Ketoconazole, Oral

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KEY POINTS

• This medicine is taken by mouth to treat or prevent fungal infections. Take it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause severe liver problems or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Some medicines may cause serious or life-threatening problems if taken with this medicine. Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antifungal; anti-infective

Generic and brand names: ketoconazole, oral; Nizoral

What is this medicine used for?

This medicine is taken by mouth to treat fungal infections in various parts of the body. This medicine does not treat viral infections like the common cold.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Be sure to tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Achlorhydria (lack of stomach acid) or hypochlorhydria (decreased amount of stomach acid)
• Adrenal gland problems
• Liver disease
• Long QT syndrome (problems with electrical activity in the heart muscle)

Some medicines may cause serious or life-threatening problems if taken with this medicine. Tell your healthcare provider about all of the medicines you take.

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check with your healthcare provider before using this medicine in children under age 2.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less or take it longer than prescribed. Do not stop taking this medicine without your healthcare provider's approval, even if you feel better.

If you have achlorhydria (your stomach does not produce acid), take the medicine with a cola drink.

Take this medicine with food. Taking it with meals may lessen the chance the drug will upset your stomach.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

An acute overdose of this medicine is not likely to cause life-threatening symptoms. If you think that you or anyone else may have taken too much of this medicine, call the poison control center at 800-222-1222.

What should I watch out for?

You need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

This medicine may cause severe liver problems. Contact your healthcare provider right away if you develop severe tiredness, loss of appetite, nausea, vomiting, yellowing of your skin or eyes, dark urine, or light-colored bowel movements. These may be symptoms of liver problems.

Do not drink alcohol while you are taking this medicine. Alcohol may increase the risk of liver problems.

Alcohol may also a cause unpleasant reaction with this medicine such as flushing, sweating, fast heartbeat, headache, nausea, and vomiting.

If you have diabetes: This medicine may affect your blood sugar level and change the amount of diabetes medicines you may need. Talk to your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; tightness in your chest; swelling of your lips, tongue, or throat; trouble breathing).

Serious (Report these to your healthcare provider right away.): Severe nausea or vomiting; severe tiredness or weakness; fast or irregular heartbeat; severe dizziness or fainting; chest pain; loss of appetite; yellowing of your skin or eyes; dark urine; light-colored bowel movements; severe stomach pain; thoughts of suicide; depression; numbness or tingling in legs or arms; unusual bruising or bleeding.

Other: Headache; mild nausea; diarrhea; mild dizziness, tiredness, or itching; breast pain or swelling.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Alcohol
• Alfentanil (Alfenta)
• Aliskiren (Tekturna) and aliskiren/hydrochlorothiazide (Tekturna HCT)
• Almotriptan (Axert)
• Alpha blockers such as alfuzosin (Uroxatral), silodosin (Rapaflo), and tamsulosin (Flomax)
• Antacids (Take antacids at least 2 hours before or 2 hours after you take this medicine.)
• Antianxiety medicines such as alprazolam (Xanax), diazepam (Valium), midazolam (Versed), and triazolam (Halcion)
• Antiarrhythmic medicines (to treat irregular heartbeat) such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), ivabradine (Corlanor), and quinidine
• Antibiotics such as azithromycin (Zithromax, Zmax), bedaquiline (Sirturo), ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), gemifloxacin (Factive), isoniazid, levofloxacin (Levaquin), moxifloxacin (Avelox), ofloxacin, pentamidine (NebuPent, Pentam), rifabutin (Mycobutin), rifampin (Rifadin), and telithromycin (Ketek)
• Antidepressants such as amitriptyline, citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac), imipramine (Tofranil), mirtazapine (Remeron), nefazodone, nortriptyline (Pamelor), and trazodone
• Antihistamines such as fexofenadine (Allegra) and loratadine (Alavert, Claritin)
• Antipsychotic medicines such as aripiprazole (Abilify), asenapine (Saphris), brexpiprazole (Rexulti), cariprazine (Vraylar), chlorpromazine, clozapine (Clozaril, FazaClo), haloperidol (Haldol), iloperidone (Fanapt), lurasidone (Latuda), paliperidone (Invega), pimozide (Orap), quetiapine (Seroquel), risperidone (Risperdal), thioridazine, thiothixene (Navane), and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), clobazam (Onfi), oxcarbazepine (Trileptal), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Apomorphine (Apokyn)
• Bosentan (Tracleer)
• Buspirone
• Calcium channel blockers such as amlodipine (Norvasc), amlodipine/atorvastatin (Caduet), felodipine, isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), nimodipine (Nymalize), nisoldipine (Sular), and verapamil (Calan, Covera, Verelan)
• Cancer medicines such as arsenic trioxide (Trisenox), axitinib (Inlyta), bosutinib (Bosulif), busulfan (Busulfex, Myleran), cabazitaxel (Jevtana), cabozantinib (Cometriq), ceritinib (Zykadia), cobimetinib (Cotellic), crizotinib (Xalkori), cyclophosphamide (Cytoxan), dabrafenib (Tafinlar), dasatinib (Sprycel), degarelix (Firmagon), docetaxel (Docefrez, Taxotere), everolimus (Afinitor, Zortress), ibrutinib (Imbruvica), ifosfamide (Ifex), imatinib (Gleevec), irinotecan (Camptosar), lapatinib (Tykerb), nilotinib (Tasigna), olaparib (Lynparza), palbociclib (Ibrance), pazopanib (Votrient), regorafenib (Stivarga), ruxolitinib (Jakafi), sonidegib (Odomzo), sorafenib (Nexavar), sunitinib (Sutent), toremifene (Fareston), trabectedin (Yondelis), tretinoin (Atralin, Renova, Retin-A), vandetanib (Caprelsa), vemurafenib (Zelboraf), vinblastine, vincristine (Marqibo), and vinorelbine (Navelbine)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Altoprev), and simvastatin (Zocor)
• Cinacalcet (Sensipar)
• Colchicine (Colcrys)
• Corticosteroids such as budesonide (Entocort, Rhinocort, Uceris), dexamethasone, fluticasone (Flonase, Flovent, Veramyst), methylprednisolone (Medrol, Solu-Medrol), and prednisone (Prednisone Intensol)
• Daclatasvir (Daklinza)
• Diabetes medicines such as chlorpropamide, glipizide (Glucotrol), glyburide (Glynase), and tolbutamide
• Digoxin (Lanoxin)
• Doxepin (Silenor)
• Eletriptan (Relpax) (Do not take antifungal medicines within 72 hours of taking this medicine.)
• Eliglustat (Cerdelga)
• Eplerenone (Inspra)
• Erectile dysfunction medicines such as avanafil (Stendra), sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra, Staxyn)
• Ergot medicines such as bromocriptine (Cycloset, Parlodel), dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar), and methylergonovine
• Fingolimod (Gilenya)
• Flibanserin (Addyi)
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), etravirine (Intelence), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), maraviroc (Selzentry), nelfinavir (Viracept), nevirapine (Viramune), rilpivirine (Edurant), ritonavir (Norvir), saquinavir (Invirase), tipranavir (Aptivus), and zidovudine (Retrovir)
• Hormonal birth control implants, IUDs, patches, pills, shots, and vaginal rings (Talk to your healthcare provider if you need birth control.)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Lomitapide (Juxtapid)
• Losartan (Cozaar)
• Macitentan (Opsumit)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, mefloquine, primaquine, and quinine
• Medicines to block or prevent stomach acid such as cimetidine (Tagamet), dexlansoprazole (Dexilant), esomeprazole (Nexium), famotidine (Pepcid), lansoprazole (Prevacid), nizatidine (Axid), omeprazole (Prilosec), pantoprazole (Protonix), rabeprazole (AcipHex), and ranitidine (Zantac)
• Medicines to treat breathing or lung problems such as arformoterol (Brovana), formoterol (Perforomist), salmeterol (Serevent), and theophylline
• Medicines to treat low sodium levels such as conivaptan (Vaprisol) and tolvaptan (Samsca)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), cilostazol (Pletal), clopidogrel (Plavix), rivaroxaban (Xarelto), ticagrelor (Brilinta), and warfarin (Coumadin)
• Mifepristone (Korlym, Mifeprex)
• Naloxegol (Movantik)
• Nausea medicines such as aprepitant (Emend), dolasetron (Anzemet), granisetron (Sancuso), and ondansetron (Zofran)
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as celecoxib (Celebrex), diclofenac (Cambia, Voltaren, Zipsor), flurbiprofen, ibuprofen (Advil, Motrin), meloxicam (Mobic), naproxen (Aleve, Anaprox, Naprelan), and piroxicam (Feldene)
• Ospemifene (Osphena)
• Other antifungal medicines such as amphotericin b (Abelcet, AmBisome, Amphotec), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Pain medicines such as codeine (Tylenol #3), fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone (Hysingla, Zohydro), methadone (Dolophine, Methadose), oxycodone (OxyContin, Roxicodone), tapentadol (Nucynta), and tramadol (ConZip, Ultram)
• Ranolazine (Ranexa)
• Sleeping pills such as ramelteon (Rozerem) and zolpidem (Ambien, Edluar, Intermezzo)
• St. John's wort
• Stimulants such as armodafinil (Nuvigil) and modafinil (Provigil)
• Sucralfate (Carafate)
• Tofacitinib (Xeljanz)
• Tolterodine (Detrol)

Ask your healthcare provider or pharmacist if you need to avoid products that contain grapefruit, Seville oranges, and tangelos while you are taking this medicine. These fruits and juices can affect the way this medicine works and may increase your risk of serious side effects.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.