FDA Warns of Nizoral Liver Injury Adrenal Gland Problems

Washington, DC: The Food and Drug Administration (FDA) has issued a notice regarding the risk for severe liver injuries and adrenal gland problems related to Nizoral (ketoconazole) oral tablets. The agency is also considering limiting the drug' use, and advising that it can lead to harmful drug interactions with other medications.

The FDA has approved label changes and added a new Medication Guide to address these safety issues. As a result, Nizoral oral tablets should not be a first-line treatment for any fungal infection. Nizoral should be used for the treatment of certain fungal infections, known as endemic mycoses, only when alternative antifungal therapies are not available or tolerated. Nizoral tablets can cause liver injury, which may potentially result in liver transplantation or death. FDA has revised the Boxed Warning, added a strong recommendation against its use (contraindication) in patients with liver disease, and included new recommendations for assessing and monitoring patients for liver toxicity.

Adrenal Insufficiency :Nizoral tablets may cause adrenal insufficiency by decreasing the body' production of corticosteroids.

Drug Interactions: Nizoral tablets may interact with other drugs a patient is taking and can result in serious and potentially life-threatening outcomes, such as heart rhythm problems.

Nizoral (ketoconazole) is indicated for the treatment of fungal infections when alternatives are not available or not tolerated. The topical formulations of Nizoral have not been associated with liver damage, adrenal problems, or drug interactions. These formulations include creams, shampoos, foams, and gels applied to the skin, unlike the Nizoral tablets, which are taken by mouth.

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Last updated on Jul-26-13