Safety Alerts & Recalls

What does this mean?

If you are taking ketoconazole tablets to treat an infection of the skin or nails, please be aware that this is an unapproved use of the medicine. You should follow up with your healthcare provider to discuss the risks and benefits of available therapies to treat skin and nail fungal infections.

If you are taking ketoconazole tablets for other reasons, this alert is a good reminder to regularly review the risks and benefits of your medicine with your healthcare provider.

You should seek medical attention right away if your experience any signs and symptoms of liver problems while taking ketoconazole, which include loss of appetite, nausea, vomiting, or abdominal discomfort; yellowing of the skin or the whites of the eyes (jaundice); unusual darkening of the urine or lightening of the stools; or pain and discomfort in the right upper abdomen where the liver is located.

If you have questions about this safety alert or your other medicines, please follow up with your healthcare provider.

Patients and healthcare providers are encouraged to report side effects related to the use of medicines to the FDA's MedWatch program. You can reach MedWatch by:

--- Telephone: 1-800-332-1088

--- Fax: 1-800-332-0178

--- Mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787

--- Website:

FDA Warns Ketoconazole Should Not Be Prescribed for Skin and Nail Infections

The U.S. Food and Drug Administration has issued a warning to healthcare providers to avoid prescribing the antifungal medicine ketoconazole oral tablets to treat skin and nail fungal infections. Use of this medication carries the risk of serious liver damage, adrenal gland problems, and harmful interactions with other medicines that outweigh its benefit in treating skin and nail fungal infections, which are not approved uses of the drug.

Label changes for oral ketoconazole tablets were approved in 2013 to reflect these serious risks and to remove the indications for treatment of skin and nail fungal infections. However, an FDA safety review found that ketoconazole tablets continue to be prescribed for these types of conditions. Skin and nail fungal infections in otherwise healthy persons are not life-threatening, and so the risks associated with oral ketoconazole outweigh the benefits. Other treatment options are available over-the-counter and by prescription.

Ketoconazole in tablet form is indicated to treat serious infections caused by fungi and should be used only when other effective therapy is not available or tolerated. Ketoconazole is only available as a generic. The topical forms of ketoconazole that are applied to the skin or nails have not been associated with liver damage, adrenal problems, or drug interactions.

For more information, please visit: more information here

Source: FDA
Publication Date: 2016-06-01
Last Updated: 2016-06-02

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