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The Food and Drug Administration (FDA) is taking action regarding Nizoral (ketoconazole) oral tablets, citing that use of the drug may cause severe liver injuries (Hepatotoxicity) and adrenal gland problems as well as harmful drug interactions with other medications. The FDA has approved a label change for the tablets as well as an updated medication guide to ensure patient safety during use of the prescription

Nizoral tablets has been updated to include the following information:

  • Limitation of the usage of Nizoral tablets by removing indications in which the risk outweighs the benefits. The use of ketoconazole tablets in Candida and dermatophyte infections is no longer indicated. Nizoral tablets should be used only when other antifungal drugs are not available or tolerated by the patient. (Boxed Warning, Warnings, Precautions, and Indications and Usagesections)
  • Nizoral tablets are indicated only for the treatment of the following fungal infections: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis in patients in whom other treatments have failed or who are intolerant to other therapies (Indications and Usagesection).
  • Nizoral tablets are not indicated for the treatment of fungal infections of the skin or nails.
  • A new contraindication that Nizoral tablets should not be used in patients with acute or chronic liver disease (Contraindications section).
  • Updated information on the risk of liver injury, or hepatotoxicity, with new assessment and monitoring recommendations (Boxed Warning, Warnings, and Precautions sections).
  • Updated information on drug interactions (Precautions section).
  • · A warning regarding adrenal insufficiency with recommendations for monitoring populations at risk (Warnings section).

[Courtesy of the FDA]

Nizoral, used for treatment of certain fungal infections known as endemic mycoses, is to be used only when alternative antifungal therapies are not available, and never has a first-line treatment for such infections.

Liver injury from use of Nizoral may cause complications such as potential liver transplantation and even death. The FDA strong recommends against its use for patients with liver disease and encourages proactive monitoring of patients for liver toxicity.

As the FDA continues to evaluate the safety of Nizoral updates regarding the dangers of use will be communicated to the public when such information becomes available. If you are taking NIzoral please consult with your primary care physician to understand if you are at risk for liver injury or other complications due to the medication. Your doctor may be unaware of the dangers of Nizoral, if so, consult a third party licensed medical provider.

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