Dermazol

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Dermazol

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Method of action: Antifungal Broad Spectrum

Treatment option: Dermatitis, Infection

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 Dermazol

Quick Facts: Dermazol (Ketoconazole)

Property Description
Active ingredient Ketoconazole
Form Cream, Shampoo, Tablet (Oral), Gel
Pharmacological class Azole Antifungal (Imidazole derivative)
Common use Addressing fungal infections
Origin Synthetic (Chemically synthesized)

What Type of Medicine is Dermazol and What Does It Contain?

Dermazol is the trade name for a medicine containing the active ingredient Ketoconazole, which is chemically classified as a synthetic Azole Antifungal agent, specifically an imidazole derivative. The drug is a monotherapy product, meaning it relies on a single, active substance for its effect, focusing entirely on antifungal efficacy. This synthetic compound is recognized for its broad-spectrum activity against various yeasts and molds.

Dermazol is differentiated from generic Ketoconazole formulations by the variety of its dosage forms, which include topical creams and shampoos, offering options for both localized skin issues and conditions affecting larger surface areas like the scalp.


What is the General Purpose of Dermazol’s Antifungal Action?

The general purpose of Dermazol is to combat fungal infections by interfering with the integrity of the fungal organism itself. It achieves this by disrupting the production of ergosterol, a specific compound that is essential for building and maintaining the fungal cell membrane. This targeted interference is why Ketoconazole is characterized as having both fungistatic (inhibiting growth) and fungicidal (killing the fungus) properties, depending on the concentration.

By causing structural weaknesses in the fungal outer layer, the medication effectively halts the growth and reproduction of the fungus. A typical neutral use scenario for its shampoo formulation is in managing conditions where fungus affects the scalp, such as dandruff or seborrheic dermatitis. This action provides relief by addressing the root cause of the fungal problem at the cellular level.

What side effects are possible with Dermazol?

Possible Side Effects and Safety Information

The information in this section outlines the formally documented adverse reactions and safety characteristics of Dermazol (Ketoconazole), based strictly on government regulatory documents.

Adverse Reactions by Frequency and Organ System

The majority of documented side effects for topical forms of Dermazol are localized to the application site. Regulatory agencies classify these reactions by their expected frequency, typically during clinical trials.

Frequency Category Official Adverse Reactions System Organ Class Focus
Common Skin burning sensation, application site pruritus (itching), erythema (redness) Skin and Subcutaneous Tissue, Application Site
Uncommon Contact dermatitis, rash, bullous eruption, hypersensitivity, application site discomfort Skin and Subcutaneous Tissue, Immune System
Not Known Urticaria (hives), alopecia (hair loss), hair discoloration, angioedema Immune System, Hair and Follicle

Serious Safety Considerations

Anaphylaxis and Severe Hypersensitivity: Severe allergic reactions, including anaphylaxis, have been documented in the post-marketing surveillance of topical ketoconazole products.

Hepatotoxicity (Liver Injury) Distinction: Major regulatory bodies have noted that while the oral form of ketoconazole is associated with a high risk of severe hepatotoxicity, this risk is not associated with the topical cream, shampoo, or gel formulations due to minimal systemic absorption.


Safety Restrictions and Special Populations

Contraindications and Restrictions: Dermazol is officially contraindicated in individuals with a known hypersensitivity to ketoconazole or any of its excipients. Contact with the mucous membranes of the eyes must be avoided. Certain topical forms carry an official warning of flammability.

Pediatric Use: Safety and efficacy have not been established in children younger than 12 years of age for many topical formulations.

Pregnancy and Lactation: Topical use in pregnancy is recommended only if the potential benefit outweighs the potential risk. Caution is advised when administering to a nursing woman, as it is not known if the substance is excreted in breast milk.

Overdose and Emergency Response

Overdose and When to Seek Help

Systemic overdose of Dermazol (Ketoconazole) is primarily associated with the oral formulation and presents a risk of serious toxicity, according to regulatory documentation. The official overdose profile emphasizes that systemic exposure poses a severe risk, which dictates the required emergency response.

Overdose manifestations officially documented include signs of acute liver injury, such as jaundice, dark urine, pale stools, and stomach pain, as well as symptoms consistent with adrenal insufficiency like profound weakness and low blood pressure. Severe, life-threatening outcomes officially noted in regulatory warnings include fatal hepatotoxicity and the risk of cardiac arrhythmias (Torsades de pointes) due to potential QT prolongation.


Required Emergency Actions

The primary action mandated by regulatory authorities is to seek immediate medical attention for any suspected overdose. Patients must also contact a Poison Control Center immediately. If the person has collapsed or is having trouble breathing, emergency services should be called.

Management of overdose is symptomatic and supportive. No specific antidote is known. Regulatory texts describe procedures such as the use of gastric lavage with activated charcoal if ingestion occurred within the first hour, and administering hydrocortisone with saline/glucose to manage signs of adrenal insufficiency. Close medical monitoring is required.

Therapeutic Uses of Dermazol

Quick Facts

  • Targeted Conditions: Seborrheic dermatitis, tinea corporis, tinea cruris, tinea pedis, and cutaneous candidiasis.
  • Goal: May help resolve certain fungal and yeast infections of the skin.
  • Therapeutic Use: Provides an established option for managing specified dermatophyte and yeast-related skin issues.

Dermazol is a compound used in the therapeutic management of a number of fungal and yeast infections affecting the skin. These indications include tinea corporis (ringworm of the body), tinea cruris (jock itch), and tinea pedis (athlete's foot). These conditions are typically caused by common dermatophyte species.

The compound is also utilized to address cutaneous candidiasis, which is a yeast infection of the skin. Additionally, Dermazol is an available option for managing the signs and symptoms of seborrheic dermatitis, a common skin condition. This medication serves as a potential component of a comprehensive treatment plan when recommended by a healthcare provider.

It is important for patients to receive guidance on the appropriate use of this product and to understand that treatment progress should be evaluated by a healthcare professional. The primary therapeutic objective of the compound is to support the resolution of the listed fungal and yeast conditions.

Eligibility and Restrictions for Use

The eligibility for using Dermazol is strictly defined by regulatory authorities and depends on the formulation (Topical vs. Oral Tablet).


Official Eligibility and Non-Eligibility

Contraindicated Populations:

  • Hypersensitivity: The medicine is contraindicated in individuals with a known allergy to Ketoconazole or any excipient ingredient in the product (all forms).
  • Liver Disease (Oral Tablet Only): The Oral Tablet formulation is absolutely contraindicated in patients with acute or chronic hepatic impairment.
  • Cardiovascular Risk (Oral Tablet Only): Use is contraindicated in patients with conditions that predispose to QTc prolongation or when taking specific interacting medications.

Age-Related Eligibility:

  • Children: Safety and effectiveness for most topical forms have not been established for pediatric subjects under 12 years of age.
  • Adults: The medicine is generally established for use in adults and adolescents ge 12 years.

Special Populations:

  • Pregnancy (Topical): Use is designated as Pregnancy Category C and is conditional, allowed only if the potential benefit justifies the potential risk to the fetus.

Regulatory documents limit the Oral Tablet to treating serious systemic fungal infections when alternative therapies are unavailable. Most topical forms are indicated for use in immunocompetent individuals.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Dermazol (oral tablets) is a potent inhibitor of the cytochrome P450 3A4 (CYP3A4) enzyme in the body. Co-administration with other medicines that are substrates for this enzyme can significantly increase their concentration in the blood, potentially leading to serious and life-threatening adverse effects, including QT prolongation.

Contraindicated Combinations

Several medicines are strictly contraindicated (should not be used) with Dermazol oral tablets. These include, but are not limited to, dofetilide, quinidine, cisapride, pimozide, and certain benzodiazepines such as oral midazolam and oral triazolam.

Other Significant Interactions

Interacting Agent Category Interaction Mechanism and Constraint
Acid-Reducing Medicines (e.g., H2-receptor antagonists, PPIs) Impair the absorption of Dermazol oral tablets by reducing gastric acidity; may require specific spacing of doses.
CYP3A4 Inducers Potent inducers (e.g., rifampicin) can decrease Dermazol levels, reducing its effectiveness; co-administration is generally not recommended.
Potentially Hepatotoxic Drugs Concurrent use of Dermazol oral tablets with other substances known to cause liver injury, including alcohol, should be avoided due to the increased risk of hepatotoxicity.

For the topical form of Dermazol (shampoo), systemic absorption is minimal, and therefore, no significant drug interactions have been identified or studied.

Mechanism of Action

Blocking the Fungal Cell Membrane Synthesis Pathway

The mechanism of action for Dermazol (Ketoconazole) involves the inhibition of the fungal enzyme lanosterol 14alpha-demethylase (CYP51). This molecular blockade stops the conversion of lanosterol to ergosterol, which is a primary sterol constituent of the fungal cell membrane and essential for its structural integrity and functionality. The consequence of this targeted enzyme inhibition is a resulting disruption of the fungal cell's stability.

Cascade Leading to Loss of Cellular Integrity

The lack of ergosterol combined with the accumulation of toxic intermediate sterols compromises the cell membrane, increasing its porosity and functional instability. This mechanistic cascade directly results in the leakage of intracellular components, which impairs the organism's ability to undergo normal growth and repair processes. This physiological outcome—either stopping growth (fungistatic) or causing cell death (fungicidal)—represents the functional consequence of the mechanism.

️ Mechanism Constraints and Off-Target Action

The molecular affinity of Ketoconazole for P450 enzymes results in a dual mechanism; at higher systemic concentrations, the molecule also inhibits certain mammalian Cytochrome P450 enzymes (e.g., 17alpha-hydroxylase). This off-target action is a secondary mechanistic factor, which results in the suppression of the natural synthesis of steroid hormones in the body.

Dosage and Administration Information

How to Use Dermazol: Official Administration Guidelines

This section describes the standard administration patterns for Dermazol (Ketoconazole).


Administration Scope

Category Official Instructions
Route of Administration The medicine is administered Orally (tablets) for systemic action or Topically (cream, shampoo, or foam/gel) for localized use.
Dosing Schedule The initial Oral Tablet (Adult) dose is typically 200 mg once daily, which may be increased to a maximum of 400 mg once daily. Topical formulations are applied once or twice daily, depending on the specific duration of the treatment course.
Timing in Relation to Meals The Oral Tablet must be taken with a meal to ensure proper absorption.
Preparation Requirements No preparation is required for tablets or cream. Topical Shampoos require the product to remain on the affected area for 5 minutes before rinsing.
Age-Group Rules Oral Dosing for children two years and older is weight-based. For younger pediatric patients, the use of topical cream or 2% foam must be determined by a healthcare professional.
Missed-Dose Rules If an oral dose is missed, the patient should skip the dose and return to the regular schedule; a double dose should not be taken.

Instruction Classifications

Classification Pattern/Constraint
Administration Method Type Oral and Topical.
Frequency Pattern Once daily, twice daily, twice weekly, or intermittent use (e.g., every 3-4 days).
Use-Context Constraints Requires food intake for oral absorption and a specific contact time for shampoo efficacy.

Resulting Procedural Structure

The official instructions establish a precise protocol that differentiates the use of systemic and topical forms. This structure defines the initial dose and corresponding frequency (e.g., 200 mg once daily or twice-weekly application) and mandates crucial contextual requirements, such as taking the oral form with food or leaving the topical shampoo on for five minutes, to maintain standardized administration. Treatment duration can range from two weeks for some topical infections up to several months for certain systemic uses.

Recent Clinical Evidence

Research evidence / Overview of studies for Dermazol


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

Research into Dermazol for these conditions has primarily used Randomized Controlled Trials (RCTs) and systematic reviews, comparing the product to a placebo or to other topical antifungals. These studies mainly involved adults who had their fungal infection confirmed by laboratory testing. Research has explored short-term symptom changes, focusing on two key outcome measurements: Mycological Cure, which assesses the fungal status using tests, and Clinical Cure, which evaluates changes in visible signs such as redness, scaling, and itching.

Studies conducted during the initial treatment and follow-up periods reported patterns observed in both the fungal status and the visible skin signs. Evidence across multiple controlled trials and systematic reviews exists for this antifungal class. However, the existing research highlights that the long-term durability of the observed changes is not consistently established. Additionally, there is variability in the design and endpoints of some of the older trials, which can limit the certainty of broad conclusions across all available studies.


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

The research base for tinea pedis relies heavily on large-scale, controlled regulatory studies, including double-blind, placebo-controlled RCTs. These trials typically monitored adults with confirmed interdigital tinea pedis. The main research objectives involved tracking Mycological Cure (the fungal status monitored on testing) and Clinical Cure (the physician’s assessment of symptom evolution) at the end of the defined treatment phase and during short-term follow-up visits.

Researchers monitored group patterns in the combined clinical and mycological outcomes, often comparing the active product against the non-medicated vehicle control. Research explored short-term symptom changes measured over the duration of the trials. The existing trials primarily focus on the interdigital form of tinea pedis, and comparative evidence against some of the newer antifungal agents on the market is not consistently available or fully established.


Evidence for use in Seborrheic Dermatitis

For conditions characterized by Malassezia, the evidence primarily stems from Randomized Controlled Trials (RCTs) using the shampoo or topical formulations. These studies explored symptom changes over defined time intervals in adults with moderate to severe conditions, often including subjects as young as 12 years. Research monitored outcomes related to physical discomfort, such as scores for scaling, redness (erythema), and pruritus (itching), as well as change in yeast population measurements on the scalp or skin.

Studies monitored how symptoms evolved in the observed populations during and immediately following the treatment phase. Research described patterns observed in symptom evolution and the concurrent change in yeast population measurements, which contributes to the broader evidence landscape for conditions characterized by Malassezia.


Evidence in Special Populations

Research available on the use of Dermazol in specific patient groups outside of healthy adults is more limited. For pediatric patients (children younger than 12), official regulatory reviews indicate that the available clinical data remains insufficient for establishing routine use of the cream or shampoo. For older adults (ge 65 years), evidence from clinical studies suggests that use in this geriatric population was observed to be similar to younger subjects; however, data for this specific subgroup remain limited.


What is Still Uncertain About the Research for Dermazol

Scientific and regulatory evaluations highlight several areas where evidence is still emerging or remains insufficient. Comparative evidence against newer generations of topical antifungals, particularly for tinea infections, is often lacking in recent, large-scale Randomized Controlled Trials. Regulatory evaluations confirm that the data for certain groups remain insufficient, particularly for young children across all indications. Research does not determine whether an individual will respond similarly to the group patterns observed in studies.

Key Studies & References

  1. Consensus for the Treatment of Tinea Pedis: A Systematic Review of Randomised Controlled Trials
  2. Ketoconazole Topical: MedlinePlus Drug Information
  3. Ketoconazole - Paediatric Use Regulatory Assessment
  4. Ketoconazole - StatPearls - NCBI Bookshelf

Frequently Asked Questions (FAQ)

Common questions about Dermazol (FAQ)


Q: How long does it typically take for Dermazol to show an effect?

A: Studies and official information indicate that fungal infections may be slow to clear up and can require continued treatment for up to several weeks.

The full course of treatment is generally described as necessary to support the resolution of symptoms and help prevent recurrence. For the oral tablet form, regulatory guidance sometimes restricts the maximum treatment course to about four weeks.

Q: Is it normal to feel a slight burning sensation when first using Dermazol?

A: According to official safety information, a skin burning sensation is documented as a common adverse reaction associated with the topical application of Dermazol.

This indicates that it is an effect frequently observed in the clinical trial setting.

Q: Why do some people say Dermazol causes dry skin?

A: While the regulatory safety information for the topical form does not explicitly list 'dry skin,' it does document common or uncommon adverse reactions such as skin burning sensation, rash, and contact dermatitis.

These local skin reactions may be experienced by users as discomfort.

Q: Does Dermazol contain steroids?

A: No. The active ingredient in Dermazol is Ketoconazole, which is chemically classified as a synthetic Azole Antifungal agent.

Official documents confirm that this medication is not classified as a steroid.

Q: What kind of evidence supports the use of Dermazol?

A: The evidence supporting the use of Dermazol stems primarily from Randomized Controlled Trials (RCTs).

These studies focus on two key measures: achieving Mycological Cure (eliminating the fungus) and Clinical Cure (resolving visible symptoms like redness or scaling) in the study population.

Q: Has Dermazol been recalled or withdrawn from any market?

A: The oral tablet formulation of the active ingredient has been withdrawn or suspended in certain regions (such as the European Union and Australia) and its use is severely restricted by the FDA in the US.

These actions are due to the documented risk of severe liver injury. The topical forms (creams and shampoos) are generally unaffected because they are absorbed minimally into the body.

Q: Does Dermazol interact with blood thinners?

A: The oral tablet is classified as a potent inhibitor of the CYP3A4 enzyme in the body.

According to official documents, this may significantly increase the concentration of other medicines in the blood, including several that regulate blood clotting (blood thinners), potentially leading to serious adverse effects.

Q: Can I use moisturizing lotions while being treated with Dermazol?

A: Regulatory patient information suggests a waiting period of 30 minutes between the application of topical Dermazol and other products on the same area.

Q: Are there any long-term effects on the skin after stopping Dermazol?

A: Regulatory documents note that the long-term durability of the changes observed after treatment is not consistently established.

Regulatory research indicates that a primary consideration is the potential for symptoms to return if the full recommended treatment duration is not followed.

Q: Is Dermazol available over the counter?

A: Most topical formulations, such as the creams and shampoos, are commonly available over the counter in pharmacies.

In contrast, the oral tablet formulation is strictly available by prescription only due to significant safety restrictions.

Q: Can I use Dermazol if I am pregnant or breastfeeding?

A: Official guidance indicates that topical use is generally designated as Pregnancy Category C and is designated as conditional use, allowed only if the potential benefit is described as outweighing the potential risk.

Caution is advised regarding use in a nursing woman, as it is not known if the substance is excreted into breast milk. Oral use is subject to much stricter risk assessment.

Q: Are there certain foods or drinks I should avoid while taking Dermazol?

A: Regulatory warnings state that individuals using the oral tablet formulation should avoid the consumption of alcoholic beverages during treatment.

Regulatory patient warnings emphasize that alcohol significantly increases the risk of serious liver problems associated with the oral medicine.

Q: Can Dermazol be used for skin conditions other than fungal infections?

A: The topical form is indicated for addressing fungal infections as well as certain chronic skin conditions like seborrheic dermatitis.

However, the oral tablet formulation is restricted to treating serious systemic fungal infections when alternative therapies are unavailable.

Q: What happens if I forget to use Dermazol one day?

A: Regulatory patient information for the topical dose generally describes the procedure to skip the missed dose and continue with the regular schedule, rather than attempting to use a double amount.

Q: Is there a generic version of Dermazol?

A: The active ingredient in Dermazol is Ketoconazole.

Official documents confirm that generic formulations containing this active substance are available.

Q: Do researchers know exactly how Dermazol works on the body?

A: While the mechanism of antifungal action is well-documented; it works by disrupting fungal cell structure.

However, regulatory documents state that the effects of the active ingredient on hormonal pathways and related outcomes are incompletely understood.

Q: What are the most commonly reported side effects of Dermazol?

A: The most commonly reported side effects for the topical form are confined to the application site.

These include skin burning sensation, itching (pruritus), and redness (erythema).

Q: Can using Dermazol make me more sensitive to the sun?

A: Sensitivity to light (photosensitivity) is listed in regulatory information as a potential side effect associated with the oral tablet formulation.

This information indicates that individuals receiving the oral form should be aware of this potential reaction.

Q: Is Dermazol a treatment I will need to use for a long time?

A: The use of the oral tablet is generally restricted to short courses, sometimes to a maximum of four weeks in certain jurisdictions, due to safety concerns.

Topical treatment may last up to several weeks to ensure clearance, but is not typically prescribed for continuous, long-term use.

Q: How does Dermazol target the infection without affecting the rest of the body?

A: The topical formulations (cream, shampoo) are applied directly to the affected area of the skin.

Official information states they have minimal systemic absorption into the rest of the body, which contributes to their lower risk profile compared to the oral tablets.

Q: What happens if I accidentally swallow a small amount of Dermazol cream?

A: The topical formulation is for external use only and should not be ingested.

Official safety instructions advise that in the event of accidental swallowing, prompt contact with a poison control center or seeking medical assistance is recommended.

Q: Why is Dermazol sometimes mentioned in articles about drug resistance?

A: The active ingredient belongs to the Azole Antifungal class, which is generally linked to discussions about fungal resistance over time.

Regulatory reviews acknowledge that the drug's efficacy should be carefully considered when drug resistance is known or suspected due to general concerns within this class of antifungals.

Q: Is there an age limit for starting Dermazol treatment?

A: The safety and effectiveness of many topical forms have not been established for children younger than 12 years of age.

For the oral tablet, the use and dose for children younger than 2 years must be determined by a healthcare professional.

Q: How do I know if Dermazol is working for me?

A: In clinical studies, the effectiveness of the medication is measured by tracking Clinical Cure.

This evaluates the changes in visible signs of the infection, such as reductions in redness, scaling, or itching.

Q: Is the information about Dermazol updated regularly by health authorities?

A: Yes, health authorities like the FDA, EMA, and TGA continually monitor the safety and efficacy data for Dermazol.

This continuous monitoring often results in regulatory actions and updates to the prescribing information and patient guidance.

How should Dermazol be stored and disposed of?

Dermazol (ketoconazole) must be stored strictly according to the conditions defined by regulatory labeling to maintain stability.

Storage Requirements

Item Requirement
Temperature Store at Controlled Room Temperature, typically 20 to 25 C (68 to 77 F) [1.7].
Protection Keep in a dry, light-protected place and do not freeze [1.2, 2.4].
Container Keep the medicine in the original package [1.1].
Child Safety Must be kept out of the sight and reach of children [1.1, 2.4].

Disposal Instructions

Unused or expired product must be discarded according to local regulations [3.2]. The product should not be flushed down the toilet or poured down a sink unless specific instructions require it [2.3]. For disposal in household trash, the medicine must first be mixed with an undesirable substance, placed in a sealed container, and all personal information scratched off the label [2.3, 2.7].

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

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