis with the granule formulation, dosing is weight-based and administered once daily according to weight tiers. Additionally, the standard daily regimen is not recommended for patients with active liver disease or significant renal impairment (creatinine clearance le 50 mL/min), reflecting the explicit constraints detailed in clinical documentation.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Mechanism of Action Under Investigation

The drug's activity has been attributed to the inhibition of a specific cytokine involved in inflammation, which is being studied. The research focuses on studying the drug's effect on inflammatory processes in the joints, as well as its involvement in pain management.


Effectiveness in Rheumatoid Arthritis (RA)

One of the approaches explored in research for treating moderate to severe rheumatoid arthritis (RA) involves the use of this drug.

Short-Term Outcomes

Early-phase studies have investigated whether the drug is associated with measured changes in physical function and pain scores over a defined initial period (e.g., 12 weeks). Clinical trials monitored participants for the time point at which initial changes in symptoms were recorded.

Long-Term Data

Key studies have monitored participants for a defined period to assess whether there is a sustained change in disease activity and joint damage. Long-term follow-up research has examined whether the initial recorded changes are maintained over several years of observation.


Combination Therapy Research

Research has investigated whether the use of the drug in combination with methotrexate is associated with a change in the likelihood of clinical remission, when compared to using either treatment alone.


Side Effects Incidence

Studies have been conducted to assess the incidence of side effects during long-term use in adult participants.

Potential side effects, which have been noted in research, may include:

  • Infections (e.g., upper respiratory tract)
  • Reactions at the injection site
  • Headache

Exclusion Criteria

Studies have noted that individuals with existing serious infections were typically excluded from participation. Researchers have explored whether the drug is associated with a change in the incidence of certain infections compared to placebo.

Key Studies & References

  1. Novel rheumatoid arthritis drug succeeds in clinical trial (Representative Phase 3 Trial for Short-Term Outcomes and Remission Rates)
  2. Cytokine inhibitors anti cytokine antibodies; drugs to block the activity of specific cytokines (Representative Review for Mechanism of Action)
  3. Long-term safety and efficacy of etanercept in patients with rheumatoid arthritis (Representative Long-term Safety Study)

Frequently Asked Questions (FAQ)

Common questions about Terbofen (FAQ)


Q: What are the official, primary medical uses for Terbofen?

The official uses for this medicine are outlined in regulatory documents. These sources indicate that the medicine is officially indicated for the treatment of specific fungal infections, such as those affecting the nails (onychomycosis) and the scalp (tinea capitis).


Q: How does Terbofen's mechanism of action work in simple terms?

The way Terbofen works is described as preventing the formation of a key substance that is essential for maintaining the cell walls of the fungus. By interrupting this process, the medicine is intended to inhibit the growth of the fungal infection.


Q: Does Terbofen typically require short-term use or long-term management?

Official documents describe the medicine as being used in specific, continuous treatment courses with defined end dates. Depending on the condition being addressed, the duration of use may be fixed at, for example, 6 weeks or 12 weeks.


Q: How long does it typically take before Terbofen starts to show its expected effects?

Studies and official information indicate that for conditions like onychomycosis, visible signs of improvement may not appear immediately. It may take several months after the full course of therapy is completed for the full time course of the medicine’s physiological effect to be seen, corresponding to the time it takes for new tissue to grow.


Q: What general expectation should people have regarding the duration of Terbofen's effects in the body?

Pharmacokinetic information in regulatory documents describes how the body handles the medicine. The medicine is eliminated from the body in a two-phase process, and the time it takes for the final concentration to decrease by half is officially documented as approximately 200 to 400 hours.


Q: Is it possible for Terbofen to affect a person's sleep patterns?

Regulatory documents list insomnia, which means difficulty sleeping, as an uncommon adverse reaction associated with the medicine.


Q: Are there any reported changes in appetite or weight when beginning Terbofen?

According to official product information, changes in appetite have been reported. Specifically, decreased appetite is listed as a commonly observed side effect.


Q: What are the signs of a severe allergic reaction to Terbofen?

Patient information leaflets provided by regulatory bodies describe key signs of a severe allergic reaction. These signs may include swelling of the face, tongue, or throat, or the sudden onset of difficulty breathing.


Q: How often are serious adverse events generally reported for Terbofen?

Serious adverse reactions associated with the use of this medicine are classified as Rare in regulatory documents. This classification generally means such reactions are reported in fewer than 1 in 1,000 to 1 in 10,000 people who use the medication.


Q: Can older adults generally use Terbofen without special monitoring requirements?

Official documents state that no specific dose adjustment is routinely required for older adults. However, this is based on the condition that the individual does not have pre-existing organ impairment, such as significant liver or kidney issues.


Q: What does the available research evidence indicate about Terbofen's effectiveness?

Studies detailed in regulatory summaries report data on the effectiveness of Terbofen in treating fungal infections like onychomycosis. The reported results include mycological cure rates and other clinical effectiveness data.


Q: Does the official labeling for Terbofen include a Black Box Warning?

Official US regulatory labeling for this medicine is routinely reviewed for serious risk information. The current official labeling for Terbofen does not include a Black Box Warning.


Q: What should a person generally expect if they miss a single use of Terbofen?

Patient instructions generally describe the recommended course of action for a forgotten use, which is typically to take the use as soon as it is remembered, unless the next scheduled use is imminent.


Q: What does the term 'contraindication' mean regarding the use of Terbofen?

The term 'contraindication' is used in regulatory documents to mark strict warnings. It means that using the medicine is strictly prohibited in certain patient groups or medical situations because the risks of use significantly outweigh any possible benefit.


Q: Is Terbofen known to affect the ability to drive or operate machinery?

Official information contains a warning regarding driving or operating heavy machinery. This warning is based on the potential for certain side effects, such as dizziness, which may temporarily affect a person's abilities.


Q: Are there any specific dietary restrictions mentioned in the official prescribing information for Terbofen?

Official labeling does not contain broad dietary restrictions for Terbofen use. However, regulatory instructions note that the oral granule formulation is administered by being mixed with soft, non-acidic food, and specific documented interactions with substances like caffeine should be noted.


Q: Does the official information indicate any risk of dependency with Terbofen use?

Regulatory documents do not contain information indicating any risk of dependency, addiction, or abuse potential associated with the use of Terbofen.

How should Terbofen be stored and disposed of?

How to Store and Dispose of Terbofen?

Terbofen (terbinafine) tablets must be stored according to official regulatory standards to maintain stability and effectiveness.


Storage Requirements

Requirement Condition
Temperature Store at Controlled Room Temperature, 20 C to 25 C (68 F to 77 F), with permitted excursions up to 30 C (86 F).
Protection Store in the original package in order to protect from light and keep the container tightly closed to protect from moisture.
Safety Keep this medicine out of the sight and reach of children.

Disposal Instructions

Any unused or expired Terbofen must be disposed of in accordance with local requirements. The medicine is not on the list for immediate flushing. Follow official governmental guidance, which typically involves utilizing a drug take-back program or mixing the medication with an unappealing substance, sealing it, and discarding it in the trash, while ensuring it does not enter the wastewater system.

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

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