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Ketoconazole

Pronunciation

Generic Name: ketoconazole (KEE-toe-KON-a-zole)
Brand Name: Nizoral

Ketoconazole should only be used when other treatments cannot be used or have not worked. Talk with your doctor to be sure that the benefits of using ketoconazole outweigh the risks.

Serious and sometimes fatal liver problems, including the need for liver transplant, have occurred with the use of ketoconazole. Some patients this happened to were not at risk for liver problems. Contact your doctor immediately if you have symptoms of liver problems (eg, unusual fatigue, yellowing of the eyes or skin, dark urine, pale stools, loss of appetite, stomach pain, vomiting, severe or persistent nausea). Most of the time, but not always, liver problems have gone back to normal after ketoconazole was stopped. Your doctor will perform liver function tests before you begin taking ketoconazole and at times during treatment.

Use of ketoconazole along with certain other medicines may increase your risk of serious and sometimes fatal heart problems, including irregular heartbeat. Do not take ketoconazole if you are also taking cisapride, disopyramide, dofetilide, dronedarone, methadone, pimozide, quinidine, or ranolazine.


Ketoconazole is used for:

Treating fungal infections. It may also be used for other conditions as determined by your doctor.

Ketoconazole is an azole antifungal. It kills sensitive fungi by interfering with the formation of the fungal cell membrane.

Do NOT use ketoconazole if:

  • you are allergic to any ingredient in ketoconazole
  • you have liver problems
  • you are taking alprazolam, cisapride, disopyramide, dofetilide, dronedarone, eplerenone, an ergot alkaloid (eg, dihydroergotamine, ergotamine), felodipine, irinotecan, lovastatin, lurasidone, methadone, nisoldipine, oral midazolam, pimozide, quinidine, ranolazine, simvastatin, tolvaptan, or triazolam
  • you are taking colchicine and also have kidney or liver problems

Contact your doctor or health care provider right away if any of these apply to you.

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Before using ketoconazole:

Some medical conditions may interact with ketoconazole. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you are allergic to other azole antifungals (eg, itraconazole)
  • if you have low stomach acid (eg, hypochlorhydria)
  • if you have a history of liver disease, regular alcohol use, alcohol abuse or dependence, adrenal gland problems, or blood problems (eg, porphyria)
  • if you have a history of irregular heartbeat (eg, QT prolongation) or if a member of your family has a certain type of irregular heartbeat called congenital long QT syndrome

Some MEDICINES MAY INTERACT with ketoconazole. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Many prescription and nonprescription medicines (eg, used for infections, HIV, seizures, anxiety, sleep, heartburn, diabetes, high cholesterol, heart problems, high blood pressure, allergies, irregular heartbeat, pain, blood thinning, asthma, migraines, mood or mental problems, cancer, prostate problems, immune system suppression, erectile dysfunction, urinary problems, or contraception [birth control]), multivitamin products, or herbal or dietary supplements because they may interact with ketoconazole. Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with ketoconazole

This may not be a complete list of all interactions that may occur. Ask your health care provider if ketoconazole may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use ketoconazole:

Use ketoconazole as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Ketoconazole comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get ketoconazole refilled.
  • Take ketoconazole by mouth with or without food.
  • Talk with your doctor if you are also taking antacids, an H2 blocker (eg, famotidine), or a proton pump inhibitor (PPI) (eg, omeprazole). You may need to take this drug with an acidic drink (eg, nondiet cola).
  • Do not take aluminum hydroxide within 1 hour before or 2 hours after you take ketoconazole.
  • To clear up your infection completely, take ketoconazole for the full course of treatment. Keep taking it even if you feel better in a few days.
  • Ketoconazole works best if it is taken at the same time each day.
  • If you miss a dose of ketoconazole, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use ketoconazole.

Important safety information:

  • Ketoconazole may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use ketoconazole with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Rarely, ketoconazole may cause a severe allergic reaction right after you take the first dose. Symptoms may include difficulty breathing; tightness in the chest; swelling of the eyelids, face, or lips; or rash or hives. If this happens, seek medical care at once.
  • Use of alcohol with ketoconazole has rarely caused symptoms such as flushing, rash, swelling of the hands and feet, nausea, and headache. Do not drink alcohol while taking ketoconazole.
  • Do NOT take more than the recommended dose, stop taking ketoconazole, or use ketoconazole for longer than prescribed without checking with your doctor.
  • Tell your doctor or dentist that you take ketoconazole before you receive any medical or dental care, emergency care, or surgery.
  • Ketoconazole only works against fungi; it does not treat viral infections (eg, the common cold) or bacterial infections.
  • Be sure to use ketoconazole for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The infection could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
  • Ketoconazole may lower blood testosterone levels. This may lead to decreased sexual ability, enlarged breasts, or low sperm counts. Testosterone levels return to normal after ketoconazole is stopped. Discuss any questions or concerns with your doctor.
  • Diabetes patients - Ketoconazole may increase the risk of low blood sugar from your diabetes medicine. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Hormonal birth control (eg, birth control pills) may not work as well while you are using ketoconazole. To prevent pregnancy, use an extra form of birth control (eg, condoms).
  • LAB TESTS, including liver function tests, may be performed while you use ketoconazole. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Ketoconazole should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using ketoconazole while you are pregnant. Ketoconazole is found in breast milk. Do not breast-feed while using ketoconazole.

Possible side effects of ketoconazole:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; headache; mild stomach pain or upset; nausea.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloating; burning, numbness, or tingling; chest pain; depression; dizziness or light-headedness; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; swelling of the hands, ankles, or feet; swollen or tender abdomen; symptoms of liver problems (eg, unusual fatigue, yellowing of the eyes or skin, dark urine, pale stools, loss of appetite, stomach pain, vomiting, severe or persistent nausea); thoughts of suicide; unusual bruising or bleeding; unusual tiredness or weakness; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch .

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of ketoconazole:

Store ketoconazole between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep ketoconazole out of the reach of children and away from pets.

General information:

  • If you have any questions about ketoconazole, please talk with your doctor, pharmacist, or other health care provider.
  • Ketoconazole is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take ketoconazole or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about ketoconazole. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to ketoconazole. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using ketoconazole.

Issue Date: November 5, 2014
Database Edition 14.4.1.002
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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