Nizoral (Oral)

Ketoconazole is used to treat serious fungal or yeast infections, including candidiasis (thrush, oral thrush), blastomycosis (Gilchrist's disease), coccidioidomycosis (Valley fever, San Joaquin Valley fever), histoplasmosis (Darling's disease), chromoblastomycosis (chromomycosis), or paracoccidioidomycosis (South American blastomycosis, Lutz-Splendore-Almeida disease). This medicine works by killing the fungus or yeast, or stopping its growth.

Ketoconazole is also used to treat parasitic fungal infections on the skin (like athlete's foot or ringworm) that cannot be treated with topical medicine or griseofulvin, or for patients who cannot take griseofulvin.

This medicine is available only with your doctor's prescription.

It is very important that your doctor checks your or your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

If your or your child's symptoms do not improve, or if they get worse, check with your doctor. You may need to take this medicine for several months before your infection improves.

Do not use this medicine together with alprazolam, cisapride, colchicine, disopyramide, dofetilide, dronedarone, eplerenone, felodipine, irinotecan, lovastatin, lurasidone, methadone, nisoldipine, oral midazolam, pimozide, quinidine, ranolazine, simvastatin, terfenadine, tolvaptan, triazolam, or ergot medicines (such as dihydroergotamine, ergometrine, ergotamine, methylergometrine). Using these medicines together may cause serious unwanted effects.

Liver problems may occur while you are taking this medicine. Check with your doctor right away if you have more than one of these symptoms: abdominal or stomach pain or tenderness, clay-colored stools, dark urine, decreased appetite, fever, headache, itching, loss of appetite, nausea and vomiting, skin rash, swelling of the feet or lower legs, unusual tiredness or weakness, or yellow eyes or skin.

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Avoid drinking alcohol while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medication, the chances of using the medicine must be weighed against the good it will do. This is a decision you and your clinician will make. For this medicine, the following should be considered:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medication or any other medications. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ketoconazole in children younger than 2 years of age. Safety and efficacy have not been established.

Geriatric

No details is available on the relationship of age to the effects of ketoconazole in geriatric patients.

Breast Feeding

There are no adequate studies in women for determining infant chance when using this medication during breastfeeding. Weigh the potential benefits against the potential chances before using this drug while breastfeeding.

Interactions with Medicines

Although certain drugs should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are using this drug, it is especially critical that your healthcare professional know if you are taking any of the medications listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medication with any of the following drugs is not advised. Your physician may decide not to treat you with this medication or change some of the other drugs you take.

• Alfuzosin
• Alprazolam
• Amiodarone
• Aripiprazole
• Artemether
• Astemizole
• Atazanavir
• Bedaquiline
• Bepridil
• Buprenorphine
• Cisapride
• Citalopram
• Clarithromycin
• Clozapine
• Colchicine
• Conivaptan
• Crizotinib
• Dabrafenib
• Dihydroergotamine
• Disopyramide
• Dofetilide
• Domperidone
• Donepezil
• Dronedarone
• Eletriptan
• Eliglustat
• Encorafenib
• Entrectinib
• Eplerenone
• Ergoloid Mesylates
• Ergonovine
• Ergotamine
• Etrasimod
• Felodipine
• Fexinidazole
• Finerenone
• Flibanserin
• Fluconazole
• Fostemsavir
• Gepirone
• Glasdegib
• Halofantrine
• Iloperidone
• Irinotecan
• Irinotecan Liposome
• Isavuconazonium Sulfate
• Ivabradine
• Ivosidenib
• Levoketoconazole
• Lomitapide
• Lopinavir
• Lovastatin
• Lumefantrine
• Lurasidone
• Macimorelin
• Maraviroc
• Mavacamten
• Mefloquine
• Mesoridazine
• Methadone
• Methylergonovine
• Methysergide
• Midazolam
• Mifepristone
• Mobocertinib
• Naloxegol
• Nimodipine
• Nisoldipine
• Ondansetron
• Osilodrostat
• Pacritinib
• Panobinostat
• Pazopanib
• Pimavanserin
• Pimozide
• Piperaquine
• Pitolisant
• Propafenone
• Quinidine
• Quinine
• Ranolazine
• Relugolix
• Ribociclib
• Saquinavir
• Selpercatinib
• Silodosin
• Simvastatin
• Solifenacin
• Sorafenib
• Sparfloxacin
• Sunitinib
• Tamoxifen
• Telaprevir
• Terfenadine
• Thioridazine
• Tolvaptan
• Toremifene
• Trazodone
• Triazolam
• Ubrogepant
• Vandetanib
• Vardenafil
• Vemurafenib
• Venetoclax
• Vilanterol
• Vinflunine
• Voclosporin
• Ziprasidone

Using this medicine with any of the following medications is typically not recommended, but may be required in some cases. If both drugs are prescribed together, your clinician may change the dose or how often you use one or both of the medicines.

• Abemaciclib
• Acalabrutinib
• Adagrasib
• Ado-Trastuzumab Emtansine
• Afatinib
• Alfentanil
• Aluminum Carbonate, Basic
• Aluminum Hydroxide
• Aluminum Phosphate
• Amitriptyline
• Anagrelide
• Apalutamide
• Apixaban
• Apomorphine
• Aprepitant
• Arsenic Trioxide
• Asenapine
• Atogepant
• Atorvastatin
• Avacopan
• Avanafil
• Avapritinib
• Axitinib
• Azithromycin
• Benzhydrocodone
• Berotralstat
• Betrixaban
• Boceprevir
• Bosutinib
• Bretylium
• Brexpiprazole
• Brigatinib
• Bromocriptine
• Budesonide
• Buserelin
• Busulfan
• Cabazitaxel
• Cabozantinib
• Calcifediol
• Calcium
• Calcium Carbonate
• Carbamazepine
• Cariprazine
• Ceritinib
• Cerivastatin
• Chloroquine
• Chlorpromazine
• Cilostazol
• Cimetidine
• Ciprofloxacin
• Clofazimine
• Clomipramine
• Clonazepam
• Clopidogrel
• Clothiapine
• Cobicistat
• Cobimetinib
• Codeine
• Copanlisib
• Cyclobenzaprine
• Dabigatran Etexilate
• Daclatasvir
• Daridorexant
• Darunavir
• Dasabuvir
• Dasatinib
• Deflazacort
• Degarelix
• Delamanid
• Delavirdine
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexamethasone
• Dexlansoprazole
• Dexmedetomidine
• Dihydrocodeine
• Dihydroxyaluminum Aminoacetate
• Dihydroxyaluminum Sodium Carbonate
• Docetaxel
• Dolasetron
• Doxepin
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Droperidol
• Duvelisib
• Ebastine
• Edoxaban
• Efavirenz
• Elacestrant
• Elagolix
• Elbasvir
• Elexacaftor
• Elvitegravir
• Enzalutamide
• Eribulin
• Erlotinib
• Erythromycin
• Escitalopram
• Esomeprazole
• Eszopiclone
• Etravirine
• Everolimus
• Famotidine
• Fedratinib
• Felbamate
• Fentanyl
• Fesoterodine
• Fingolimod
• Flecainide
• Fluoxetine
• Fluticasone
• Formoterol
• Fosaprepitant
• Foscarnet
• Fosphenytoin
• Futibatinib
• Gatifloxacin
• Gemifloxacin
• Gilteritinib
• Gonadorelin
• Goserelin
• Granisetron
• Grazoprevir
• Haloperidol
• Histrelin
• Hydrocodone
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibrexafungerp
• Ibrutinib
• Ibutilide
• Idelalisib
• Ifosfamide
• Imatinib
• Indinavir
• Infigratinib
• Inotuzumab Ozogamicin
• Isoniazid
• Istradefylline
• Ivacaftor
• Ixabepilone
• Lansoprazole
• Lapatinib
• Larotrectinib
• Lefamulin
• Lemborexant
• Lenacapavir
• Leniolisib
• Lenvatinib
• Leuprolide
• Levofloxacin
• Levomethadyl
• Levomilnacipran
• Lofexidine
• Lorlatinib
• Lumacaftor
• Lumateperone
• Lurbinectedin
• Macitentan
• Magaldrate
• Magnesium Carbonate
• Magnesium Hydroxide
• Magnesium Oxide
• Magnesium Trisilicate
• Manidipine
• Meperidine
• Methotrexate
• Methotrimeprazine
• Metronidazole
• Midostaurin
• Mirtazapine
• Mirvetuximab Soravtansine-gynx
• Mitapivat
• Mitotane
• Mizolastine
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Nafarelin
• Nefazodone
• Nelfinavir
• Neratinib
• Nevirapine
• Nifedipine
• Nilotinib
• Nirmatrelvir
• Nizatidine
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Olaparib
• Omaveloxolone
• Ombitasvir
• Omeprazole
• Osimertinib
• Ospemifene
• Oxaliplatin
• Oxycodone
• Ozanimod
• Paclitaxel
• Palbociclib
• Paliperidone
• Palovarotene
• Pantoprazole
• Papaverine
• Parecoxib
• Paritaprevir
• Paroxetine
• Pasireotide
• Pemigatinib
• Pentamidine
• Pentazocine
• Perphenazine
• Pexidartinib
• Phenobarbital
• Phenytoin
• Pipamperone
• Pirtobrutinib
• Pixantrone
• Ponatinib
• Ponesimod
• Pralsetinib
• Primidone
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Protriptyline
• Quetiapine
• Quizartinib
• Rabeprazole
• Ranitidine
• Reboxetine
• Regorafenib
• Retapamulin
• Rifabutin
• Rifampin
• Rifapentine
• Rimegepant
• Risperidone
• Ritonavir
• Rivaroxaban
• Romidepsin
• Roxatidine
• Ruxolitinib
• Salmeterol
• Selumetinib
• Sertindole
• Sertraline
• Sevoflurane
• Sildenafil
• Simeprevir
• Siponimod
• Sirolimus
• Sirolimus Protein-Bound
• Sodium Bicarbonate
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Sonidegib
• Sotalol
• Sparsentan
• St John's Wort
• Sucralfate
• Sufentanil
• Sulpiride
• Sultopride
• Suvorexant
• Tacrolimus
• Tadalafil
• Tamsulosin
• Tazemetostat
• Telavancin
• Telithromycin
• Temsirolimus
• Tenofovir Alafenamide
• Tetrabenazine
• Tezacaftor
• Thiotepa
• Ticagrelor
• Tipranavir
• Tolterodine
• Topotecan
• Trabectedin
• Tramadol
• Triclabendazole
• Trimetrexate
• Trimipramine
• Triptorelin
• Upadacitinib
• Valbenazine
• Valdecoxib
• Vamorolone
• Venlafaxine
• Verapamil
• Vilazodone
• Vinblastine
• Vincristine
• Vincristine Sulfate Liposome
• Vinorelbine
• Vorapaxar
• Voriconazole
• Vorinostat
• Warfarin
• Zaleplon
• Zanubrutinib
• Zolpidem
• Zotepine
• Zuclopenthixol
• Zuranolone

Using this medicine with any of the following medicines may cause an increased chance of certain adverse effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the drugs.

• Acenocoumarol
• Alitretinoin
• Almotriptan
• Alosetron
• Amlodipine
• Amprenavir
• Anisindione
• Aripiprazole Lauroxil
• Bexarotene
• Bosentan
• Chlordiazepoxide
• Cinacalcet
• Clobazam
• Cyclosporine
• Darifenacin
• Dicumarol
• Didanosine
• Dutasteride
• Fosamprenavir
• Galantamine
• Isradipine
• Methylprednisolone
• Mometasone
• Nicardipine
• Oxybutynin
• Paricalcitol
• Phenprocoumon
• Pioglitazone
• Praziquantel
• Prednisone
• Ramelteon
• Repaglinide
• Roflumilast
• Tolbutamide
• Tretinoin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medications may additionally cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not advised, but may be unavoidable in some cases. If used together, your clinician may change the dose or how frequently you use this drug, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol
• Grapefruit Juice

Other Medical Problems

The presence of other medical issues may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Achlorhydria (absence of stomach acid)—May not be absorbed from the stomach in patients with this condition.

• Adrenal issues or
• Heart disease, history of or
• Heart rhythm issues (eg, QT prolongation), or history of—These conditions may cause adverse effects to become worse.

• Liver disease, acute or chronic—Should not be used in patients with this condition.

Along with its necessary effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor right away if any of the following side effects happen:

Rare

• Back, leg, or stomach pains
• black, tarry stools
• bleeding gums
• blood in the urine or stools
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in color vision
• change in the ability to see colors, especially blue or yellow
• chest pain
• chills
• confusion
• cough
• dark urine
• difficulty seeing at night
• difficulty swallowing
• dizziness
• fast heartbeat
• fever
• general body swelling
• headache
• hoarseness
• increased sensitivity of the eyes to sunlight
• irritation
• joint pain, stiffness, or swelling
• light-colored stools
• loss of appetite
• mood or mental changes
• severe nausea or vomiting
• nosebleeds
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness of the skin
• skin rash, hives, itching
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swelling of the eyelids, face, lips, hands, or feet
• swollen glands
• tightness in the chest
• trouble sleeping
• troubled breathing or swallowing
• unusual bleeding or bruising
• unusual tiredness or weakness
• vision changes
• yellow eyes or skin

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you how to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

Rare

• Change in number of sperm and their ability to move
• decreased interest in sexual intercourse
• diarrhea
• hair loss or thinning of the hair
• inability to have or keep an erection
• loss in sexual ability, desire, drive, or performance
• sleepiness or unusual drowsiness
• swelling of the breasts or breast soreness for both female and male

Other side effects not listed may also happen in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Nizoral

Available Dosage Forms:

• Tablet

Therapeutic Class: Antifungal

Chemical Class: Imidazole

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Do not stop taking this medicine without checking first with your doctor.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

It is best to take this medicine with food.

Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

If you are taking this medicine together with an antacid-containing aluminum, it should be taken with an acidic beverage (such as non-diet cola). Antacid-containing aluminum should be taken at least 1 hour before or 2 hours after taking this medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):For fungal infections: Adults—At first, 200 milligrams (mg) once a day. Your doctor may increase your dose as needed. Children 2 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 3.3 to 6.6 milligrams (mg) per kilogram (kg) of body weight per day. Children younger than 2 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

• What is ketoconazole cream used for?