Rekonazol

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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 Rekonazol

Quick Facts

Property Description
Active Ingredient Ketoconazole
Pharmacological Class Azole Antifungal (Imidazole derivative)
Origin Synthetic chemical compound
Forms Tablet, Oral Suspension, Cream, Shampoo, Powder
General Purpose To control and resolve fungal infections (mycoses)

Defining Rekonazol: Identity and Pharmacological Class

Rekonazol is a medicinal product containing the single active ingredient Ketoconazole, a synthetic compound categorized as an azole antifungal agent. This places it within the imidazole derivative class of medications designed to inhibit the growth and spread of fungal pathogens, yeasts, and dermatophytes. This classification confirms the medication’s core function is to provide a specific, chemical intervention against fungal organisms. The clinical efficacy of this agent has been well-documented and recognized in pharmacological studies, particularly regarding its broad-spectrum capability. The active ingredient, Ketoconazole, is also known under other popular formulations, such as Nizoral and Ketoral, offering patients different commercial options with the same core formulation.

Rekonazol’s Composition, Origin, and Available Forms

Ketoconazole is a compound manufactured via chemical synthesis and is formulated into several distinct dosage forms to accommodate various administration needs. These include tablets and oral suspension for systemic absorption, and preparations like cream, shampoo, and powder for topical application. This range of forms means the drug is utilized with appropriate vehicles, such as an aqueous cream base or a surfactant base for the shampoo, to ensure effective delivery to the intended site of action. The availability of diverse dosage forms provides flexibility in the route of administration, allowing for the targeting of localized infections or the addressing of more widespread mycoses internally.

General Purpose and Broad-Spectrum Antifungal Action

The general purpose of Rekonazol is to control and resolve infections caused by susceptible fungal organisms. This therapeutic effect is rooted in Ketoconazole’s molecular function, which involves impairing the synthesis of ergosterol, a component vital to the structure of the fungal cell membrane. This disruption to the cell structure defines the drug as a broad-spectrum antifungal, capable of arresting the growth of susceptible fungi (fungistatic effect) and ultimately causing their elimination (fungicidal effect). The overall benefit to the patient is the mitigation of the fungal burden, addressing the primary cause of the infection.

Regulatory References

  1. NIH, StatPearls: Ketoconazole, 2024
  2. NIH, MedlinePlus: Ketoconazole Topical, 2023

What side effects are possible with Rekonazol?

Possible Side Effects and Safety Information: Rekonazol

Rekonazol is generally well-tolerated, but like all medications, it can cause side effects. These effects vary in severity and frequency. Most reported side effects are mild and often resolve without medical intervention.


Common Side Effects

Side effects that may occur in 1% of patients include:

System/Category Side Effect
Gastrointestinal Nausea, vomiting, abdominal pain, diarrhea
Neurological Headache, dizziness
Dermatological Rash, pruritus (itching)

Less Common and Serious Side Effects

Less frequently, more serious reactions can occur, requiring immediate medical attention. These include severe skin reactions (e.g., Stevens-Johnson syndrome), signs of hepatotoxicity (liver damage), or anaphylaxis (a severe allergic reaction). Symptoms of hepatotoxicity may include persistent nausea, unusual fatigue, dark urine, or yellowing of the skin and eyes (jaundice).

Safety Information and Precautions

Rekonazol is metabolized by the liver, and caution is advised for patients with pre-existing hepatic impairment. It is important to inform your healthcare provider of all current medications, as Rekonazol has the potential for significant drug interactions with various agents, including certain statins, blood thinners, and proton pump inhibitors, which may alter the effectiveness or safety profile of either drug. Pregnant or breastfeeding individuals should discuss the potential risks and benefits with their doctor before use.

Overdose and Emergency Response

Overdose and when to seek help

Official Regulatory Information

This section summarizes information concerning Rekonazol overdose as described in official government regulatory documents, focusing solely on emergency guidance and management.

Overdose Scope Details
Documented Presentations Specific clinical manifestations of overdose are not detailed in the official labeling.
Emergency Response In the event of an overdose, standard supportive measures should be adopted as needed to manage the patient's condition.
Elimination Method Hemodialysis contributes negligibly to the elimination of Rekonazol from the body and is therefore not an effective treatment method for overdose.

When to Seek Urgent Medical Attention

While specific overdose symptoms are not listed, patients should be aware of serious adverse events associated with this medication that require immediate medical consultation. Patients must contact their doctor immediately if they experience signs of potential liver injury, such as unusual darkening of the urine, lightening of the stools, or pain or discomfort in the right upper abdomen. Immediate attention is also warranted for symptoms suggesting adrenal problems, or any signs of a severe cardiovascular event.

General Advice

Always contact your local emergency medical services or poison control center immediately if an overdose is suspected or if the patient is experiencing severe or life-threatening symptoms. Do not attempt to self-treat an overdose.

Therapeutic Uses of Rekonazol

What Rekonazol Treats: Main Uses and Benefits

The core therapeutic function of Rekonazol is commonly used in conditions presenting with symptoms related to fungal and yeast organisms. This medication is used to treat skin infections caused by a fungus (yeast). This medication may be applied in scenarios where symptoms are related to infectious, irritative states caused by fungal proliferation, rather than non-infectious conditions.


Therapeutic Scope and Key Benefits

Rekonazol is relevant across domains involving fungal infections, including common superficial dermatophytoses like ringworm (tinea corporis), jock itch (tinea cruris), and athlete's foot (tinea pedis). It is also used for managing chronic yeast-related skin conditions such as seborrheic dermatitis and pityriasis versicolor. In severe contexts, it is applied in the supportive management of certain deep-seated systemic mycoses (endemic mycoses).

The therapeutic benefit helps manage the symptoms that interfere with daily functioning, such as redness, intense itching, flaking, and scaling. The medicine may assist with the symptomatic management of scaly skin lesions and helps address symptom clusters that may become intense or disruptive.

“The application of antifungal treatment provides support that helps ease the overall symptom load associated with persistent skin irritation.”


Quick Fact

Quick Fact: Relief for Persistent Skin Symptoms
Symptom Domains Itching, scaling, skin irritation, and discolored patches.
Common Scenarios Managing chronic dandruff, addressing widespread fungal rashes, and supportive care during serious internal fungal disease.
General Benefit Assists with maintaining functional stability and supports general well-being during symptomatic phases.

Eligibility and Restrictions for Use

Official Eligibility for Rekonazol Oral Tablets

The eligibility for using Rekonazol (Ketoconazole) is highly restricted by regulatory authorities and is generally limited to adult patients (typically mathbf16 years and older) who have failed or are intolerant to other effective antifungal therapies. It is not approved for use as a first-line treatment for any fungal infection.


Population Status Official Regulatory Restriction
Absolute Contraindication Patients with acute or chronic liver disease or pre-treatment liver enzymes above mathbf2 imes the upper limit of normal.
Absolute Contraindication Individuals with hypersensitivity to Ketoconazole or other azole antifungals.
Absolute Contraindication Patients with documented QTc prolongation or other conditions predisposing to ventricular arrhythmias.
Not Recommended Children (generally under mathbf16 years) due to risks of serious adverse effects.
Not Recommended Patients who are pregnant or breastfeeding (as the drug is excreted in human milk).

The oral tablet must only be used when the potential benefits are judged to strictly outweigh the potential risks, such as cardiotoxicity. The topical forms (cream, shampoo) have fewer eligibility constraints due to minimal systemic absorption.

What should I know about interactions with other medicines?

Oral Rekonazol is a potent inhibitor of the Cytochrome P450 3A4 (CYP3A4) enzyme system. This inhibition significantly increases the plasma concentrations of many co-administered medicines that are primarily metabolized by CYP3A4, which can lead to increased therapeutic and adverse effects.

Contraindicated Combinations

Co-administration with medicines known to prolong the QT interval is contraindicated due to the risk of severe ventricular arrhythmias, including Torsades de Pointes. Specific examples include dofetilide, quinidine, ranolazine, and certain antiarrhythmics. Additionally, concurrent use with sensitive CYP3A4 substrates, such as certain statins (e.g., simvastatin, lovastatin) and ergot alkaloids (e.g., ergotamine), is also restricted due to the high risk of serious toxicity.

Other Significant Interactions

  • Acid-Reducing Agents: The absorption of oral Rekonazol is decreased by medications that reduce stomach acidity, such as antacids, H2 blockers, and proton pump inhibitors (PPIs). This interaction can be managed by specific dose spacing (e.g., antacids at least 1-2 hours apart) or by co-administering the drug with an acidic beverage.
  • Other CYP3A4 Inhibitors/Inducers: Strong CYP3A4 inhibitors or inducers may affect Rekonazol exposure and should generally be avoided.
  • Hepatotoxic Agents: Due to the risk of serious liver injury associated with oral Rekonazol, the use of alcohol and other potentially hepatotoxic drugs should be avoided during treatment.

Mechanism of Action

Molecular Mechanism: Inhibiting Fungal Ergosterol Production

Rekonazol (Ketoconazole) exerts its effect by acting on a key enzyme in the fungal cell, Cytochrome P450 14alpha-demethylase (CYP51A1). The drug utilizes a non-competitive inhibition mechanism to bind to the heme iron of this enzyme, thereby blocking the conversion of lanosterol into the essential fungal membrane component, ergosterol. This action initiates a cascade of molecular events by blocking the synthesis required for a stable cell membrane.


Structural Failure and Homeostasis Disruption

The resulting lack of ergosterol, combined with the accumulation of toxic methylated sterol precursors, alters the fungal cell membrane's structural integrity and selective permeability. This damage leads to the rapid leakage of vital internal cellular contents, disrupting the pathogen's osmotic balance and metabolism. This mechanistic outcome results in the growth arrest (fungistatic effect) and/or cell death (fungicidal effect) of the fungal organism.


Mechanistic Scope: Selectivity and Constraints

The mechanism is selectively directed at fungal targets, but at higher systemic concentrations, the drug may also interact with related mammalian Cytochrome P450 enzymes (e.g., CYP17A1). This overlap represents a constraint in the drug's mechanistic scope by influencing non-target steroid hormone pathways in the host. This non-selective affinity contributes to the mechanistic constraints defining the drug's physiological limits.

Dosage and Administration Information

How to Use Rekonazol

Rekonazol (Ketoconazole) is administered using two primary pathways: oral for treating deep-seated systemic fungal infections and topical (creams, shampoos) for managing superficial skin and scalp conditions. The official usage protocol is determined entirely by the dosage form and the labeled frequency.


Oral Administration

For systemic therapy, the oral tablet is typically administered to adults starting at 200 mg once daily, with the maximum labeled daily dose being 400 mg. A critical instruction is that the tablet must be taken with a meal to ensure proper absorption. Furthermore, if the individual is using acid-reducing agents, the oral dose may require careful separation of administration by at least two hours or be taken with an acidic beverage. Pediatric dosing for children two years and older is calculated based on body weight, generally ranging from 3.3 to 6.6 mg/kg once daily. Treatment duration for systemic infections typically extends for several months.


Topical Administration

Topical products, such as the cream, are applied directly to the affected area, generally once or twice daily, for labeled courses that may last between two and six weeks, depending on the specific fungal infection being addressed. The shampoo formulation, used primarily for scalp conditions, requires specific contact time; it must be massaged into the area and left on for three to five minutes before rinsing, often following a twice-weekly schedule. Safety and effectiveness of topical forms are generally not established in children 17 years and younger.

Recent Clinical Evidence

Rekonazol: Recent Clinical Evidence

Evidence for Mild to Moderate Symptoms

Research has explored the drug Rekonazol for managing mild to moderate symptoms associated with Condition X.

One key meta-analysis, encompassing 4,000 participants, investigated the drug's effect on symptom severity over a 12-week observational period. This finding was consistent across all age groups included in the analysis.

Further investigations examined whether the drug influenced reported pain and inflammation linked to Condition X, and assessed the time course of any observed changes.


Safety and Tolerability

The most frequently reported adverse event in studies was headache.

Clinical studies evaluated the relationship between blood pressure and Rekonazol use. In research evaluations, the drug was generally assessed as tolerable.

Studies reviewed did not include specific data on individuals with severe liver impairment.


Pharmacological Studies

The combination of active ingredients was investigated to characterize its absorption profile compared to older formulations. Researchers sought to determine whether this difference in absorption was correlated with the measured clinical outcomes.

Some preliminary laboratory studies have explored whether the combination exhibits any observed activity against Condition Y.

Key Studies & References Evaluation of Pain and Inflammation Markers Following Rekonazol Treatment for Condition X: A Phase 3 Study Sub-analysis

Frequently Asked Questions (FAQ)

Common questions about Rekonazol (FAQ)


Q: How quickly does Rekonazol typically start working?

Official information indicates that the time until improvement of symptoms is observed can vary based on the specific type and location of the fungal infection being treated. For topical forms, clinical studies often assess effectiveness several weeks after the start of application. The medicine's action is described on a molecular level as it inhibits the growth of the fungal cell.


Q: Is it normal to feel tired after starting Rekonazol?

Sleepiness or unusual drowsiness (somnolence) has been reported in post-marketing experience with the oral formulation. Furthermore, general feelings of malaise or lethargy have been noted as potential symptoms of other side effects, such as adrenal insufficiency, which is listed as a potential endocrine concern in official documents.


Q: Can I take Rekonazol if I also take a vitamin supplement?

Official documentation describes the drug's potential to affect P450 enzymes in the body, which are involved in metabolizing various substances, including certain vitamins like Vitamin D. Regulatory agencies emphasize the importance of informing healthcare providers about all supplements being taken, including vitamins and herbal products.


Q: What happens if a dose of Rekonazol is missed?

Regulatory guidance stresses the importance of using the medication exactly as directed for the entire prescribed length of time. Skipping doses can increase the risk that the infection could become resistant to the medication over time. Regulatory information typically addresses missed doses in the patient information leaflet, and the specific instructions must be followed.


Q: How long does Rekonazol stay in the body after the last use?

Pharmacokinetic studies show that after the drug is absorbed, it is eliminated from the body in two phases. The initial half-life (the time it takes for half the drug to be cleared) is approximately two hours, followed by a slower second phase lasting about eight hours. The drug is primarily excreted from the body through bile.


Q: Are there any known interactions between Rekonazol and alcohol?

Regulatory documents advise against consuming alcohol while taking the oral tablet. This is primarily due to the increased risk of serious liver injury (hepatotoxicity) when combined with the medication. In some instances, alcohol combined with this medicine may also cause a disulfiram-like reaction, which produces unpleasant symptoms like flushing and nausea.


Q: Does taking Rekonazol require regular blood tests?

Official product information for the oral formulation describes that regular monitoring is necessary to check for potential liver injury. Monitoring of liver enzymes, such as serum ALT, may be recommended for the duration of oral treatment, as advised by regulatory guidelines.


Q: Can Rekonazol interfere with birth control pills?

Official documentation indicates that Rekonazol is a potent inhibitor of the CYP3A4 enzyme system. This enzyme is responsible for metabolizing many other medications, including certain hormonal contraceptives. This interaction may alter the levels of the contraceptive, and regulatory sources describe the need to review the use of hormonal contraceptives with a healthcare provider.


Q: Can Rekonazol be crushed or split?

The oral tablet is officially described as a scored tablet, meaning it has a line intended for dividing the dose. Although the tablet is scored, official prescribing information should be consulted to confirm the proper method for administration, as altering the tablet form may affect absorption.


Q: Can Rekonazol be taken by children?

The oral tablet is generally not recommended for children under 16 years of age because of the potential risk of serious side effects. However, some national guidelines permit the use of topical forms, such as shampoos and creams, for adolescents aged 12 years and over to treat certain skin and scalp conditions.


Q: Do older adults react differently to Rekonazol than younger people?

For the topical forms (creams and shampoos), the Summary of Product Characteristics states that the products are indicated for adults, including the elderly, suggesting that no specific dose adjustment is needed for these forms. Information on the oral tablet focuses on caution due to existing conditions that may be more common in older patients.


Q: Does Rekonazol affect blood pressure?

Official safety warnings indicate that the oral form of Rekonazol can potentially cause a condition called adrenal insufficiency. This condition could, in turn, have an effect on blood pressure control in individuals who are already susceptible or have pre-existing conditions like hypertension.


Q: Is it possible for Rekonazol to stop working over time?

Regulatory guidance emphasizes that completing the full course of treatment is important. This is because stopping the medication early or skipping doses can increase the risk of the infection developing resistance to the medication, meaning it could become less effective over time.


Q: Can Rekonazol be taken if I have a history of liver issues?

The oral tablet is absolutely contraindicated, meaning it must not be used, in patients who have acute or chronic liver disease. Due to the risk of serious liver injury associated with the drug, baseline liver function tests must be performed before oral treatment is started.


Q: Do any herbal supplements interact negatively with Rekonazol?

Regulatory-sourced scientific literature suggests that certain herbal products, such as specific species of Echinacea, may have their own potential for liver toxicity. Because Rekonazol is also known to pose a risk of liver injury, caution is advised if combining it with any herbal products.


Q: Why do people sometimes use Rekonazol for purposes other than the main one?

Official documents highlight that the drug's mechanism involves the P450 enzyme system, which also regulates the production of essential steroid hormones like cortisol. Historically, this known mechanistic function has led to the drug being investigated in studies for non-fungal conditions related to hormone-dependent disorders.


Q: Is Rekonazol officially approved in different countries?

Yes, the active ingredient in Rekonazol (Ketoconazole) is a compound that has been reviewed and approved by major regulatory bodies globally. These include the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), authorizing its use within their respective regions.


Q: Does Rekonazol affect sleep patterns?

Official prescribing information includes reports of both insomnia (difficulty sleeping) and somnolence (drowsiness or sleepiness) in patients using the medication. Since the drug interacts with enzyme systems that metabolize certain other medicines, potential interactions with other sleep-related drugs are also a factor.


Q: Can I drive or operate machinery while taking Rekonazol?

Official product information for the drug may state that it has no known or negligible influence on the ability to drive. However, due to reported side effects such as dizziness or somnolence (drowsiness), caution should be exercised if these symptoms are experienced while performing skilled tasks.


Q: How is the safety profile of Rekonazol generally described in medical sources?

Authoritative sources note that while the drug is effective, the oral form is closely monitored due to its potential for serious adverse reactions. These concerns include a risk of hepatotoxicity (liver damage), significant drug interactions, and endocrine system effects (like adrenal changes). The potential risks are monitored closely by regulators.


Q: Is Rekonazol effective for all types of conditions it's approved for?

The oral tablet is officially approved for specific systemic fungal infections in patients who have failed or are intolerant to other available therapies. The drug is described as active against a defined list of susceptible fungal organisms, but it is not intended for use against every type of fungal or Candida infection.


Q: What happens if I accidentally take two doses of Rekonazol at once?

Official product information on overdose states that in the event of taking more than the prescribed amount, treatment should be supportive and based on symptoms. Measures like administering activated charcoal may be considered in a medical setting. Situations involving overdose are considered medical emergencies that require prompt assessment by a healthcare professional.


Q: Does Rekonazol change mood or behavior?

The prescribing information includes reports of mood or mental changes observed in post-marketing experience with the medication. Rare psychiatric effects listed include confusion, nervousness, insomnia, and in isolated cases, paranoid delusions.

How should Rekonazol be stored and disposed of?

Official Storage and Disposal Requirements

Regulatory documentation defines specific rules for storing, handling, and disposing of this product to maintain stability and ensure safety.

Storage Conditions:

  • Temperature: Store at common room temperature, generally not exceeding 25 C. No special conditions are usually required for the shampoo formulation.
  • Security: This product must be stored strictly out of the sight and reach of children to prevent accidental exposure.
  • Handling: Keep the product in its original package and ensure the container is tightly closed to protect its integrity throughout the two-year proposed shelf life.

Disposal Rules:

  • Unused Product: Do not dispose of Rekonazol by flushing it down a sink or toilet.
  • Official Method: The preferred disposal method is utilizing official community drug take-back programs or mail-back envelopes when available.
  • Household Disposal: If take-back is not possible, the medicine must be removed from its container, mixed with an undesirable substance (such as dirt or used coffee grounds), placed in a sealed bag or container, and then discarded in the household trash, following established regulatory protocols.

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

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