FDA Updates Nizoral Tablet Labeling to Limit Usage

The labeling for the antifungal product Nizoral (ketoconazole; Janssen) tablets has been updated to include warnings indicating that the drug can cause severe liver injuries and adrenal gland problems.  It has also been linked to harmful drug interactions with other medications. 

As a result, the drug label for 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 Usage sections)
  • 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 Usage section).
  • 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 hepatotoxicity, with new assessment and monitoring recommendations (Boxed Warning, Warnings, and Precautions sections).
  • Updated information on drug interactions (Precautions section). All medications that a patient is currently taking should be assessed for possible interactions with Nizoral tablets.
  • A warning regarding adrenal insufficiency with recommendations for monitoring populations at risk (Warnings section).

In addition the FDA has approved a new patient Medication Guide containing information on the potential risks.  This guide must be dispensed with every prescription for the drug. 

The topical formulations (cream, shampoo) of Nizoral have not been associated with liver damage, adrenal problems, or drug interactions.

For more information visit FDA.gov.