| IMPORTANT WARNING
| WHY is this medicine prescribed?
| HOW should this medicine be used?
| Are there OTHER USES for this medicine?
| What SPECIAL DIETARY instructions should I follow?
| What should I do IF I FORGET to take a dose?
| What SIDE EFFECTS can this medicine cause?
| What should I know about STORAGE and DISPOSAL of this medication?
| What should I do in case of OVERDOSE?
| What OTHER INFORMATION should I know?
Ketoconazole may cause liver damage, sometimes serious enough to require liver transplantation or to cause death. Tell your doctor if you drink or have ever drunk large amounts of alcohol and if you have or have ever had liver disease.
If you experience any of the following symptoms, call your doctor immediately: extreme tiredness, loss of appetite, weight loss, nausea, vomiting, yellowing of the skin or eyes, dark yellow urine, pale stools, pain in the upper right part of the stomach, fever, or rash.
Ketoconazole can cause QT prolongation (an irregular heart rhythm that can lead to fainting, loss of consciousness, seizures, or sudden death). Do not take dofetilide (Tikosyn), pimozide (Orap), quinidine (Quinidex, Quinaglute), or cisapride (Propulsid; no longer available in the US), while you are taking ketoconazole. If you experience any of the following symptoms, stop taking ketoconazole and call your doctor immediately: fast, pounding, or irregular heartbeat; fainting; loss of consciousness.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to ketoconazole.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with ketoconazole and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website ( Web Site) or the manufacturer's website to obtain the Medication Guide.
Talk to your doctor about the risk(s) of taking ketoconazole.
WHY is this medicine prescribed?
Ketoconazole is used to treat fungal infections when other medications are not available or could not be tolerated. Ketoconazole is in a class of antifungals called imidazoles. It works by slowing the growth of fungi that cause infection.
HOW should this medicine be used?
Ketoconazole comes as a tablet to take by mouth. It is usually taken once a day. To help you remember to take ketoconazole, take it at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ketoconazole exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Your doctor may increase your dose if your condition does not improve.
You may need to take ketoconazole for several weeks or months to cure your infection completely. Your doctor will probably order laboratory tests to be sure your infection has been treated completely. Continue to take ketoconazole until your doctor tells you that you should stop, even if you feel better. Do not stop taking ketoconazole without talking to your doctor. If you stop taking ketoconazole too soon, your infection may come back after a short time.
Are there OTHER USES for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before taking ketoconazole,
- tell your doctor and pharmacist if you are allergic to ketoconazole or any other medications or any of the ingredients in ketoconazole tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
- tell your doctor if you are taking alprazolam (Xanax), eplerenone (Inspra), ergot alkaloids such as ergotamine and dihydroergotamine, lovastatin (Mevacor), midazolam (Versed), nisoldipine (Sular), simvastatin (Zocor), and triazolam (Halcion). Your doctor will probably tell you not to take ketoconazole if you are taking one or more of these medications or any of the medications listed in the IMPORTANT WARNING section.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: antacids; anticoagulants ('blood thinners') such as warfarin (Coumadin); bosentan (Tracleer); buspirone (BuSpar); busulfan (Myleran); carbamazepine (Tegretol); cilostazol (Pletal); calcium channel blockers such as amlodipine (Norvasc), diltiazem (Cardizem, Dilacor, Tiazac), felodipine (Plendil), nicardipine (Cardene), nifedipine (Adalat, Procardia), and verapamil (Calan, Covera, Isoptin, Verelan); clarithromycin (Biaxin); clopidogrel (Plavix); cancer medications such as docetaxel (Taxotere), paclitaxel (Taxol), vincristine (Vincasar), vinblastine, and vinorelbine (Navelbine); immunosuppressants such as cyclosporine (Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Prograf); diazepam (Valium); digoxin (Lanoxin); erythromycin (E.E.S., E-Mycin, Erythrocin); fentanyl (Abstral, Actiq, Duragesic, Fentora, Lazanda, Onsolis); HIV medications such as indinavir (Crixivan), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase, Fortovase); loratadine (Claritin); medications for diabetes; medications for erectile dysfunction such as sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra); medications for indigestion, heartburn, or ulcers such as cimetidine (Tagamet), famotidine (Pepcid), lansoprazole (Prevacid), nizatidine (Axid), omeprazole (Prilosec), and ranitidine (Zantac); medications for irritable bowel disease, motion sickness, Parkinson's disease, ulcers, or urinary problems; methadone (Dolophine); methylprednisolone (Medrol); phenytoin (Dilantin); medications to treat tuberculosis such as isoniazid (INH, Nydrazid), rifabutin (Mycobutin), rifampin (Rifadin, Rimactane); quinine; sucralfate (Carafate); tamoxifen (Nolvadex); telithromycin (Ketek); tolterodine (Detrol); and trazodone (Desyrel). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had the conditions mentioned in the IMPORTANT WARNING section or adrenal insufficiency (condition in which the adrenal glands do not make enough steroid hormones).
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking ketoconazole, call your doctor. Do not breast-feed while you are taking ketoconazole.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking ketoconazole.
- do not drink any alcoholic beverages (including wine, beer, and medications that contain alcohol such as cough syrup) while taking ketoconazole. You may experience unpleasant symptoms such as flushing, rash, nausea, headache, and swelling of the hands, feet, ankles, or lower legs if you drink alcohol while you are taking ketoconazole.
What SPECIAL DIETARY instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do IF I FORGET to take a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What SIDE EFFECTS can this medicine cause?
Ketoconazole may cause side effects. Tell your doctor if either of these symptoms is severe or does not go away:
- stomach pain
Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them or those listed in the IMPORTANT WARNING section, call your doctor immediately:
- difficulty breathing or swallowing
- swelling of the lips or tongue
- tiredness or weakness
A small number of patients who were taking high doses of ketoconazole for prostate cancer died soon after they began taking the medication. It is not known whether they died because of their disease or their treatment with ketoconazole or for other reasons. Talk to your doctor about the risks of taking ketoconazole.
Ketoconazole may cause a decrease in the number of sperm (male reproductive cells) produced, especially if it is taken at high doses. Talk to your doctor about the risks of taking this medication if you are a man and would like to have children.
Ketoconazole may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at
] or by phone [1-800-332-1088].
What should I know about STORAGE and DISPOSAL of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
What should I do in case of OVERDOSE?
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
What OTHER INFORMATION should I know?
Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking ketoconazole.
Do not let anyone else take your medication. Ask your pharmacist if you have any questions about refilling your prescription. If you still have symptoms of infection after you finish the ketoconazole, call your doctor.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: September 15, 2013.