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What Is Ketoconazole?

Ketoconazole tablets are a prescription azole antifungal for selected systemic fungal infections. Each oral tablet contains 200 mg. Current labeling restricts oral ketoconazole to patients who cannot use other antifungal therapy and states that the tablets are not indicated for onychomycosis, cutaneous dermatophyte infections, or Candida infections.

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What Is Ketoconazole?

Ketoconazole tablets are a prescription azole antifungal for selected systemic fungal infections. Each oral tablet contains 200 mg. Current labeling restricts oral ketoconazole to patients who cannot use other antifungal therapy and states that the tablets are not indicated for onychomycosis, cutaneous dermatophyte infections, or Candida infections.

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How Does Oral Ketoconazole Work?

Ketoconazole inhibits fungal lanosterol 14-alpha-demethylase and reduces synthesis of ergosterol, a component of the fungal cell membrane. Loss of ergosterol weakens normal membrane structure and function.

Who Is Treated With Oral Ketoconazole?

Oral ketoconazole is used for blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis when other antifungal treatment is unavailable or not tolerated. It is not used for fungal meningitis due to poor penetration into cerebrospinal fluid.

How Is Oral Ketoconazole Dosed?

The recommended adult starting dose is 200 mg once daily. The dose can increase to 400 mg once daily when clinical response is insufficient. Treatment of systemic fungal infection commonly continues for about six months and until active infection has subsided.

What Serious Risks Are Linked to Oral Ketoconazole?

Oral ketoconazole carries boxed warnings for serious hepatotoxicity and QT prolongation from dangerous drug interactions. Liver injury has included fatal cases and liver transplantation. Other serious concerns include adrenal insufficiency and interactions caused by strong CYP3A inhibition. Baseline liver tests and weekly alanine aminotransferase monitoring are required during treatment.

Frequently Asked Questions About Ketoconazole

What infections does oral ketoconazole treat?

Current labeling includes selected systemic fungal infections when other antifungal therapy cannot be used.

What is the adult starting dose?

The recommended starting dose is 200 mg once daily.

Is oral ketoconazole used for common skin or nail fungal infections?

No. Current labeling states that oral ketoconazole is not indicated for onychomycosis, cutaneous dermatophyte infections, or Candida infections.

Does oral ketoconazole have boxed warnings?

Yes. The boxed warnings concern serious hepatotoxicity and QT prolongation related to drug interactions.

References

Ketoconazole. https://www.ncbi.nlm.nih.gov/books/NBK547869/. Date Accessed October 7, 2026.

Ketoconazole Tablets Prescribing Information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=369f31da-d3c3-49b8-956f-f70598760164. Date Accessed October 7, 2026.

Ketoconazole: MedlinePlus Drug Information. https://www.medlineplus.gov/druginfo/meds/a682816.html. Date Accessed October 7, 2026.

Treatment of Blastomycosis and Histoplasmosis With Ketoconazole. Results of a Prospective Randomized Clinical Trial. National Institute of Allergy and Infectious Diseases Mycoses Study Group. https://pubmed.ncbi.nlm.nih.gov/2865921/. Date Accessed October 7, 2026.

Treatment of Systemic Mycoses With Ketoconazole: Emphasis on Toxicity and Clinical Response in 52 Patients. National Institute of Allergy and Infectious Diseases Collaborative Antifungal Study. https://pubmed.ncbi.nlm.nih.gov/6293361/. Date Accessed October 7, 2026.