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Safety limits set for Nizoral

August 19, 2013

The U.S. Food and Drug Administration has determined that Nizoral—ketoconazole—oral tablets are not safe for use as a first-line treatment for fungal infections and has limited its use to specific therapies.

The drug can cause severe liver injuries, adrenal gland problems and can have harmful interactions with other medications, according to the safety alert issued through the FDA Safety Information and Adverse Event Reporting Program. Nizoral should be used only to treat fungal infections known as endemic mycoses—and only when an alternative antifungal therapy is unavailable or not tolerated—the FDA says.

The alert warns that potential liver injuries may be so severe as to lead to transplantation or death. It also warns that Nizoral may cause adrenal insufficiency by decreasing the body's production of corticosteroids and life-threatening heart rhythms when interacting with other drugs.

The FDA has approved label changes and added a new Medication Guide to address these safety issues.

Topical formulations of Nizoral—including creams, shampoos, foams and skin gels—are not associated with liver damage, adrenal problems or adverse drug interactions.

The FDA encourages health care professionals and patients to report adverse events related to Nizoral to the FDA's MedWatch Safety Information and Adverse Event Reporting Program by completing a form or by requesting a form at 800.332.1088.

The entire Nizoral safety alert is available at FDA. Search for Nizoral safety.