Generic Name: Ketoconazole (Systemic) (kee toe KOE na zole)
- This medicine is not for use to treat certain types of fungal infections. This includes fungal infections of the skin, nails, or brain. Talk with the doctor.
- This medicine must only be used when other drugs cannot be used or have not worked. Talk with your doctor to be sure that the benefits of ketoconazole (systemic) are more than the risks.
- Very bad and sometimes deadly liver problems like the need for a liver transplant have happened with this medicine. Some people did not have a raised chance of liver problems before taking ketoconazole. Most of the time, but not always, liver problems have gone back to normal after this medicine was stopped. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes. Blood tests will be needed to watch for any liver problems. Talk with your doctor.
- Taking ketoconazole with certain other drugs may raise the chance of very bad and sometimes deadly heart problems like a heartbeat that is not normal. Do not take this medicine if you are taking any of these drugs: Cisapride, disopyramide, dofetilide, dronedarone, methadone, pimozide, quinidine, or ranolazine.
Uses of Ketoconazole:
- It is used to treat fungal infections.
- It may be given to you for other reasons. Talk with the doctor.
What do I need to tell my doctor BEFORE I take Ketoconazole?
- If you have an allergy to ketoconazole or any other part of ketoconazole.
- If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If you have liver disease.
- If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with this medicine, like certain drugs that are used for high cholesterol, migraines, or mood problems. There are many drugs that must not be taken with ketoconazole.
- If you take colchicine and have kidney or liver problems.
- If you are breast-feeding. Do not breast-feed while you take this medicine.
This is not a list of all drugs or health problems that interact with ketoconazole.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take Ketoconazole?
- Tell all of your health care providers that you take ketoconazole. This includes your doctors, nurses, pharmacists, and dentists.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- Do not use longer than you have been told. A second infection may happen.
- Avoid drinking alcohol while taking this medicine.
- This medicine may lower testosterone levels. This may cause enlarged breasts, not able to get an erection, or low sperm counts. Testosterone levels go back to normal after ketoconazole (systemic) is stopped. Call the doctor if any of these effects occur.
- Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
How is this medicine (Ketoconazole) best taken?
Use ketoconazole as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- Talk with your doctor if you are also taking antacids, cimetidine, dexlansoprazole, esomeprazole, famotidine, lansoprazole, nizatidine, omeprazole, pantoprazole, rabeprazole, or ranitidine. You may need to take this medicine with an acidic drink like non-diet cola.
- Do not take aluminum hydroxide within 1 hour before or 2 hours after you take ketoconazole.
- To gain the most benefit, do not miss doses.
- Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.
- Take ketoconazole at the same time of day.
What do I do if I miss a dose?
- Take a missed dose as soon as you think about it.
- If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
- Do not take 2 doses at the same time or extra doses.
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
- Chest pain.
- A burning, numbness, or tingling feeling that is not normal.
- Swelling in the arms or legs.
- Any unexplained bruising or bleeding.
- Enlarged breasts.
- If bright lights bother your eyes.
- A type of abnormal heartbeat (prolonged QT interval) can happen with this medicine. Call your doctor right away if you have a fast heartbeat, a heartbeat that does not feel normal, or if you pass out.
What are some other side effects of Ketoconazole?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Belly pain.
- Upset stomach.
- Loose stools (diarrhea).
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
How do I store and/or throw out Ketoconazole?
- Store at room temperature.
- Store in a dry place. Do not store in a bathroom.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Check with your pharmacist about how to throw out unused drugs.
Consumer Information Use and Disclaimer
- If your symptoms or health problems do not get better or if they become worse, call your doctor.
- Do not share your drugs with others and do not take anyone else's drugs.
- Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
- Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
- This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time ketoconazole is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
This information should not be used to decide whether or not to take ketoconazole or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. 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 ketoconazole. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
Review Date: December 6, 2017
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- Drug class: azole antifungals
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