Ketoconazole is an antifungal medication that is used to treat certain infections caused by fungus.

This medicine should be used only when you cannot use other antifungal medications. Ketoconazole can cause serious harm to your liver that may result in liver transplant or cause death.

Ketoconazole is not for use in treating fungal infections of the fingernails or toenails. This medicine is also not for use in treating prostate cancer or Cushing syndrome.

Ketoconazole may also be used for purposes not listed in this medication guide.

warnings

What is the most important information I should know about Ketoconazole (Nizoral)?

You should not use ketoconazole if you are allergic to it, or if you have liver disease.

Some medicines can cause unwanted or dangerous effects when used with ketoconazole. Your doctor may change your treatment plan if you also use:

cisapride;
colchicine;
irinotecan;
methadone;
tolvaptan;
antipsychotic medicine--pimozide, lurasidone;
cholesterol medication--lovastatin, simvastatin, and others;
ergot medicine--dihydroergotamine, ergotamine, ergonovine, methylergonovine;
heart medication--disopyramide, dofetilide, dronedarone, eplerenone, felodipine, nisoldipine, quinidine, ranolazine; or
a sedative--alprazolam, midazolam, or triazolam.

Tell your doctor if you have ever had:

liver problems;
long QT syndrome (in you or a family member); or
problems with your adrenal gland.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant.

You should not breast-feed while using this medicine.

Do not give this medicine to a child without medical advice.

Side Effects

What are the side effects of Ketoconazole (Nizoral)?

Get emergency medical help if you have signs of an allergic reaction (hives, fever, chest pain, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have:

fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
unusual weakness or tiredness, dizziness, nausea, and vomiting; or
liver problems--upper stomach pain, fever, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Common side effects may include:

nausea, diarrhea, stomach pain
breast swelling;
headache, dizziness; or
abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Dosage Guidelines & Tips

How to take Ketoconazole (Nizoral)?

Use Ketoconazole (Nizoral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using ketoconazole.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may need to use this medicine for up to 6 months.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses can increase your risk of infection that is resistant to medication. Ketoconazole will not treat a viral infection such as the flu or a common cold.

While using ketoconazole, you may need frequent blood tests to check your liver function.

Store at room temperature away from moisture, heat, and light.

Do not share this medicine with another person, even if they have the same symptoms you have.

What should I do if I missed a dose of Ketoconazole (Nizoral)?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.