The antifungal medication Nizoral (ketoconazole) has recently been linked to serious side effects including liver injuries (hepatotoxicity), adrenal insufficiency, and dangerous drug interactions. In response to numerous reports of these types of complications in Nizoral users, the U.S. Food & Drug Administration (FDA) has approved label changes and added a new Medication Guide to address these safety issues. The FDA recommends only using Nizoral for the treatment of specific fungal infections, and only when all alternative courses of treatment have been exhausted.
What’s the Problem with Nizoral?
On July 26, 2013, the FDA issued a press release stating that it was taking a number of actions related to Nizoral (ketoconazole), a widely-prescribed antifungal medication manufactured by McNeil Consumer Healthcare (a subsidiary of Johnson & Johnson). Specifically, the administration is:
- limiting the use of Nizoral;
- warning that the drug has been linked to liver injuries and adrenal gland problems, and
- advising the public and medical communities that it can lead to dangerous drug interactions with several other medications.
Nizoral Liver Injury (Hepatotoxicity)
Nizoral tablets have been shown to have the potential to cause life-threatening liver injuries, which can result in the need for liver transplantation. The liver serves many vital bodily functions, the most important of which is to filter toxic substances from the blood. If there are more toxins being introduced than the liver can deal with, liver damage may result. Signs and symptoms of Nizoral-induced liver injury may include:
- discoloration or urine and feces
- chronic itching of skin
- swollen legs and/or abdomen
- easy bruising and bleeding
In response to the liver injury risk associated with Nizoral, the FDA has updated the Boxed Warning on the drug, added a recommendation against its use in individuals with pre-existing liver disease, and included new recommendations for assessing and monitoring patients for liver toxicity.
Nizoral has also been reported to have the ability to cause adrenal insufficiency. The adrenal glands produce hormones that are critical to many of the body’s normal functions. Patients suffering from adrenal insufficiency do not produce enough of two hormones known as cortisol and aldosterone. Cortisol helps the body respond to stress, and to recover from infections. This hormone also aids in the regulation of blood pressure, cardiovascular functions, and in the metabolism of proteins, carbohydrates and fats. Aldosterone is responsible for maintaining the proper balance of salt, potassium and water in the body. Symptoms of adrenal insufficiency caused by Nizoral may include:
- unusual fatigue and muscle weakness
- dizziness when standing
- nausea, vomiting and/or diarrhea
- loss of appetite
- stomach ache
- weight loss
- dark tanning of the skin
- craving for salt
In addition to the risks to the liver and adrenal glands, Nizoral tablets may also interact with other medications a person is taking, and can result in potentially life-threatening reactions such as heart rhythm problems. See the FDA Drug Safety Communication for additional information, including a Data Summary.
FDA Recommendation on Nizoral
The FDA is recommending that Nizoral only be prescribed for the treatment of certain fungal infections known as endemic mycoses when the potential benefits outweigh the risks, and when alternative courses of treatment are either not available or tolerated well. Physicians should assess the liver status of the patient before prescribing Nizoral, and monitor serum ALT levels during treatment. Adrenal function should be closely monitored in patients with adrenal insufficiency or with borderline adrenal function and in patients under significant stress. Additionally, prescribing doctors should review all concomitant medications for the potential for adverse drug interactions with Nizoral.