Fungarest

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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 Fungarest

Property Description
Active ingredient Ketoconazole
Form Cream, Shampoo, Tablet
Pharmacological class Antifungal agent (Azole derivative)
Common use Addressing fungal and yeast infections
Origin Synthetic chemical entity

What Type of Medicine is Fungarest and How is it Classified?

Fungarest is a brand name for a pharmaceutical preparation whose primary active substance is Ketoconazole, a synthetic chemical entity classified as an antifungal agent. This preparation belongs to the azole pharmacological family, specifically recognized as an imidazole derivative. Its broad-spectrum antimycotic agent status means it is engineered to target and address various pathogenic yeasts and fungi, positioning it for use against numerous fungal organisms that cause infection. Ketoconazole is a foundational treatment in its class used in managing fungal overgrowth.

Composition, Origin, and Available Forms

Fungarest is consistently formulated as a single active ingredient product, containing only the therapeutic compound Ketoconazole along with the necessary base materials appropriate for the final delivery method. The preparation's utility is enhanced by its availability in multiple dosage forms, notably as a cream and shampoo for localized topical administration to the skin or scalp, and in a tablet form for oral delivery and systemic internal effect. Unlike some newer antifungals, Ketoconazole is characterized by its established history of use in both prescription and over-the-counter topical preparations depending on the country and concentration.

What is the General Purpose of Fungarest?

The general purpose of the Fungarest preparation is to stop the spread and eliminate fungal organisms that cause infections in the body, such as tinea versicolor or certain forms of dandruff linked to yeast overgrowth. The fundamental benefit is achieved because Ketoconazole interferes with the synthesis of ergosterol, a vital component required for the structural stability of the fungal cell membrane. This specific interference with the fungal organism's necessary biological processes prevents its growth and proliferation, offering a targeted solution to relieve symptoms and halt the progression of fungal-related conditions.

Regulatory References

  1. NIH
  2. FDA

What side effects are possible with Fungarest?

Possible Side Effects and Safety Information

The most significant safety consideration for oral Fungarest (ketoconazole) is the potential for serious hepatotoxicity (liver injury). This adverse reaction has resulted in cases requiring liver transplantation or leading to death, even in patients without pre-existing liver conditions. Due to this severe risk, the medicine is generally reserved for treating serious fungal infections when other effective therapies are not tolerated or available.

Adverse Reaction Profile

Category Common Side Effects (Reported in 1% to 10% of patients) Serious Adverse Reactions (Less Common, but Clinically Significant)
Gastrointestinal Nausea, vomiting, diarrhea, stomach pain, headache -
Endocrine/Hormonal Gynecomastia (male breast enlargement), decreased libido Adrenal insufficiency (reduced cortisol production), especially at high doses.
Hepatobiliary Abnormal liver function test results Severe hepatotoxicity (liver cell damage, cholestatic hepatitis), which may be fatal or require liver transplant.
Cardiovascular - QT interval prolongation (a rare, life-threatening heart rhythm abnormality), particularly when combined with contraindicated medications.

Safety Considerations and Limitations

  • Liver Monitoring: Close monitoring of liver function is necessary during treatment. The drug is contraindicated in patients with acute or chronic liver disease.
  • Drug Interactions: Fungarest inhibits the CYP3A4 enzyme and is contraindicated with numerous medications (e.g., specific antiarrhythmics, statins, and benzodiazepines) due to the risk of increasing their plasma concentrations, potentially leading to serious or fatal adverse events like heart rhythm abnormalities.
  • Adrenal Function: The drug may suppress adrenal gland function. Patients with existing adrenal insufficiency or those under prolonged stress may require adrenal function monitoring.

Connection to the Overall Safety Profile

The regulatory safety profile highlights the substantial and potentially fatal risk of liver injury, distinguishing it from less severe antifungal options. The official warnings emphasize this hepatotoxicity risk and the potential for life-threatening drug interactions and hormonal suppression. Consequently, the drug’s use is strictly limited to situations where the potential benefit clearly outweighs the well-documented risks, mandating cautious monitoring and patient awareness.

Overdose and Emergency Response

Overdose and when to seek help

The most serious systemic risks associated with ketoconazole (the active ingredient in Fungarest) relate primarily to oral tablet formulations, which have been severely restricted or suspended in many regions. Topical forms (shampoos, creams) have very low systemic absorption and are not generally associated with these risks.

Overdose Symptoms and Risks (Oral Tablets)

Oral ketoconazole overdose is linked to two major potential outcomes:

  • Serious Liver Injury (Hepatotoxicity): This includes cases of acute liver failure that have been fatal or required transplantation. Symptoms requiring immediate attention include yellowing of the skin or eyes (jaundice), unusual dark urine, light stools, severe fatigue, or persistent nausea and vomiting.
  • Adrenal Insufficiency: Overdose may suppress the adrenal gland, potentially leading to a deficiency in natural corticosteroids. Symptoms can include profound weakness, fatigue, loss of appetite, and low blood pressure.

Emergency Actions

Seek emergency medical attention immediately if you experience any signs of liver injury or adrenal problems, or if a large quantity of the oral tablets has been ingested. For recent oral overdose, medical professionals may use supportive measures, including gastric lavage and activated charcoal. If accidental ingestion of a topical product occurs, contact a poison control center or healthcare professional for guidance.

Therapeutic Uses of Fungarest

Fungarest is widely recognized as a topical antifungal medication generally used to help manage a number of common skin conditions caused by fungal or yeast growth. The main uses fall into three core therapeutic domains, assisting in addressing symptoms that create noticeable physiological strain, such as scaling, redness, and itching.

The formulation is applied across domains where short-term symptom management is appropriate, particularly for common dermatophytoses like athlete's foot, jock itch, and ringworm, as well as conditions like seborrheic dermatitis and pityriasis versicolor. This approach is relevant when supportive symptom management is appropriate.

“This medication is commonly used to help with symptoms related to inflammatory or irritative states of the skin.”

Support for Common Skin Fungal Manifestations

This section covers conditions presenting with systemic or localized discomfort, such as those caused by dermatophytes. Using the formulation helps address symptoms related to inflammatory or irritative states, which contributes to improved day-to-day comfort during symptomatic periods.

Easing Symptoms of Seborrheic Dermatitis and Dandruff

This domain focuses on conditions characterized by periods of heightened symptoms, like flaking and scaling associated with seborrheic dermatitis and dandruff. Fungarest assists in managing these symptoms, which may help ease patient distress and supports general well-being during symptomatic phases.

Quick Fact: Relief for Noticeable Itching Fungarest is commonly used to help ease symptoms related to inflammatory or irritative states of the skin, including noticeable itching, which helps improve day-to-day comfort during symptomatic periods.

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

The eligibility for using the medicine Fungarest (Ketoconazole) is strictly defined by the formulation, with the oral tablet having significant regulatory restrictions not applied to the topical cream or shampoo.

Contraindicated Populations (Oral Tablet)

The systemic oral tablet is contraindicated in several population groups due to the risk of severe adverse effects:

  • Patients with acute or chronic liver disease.
  • Patients with known hypersensitivity to Ketoconazole or any component of the formulation.
  • Pregnant women (Use is strictly contraindicated).

Restricted and Limited Use

The oral tablet is not a first-line treatment and should only be used when alternative effective antifungal therapy is unavailable or not tolerated. Use in pediatric patients is not recommended due to potential hepatotoxicity.

Age Group / Status Oral Tablet Eligibility Status
Pediatric Patients Use is not recommended (Safety and efficacy in children under 2 years are not established).
Breastfeeding Not recommended during treatment and for one day after the final dose.
Topical Formulations (Cream/Shampoo) are generally considered acceptable for use during pregnancy and breastfeeding due to minimal systemic absorption, but safety in children under 12 years has not been established.

What should I know about interactions with other medicines?

Fungarest (ketoconazole) is a potent inhibitor of the Cytochrome P450 3A4 (CYP3A4) enzyme system and, to a lesser extent, the P-glycoprotein (P-gp) transport system. These interactions can significantly increase the concentration of other co-administered medicines in the bloodstream, leading to enhanced effects and an increased risk of serious adverse reactions. Consequently, several drug combinations are strictly contraindicated.

Medications to Avoid (Major Interactions)

Ketoconazole's inhibition of CYP3A4 can dangerously elevate levels of drugs that prolong the QT interval of the heart's electrical cycle, which can cause life-threatening heart rhythm issues (e.g., Torsades de Pointes). Examples of contraindicated drugs include:

Drug Class Examples Potential Risk
Antiarrhythmics Dofetilide, Quinidine Serious heart rhythm abnormalities
Statins Simvastatin, Lovastatin Rhabdomyolysis (severe muscle damage)
Ergot Alkaloids Ergotamine, Dihydroergotamine Vasospasm (severe blood flow impairment)
Benzodiazepines Triazolam, Oral Midazolam Profound sedation and respiratory depression
Other Pimozide, Nisoldipine, Lurasidone Increased toxicity and side effects

Moderate Interactions

Close medical monitoring and dosage adjustments are required for many other drugs, including certain anticoagulants (e.g., Warfarin, Apixaban) to prevent bleeding risk, some HIV medications, and specific calcium channel blockers. Furthermore, drugs that significantly induce (speed up) CYP3A4 (such as Rifampicin) can decrease Fungarest’s effectiveness by rapidly lowering its concentration.

Food and Alcohol

  • Alcohol: Avoid consuming alcoholic beverages, as this combination increases the risk of serious liver problems (hepatotoxicity) and may trigger a disulfiram-like reaction (flushing, nausea).
  • Stomach Acid Reducers: Antacids, H2-receptor blockers (e.g., Cimetidine), and Proton Pump Inhibitors (PPIs) reduce stomach acidity, which is essential for Fungarest absorption. Fungarest should be taken with an acidic drink (like non-diet cola) or separated from antacid administration.

Mechanism of Action

How Fungarest Works

Fungarest, containing Ketoconazole, acts exclusively at the cellular level of the fungal organism through a targeted enzymatic mechanism. The molecule functions as a specific inhibitor of the fungal enzyme Lanosterol 14-alpha-demethylase (CYP51A1), an enzyme essential for the ergosterol biosynthesis pathway. The drug's imidazole ring coordinates with the heme iron at the enzyme's active site, functionally arresting this fundamental metabolic sequence.

This enzyme blockade initiates a dual physiological cascade: severe depletion of the vital membrane component ergosterol and the simultaneous accumulation of toxic intermediate sterols. This stress compromises the structural integrity and fluidity of the fungal cell membrane, leading to the inhibition of fungal proliferation (fungistatic effect) and, in high concentrations, cellular lysis (fungicidal effect).

The drug's mechanism is biologically constrained by the fungal cell's ability to adapt. Reduced effectiveness can arise from genetic changes in the gene encoding the target enzyme or the overexpression of efflux pumps that modulate intracellular drug concentration, outlining biological scenarios where the drug's action is physiologically constrained.

Dosage and Administration Information

Fungarest, containing the active substance Ketoconazole, is administered through distinctly defined oral and topical routes, each with specific usage protocols. The oral tablet is intended for systemic delivery, typically starting at 200 milligrams once daily, and may be increased to a maximum of 400 milligrams daily. A key requirement for the oral form is that it must be taken with a meal to ensure proper absorption. For pediatric patients aged two years and older, oral dosing is standardized based on body weight, typically ranging from 3.3 to 6.6 mg per kilogram per day.

The topical forms, including creams and shampoos, are strictly for external use on the skin and scalp. The topical cream is generally applied once daily for common cutaneous fungal infections, while seborrheic dermatitis often requires application twice daily. Treatment duration is based on the condition, such as two weeks for most tinea infections, extending up to six weeks for tinea pedis.

When using the shampoo preparation, the product is applied, lathered, and left in place for a specified contact time of three to five minutes before being thoroughly rinsed. This procedural step is for achieving the administration requirements. Topical forms are not intended for use in the eyes, mouth, or internally. No specific dose adjustment is typically noted for older adults or individuals with renal impairment.

Recent Clinical Evidence

Research evidence / Overview of studies for Fungarest

The clinical evaluation of Fungarest (Ketoconazole) topical formulations is conducted through controlled research that follows established protocols. This overview summarizes the structure of the existing evidence, what research has explored, and the recognized gaps in the current data.


Evidence for Use in Seborrheic Dermatitis and Dandruff

Research for seborrheic dermatitis and dandruff was explored primarily through short-term, randomized controlled trials (RCTs), including active-comparator designs. Researchers monitored outcomes linked to inflammatory or irritative states, such as overall clinical status and specific physical discomfort (redness, scaling, itching). Findings describe patterns observed over typical two- to four-week treatment periods, with limited data on long-term status after trials end.

Evidence for Use in Common Dermatophytoses and Cutaneous Yeast Infections

Fungarest was studied for conditions like ringworm and athlete's foot using short-term, vehicle-controlled RCTs. The primary objective was to track a composite outcome called the specified study endpoint, defined as achieving both a specified change in clinical signs and a specified mycological status (fungal presence or absence). Data show patterns related to how frequently this endpoint was met within the studied adult populations.

Evidence for Use in Tinea Versicolor

Research explored Tinea Versicolor through controlled clinical trials focusing on tracking changes in skin discoloration and the status of the causative fungus. While treatment courses are short-term, follow-up research has documented patterns of recurrence over intermediate periods (up to one or two years), highlighting that the long-term durability of the observed response is not fully established.

Remaining Uncertainties and Evidence Gaps

The foundation of the regulatory evidence includes short-term trials, and follow-up durations were limited across many core studies. This means minimal insight exists for long-term outcomes. Furthermore, there is limited information for the use of the topical formulations in children younger than 12 years. The research findings reflect only the specific immunocompetent adult populations under which the studies were conducted.

Key Studies & References

  1. Ketoconazole (NIH Bookshelf - StatPearls)
  2. Ketoconazole Topical (NIH MedlinePlus Drug Information)

Frequently Asked Questions (FAQ)

Common questions about Fungarest (FAQ)

Q: How quickly does Fungarest usually start to work?

The time until a reduction in the signs of infection may be observed varies depending on the type of infection being addressed. According to official product information, for the oral tablet, drug concentrations in the body typically reach their highest levels within 1 to 4 hours after a dose. Full clearance of the condition may require several weeks of continued use as prescribed.


Q: Do I need to take Fungarest with food?

Regulatory documents indicate that the oral tablet formulation is best taken with a meal. Taking the medicine with food is described as improving the absorption of Fungarest into the body. This condition does not apply to the topical forms, such as the cream or shampoo.


Q: What common medicines interact with Fungarest?

Fungarest is a strong inhibitor of an enzyme called CYP3A4. This means it can significantly increase the concentration of many other medicines in the bloodstream. Official warnings describe serious interactions with several classes of medicines, including certain heart rhythm drugs, cholesterol-lowering drugs (statins), and specific sedatives.


Q: Is it true that Fungarest can affect hormone levels?

Yes, official warnings and safety information describe effects on the endocrine system (hormone-producing glands). At higher doses, the drug may decrease the production of adrenal corticosteroids, potentially leading to adrenal insufficiency. Other reported effects related to hormone levels include decreased libido and gynecomastia (male breast enlargement).


Q: Can Fungarest be used by the elderly?

Official documents state that no specific dose adjustment is generally recommended for older adults. However, regulatory documents note that the oral tablet is strictly reserved for treating serious fungal infections when other effective therapies are not available or tolerated due to the potential for severe risks.


Q: Can Fungarest be crushed or mixed with food?

Research has described that absorption may differ when the oral tablet is administered as a liquid suspension compared to a crushed tablet. This medicine requires an acidic environment to dissolve and absorb properly, and this process can be influenced by how the tablet is consumed or altered.


Q: Can Fungarest be used for skin infections, or only internal ones?

The oral tablet is officially indicated only for specific systemic (internal) fungal infections. It is explicitly not indicated for treating routine fungal infections of the skin or nails. The cream and shampoo forms, however, are specifically indicated for external use on the skin and scalp.


Q: What happens if I miss a scheduled dose of Fungarest?

If a dose is missed, regulatory information advises applying or taking it as soon as you remember. If a dose is missed, official product information advises referring to the specific instructions provided on when to take the next dose and when to skip the missed dose. Regulatory documents state that doses should not be doubled.


Q: Are there any specific foods or drinks to avoid while using Fungarest?

Regulatory documents explicitly advise avoiding alcohol consumption during treatment due to the increased risk of serious liver problems (hepatotoxicity). Furthermore, drugs that reduce stomach acid are noted as potentially affecting the absorption of the oral tablet, as stomach acidity is necessary for this process.


Q: Why is Fungarest sometimes prescribed for fungal infections of the nails?

Official FDA labeling states that the oral tablet is not indicated for the treatment of fungal infections of the nails (onychomycosis) when used for systemic infections. Topical forms are indicated only for skin conditions.


Q: Can Fungarest be taken long-term?

The maximum duration of therapy is determined by the treating physician and the type of infection. For systemic infections, the usual treatment duration is often described as around six months. Official documents note that prolonged use has been associated with reports of serious liver injury.


Q: What did the major clinical trials for Fungarest focus on?

Major clinical trials for the topical formulations of Fungarest primarily focused on short-term outcomes. Researchers measured specific endpoints, such as overall clinical status change and achieving a mycological cure (the absence of fungus), for conditions like seborrheic dermatitis, athlete's foot, and tinea versicolor.


Q: Why is Fungarest not used for some common types of yeast infections?

The oral tablet carries a substantial risk of severe liver injury (hepatotoxicity) compared to other available antifungal options. For this reason, official regulatory guidance strictly limits its use, stating it should only be employed when alternative effective antifungal therapy is not available or tolerated.


Q: What happens if Fungarest is stopped too soon?

Official information advises that the infection may not clear up completely or the symptoms may return if the medicine is stopped before completing the full course prescribed by the physician. Following the prescribed duration is considered essential for achieving the intended outcome of the treatment.


Q: Does taking Fungarest affect blood test results?

Yes. Due to the risk of liver injury, the regulatory label for the oral tablet requires close monitoring of liver function tests (LFP) during treatment. These tests include measuring serum ALT, AST, and bilirubin levels.


Q: Can Fungarest make you tired or dizzy?

Dizziness is listed in some regulatory-linked safety profiles as a reported side effect of the oral tablet formulation. If this effect occurs, official safety materials should be consulted for guidance.


Q: Can men and women use Fungarest for the same conditions?

Yes, the oral tablet is indicated for systemic fungal infections in both men and women. However, the safety profile notes specific side effects related to hormone levels, such as gynecomastia (male breast enlargement), that are specific to male patients.


Q: Is Fungarest considered effective for skin fungus?

Studies and official information indicate that the topical formulations (cream and shampoo) are effective for treating various cutaneous fungal infections, such as tinea versicolor and athlete's foot (tinea pedis). The oral tablet, however, is not indicated for these conditions.


Q: Why might a doctor choose Fungarest over another antifungal drug?

Official regulatory guidance states that, due to its risks, the oral tablet should only be chosen by a physician when other effective antifungal therapy is not available or not tolerated by the patient. Its use is limited to situations where the potential benefit is judged to clearly outweigh the documented risks.


Q: Does Fungarest treat the symptoms or the underlying cause?

Fungarest is designed to treat the underlying cause of the infection. It works by interfering with the synthesis of ergosterol, a vital component required for the fungal cell membrane's structural stability, which prevents the fungal organism's growth and proliferation.


Q: Is the onset of action different for the cream versus the tablet?

Yes. The oral tablet is quickly absorbed into the body, with drug concentrations typically peaking within 1 to 4 hours. For the topical cream/shampoo, while you apply it immediately, the time to full clinical clearance of the skin infection may take several weeks as symptoms can be slow to resolve.


Q: Can I take Fungarest if I have a history of allergies?

The medicine is contraindicated (should not be used) in patients with a known hypersensitivity to ketoconazole or any of the inactive ingredients used in the formulation. Hypersensitivity refers to a severe allergic reaction to the drug.


Q: Is there a maximum time frame Fungarest is generally used for?

The official duration of use is determined by the treating physician based on the specific infection being addressed. For systemic infections, the usual treatment duration is generally stated as up to six months.

How should Fungarest be stored and disposed of?

How to Store and Dispose of Fungarest

Proper storage and disposal of Fungarest (Ketoconazole) is essential to maintain the drug's effectiveness and ensure safety.

Storage Requirements

Store the medication at controlled room temperature, typically between 20°C and 25°C (68°F and 77°F). It is important to keep the container tightly closed and in its original packaging. Store away from excess heat and moisture; for example, avoid storing it in the bathroom. The medication must be protected from light and should not be allowed to freeze.

Safety and Disposal

Always place the container in a safe location, up and away and out of sight and reach of children and pets. Ensure safety caps are always locked. To dispose of medicine no longer needed, do not flush it down the toilet or throw it in the household trash. Instead, consult a pharmacist or local waste disposal service for guidance on local requirements for safe disposal. These measures help protect the environment.

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

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