Sugen

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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 Sugen

What is Sugen? Defining the Antifungal Medication

Property Description
Active Ingredient Ketoconazole (INN)
Forms Tablet, Cream, Gel, Foam, Shampoo
Pharmacological Class Antifungal Agent (Azole Derivative)
General Purpose Controls fungal and yeast infections
Origin Synthetic Compound

What Type of Medicine is Sugen (Ketoconazole)?

Sugen is the trade designation for a medication whose active ingredient is the substance, Ketoconazole, which is formally classified as a synthetic broad-spectrum antifungal agent. This compound is categorized within the larger family of Azole Antifungals, specifically identified as an imidazole derivative. The medicine is typically dispensed as a prescription-only (Rx) product, particularly the oral tablet form.

Its classification confirms its targeted, chemical design. Its role as a fungistatic agent, which primarily causes growth arrest in fungal cells, is clinically recognized for its essential role in the management of numerous fungal conditions. Azole antifungals, including Ketoconazole, are foundational tools for managing various fungal and yeast diseases.

Forms, Composition, and General Purpose

The active agent Ketoconazole is a single active ingredient product available in multiple pharmaceutical forms to facilitate both systemic and localized administration. These forms include oral tablets for internal use and various topical preparations such as cream, gel, foam, and shampoo. This variety allows for flexibility in treatment, differentiating it from agents restricted to a single route.

The efficacy of topical Ketoconazole formulations relies on high local concentrations achieved on the skin or scalp. The medicine's overall general purpose is to reduce the burden of fungal organisms, thereby helping the body manage and resolve the underlying fungal infection, whether it is an internal or external presentation.

What side effects are possible with Sugen?

Possible Side Effects and Safety Information

The official safety profile for Sugen (Ketoconazole oral tablet) is structured around key adverse reactions and regulatory limitations documented by government health authorities. Adverse reactions are grouped by System-Organ Class (SOC) to identify affected body systems, with many side effects categorized as Common (e.g., Nausea and Vomiting) or as Frequency not reported (e.g., Headache, Dizziness) in regulatory labeling.


Serious Adverse Reactions and Safety Constraints

The medicine carries a regulatory Boxed Warning highlighting two critical, potentially fatal safety concerns: severe Hepatotoxicity (liver injury) and serious Cardiac Disorders. The risk of liver injury includes cases requiring transplantation and has been reported with both short and long treatment durations. Cardiac safety concerns involve the risk of QT prolongation and Ventricular Dysrhythmias, specifically Torsades de pointes.

System-Organ Class (SOC) Focus Documented Adverse Reactions (High-Level)
Hepatobiliary Disorders Hepatotoxicity, Hepatitis, Jaundice
Cardiac Disorders QT prolongation, Torsades de pointes
Endocrine Disorders Adrenal Insufficiency, Gynecomastia
Nervous System Disorders Headache, Dizziness, Reversible increased intracranial pressure

Population and Contextual Restrictions

Sugen is contraindicated in patients with pre-existing acute or chronic liver disease. Its use is also strictly prohibited alongside numerous specific medications that interact to elevate the risk of life-threatening cardiac events. Additionally, official documents note that efficacy and safety data are often insufficiently established for oral use in certain pediatric populations. Regulatory labels require regular monitoring of liver function tests during treatment to detect adverse effects.

Overdose and Emergency Response

Overdose and When to Seek Help — Official Regulatory Information for Sugen

The regulatory profile for Sugen (Ketoconazole) addresses the official manifestations and actions required in cases of acute oral overdose, with a focus on serious organ toxicity. Treatment protocols are limited to supportive care as no specific antidote is known.


Overdose Scope

Feature Official Regulatory Documentation
Documented Overdose Presentations Symptoms associated with acute liver injury (hepatotoxicity), including anorexia, fatigue, nausea, and jaundice (yellowing of the skin or eyes).
Physiological Systems Affected (as stated in label) Hepatic system (acute liver failure or injury requiring transplantation) and Endocrine system (risk of adrenal insufficiency).
Dose-related or Exposure-related Factors (if applicable) Acute overdose of the oral tablet is the primary context for severe systemic toxicity. Topical overdose is not expected to result in systemic toxicity.
Emergency-response statements Symptomatic and supportive treatment must be carried out. For severe adrenal effects, specific supportive interventions, such as hydrocortisone administration, are described.
When immediate medical help is required Seek immediate medical attention or call emergency services if the victim has collapsed, had a seizure, has trouble breathing, or cannot be awakened.

Resulting Overdose Structure

Official overdose statements:

  • Acute oral overdose is documented to present with signs of acute liver injury, which may be potentially fatal or require liver transplantation.
  • Regulatory guidance mandates contacting emergency services immediately if the patient exhibits collapse or severe respiratory distress.
  • Management procedures may include activated charcoal if ingestion is recent, and close monitoring of blood pressure and fluid and electrolyte balance.

Connection to the overall overdose profile:

Regulatory documents define the overdose profile primarily through the risk of severe organ toxicity (hepatic and adrenal effects) resulting from acute oral exposure. These official risks mandate that individuals experiencing specific, life-threatening symptoms must immediately seek urgent medical help. Since no specific neutralizing substance is documented, the official instructions for healthcare providers center on procedural supportive and symptomatic measures to manage the systemic effects.

Therapeutic Uses of Sugen

The therapeutic role of Sugen (Ketoconazole) is centered on addressing fungal and yeast infections across different systems.

Sugen is generally used in situations involving certain distressing symptoms related to severe, widespread, or serious fungal infections, including blastomycosis, coccidioidomycosis, and histoplasmosis. This supports the management of the systemic fungal burden and may assist with maintaining functional stability during serious episodes. This is relevant in contexts involving heightened systemic burden, and is applied in clinical settings where supportive symptom management is appropriate, particularly where functional stability becomes affected.

The medication is also applied to manage chronic or recurrent superficial conditions, such as severe seborrheic dermatitis and tinea infections that have become more disruptive (ringworm, athlete's foot). The benefit contributes to improved comfort by addressing symptoms like scaling, flaking, itching, and redness, which may assist with the appearance of the affected area.

Quick Fact: Relief for Pruritus and Scaling
Sugen assists with easing groups of symptoms related to inflammatory or irritative states on the skin, particularly the intense itching (pruritus) and flaking common in fungal overgrowth.

Regulatory References

  1. MedlinePlus Drug Information overview

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Sugen — Official Regulatory Information

The eligibility profile for oral Sugen (Ketoconazole) is defined by stringent regulatory criteria. Use is officially restricted to adult patients who have certain severe systemic fungal infections only when alternative effective antifungal therapies have failed or are not tolerated. The medicine is not established for use in non-life-threatening fungal infections, as regulatory bodies determined the known risks outweigh the potential benefit for these conditions.

Eligibility Limitation Regulatory Status
Acute or Chronic Liver Disease Contraindicated (Absolute Prohibition)
QTc Prolongation or Arrhythmia Contraindicated (Risk of serious cardiac events)
Hypersensitivity Contraindicated (Known allergy to the drug or imidazole antifungals)
Specific Population Rule Official Classification
Children < 2 Years Safety and effectiveness are not established (US Labeling).
Pregnancy Contraindicated (EU Regulation) or Conditional Use (US Category C).
Breastfeeding (Lactation) Contraindicated (EU Regulation).

Connection to the overall eligibility profile:

Governmental authorities define eligibility by mandating that use is contingent upon the failure of alternatives and establishing strict absolute contraindications based on pre-existing hepatic and cardiac integrity, thereby severely limiting the eligible population.

What should I know about interactions with other medicines?

Sugen (sunitinib) can interact with many other medicines, which may alter its effectiveness or increase the risk of side effects. It is critical to inform your healthcare provider of all prescription, over-the-counter, and herbal supplements you are currently taking.

Medications that Affect Sugen Levels

Sugen is metabolized primarily by the CYP3A4 enzyme. Therefore, concurrent use with strong CYP3A4 inhibitors can increase the concentration of Sugen in the blood, potentially leading to increased toxicity. Conversely, strong CYP3A4 inducers can decrease Sugen levels, which may reduce its therapeutic effect. Dose adjustments or switching to alternative medicines may be necessary.

Interaction Type Examples of Interacting Medicines
Strong CYP3A4 Inhibitors Ketoconazole, Itraconazole, Clarithromycin, Fluconazole
Strong CYP3A4 Inducers Rifampin, Phenytoin, Carbamazepine, St. John's Wort

Risk of Irregular Heart Rhythm

Sugen is associated with a risk of QTc interval prolongation, an electrical disturbance of the heart rhythm. Taking Sugen with other medicines that also prolong the QTc interval can increase this risk. Examples include certain antiarrhythmics (e.g., amiodarone, dronedarone), some antipsychotics, and certain antibiotics (e.g., azithromycin).


Other Significant Interactions

  • Bisphosphonates: Co-administration may increase the risk of osteonecrosis of the jaw.
  • Diabetes Medications (Oral): Sugen may increase the risk of hypoglycemia (low blood sugar) when taken with certain antidiabetic drugs.

Grapefruit juice and grapefruit products should be avoided during treatment as they can act as CYP3A4 inhibitors and increase Sugen concentration.

Mechanism of Action

Disruption of Fungal Cell Structure via Ergosterol Blockade

Sugen ( Ketoconazole) exerts its primary action by targeting and inhibiting the crucial fungal enzyme lanosterol 14alpha-demethylase ( CYP51A1). This molecular interference halts the synthesis of ergosterol, an essential structural component of the fungal cell membrane. The resulting depletion of ergosterol and the accumulation of toxic, abnormal sterols compromise the membrane's integrity, leading to the fungistatic (growth-arresting) and eventually fungicidal (cell-killing) physiological effect on the organism.


Physiological Constraints from Off-Target Enzyme Inhibition

The molecule's broader affinity for cytochrome P450 enzymes also results in the concentration-dependent inhibition of certain human steroidogenic enzymes ( CYP17A1, CYP21A2). This off-target mechanism can reduce the body's synthesis of certain steroid hormones. This effect creates a physiological constraint that limits the maximum systemic drug exposure needed to allow maximal operation of the fungistatic and fungicidal mechanism.

Dosage and Administration Information

How to Use Sugen (Ketoconazole) — Official Administration Guidelines

Sugen is administered via two primary official routes: the oral route for treating systemic fungal infections, and the topical route (cream, shampoo, gel, foam) for external cutaneous conditions. The manner of use is governed by the pharmaceutical form and labeling.


Standard Dosing and Frequency

Administration Type Dosing Pattern (Adults) Frequency and Duration
Oral Tablet (200 mg) Initial dose is 200 mg once daily. May be increased to a maximum of 400 mg daily based on response. Once daily for typical durations of 6 months for systemic infections.
Topical Cream 2% Apply a sufficient amount to cover the affected area and immediate surroundings. Once or Twice Daily for 2 to 6 weeks (e.g., 6 weeks for athlete's foot).

Administration Requirements

Oral administration is dependent on gastric acidity. The tablet must be taken with food to ensure proper absorption and effectiveness. For patients using gastric pH-altering medicines (e.g., antacids), these agents must be administered at least two hours after the Sugen oral dose. Dosing for pediatric patients (ages 2 years and older) follows a body weight calculation, typically ranging from 3.3 mg/kg to 6.6 mg/kg once daily.

Topical forms also have specific requirements. For example, when using the 2% shampoo for certain skin conditions, the procedure requires the lather to remain on the skin for 5 minutes before being rinsed off. The regulatory labels do not specify dose adjustments for renal or hepatic impairment.

Recent Clinical Evidence

Evidence for Topical Use in Seborrheic Dermatitis and Tinea Infections

The research supporting the use of Sugen (ketoconazole) in topical forms—such as shampoos, creams, and gels—is primarily built upon short-term, randomized, controlled clinical trials (RCTs) and scientific reviews. This research was evaluated in trials assessing short-term or episodic symptom patterns. The studies focused on the research objectives and the outcomes measured in trials, such as scaling, redness, and itching.

The research included immunocompetent adults and adolescents who had conditions characterized by fluctuating or episodic manifestations, such as seborrheic dermatitis (SD) and common tinea (ringworm) infections. For SD, studies monitored outcomes linked to inflammatory or irritative states. For tinea infections, research examined outcomes related to physical discomfort and confirmed mycological clearance, meaning whether laboratory tests confirmed the clearance of the fungus. Research describes patterns observed in the studies regarding how symptoms evolved over the short treatment course.


Evidence for Systemic Use in Serious Fungal Infections

The oral tablet form of Sugen was studied for the management of certain serious, systemic fungal infections, such as Histoplasmosis and Blastomycosis. This use is highly restricted by regulators due to safety and the availability of newer agents. The evidence for these uses relies primarily on older data, and the overall evidence quality varies compared to the evidence for topical use.

This body of research is largely composed of older, smaller, non-randomized, open-label studies. Studies monitored outcomes related to systemic or functional imbalance, such as measures reflecting daily functioning or activity level, and confirmed mycological clearance. Results apply only to the populations studied. Sample sizes were modest in the primary prospective studies, and the available comparative evidence against currently available alternative antifungal treatments is lacking.

Key Studies & References

  1. An Efficacy Study of a New Formulation of Ketoconazole 2% Cream in Patients With Tinea Pedis (NCT01110330)

Frequently Asked Questions (FAQ)

Common questions about Sugen (FAQ)

Q: What is the longest time someone typically stays on Sugen?

A: Studies and official drug information for systemic (internal) fungal infections often report treatment durations of up to 6 months. The total length of treatment is highly dependent on the condition being treated and the patient's response, as determined by a healthcare provider.


Q: Does Sugen interact with common supplements like multivitamins or fish oil?

A: Official drug information warns that Sugen can potentially interact with many prescription and over-the-counter medicines, vitamins, and herbal products. Regulatory documents advise that a full list of all products, including supplements, be reviewed by a healthcare provider.


Q: What are the long-term side effects associated with Sugen?

A: According to the official product information, the most significant risks associated with Sugen are serious and potentially fatal Hepatotoxicity (liver injury) and serious Cardiac Disorders (such as irregular heart rhythms). The risk of liver injury has been reported with both short and long treatment courses.


Q: Does taking Sugen affect fertility in men or women?

A: Official sources note that high doses of oral Sugen may cause a decrease in the number of sperm (azoospermia) in men. The official labeling focuses heavily on use during pregnancy and breastfeeding. Concerns regarding fertility are best discussed with a healthcare professional.


Q: What should I do if my Sugen tablets look slightly different than before?

A: Regulatory guidance requires that medication be stored properly in its original container to maintain quality. Concerns about the physical appearance or integrity of the tablets can be directed to a pharmacist for guidance.


Q: Is it common for patients to have to adjust their Sugen dosage over time?

A: The official dosing regimen indicates that the initial daily dose may be increased to a specific maximum amount. This adjustment is based on the treating healthcare provider’s assessment of the patient’s clinical response to the medication.


Q: Why do some people need to take breaks from Sugen treatment?

A: Treatment may need to be interrupted or discontinued, particularly if monitoring reveals signs of liver injury, such as significantly increased serum transaminase values (ALT). This decision is made based on regular monitoring.


Q: Does Sugen make your skin more sensitive to the sun?

A: Yes, photosensitivity (increased skin sensitivity to sunlight) is listed as an adverse reaction in some drug information sources. If photosensitivity is experienced, following sun safety guidelines is generally recommended.


Q: Can Sugen treatment affect my liver enzymes?

A: Yes, Sugen is strongly associated with Hepatotoxicity (liver injury) and requires regular monitoring of your liver function tests (which measure liver enzymes). Abnormal liver enzyme tests are a common finding in some official safety reports.


Q: What are the signs of a serious, but rare, side effect from Sugen?

A: Signs of serious liver injury include yellowing of the skin/eyes (jaundice), dark urine, pale stools, or extreme tiredness. Signs of a serious heart problem include a fast, pounding, or irregular heartbeat or sudden dizziness or fainting.


Q: Are there restrictions on driving or operating machinery while taking Sugen?

A: Some reported side effects, such as dizziness and headache, may affect the ability to drive or operate machinery. If symptoms such as dizziness are experienced, caution is warranted when driving or operating machinery.


Q: How soon after stopping Sugen does it leave the body?

A: Pharmacokinetic data shows that the elimination of Sugen from the blood occurs in two phases. Following the initial quick drop, the medicine has a later, longer half-life of about 8 hours.


Q: Can I take herbal remedies while undergoing treatment with Sugen?

A: The official label specifically calls out St. John's Wort as a strong enzyme inducer that can decrease Sugen levels and reduce its effectiveness. For safety, all herbal products are advised to be disclosed to a healthcare provider.


Q: Does Sugen cause hair loss like traditional chemotherapy?

A: Hair loss (alopecia) is listed as an adverse reaction in official safety documents. However, this is a side effect of the medicine's chemical profile, which is distinct from the mechanism that causes hair loss with traditional chemotherapy drugs.


Q: Is Sugen used as a first-line treatment or usually after other drugs fail?

A: Official regulatory documents clearly state that oral Sugen is restricted for use only when other effective antifungal therapies have failed or are not tolerated. It is therefore not typically used as a first-line treatment.


Q: Why do they sometimes test a tumor for specific markers before prescribing Sugen?

A: The regulatory classification for Sugen is an antifungal agent, meaning its approved purpose is to treat fungal infections, not tumors. Official regulatory guidance does not connect the use of this antifungal agent to tumor markers.


Q: Why is Sugen given orally instead of by injection or IV?

A: The oral tablet formulation is used because the drug's absorption into the bloodstream requires gastric acidity and is enhanced by taking it with food. This makes the oral route an effective way for the medication to reach the body's systemic circulation.


Q: What is the typical range of duration for a Sugen treatment cycle?

A: Treatment duration is highly condition-dependent. For topical forms, treatment may be as short as 2 to 6 weeks. For serious systemic infections, treatment is typically much longer, often up to 6 months.


Q: Is it normal to feel nauseous or have an upset stomach when first taking Sugen?

A: Nausea and vomiting are listed as common side effects of the oral tablet. To help manage this, the official instructions require the tablet to be taken with food, which aids absorption and can help minimize gastrointestinal upset.


Q: Why do doctors prescribe Sugen instead of a similar-sounding medicine?

A: Official warnings state that oral Sugen is reserved for serious fungal infections only when alternative agents are unavailable or not tolerated. This is due to its elevated risk of liver and heart toxicity compared to many newer antifungal alternatives.


Q: What types of professional caregivers typically monitor patients taking Sugen?

A: Regulatory guidance mandates frequent and regular monitoring of liver function and cardiac health. This close monitoring typically involves a coordinated effort by physicians, specialists, and nurses throughout the course of treatment.


Q: Has Sugen been approved for use in other countries besides the US?

A: Yes, the drug's regulatory documentation is published by multiple governmental authorities, including the European Medicines Agency (EMA) and the UK's MHRA. This confirms its approval and use in numerous regions outside of the US.


Q: What are the outcomes related to systemic or functional imbalance, such as measures reflecting daily functioning or activity level?

A: Older studies for serious systemic use monitored a variety of results related to patient well-being, including measures reflecting daily functioning and activity level, alongside laboratory results confirming the clearance of the fungal infection.


Q: Is it true that Sugen can cause changes in taste perception?

A: Yes, changes in the ability to taste food (dysgeusia) is reported as an adverse reaction in some official drug information sources.


Q: Does Sugen cause dry mouth or changes to oral health?

A: Yes, dry mouth is listed as an adverse reaction in some official drug information sources.

How should Sugen be stored and disposed of?

Official Storage and Disposal Requirements

Sugen (Ketoconazole) must be stored according to strict regulatory mandates to ensure product integrity and safety. Tablets require storage at controlled room temperature, typically 15 C to 30 C (59 F to 86 F). The product must be protected from moisture and freezing, and kept in a tightly closed, light-resistant container. All medication must be kept out of the sight and reach of children.

Disposal must follow official guidance. Unused or expired medication should be returned to a drug take-back program. If no program is available, the product must be mixed with an undesirable substance and placed in a sealed bag before discarding in the trash. The medication should not be flushed down a toilet or poured down a drain.

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

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