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FDA Warns of Safety Concerns Associated with Nizoral® Antifungal Medication

On July 26, 2013, the Food and Drug Administration (FDA) issued a drug safety communication that use of the antifungal medication, Nizoral®, may cause fatal liver injury and adrenal gland problems, and may interact dangerously with other drugs. In conjunction with this drug safety communication, the FDA has approved label changes for Nizoral® involving recommendations that the drug only be used to treat certain fungal infections, and only if alternative antifungal therapies are not available or cannot be tolerated by the patient. Specifically, FDA approval of Nizoral® has been restricted to the treatment of blastomycosis, coccidiodomycosis, histoplasmosis, chromomycosis, and paracoccidiodomycosis. And even then, Nizoral® remains a drug of last resort.

The FDA issued these restrictions after completing a comprehensive benefit-risk assessment on the safety and efficacy of Nizoral®. Reviewers found that Nizoral® use may increase the risk of liver injury, which could result in death or the need for a liver transplant. They also found that Nizoral® can decrease the production of corticosteroids, leading to adrenal gland problems that disrupt the balance of salt and water in the body. Nizoral® also was found to produce serious and potentially fatal side effects, including heart problems, when taken in conjunction with certain other medications.

The FDA warns patients to be aware of health risks associated with Nizoral®, and to contact a healthcare provider immediately if they start to display any signs of liver problems while taking Nizoral®, including:

– Loss of appetite, nausea, vomiting, or other abdominal problems

– Fever and fatigue

– Signs of jaundice, i.e., yellowing of the skin or whites of the eyes

– Unusually dark urine or lightly colored stool

– Pain and discomfort in the upper right abdomen, near the liver

Before taking Nizoral®, the FDA recommends patients inform their doctor of any other medications they are taking, due to the risk of potentially serious drug interactions. The FDA also cautions against using Nizoral® in conjunction with alcohol and medications containing acetaminophen, due to the increased risk of liver problems.


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