Bunafine

Quick links to important sections

Bunafine

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 Bunafine

Quick Facts

Property Description
Active Ingredient Butenafine hydrochloride (C23H28ClN)
Form Cream, Solution, Gel (Topical Dosage Forms)
Pharmacological Class Benzylamine Antifungal
Common Purpose Addressing Fungal infections of the skin (Dermatophytoses)
Origin Synthetic Compound
Differentiating Feature Highly lipophilic for prolonged skin retention

Bunafine is a formulation centered on the synthetic active ingredient, Butenafine, specifically the Butenafine hydrochloride salt (C23H28ClN). The substance is chemically categorized as a Benzylamine derivative, classified as a Benzylamine Antifungal. This Pharmacological Class is recognized for its potent anti-infective agent properties and is structurally related to the Allylamine Antifungals such as terbinafine.

What Type of Medicine is Butenafine?

Butenafine is a specialized single-component product designed exclusively for the Topical route of administration to the skin. It is supplied in various Topical Dosage Forms, most commonly a Cream, but also available as a Solution or Gel. This topical composition utilizes an emollient or hydroalcoholic vehicle to deliver the Butenafine component directly to the affected skin surface. The compound is distinctive for its highly lipophilic nature, which results in its substantial and prolonged retention within the skin’s layers. This prolonged skin retention is a recognized feature that contributes to its sustained effect against fungal pathogens.

General Purpose and Mechanism Principle

The overarching general purpose of Bunafine as an Anti-infective agent is to eliminate the fungal organisms responsible for common Fungal infections of the skin (Dermatophytoses). The benefit it provides is derived from its fundamental physiological action of synthesis inhibition of sterols. Butenafine functions by inhibiting the Squalene epoxidase enzyme, thereby blocking the crucial biosynthesis of ergosterol, an essential component of the fungal cellular membranes. This action creates fungicidal properties by severely disrupting the cell's structural integrity and inhibiting its growth.

What side effects are possible with Bunafine?

Possible Side Effects and Safety Information

The safety profile of Bunafine, which contains the topical antifungal Butenafine, is primarily characterized by localized adverse reactions at the application site. The information below reflects the official classifications and safety notes documented in regulatory sources such as the FDA Prescribing Information and DailyMed.


Officially Documented Adverse Reactions

The vast majority of adverse events reported in clinical trials are mild, transient, and related to the point of application, falling under the System-Organ Classes of Skin and Subcutaneous Tissue Disorders and General Disorders and Administration Site Conditions.

Reaction Category Specific Adverse Effects Frequency Classification
Cutaneous/Local Burning/Stinging, Itching (Pruritus), Irritation, Redness (Erythema) Common (incidence ge 1% in trials)
Hypersensitivity Contact Dermatitis, Localized Soreness Less Common/Infrequent

Reactions such as burning and stinging are typically reported upon initial application of the medicine. No systemic serious adverse reactions are documented in the official regulatory data for the topical formulation.


Regulatory Safety Constraints and Special Populations

Official labeling mandates specific safety constraints and addresses certain patient groups:

  • Contraindication: Bunafine is formally contraindicated in individuals with a known hypersensitivity to butenafine or any of the product's inactive ingredients.
  • Usage Restriction: The product is for external use only and is not approved for ophthalmic, oral, or intravaginal application.
  • Pediatric Safety: The safety and effectiveness of the medicine have not been established in children younger than 12 years of age. Use in this population is therefore not covered under the established regulatory safety profile.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory profile for Bunafine, a topical medication, confirms that no overdosage is expected from routine use or over-application to the skin due to minimal systemic absorption. The official guidance on overdose management is therefore strictly focused on scenarios involving accidental oral ingestion of the product.

Documented Overdose Manifestations and Actions

Scenario and Manifestations Required Regulatory Action
Accidental Oral Ingestion is the primary risk scenario, noted particularly in children le 3 years of age.
If the product is swallowed, an individual must seek medical help or contact a Poison Control Center right away [Source: FDA DailyMed].
Reported manifestations following ingestion may include nausea, headache, and vomiting.
Management is generally symptomatic and supportive, as no specific antidote is specified in the regulatory labeling.
Official safety data for unintentional exposures does not report serious adverse events or fatalities.

Summary of Regulatory Mandates

Regulatory authorities mandate immediate action following accidental ingestion. This official guidance overrides all other considerations and serves as the definitive instruction for managing potential overdose. The required action is a direct instruction to secure professional medical assessment for the individual who has swallowed the product.

Therapeutic Uses of Bunafine

Bunafine is a topical medication indicated for the management of symptoms associated with common dermatophyte infections. It may be utilized to help ease the discomfort and skin changes related to conditions such as athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis). The primary application involves treating the affected skin to help provide relief from associated distress. A key benefit reported is the easing of symptoms like itching, burning, cracking, and scaling that may accompany these infections.

Quick Fact: Relief for Itching, Burning, and Scaling

Eligibility and Restrictions for Use

Official Eligibility and Contraindications

The eligibility profile for Bunafine (Butenafine hydrochloride) is strictly defined by regulatory authorities based on age, documented sensitivity, and physiological status. Adherence to these rules ensures compliance with the medicine's official labeling requirements.

Who Must Not Use Bunafine (Contraindications)

The absolute prohibition for using Bunafine is for individuals with a known or suspected sensitivity (hypersensitivity) to Butenafine hydrochloride or any component found in the cream formulation.

Age and Conditional Use Restrictions

Eligibility Factor Official Regulatory Status
Approved Age Group Adults and children 12 years of age and older.
Children Under 12 Safety and efficacy have not been established in this age group.
Pregnancy Status Classified as Pregnancy Category C; use is permitted only if clearly needed.
Nursing Mothers Caution is advised due to the unknown status of excretion into human milk.
Class Sensitivity Caution is advised for patients with known sensitivity to related allylamine antifungals.

This profile strictly establishes an exclusion for individuals with known hypersensitivity and details the conditional use restrictions for specific pediatric and reproductive populations as defined in the official labeling.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official interaction profile for Butenafine topical is primarily defined by the drug's formulation and how the body handles the medicine. The minimal level of active ingredient that reaches the systemic circulation following application to the skin is the key factor informing the regulatory position on interactions.

Official Regulatory Status of Systemic Interactions

Interaction Entity Map (High-Level) Official Regulatory Status
Documented Drug-Drug Interactions None documented.
Formal Contraindications None listed in official labeling due to interaction risk.
Metabolic/Enzyme Interactions Potential interactions have not been systematically evaluated.
Food, Alcohol, Herbal Products No known interactions are documented in regulatory labeling.
Timing-based Administration Rules None required due to interaction risk.

Connection to the Overall Interaction Profile

Official regulatory documents indicate that the systemic exposure of Butenafine following topical use is low. Because of this pharmacokinetic characteristic, the U.S. Food and Drug Administration (FDA) prescribing information states that potential drug interactions between Butenafine topical and other medicines have not been systematically evaluated. As a result, the regulatory documentation lists no specific medicinal products that must be avoided, no required spacing or timing of administration, and no restrictions related to co-administration with food, alcohol, or supplements.

Mechanism of Action

Targeting the Fungal Ergosterol Biosynthesis Pathway

The mechanism of action for Butenafine involves a targeted disruption of the fungal organism's cell structure, achieved through specific enzyme inhibition. Butenafine acts as a selective inhibitor of the enzyme Squalene epoxidase . This enzyme is essential for the Fungal Ergosterol Biosynthesis Pathway, which synthesizes ergosterol, a key structural lipid of the fungal cell membrane. By blocking this specific metabolic step, the drug initiates a cascade that results in irreversible damage to the fungal cell.


Dual Action: Depletion and Toxic Accumulation

The inhibition of Squalene epoxidase produces a dual effect on the fungal cell: it prevents the production of ergosterol while causing a toxic buildup of the enzyme's substrate, squalene, within the membrane. This combination compromises the membrane’s structural integrity and function, resulting in cell lysis, which defines its fungicidal property. The compound's lipophilicity facilitates its retention in the outer skin layer, supporting continuous enzyme inhibition at the site of action.

Dosage and Administration Information

How to Use Bunafine: Administration Guidelines

Bunafine (butenafine hydrochloride) is designated strictly for external topical use only and is not to be ingested or applied to mucous membranes such as the eyes or mouth. Proper usage involves applying the medication as a thin layer to the affected area and a margin of surrounding clear skin. The area of skin must be washed and completely dried before each application.


Dosing Regimens

Instructions define specific application schedules and durations that vary by the fungal infection being addressed:

Indication Frequency Treatment Duration
Tinea cruris, Tinea corporis, Tinea versicolor Once daily 2 weeks
Tinea pedis (Interdigital) Twice daily 1 week
Tinea pedis (Interdigital) Once daily 4 weeks

These regimens reflect the fixed frequencies (once daily or twice daily). If a dose is missed, it is generally applied as soon as it is remembered unless it is near the time for the next scheduled dose, in which case the missed dose is skipped.


Age-Specific Use and Constraints

The medication is for use in individuals 12 years of age and older at the standard adult dosing schedule. Its safety and effectiveness have not been established in children younger than 12 years. Standard practice involves avoiding occlusive dressings (airtight coverings) over the application area unless otherwise directed. Crucially, the medication must be applied for the full duration prescribed by the regimen, regardless of any early improvement in the appearance of the affected skin.

Recent Clinical Evidence

Research Evidence / Overview of studies for Bunafine


Evidence for use in Tinea Pedis (Athlete's Foot)

The research base for tinea pedis, commonly known as athlete’s foot, includes Randomized Controlled Trials (RCTs). These studies were conducted under specific, controlled conditions, often comparing Bunafine's measured outcomes to an inactive cream (a vehicle or placebo) or to other topical antifungal agents to determine patterns of response. These studies were generally short-term, with observation periods extending only a few weeks past the completion of treatment.

Researchers typically focused on a composite outcome called Therapeutic Cure. This required two measurements: first, the Mycological Cure, which meant laboratory tests indicated the absence of the fungal organism via lab tests; and second, the Clinical Cure, which involved assessing changes in physical signs and outcomes related to physical discomfort, such as scaling and fissuring. Findings from these trials describe patterns observed in the studies regarding the achievement of both fungal clearance and changes in physical signs when Bunafine was evaluated in these patient groups.


Evidence for use in Tinea Cruris and Tinea Corporis (Jock Itch and Ringworm)

The evidence base for tinea cruris (jock itch) and tinea corporis (ringworm) includes Randomized Controlled Trials and active comparator trials. These research efforts were studied for infections on the body and in the groin area. The main purpose of these trials was to see how symptoms evolved in the observed populations during the study period.

The outcomes monitored by researchers included both Mycological Cure and an assessment of outcomes linked to inflammatory or irritative states, such as redness and itching. The data show patterns related to the fungal clearance rates and changes in these physical signs. Research efforts often examined tinea cruris and tinea corporis as a pooled group, meaning dedicated data for ringworm alone may be limited.


Research Gaps and Unanswered Questions

The available evidence largely stems from studies focused on short-term symptom changes and intermediate follow-up durations. The primary focus of these core trials was to establish measured changes in the condition at a specific point in time. Research has explored the rate at which the infection returns, or relapses, but the data are still emerging regarding the long-term patterns after the study period.

Evidence in specific patient populations is limited. Data for children under 12 years of age remain insufficient, as this group was often excluded from the core clinical trials. Furthermore, subgroup findings are uncertain, as the initial research generally focused on broad groups of people with confirmed fungal infections rather than individuals with specific comorbidities.

Frequently Asked Questions (FAQ)

Common questions about Bunafine (FAQ)

Q: What is the difference between Bunafine and other similar medications?

Bunafine is classified as a Benzylamine antifungal. Regulatory sources note that it is chemically related to the Allylamine class of antifungals, which includes medicines like terbinafine. Both classes work by blocking the ergosterol pathway in the fungal cell.

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

Official guidance advises stopping use if signs of a severe allergic reaction develop. These signs include hives, difficulty breathing, or swelling of the face, lips, tongue, or throat. Localized reactions that require immediate attention include severe blistering, burning, or worsening irritation of the treated skin.

Q: Are there different approved strengths of Bunafine tablets/capsules?

The active ingredient in Bunafine is Butenafine hydrochloride, which is approved for topical use as a 1% cream. As it is a topical medicine, it is not available in tablet or capsule forms, and the core regulatory documents list the 1% concentration as the approved strength for the cream.

Q: What percentage of users report side effects in clinical trials? (Research curiosity)

In clinical studies, common side effects such as stinging, burning, irritation, or worsening of the underlying skin condition were reported in 1% or more of the patients evaluated. The full regulatory documents contain detailed tables with specific incidence rates for each reported adverse event observed during the trials.

Q: What is the usual time frame for seeing the full benefits of Bunafine?

While official information indicates that patients may experience early relief of skin symptoms within 2 to 3 days, achieving the full therapeutic response (as defined in clinical studies) can take longer. The full benefit is typically observed at the end of the prescribed treatment duration, which may be 2 or 4 weeks, depending on the type of fungal infection being treated.

Q: Why do some people say Bunafine made their symptoms worse initially?

Official adverse reaction sections report that the common local side effects of Butenafine include application site reactions such as burning, stinging, or irritation. These effects are often temporary, but they can be perceived as the underlying skin condition worsening upon initial use.

Q: What is the shelf life of Bunafine after the bottle is opened?

Regulatory labeling primarily mandates that the container must be kept tightly closed and stored at controlled room temperature to ensure stability up to the expiration date. While core labeling does not specify an exact post-opening shelf life, some regulatory-reviewed patient information suggests a shelf life limit, such as 3 months after opening, if the product is not already past its printed expiration date.

Q: What is the success rate described in the key clinical trials for Bunafine?

Official clinical studies measured the success of Bunafine based on a composite outcome called "Complete Cure" (absence of fungus and absence of symptoms). For example, regulatory documents show the complete cure rate for tinea corporis was reported as 51% at an eight-week follow-up in one pivotal trial.

Q: What does 'contraindicated' mean in relation to Bunafine?

The term "contraindicated" means there is a specific, formal reason that prohibits the use of a medicine. For Bunafine, the only formal contraindication in the official label is a known or suspected hypersensitivity (allergy) to Butenafine hydrochloride or any ingredient in the cream.

Q: Does Bunafine have a risk of dependence or misuse?

Regulatory status indicates that Butenafine hydrochloride topical cream is not classified as a controlled substance under the Drug Enforcement Administration (DEA) schedule. As a topical antifungal, official documentation does not indicate any noted risk of dependence or potential for misuse.

Q: Does Bunafine cause dizziness or affect driving ability?

Dizziness is not listed as a common or systemic side effect in the official regulatory documents. Since the medication is applied topically and is absorbed minimally, systemic side effects that could affect the central nervous system or driving ability are not listed or addressed in the official labeling.

Q: Can Bunafine be taken if a person has high blood pressure?

Official regulatory labeling lists no specific contraindications or warnings related to high blood pressure. Due to the very low systemic exposure from topical use, the official documentation does not indicate an effect on blood pressure or interference with related medications.

Q: Is it normal to feel tired when first starting Bunafine?

Tiredness (fatigue) or other related central nervous system side effects are not listed among the common or less common adverse reactions documented in the official prescribing information for topical Butenafine.

Q: How quickly does Bunafine start working after the first dose?

Official patient information reports that users may notice early relief of cutaneous symptoms within 2 to 3 days after first applying the medication. The label emphasizes that the medication is intended for use during the full treatment duration.

Q: What happens if I stop taking Bunafine suddenly? (Seeking factual information on documented withdrawal)

The regulatory label indicates that the medicine is intended to be used for the full prescribed duration, even if symptoms clear early, as a measure to prevent the infection from returning. Withdrawal symptoms are not noted since the medication acts locally on the skin.

Q: What are the guidelines for managing common, minor side effects of Bunafine?

Official patient guidance states that use should be discontinued if irritation, burning, stinging, or redness becomes excessive. Regulatory documents advise consulting a healthcare professional if symptoms worsen or do not show improvement.

Q: Why does Bunafine have a Boxed Warning in the official information?

According to the official Food and Drug Administration (FDA) prescribing information, Butenafine hydrochloride topical cream does not carry a Boxed Warning (also known as a Black Box Warning).

Q: Is there a generic version of Bunafine available?

Yes, official marketing status documents confirm that Butenafine has been approved as an Abbreviated New Drug Application (ANDA). This designation means that generic versions of the topical medicine are available alongside the brand-name product.

Q: How long after stopping Bunafine can I start a new medication safely?

Due to the minimal amount of the medicine absorbed into the body and the lack of systemic drug-drug interactions, regulatory documents do not define a specific 'washout' period. The concentration of the drug in the bloodstream is very low shortly after the last application.

Q: Is it true that Bunafine can affect sleep patterns?

Trouble sleeping (insomnia) is not listed as a commonly reported or known adverse reaction in the official regulatory prescribing information for topical Bunafine.

Q: What kind of medical monitoring is recommended while on Bunafine long-term?

Because Bunafine is used topically for short periods (typically 1 to 4 weeks), official labeling does not require any specific long-term systemic monitoring or regular laboratory testing.

Q: Can Bunafine be used by people with epilepsy?

The regulatory label contains no contraindications specifically related to epilepsy or seizure disorders. Due to the very low systemic absorption of the topical formulation, the effects on central nervous system conditions are not typically addressed in the official labeling.

Q: How does Bunafine affect the liver?

Official safety profiles note that the amount of the drug absorbed into the bloodstream after topical application is minimal. Therefore, the risk of clinically significant systemic side effects, including effects on the liver, is not reported or documented in the adverse reaction profile.

Q: What are the known effects of Bunafine overdose?

Regulatory documents state that no cases of overdose involving Butenafine topical cream have been reported. Official safety information describes contacting a Poison Control Center or seeking immediate medical assistance if the cream is accidentally swallowed.

Q: Can Bunafine be taken if a person has stomach ulcers?

The regulatory label does not list stomach ulcers or other gastrointestinal conditions as a contraindication. Given the topical nature of the medicine and minimal systemic absorption, effects on the gastrointestinal tract are not typically addressed in the official labeling.

How should Bunafine be stored and disposed of?

How to Store and Dispose of Butenafine Hydrochloride Cream (Bunafine)

Butenafine Hydrochloride Cream 1% must be stored and disposed of strictly according to official regulatory labeling to ensure product stability and safety.

Storage Requirements

The cream requires storage at controlled room temperature, specifically maintained between 20 C and 25 C (68 F to 77 F). The container must be kept tightly closed to protect the product, and it must not be frozen. As a mandatory safety requirement, the medicine must be stored out of the reach of children.

Disposal Instructions

Unused or expired product should be disposed of by following official governmental guidelines. This typically involves using a designated drug take-back program. If a take-back option is unavailable, the medicine must be mixed with an undesirable substance (such as dirt) and placed in a sealed container before being thrown in the household trash. The cream must not be disposed of in a sink or toilet.

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

Available in countries:

Equivalent of Bunafine found in:

A-Z Index: