FDA Issues Serious Warning about Anti-Fungal Drug Nizoral

FDA Issues Serious Warning about Anti-Fungal Drug Nizoral

By Courtney Coren

The U.S. Food and Drug Administration issued a safety announcement this month about the anti-fungal medication Nizoral (ketoconazole), saying that the oral tablet fungal treatment has been linked to liver injuries, adrenal gland problems, and can cause an adverse reaction when combined with other medications.

In its July 26, warning, the agency said it was requiring a label change be made to the Nizoral oral tablets, and that the anti-fungal drug should not be used as a first line of treatment. Doctors should use other anti-fungal treatments before turning to Nizoral for their patients because the problems can be very serious.

Nizoral Side Effects Can be Severe

The first Nizoral problem the FDA warns about is liver injury, also called hepatotoxicity, which the FDA said can be serious enough that it can result in a patient needing a liver transplant and can even lead to death. The agency warns that patients with liver disease should not be prescribed Nizoral to treat their fungal infections. It also recommends that patients that are on Nizoral tablets be monitored regularly for liver toxicity.

“Serious liver damage has occurred in patients receiving high doses of Nizoral for short periods of time as well as those receiving low doses for long periods,” the FDA said. “Some of these patients had no obvious risk factors for liver disease.”

The FDA added that in some cases the Nizoral liver injury was reversible when the patient discontinued use of the anti-fungal medication, but that it wasn’t true in all cases.  

Symptoms of liver problems include loss of appetite, nausea, vomiting, fever, fatigue, yellowing of skin, darkened urine, and pain in the upper right side of the abdomen, because that’s where the liver is.

The second major problem found in patients who took Nizoral oral tablets is adrenal gland problems, also called adrenal insufficiency. This prevents the body from producing enough corticosteroids, which help the body properly balance water, salts, and minerals. Nizoral adrenal insufficiency can lead to a variety of health problems for the patient.

The third issue that the FDA warns about is mixing Nizoral with other medications, which can cause very serious Nizoral side effects including inducing heart rhythm problems. The agency recommends that doctors consider all the drugs that a patient is taking before prescribing Nizoral to be sure there will not be a negative reaction.

In 2012, when different forms of Nizoral (ketoconazole) were prescribed, 12 percent of the prescriptions were for the oral tablets.

The most commonly used reasons for prescribing Nizoral is to treat superficial skin and fungal infections that have developed under fingernails.

Get Legal Help for Your Nizoral Side Effect Injury

If you or someone you know experienced any of the injuries detailed above, including liver failure, adrenal problems or adverse drug reaction, after taking Nizoral oral tablets, legal options are available to you. Learn more and get a free legal consultation regarding a claim’s eligibility at the Nizoral (Ketoconazole) Drug Injury Class Action Lawsuit Investigation. Experienced legal professionals have access to medical experts to assess whether or not a Nizoral oral tablet may be playing a role in your current pain, discomfort or other serious side effects, so act now.

Updated August 1st, 2013

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