FDA Limits Use of Nizoral

The FDA has limited the use of Nizoral (ketoconazole) oral tablets, warning that the oral tablets can cause severe liver injuries and adrenal gland problems and advising that it can lead to harmful drug interactions with other medications. 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 and only used for the treatment of certain endemic mycoses, only when alternative antifungal therapies are not available or 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. The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) announced their negative risk-benefit assessment for oral ketoconazole-containing medicines used to treat infections caused by dermatophytes and yeasts and recommended suspensions of these medicines throughout the European Union. FDA will continue to evaluate the safety of Nizoral tablets.