Ketoconazole (Oral)

Generic name: Ketoconazole
Drug class: Azole antifungals

Usage of Ketoconazole (Oral)

Ketoconazole is used to treat serious fungal or yeast infections, such as 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 preventing its growth.

Ketoconazole is also used to treat parasitic fungal infections on the skin (such as 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.

Ketoconazole (Oral) side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

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

nausea or vomiting, severe

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 occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or 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 occur 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.

Before taking Ketoconazole (Oral)

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

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. 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 information 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 risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines 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 taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. 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 medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines 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 medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor 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

Buserelin

Calcium

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 risk of certain side 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 medicines.

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 medicines may also 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 recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Grapefruit Juice

Relate drugs

How to use Ketoconazole (Oral)

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.

Warnings

It is very important that your doctor check 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 become worse, check with your doctor. You may need to take this medicine for several months before your infection gets better.

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 are having 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.

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