Tigal

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Tigal

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 Tigal

Quick Facts

Property Description
Active ingredient Terbinafine Hydrochloride
Form Tablets, Cream, Solution, Spray, Powder
Pharmacological class Antifungal Agent (Allylamine)
General purpose Elimination of fungal pathogens
Origin Synthetic allylamine derivative

What Type of Medicine is Tigal (Terbinafine Hydrochloride)?

Tigal is a recognized, prescription medicine classified as an antifungal agent, with its core identity derived from the active substance, Terbinafine Hydrochloride. This compound is a synthetic allylamine derivative, which places it within the specific pharmacological class of allylamine antifungals. Agents in this class act as non-competitive inhibitors of the fungal enzyme squalene epoxidase, a mechanism utilized for its efficacy against dermatomycoses.

As a single-component product, Tigal maintains a direct focus on antimycotic action. This pharmacological classification defines the medicine's role: to eliminate or control fungal organisms. The formulation is commonly available for two distinct routes of administration, addressing both localized surface infections and more pervasive internal fungal issues.

What is the General Purpose and Form of Tigal?

The core therapeutic goal of Tigal is to exert a definitive fungicidal action, actively leading to the elimination of susceptible fungal cells. The mechanism is designed to disrupt the synthesis of ergosterol, an essential component of the fungal cell membrane, resulting in fungal cell death. This targeted action allows the medicine to counteract various fungal presences.

Tigal is manufactured in multiple dosage forms, offering specific delivery options. Tablets are intended for systemic use, where the substance is absorbed to act throughout the body. Conversely, preparations such as cream, solution, spray, and powder are formulated for topical administration, delivering the agent directly to the surface. This availability of diverse pharmaceutical preparations is a key factor that ensures appropriate management whether the intervention is systemic or localized.

Regulatory References

  1. Terbinafine - StatPearls - NCBI Bookshelf

What side effects are possible with Tigal?

Possible Side Effects and Safety Information

The safety profile of oral Tigal (terbinafine) is categorized by regulatory authorities based on the frequency and system-organ class (SOC) of the reported adverse reactions.

Adverse Reaction Categories

Adverse reactions are classified into formal categories, including Very Common (ge1/10), Common (ge1/100 to <1/10), Rare (ge1/10,000 to <1/1,000), and Not Known (frequency cannot be estimated from available data).

Common and Expected Reactions

The most frequently documented side effects (Very Common or Common) involve the following system-organ classes:

  • Gastrointestinal Disorders: Diarrhea, dyspepsia, abdominal pain, nausea.
  • Nervous System Disorders: Headache.
  • Skin and Subcutaneous Tissue Disorders: Rash, urticaria (hives).
  • Taste Disturbances: Dysgeusia (taste disturbance or loss of taste/ageusia).

Serious Adverse Reactions

Regulatory documents emphasize the risk of rare but serious adverse reactions, primarily identified through post-marketing surveillance:

  • Hepatotoxicity: Rare cases of hepatic failure, hepatitis, or cholestasis have occurred, sometimes leading to liver transplant or death. Liver injury may occur in patients with and without pre-existing liver disease.
  • Severe Skin Reactions: Serious conditions, including Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
  • Hematologic Effects: Rare cases of severe blood disorders, such as neutropenia and pancytopenia.
  • Lupus Erythematosus: Precipitation or exacerbation of cutaneous and systemic lupus erythematosus has been reported.

Safety Restrictions and Monitoring

Restrictions: The oral tablet is contraindicated in patients with chronic or active liver disease. Use is generally not recommended in patients with renal impairment.

Time-Related Patterns: Regulatory labeling notes that taste and smell disturbances may be severe and, in rare instances, prolonged (greater than one year) or permanent.

This structured safety information outlines the documented range of risks, from common, mild gastrointestinal effects to rare, serious organ-system disorders, and specifies population restrictions based on authoritative regulatory findings.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory documents outline the specific signs and actions required in the event of an overdose of Tigal (Terbinafine Hydrochloride).

Acute oral overdose has been reported following ingestions of up to 5 grams of the active substance. Documented clinical manifestations of overdose primarily affect the gastrointestinal and nervous systems, commonly including nausea, vomiting, abdominal pain, headache, and dizziness.

Required Emergency Actions

If an overdose is suspected, professional medical assistance is required. Immediate emergency medical services must be contacted if the affected individual exhibits severe signs of toxicity, such as being collapsed, experiencing a seizure, having trouble breathing, or being unable to be awakened.

No specific antidote is known for Terbinafine Hydrochloride overdose. Management procedures documented in official prescribing information focus on eliminating the unabsorbed substance, typically by administering activated charcoal, and providing subsequent symptomatic and supportive therapy.

Population-specific notes state that the clearance of the substance is decreased by approximately 50% in patients with renal impairment or hepatic cirrhosis. This is a factor considered during the medical management of an overdose situation.

Therapeutic Uses of Tigal

What Tigal Treats: Main Uses and Benefits

Tigal (Terbinafine) is commonly used to help with fungal infections that cause persistent and pervasive symptoms across the body. It supports managing symptoms associated with fungal infections and is used in situations involving certain distressing symptoms caused by fungal pathogens. Its therapeutic scope is relevant in contexts where the site, severity, or extent of the infection may warrant a systemic approach.

This medication is commonly used for managing a variety of dermatophyte infections, including onychomycosis (fingernail and toenail fungus), Tinea Capitis (scalp ringworm), and severe or extensive fungal skin manifestations such as Tinea Corporis, Tinea Cruris, and Tinea Pedis.

Fungal Infections of Nail and Hair Structures

Tigal is commonly used for managing conditions involving structural damage of the keratinized structures. These conditions present with manifestations such as thickening, discoloration, and crumbling of the nail plate. The key benefit is the support for the process of clearance, which supports the appearance of un-thickened, un-discolored tissue.

Severe and Extensive Fungal Skin Manifestations

The medication is applied in clinical settings marked by heightened symptoms of ringworm where previous localized symptom management has been insufficient. It helps address symptom clusters such as intense itching (pruritus), noticeable scaling, and pronounced redness. Using Tigal provides supportive therapeutic benefit that contributes to easing the overall symptom load, assisting with maintaining functional stability.


Quick Fact: Support for Persistent Fungal Symptoms Tigal is considered relevant in conditions characterized by periods of heightened symptoms of fungal origin, providing support that helps ease the overall symptom burden in situations involving deep-seated fungal infections of the nails or scalp, or extensive manifestations on the skin.

Regulatory References

  1. Medsafe New Zealand guidance on Terbinafine

Eligibility and Restrictions for Use

Contraindications (Absolute Exclusion)

Tigal (Terbinafine) is formally contraindicated for individuals with a history of allergic reaction or hypersensitivity to oral Terbinafine due to the risk of anaphylaxis. It is also an absolute contraindication for patients with pre-existing chronic or active liver disease.


Restricted Use and Special Populations

Use is not recommended for patients with severe renal impairment (creatinine clearance < 50 mL/min), a classification based on insufficient data in this population. Use is also not recommended during pregnancy due to limited clinical experience, or for breastfeeding mothers as the substance passes into breast milk. Caution is required for patients with Lupus Erythematosus or Psoriasis, as regulatory documents note reports of potential exacerbation of these conditions.


Age-Related Eligibility

The medicine is approved for adults for labeled systemic uses. For pediatric patients, the oral granule formulation is approved for children mathbfge 4 years of age for Tinea Capitis; safety and efficacy have not been established below this minimum age threshold. Use in older adults is permitted, but the possibility of pre-existing kidney or liver impairment must be carefully considered.

What should I know about interactions with other medicines?

The official interaction profile for oral Tigal (Terbinafine Hydrochloride) is primarily structured by a pharmacokinetic interaction involving the cytochrome P450 (CYP) enzyme system. Tigal is officially documented as a potent inhibitor of the CYP450 2D6 (CYP2D6) isozyme. This inhibition reduces the clearance of certain co-administered medicinal products, which can lead to documented increased systemic exposure of substances such as Desipramine (an antidepressant), certain beta-blockers, and Class 1C antiarrhythmics (e.g., flecainide).

Conversely, the systemic exposure of Tigal itself can be significantly altered. Co-administration with enzyme inducers, notably Rifampin, is officially documented to increase the clearance of Tigal, resulting in reduced systemic exposure. Conversely, co-administration with enzyme inhibitors, such as Cimetidine and Fluconazole, are documented to increase Tigal's systemic exposure. A formal contraindication condition exists for the oral formulation in individuals with chronic or active liver disease due to the officially recognized risk of compounded hepatic stress. The medicine is also documented to inhibit the clearance of the substance Caffeine.

Mechanism of Action

How Tigal Works

Tigal's action is defined by a selective, dual-action mechanism targeting essential fungal biochemistry.


Direct Blockade of Fungal Enzyme Activity

The mechanism initiates with the non-competitive inhibition of the enzyme squalene epoxidase, an essential molecule in the fungal cell's sterol biosynthesis pathway. This blockade halts the ergosterol biosynthesis pathway. The drug's activity demonstrates selectivity for the fungal enzyme, contrasting with its activity on the mammalian analogue.


Dual-Action Cellular Lysis Mechanism

By blocking the enzyme, the drug simultaneously causes two lethal cellular consequences: first, the depletion of essential membrane-stabilizing ergosterol, and second, the accumulation of the precursor squalene within the cell. This dual-action cascade destabilizes the fungal cell membrane, leading to its lysis and death (fungicidal effect), which constitutes the final cellular consequence of the mechanism.

Dosage and Administration Information

Tigal (Terbinafine) is administered through distinct routes based on the required systemic or localized action. For infections of the nails and scalp, treatment is given orally via 250 mg tablets or weight-based granules. Superficial skin infections are managed through topical preparations, such as cream or solution.

Oral Administration Schedule

The standard adult regimen for oral tablets is defined as once daily. The duration of this treatment course is standardized based on the infection site:

Indication Standard Adult Dose Treatment Duration
Fingernail Onychomycosis 250 mg once daily 6 weeks
Toenail Onychomycosis 250 mg once daily 12 weeks

The oral tablet may be taken independently of food. If a tablet dose is missed, it should be taken as soon as possible unless the time for the next scheduled dose is near, in which case the missed dose is skipped. Double doses are not part of the administration protocol.

Preparation for Oral Granules

For pediatric patients receiving oral granules for Tinea Capitis, the dose is determined based on weight class. The contents of the packet must be mixed with a spoonful of soft, non-acidic food, such as pudding or mashed potatoes. This mixture must be swallowed immediately and entirely without chewing. The topical forms are for external application to the affected and surrounding areas only.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Tigal (Terbinafine)

This overview summarizes the formal clinical research and studies conducted on Tigal (Terbinafine) as reviewed by regulatory bodies, focusing strictly on the evidence base without offering medical advice or making claims about individual results.

Evidence Summary for Systemic Use (Oral Tablets)

Tigal tablets was evaluated in primarily through Randomized Controlled Trials (RCTs) and subsequent Meta-analyses. These studies were conducted to evaluate oral Tigal for more pervasive fungal infection contexts. This research was used in research examining short-term symptom changes and outcomes related to systemic or functional imbalance.

Evidence for Fingernail and Toenail Fungus (Onychomycosis)

Research for fungal nail infections involved large-scale RCTs and pooled analyses. This research was designed to track outcomes over time. Studies monitored patients with conditions characterized by fluctuating manifestations, measuring the status of the fungal pathogen (Mycological Cure) and the measurement of nail appearance changes. The studies focused on Adults with confirmed infections and described patterns in the measured status of the fungal pathogen. However, the evidence is limited because a final assessment of nail appearance requires a long follow-up duration.

Evidence for Scalp Ringworm (Tinea Capitis)

Tigal was evaluated for use in Tinea Capitis, a condition primarily affecting children. The research used comparative RCTs and explored patterns of Mycological Cure and Clinical Resolution of symptoms. Data show patterns related to the measured mycological status of the pathogen. Research highlights changes measured during the study period, but evidence quality varies across studies, and findings were mixed depending on the specific type of fungus causing the infection.

Evidence Summary for Topical Use (Creams and Solutions)

Topical formulations have been evaluated in short-term, placebo-controlled Randomized Controlled Trials, focusing on conditions where symptoms may vary in intensity.

Evidence for Athlete's Foot and Localized Skin Ringworm

Research examined short-term symptom changes in Adults and Adolescents with localized fungal infections. Trials described the measured outcomes related to Mycological status. The majority of reports described patterns in the measured Clinical Cure metrics for the specific interdigital presentation of the condition. However, the studies were designed for and the results apply only to the localized and non-extensive forms of these conditions.

What Is Still Uncertain About the Evidence for Tigal

Official reviews describe several research limitations that provide context but not individual predictions:

  • Limited Subgroup Data: Data for certain groups, such as the very young or those with specific underlying health conditions, remain insufficient.
  • Long-Term Follow-up: While studies monitored patients for some time, data provides limited information on long-term outcomes tracking patterns of recurrence far into the future for all indications.

Key Studies & References

  1. Cumulative meta-analysis of systemic antifungal agents for the treatment of onychomycosis
  2. Terbinafine - StatPearls (Source for general clinical use and special population notes)

Frequently Asked Questions (FAQ)

Common questions about Tigal (FAQ)


Q: What condition is Tigal most commonly prescribed for?

A: Official product information states that oral Tigal is approved for treating systemic fungal infections, including onychomycosis (fungal infections of the nails) and tinea capitis (scalp ringworm).


Q: Do the side effects of Tigal typically go away on their own after the first few weeks of use?

A: The experience with many common side effects reported with Tigal is that they may lessen or disappear after the medicine is stopped. However, official safety documentation notes that in rare instances, taste and smell disturbances may be prolonged, lasting over a year, or potentially becoming permanent.


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

A: Regulatory information indicates that the active substance in oral Tigal reaches its highest level in the bloodstream approximately two hours after taking a dose. However, the medicine must build up in the skin, hair, and nails to reach a therapeutic level, meaning the therapeutic effect is achieved over time.


Q: When can a person typically expect to see or feel the effects of Tigal?

A: Because Tigal targets the fungus in the nail beds, the time to see the full change depends on how quickly the healthy nail grows. Official treatment durations are strictly set for 6 weeks for fingernails and 12 weeks for toenails, reflecting the time required for healthy, uninfected nail to grow out.


Q: How long does Tigal stay in the body or system after the last dose?

A: The effective half-life of oral Tigal in the bloodstream is approximately 36 hours. Because the medicine accumulates in tissues like skin and fat, the official terminal half-life is significantly longer, ranging from 200 to 400 hours after the final dose.


Q: Is there a known interaction between Tigal and alcohol?

A: No official contraindication exists for consuming alcohol while taking Tigal. However, alcohol may potentially worsen some side effects, such as headaches, and it may compound the rare risk of serious liver problems already documented with the drug.


Q: Does Tigal interact with common supplements like vitamins, minerals, or herbal products?

A: Regulatory sources indicate that there is not enough data or official information to confirm that complementary medicines, herbal remedies, and supplements are safe to take with oral Tigal.


Q: What happens if Tigal is taken with blood pressure or heart medications?

A: Official drug labeling warns that Tigal is known to inhibit the clearance of certain heart and blood pressure medications. Specifically, this affects medicines like beta-blockers and Class 1C antiarrhythmics, which can lead to increased amounts of those medicines in the body.


Q: Can older adults (seniors) safely take Tigal?

A: Official information states that the use of Tigal in older adults is generally permitted. However, because older people may be more likely to have pre-existing conditions, the possibility of underlying kidney or liver impairment requires careful assessment based on regulatory warnings.


Q: Is Tigal known to affect a person's ability to drive or operate machinery?

A: Regulatory documents indicate that there is no specific data on whether Tigal tablets affect a person’s ability to drive or operate machinery. However, if a patient experiences dizziness, which is a reported side effect, it is prudent to avoid these activities, as a matter of general safety.


Q: Is Tigal generally considered a first-line treatment for its approved use?

A: Based on the evidence reviewed by regulators, Tigal is highly effective and widely used for conditions like fungal nail infections and tinea capitis. It is often utilized because these conditions are pervasive and difficult to treat with localized topical medications alone.


Q: What do the clinical studies or research evidence say about Tigal's outcomes?

A: Research evidence shows that clinical success rates for fungal nail infections treated with Tigal vary widely depending on how success is defined in the studies. Reported rates for complete cure in clinical trials range from approximately 16% to over 30% for treatment success.


Q: Are there ongoing clinical trials related to Tigal that people can learn about?

A: Yes, government resources, such as the ClinicalTrials.gov database, list ongoing studies related to Tigal. These trials often focus on aspects like bioequivalence, which measures how similar different drug formulations are, and comparisons against other existing treatments.


Q: Why is Tigal sometimes prescribed instead of an older, similar medicine?

A: Tigal is often selected because of its strong fungicidal activity, meaning it actively kills fungal cells. It is also known for its ability to reach and maintain therapeutic concentrations in the skin, hair, and nails, offering a different profile compared to some older medications that may have varying effectiveness in these areas.


Q: Is it true that taking Tigal can make a person more sensitive to the sun?

A: While not a common side effect, official post-marketing surveillance has documented rare reports of photosensitivity with Tigal. Photosensitivity is an increased sensitivity or strong reaction of the skin to sunlight.


Q: Does Tigal affect sleep patterns or cause insomnia?

A: Regulatory safety information indicates that changes in sleep patterns, including reports of sleep problems, have been noted as adverse events in post-marketing surveillance for Tigal.


Q: Is there any information about Tigal potentially impacting fertility?

A: Official sources state that there is no evidence suggesting that oral Tigal reduces or impairs fertility in either men or women.

How should Tigal be stored and disposed of?

How to Store and Dispose of Tigal (Terbinafine Hydrochloride)

Storage and disposal requirements for Tigal are defined by regulatory labeling to maintain stability and safety.

Storage Conditions

Oral tablets must be stored at Controlled Room Temperature (20 C to 25 C), protected from light and moisture. The medicine must be kept out of the sight and reach of children. Topical forms (cream/solution) are generally stored below 25 C and may have strict stability limits after first opening, such as 28 days or 12 weeks.

Disposal Instructions

Unused or expired Tigal must not be discarded via wastewater or household waste. Regulatory documents instruct that the product should be returned to a pharmacist for proper, environmentally protected disposal, as these measures help prevent environmental contamination.

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

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