ketoconazole
Ketoconazole tablet is taken by mouth to treat certain serious fungal infections, including ones caused by blastomycosis and coccidioidomycosis (also known as "valley fever"). Ketoconazole tablet isn't a first-choice option, but it's only for people who haven't responded well to or can't take safer alternative antifungals. This is because ketoconazole tablet can interact with many medications and potentially serious side effects, such as heart rhythm problems and liver problems. It's available as a lower-cost generic tablet by prescription only.
What is Ketoconazole tablet?
What is Ketoconazole tablet used for?
Certain fungal infections that has spread throughout the body
How Ketoconazole tablet works
Ketoconazole tablet is an azole antifungal medication that works by stopping the fungus from being able to make a protective covering. This causes the fungus to not grow or survive.
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What are the side effects of Ketoconazole tablet?
Common Side Effects
- Nausea
- Vomiting
- Diarrhea
- Constipation
- Stomach pain
- Passing gas
- Dry mouth
- Tongue discoloration
Other Side Effects
- Headache
- Changes in sleep
- Dizziness
- Sensitivity to light
- Breast growth in males
- Rash
- Muscle pain
Serious Side Effects
- Liver damage: nausea, vomiting, feeling tired, stomach pain, yellowing of your skin or whites of your eye (jaundice), dark-colored urine, pale-colored stool
- Abnormal heart rhythm (QT prolongation): chest pounding, short of breath, chest pain, feeling faint or lightheaded
- Extremely low cortisol levels (adrenal insufficiency): feeling very weak or tired, dizziness, weight loss, no appetite
- Serious allergic reaction: hives, rash, blisters, skin reddening, swelling of the lips or tongue, difficulty breathing
Source: DailyMed
The following side effects have also been reported
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:
Less common—For cream, shampoo, foam, or gel
Itching, stinging, burning, or irritation not present before use of this medicine
Rare—For cream, foam, or gel
bleeding from sore in the mouth
blistering, crusting, irritation, itching, or reddening of the skin
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
cracked, dry, or scaly skin
discoloration of the fingernails or toenails
dizziness
eye dryness, irritation, or swelling
red rash with watery, yellow-colored, or pus filled blisters with or without thick yellow to honey-colored crusts
skin dryness, pain, rash, redness, or swelling
sore in the mouth or on the gums
swelling of the face
Rare—For shampoo
Hair loss and irritation
Incidence not known—For gel
Incidence not known—For shampoo
Blistering, burning, crusting, dryness, or flaking of the skin
burning sensation of the skin
burning, itching, redness, skin rash, swelling, or soreness at the application site
discoloration of the hair
fast heartbeat
hoarseness
irritation
itching, scaling, severe redness, or soreness of the skin
joint pain, stiffness, or swelling
rash
shortness of breath
swelling of the eyelids, face, lips, hands, or feet
thinning of the hair
tightness in the chest
troubled breathing or swallowing
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:
Less common—For shampoo or gel
Dryness or oiliness of the hair and scalp
headache
Rare—For shampoo
Abnormal hair texture
mild dryness of the skin
scalp pustules
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.
Pros and cons of Ketoconazole tablet
Pros
Works well to treat severe fungal infections
Can be taken if you have kidney problems
Available as a lower-cost generic
Only needs to be taken once a day
Cons
Not a first-choice medication for fungal infections
Can cause serious side effects, such as liver and heart rhythm problems
Interacts with many medications
Usually must be taken for a long time (about 6 months)
Pharmacist tips for Ketoconazole tablet
Don't stop taking ketoconazole tablet unless your provider specifically told you to do so. Otherwise, your infection might get worse or become harder to treat. Make sure to finish your entire treatment course even if you feel better.
Take ketoconazole tablet with or without food. But it commonly causes stomach upset, so taking it with food can help.
Ketoconazole tablet interacts with many commonly used medications. Some medications might need dose adjustments, while others, such as medications that can cause certain heart rhythm problems, might need to be stopped. Make sure to tell your provider and pharmacist about all the medications you're taking, including over-the-counter medications, vitamins, and supplements, before starting and while taking ketoconazole tablet.
If you take any medications that lower your stomach acid (e.g., famotidine (Pepcid) or omeprazole (Prilosec)), take them at least 1 hour before or 2 hours after taking ketoconazole tablet. This is because these medications can affect how well ketoconazole tablet is absorbed into your body. It's also recommended to take ketoconazole tablet with an acidic beverage like orange juice or non-diet soda.
Don't drink alcohol while you're taking ketoconazole tablet. You can experience a serious reaction called a disulfiram-like reaction. Symptoms of this reaction include headache, nausea, flushing, and rash. Alcohol with ketoconazole tablet also raises your risk of liver damage.
Make sure to mark your calendar with your appointments to see your provider and have any tests (e.g., liver function tests, electrocardiogram (EKG)) done so you're properly monitored while taking ketoconazole tablet.
Contact your provider if you develop other symptoms of an illness or if your symptoms become worse. This could be a sign that you're infected with a virus or bacteria instead of a fungus. If so, you'll need to a different medication than ketoconazole tablet because it's only used to treat certain fungal infections.
Frequently asked questions about Ketoconazole tablet
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What are the risks and warnings for Ketoconazole tablet?
Ketoconazole tablet can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Not for skin or nail fungal infections, or other non-FDA-approved uses
Ketoconazole tablet can cause very serious side effects, such as liver damage and heart problems. Your provider will only prescribe this medication if you have a very serious fungal infection that have spread throughout the body, and only if you have no safer options. Ketoconazole tablet shouldn't be used to treat nail fungal infections, surface-level fungal skin infections, or Candida yeast infections.
Liver damage
Risk factors: Liver problems| Drinking alcohol | Taking other medications that can cause liver problems
People who took ketoconazole tablets have reported developing very serious liver problems, including ones that needed liver transplant. Because of this risk, your provider will order blood tests before you start and during treatment to check your liver function tests to make sure your liver is healthy. Get medical attention right away if you notice yellowing of your skin or the whites of your eyes; stool changes; dark or brown urine; swelling of your stomach; stomach pain; or confusion. Your provider might ask you to stop taking ketoconazole tablet in order to prevent further liver damage.
Life-threatening abnormal heart rhythm
Risk factors: Low blood potassium or magnesium levels | Older age | Kidney problems | History of heart problems, slow heart rate, or other abnormal heart rhythms (arrhythmias) | Personal or family history of long QT syndrome | Taking other medications that cause QT prolongation
Ketoconazole tablet can affect your heart rhythm, which can be serious and life-threatening. One example includes lengthening the time period from when the heart pumps and then relaxes. This is known as QT prolongation. Your risk is higher if you have certain factors, including abnormal electrolyte levels, heart rhythm problems, or are taking other medications that cause heart rhythm problems, such as amiodarone (Pacerone) and ciprofloxacin (Cipro), among others. To lower your risk, your provider might periodically monitor your heart and perform electrocardiograms (EKGs) to make sure your heart rhythm is normal. If you feel your chest pounding, have trouble breathing, have chest pain, or feel faint or lightheaded while taking ketoconazole tablet, call 911 right away.
Low cortisol levels (adrenal insufficiency)
Risk factors: Recent intensive care unit (ICU) stay | Recent major surgery | History of adrenal problems | Taking higher doses of ketoconazole tablet
Ketoconazole tablet can lower your cortisol levels. Cortisol is a hormone your body makes that's involved in many things, such as controlling your blood sugar, maintaining your blood pressure, and lowering inflammation. Let your provider know if you experience symptoms of low cortisol (adrenal insufficiency), such as weakness, fatigue, dizziness, loss of appetite, or mood changes. Your provider will decide whether it's still appropriate for you to continue ketoconazole tablet.
Allergic reactions
Severe allergic reactions to ketoconazole tablet are possible, including life-threatening reactions like facial swelling, hives, and anaphylaxis (e.g., closing of the throat). If you notice difficulty breathing; a choking sensation; dizziness; fast heartbeat; nausea; or swelling around your eyes, lips, or tongue after taking ketoconazole tablet, get medical attention right away.
Interactions with other medications
Ketoconazole tablet interacts with a lot of commonly used medications, including over-the-counter (OTC) medications, vitamins, and herbal supplements. Some of these interactions can be dangerous or life-threatening. When ketoconazole tablet is taken with other medications, it can cause your body to absorb more of those medications. This can raise your risk for serious side effects. Some examples include alprazolam (Xanax) and statins like simvastatin (Zocor) or lovastatin. This isn't a complete list, so make sure to tell both your healthcare provider and your pharmacist about all medications and OTC products you're taking before you start ketoconazole tablet, even if you only take them once in a while or as needed.
Ketoconazole tablet dosage forms
| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 200mg | 30 tablets | $24.00 | $0.80 |
Typical dosing for Ketoconazole tablet
Your provider will determine the dose of ketoconazole tablet and length of treatment depending on what type of fungal infection you have and how serious it is. The usual length of treatment is 6 months.
Adults: The typical starting dose is 200 mg by mouth once daily. If needed, your provider might raise the dose to 400 mg once daily.
Children ages 2 years and older: Your child's provider will calculate the dose based on your child's body weight. The typical dose is 3.3 mg/kg to 6.6 mg/kg by mouth once daily.
More on Ketoconazole tablet dosage forms
Interactions between Ketoconazole tablet and other drugs
More on Ketoconazole tablet interactions
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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
How much does Ketoconazole tablet cost?
Ketoconazole tablet contraindications
Taking certain medications that interact with ketoconazole tablet
Severe liver problems
What are alternatives to Ketoconazole tablet?
Certain fungal infections that has spread throughout the body
Aspergillosis in people in which amphotericin b (Ambisome) hasn't worked or isn't tolerated
What is the latest news about Ketoconazole tablet?
Ketoconazole tablet images
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References
Best studies we foundAl-Khatib, S.M., et al. (2003). What clinicians should know about the QT interval. JAMA.
Burel Pharmaceuticals, LLC. (2023). Ketoconazole tablet [package insert]. DailyMed.
Centers for Disease Control and Prevention. (2020). Valley fever (coccidioidomycosis).
Centers for Disease Control and Prevention. (2022). Blastomycosis.
Centers for Disease Control and Prevention. (2022). Candidiasis.
Geißel, B., et al. (2018). Azole-induced cell wall carbohydrate patches kill Aspergillus fumigatus. Nature Communications.
Maideen, N. M. P. (2019). Clinically important and pharmacologically relevant drug interactions with alcohol. American Journal of Research in Medical Sciences.
Moudgal, V. V., et al. (2003). Antifungal drugs in pregnancy: A review. Expert Opinion on Drug Safety.
National Institute of Diabetes and Digestive and Kidney Diseases. (2018). Definition & facts of adrenal insufficiency & Addison's disease.
Rautemaa-Richardson, R., et al. (2017). Systemic fungal infections. Medicine.
Sinawe, H., et al. (2023). Ketoconazole. StatPearls.
U.S. Food and Drug Administration. (2017). FDA drug safety communication: FDA limits usage of Nizoral (ketoconazole) oral tablets due to potentially fatal liver injury and risk of drug interactions and adrenal gland problems.
You and Your Hormones. (2019). Cortisol.
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