Ketoconazole
Ketoconazole is an azole antifungal medication used to treat various fungal infections including skin conditions like athlete's foot, ringworm, and seborrheic dermatitis, as well as systemic fungal infections. It works by inhibiting the synthesis of ergosterol, a critical component of fungal cell membranes. Due to its potential for serious side effects including liver toxicity and drug interactions, it requires monitoring and is typically reserved for cases where other treatments have failed.
Azole antifungal for treating skin and systemic fungal infections, requiring liver monitoring due to potential toxicity.
Key facts at a glance
- ATC
- D01AC08
- RxNorm
- 6135
- Generic
- Ketoconazole
- Class
- atc-d01
- Brands
- T8 Keto Flush, Ketodan, Mal-A-Ket, Ketochlor, Keto-C, Malacetic, Nizoral, Mal-A-Ket Wipes, Recorlev, Suffusion, Kuric, Xolegel, Extina
- Availability
- rx
- Pregnancy
- C
- Lactation
- caution
- Routes
- topical, otic, oral
- Forms
- spray, solution, gel, cream, tablet
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 500mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 250mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 400mg daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
9 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks, topical use may be safer
regular fetal monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
second trimesteravoid if possible
avoid use unless benefits outweigh risks
regular fetal monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
third trimesteravoid if possible
avoid use unless benefits outweigh risks, may affect fetal adrenal function
regular fetal monitoring and fetal adrenal function
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
breastfeedingavoid
discontinue breastfeeding or avoid drug, ketoconazole passes into breast milk
monitor infant for adverse effects
Use of this medication in this population requires careful consideration of risks and benefits.
geriatric
65 years and aboveconsider dose reduction, start at lower end of dosing range
use with caution due to increased sensitivity, monitor liver function closely
regular liver function tests and renal function monitoring
Use with caution and monitor for adverse effects.
pediatric_age
under 2 yearsnot recommended
avoid systemic use in children under 2 years, topical formulations may be used with caution
close monitoring if used
Use of this medication in this population requires careful consideration of risks and benefits.
pediatric_age
2 to 12 yearsadjust dose based on body weight
use only when benefits outweigh risks, topical formulations preferred
monitor liver function and for adverse effects
Use with caution and monitor for adverse effects.
renal_impairment
severe renal impairmentdose reduction may be needed, monitor closely
use with caution, ketoconazole is not significantly renally excreted but metabolites may accumulate
regular monitoring of renal function and drug levels if available
Use with caution and monitor for adverse effects.
hepatic_impairment
moderate to severe hepatic impairmentavoid or significantly reduce dose
contraindicated in severe hepatic impairment due to hepatotoxic potential, use with extreme caution in moderate impairment
frequent liver function tests, monitor for signs of hepatotoxicity
Use of this medication in this population requires careful consideration of risks and benefits.
Statistics and clinical data
FDA approval year
Original FDA approval for oral ketoconazole
Drug class
ATC code J02AB02 for systemic antifungals
Primary indications
Approved therapeutic uses including candidiasis, dermatophytosis, seborrheic dermatitis
Mechanism of action
Primary pharmacological mechanism
Treats cutaneous fungal infections (tinea, pityriasis versicolor, seborrheic dermatitis), oral and esophageal candidiasis, and systemic fungal infections like blastomycosis and histoplasmosis when other antifungals are ineffective.
Inhibits fungal cytochrome P450 enzymes, blocking the synthesis of ergosterol—an essential component of fungal cell membranes—causing cell death.
Can cause severe hepatotoxicity; regular liver function monitoring required. Multiple drug interactions due to CYP450 inhibition. Oral form carries FDA black box warning for hepatotoxicity and QT prolongation. Topical formulation has minimal systemic absorption.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed August 24, 2026. · Read our editorial policy