In an FDA Safety Alert issued today, the FDA warned of potentially serious liver failure that can result in need for liver transplant, or death and adrenal insufficiency that has been observed with Nizoral (ketoconazole) tablets. This pertains to both the brand and generic versions of the tablet form of the drug. The Agency advises that the product should not be used as a first line agent for any fungal infection and that it should be reserved only when other treatments are not available or cannot be tolerated.
The Safety Alert provides information on the types of liver injury as well as the adrenal problems and describes additional drug interaction data that may be of significant concern. The safety alert can be found here. At this link, there are also additional facts about Nizoral and information for patients and healthcare providers. The new label just approved for Nizoral can be found under the Data Summary tab at the link above.
The Safety Alert also provides a data summary that describes the Agency’s actions and the label changes that resulted from the data review.
The FDA notes that it is only the systemic oral product that may cause these serious adverse events. The topical approved products are not implicated.