Nizoral (ketoconazole) is an antifungal drug indicated for the treatment of the following fungal infections when alternatives are not available or not tolerated: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. Nizoral tablets should not be used for fungal meningitis because it penetrates poorly into the cerebrospinal fluid. 

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program using the contact information at the bottom of this page.

 

Related Information

• FDA advises against using oral ketoconazole in drug interaction studies due to serious potential side effects
• FDA Drug Safety Communication: FDA limits usage of Nizoral (ketoconazole) oral tablets due to potentially fatal liver injury and risk of drug interactions and adrenal gland problems
• FDA Drug Safety Podcast: FDA limits usage of Nizoral (ketoconazole) oral tablets due to potentially fatal liver injury and risk of drug interactions and adrenal gland problems
• Comunicado de la FDA sobre la seguridad de los medicamentos: FDA limita el uso de tabletas orales de Nizoral (ketoconazol) debido a lesiones potencialmente fatales al hígado y riesgo de interacción con medicamentos y problemas de las glándulas suprarrenales

Regulatory History and Labeling from Drugs@FDA

• Nizoral (ketoconazole) Labeling Information