Ketoconazole | Side Effects, Dosage, Usage, and More (2023)

This drug has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). Warns doctors and patients about the effects of drugs that can be dangerous.

  • liver failure: This medicine can cause liver failure. Your doctor will monitor your liver function while you are taking this medicine.
  • Do not use as first treatment: This medication should only be used when other treatments are not an option or when the potential benefits outweigh the risks. These serious risks include liver failure and heart rhythm problems.
  • QT prolongation and drug interactions leading to QT prolongation: Taking ketoconazole with certain medications can cause changes in the electrical activity of your heart called QT prolongation. QT prolongation can cause irregular heartbeats that can be fatal. These drugs include dofetilide,quinidine, pimozide, cisapride, methadone, disopyramide, dronedarone, and ranolazine should not be used with ketoconazole due to increased risk of life-threatening heartbeat or heart rhythm problems.
  • appropriate use: Because ketoconazole tablets can cause serious side effects, ketoconazole tablets should not be used to treat onychomycosis, dermatophyte skin infections, or Candida infections. Use ketoconazole only when other effective antifungal therapy is not available or tolerated and if the potential benefits are considered to outweigh the potential risks.
  • Liver problems (hepatotoxicity): Hepatic failure, requiring liver transplantation, occurred during the use of oral ketoconazole. Taking this medication increases the risk of liver damage, so your doctor should closely monitor your liver function.

  1. Ketoconazole oral tablet is only available as a generic drug.
  2. Ketoconazole is used to treat yeast and fungal infections of the skin, hair, nails, and blood.
  3. This medication is available as an oral tablet, topical cream, shampoo, and topical gel.

Ketoconazole is a prescription medication. It is available as an oral tablet, topical cream, topical foam, shampoo, and topical gel. The oral tablet is only available as a generic drug.

Because it is used

Ketoconazole is used to treat yeast and fungal infections of the skin, hair, nails, and blood. This medicine is only given when other treatments have not worked or have caused too many side effects.

How it works

Ketoconazole belongs to a group of medicines called antifungals. A drug class is a group of drugs that work in a similar way. These drugs are often used to treat similar conditions.

Ketoconazole prevents fungi and yeast from causing infections.

Ketoconazole can cause mild or serious side effects. The following list contains some of the major side effects that can occur when using ketoconazole.

This list is not inclusive of all possible side effects.

For more information about the possible side effects of ketoconazole or advice on how to treat a concerning side effect, talk to your doctor or pharmacist.

The most common side effects

Some of the more common side effects of ketoconazole include:

  • nausea
  • headache
  • diarrhea
  • stomachache
  • abnormal liver function test results

If these effects are mild, they may go away in a few days to a few weeks. If they are more severe or do not go away, contact your doctor or pharmacist.

serious side effects

Call your doctor right away if you experience serious side effects. Call 911 if your symptoms seem life-threatening or if you think you have a medical emergency. Serious side effects and their symptoms may include the following:

  • Liver problems (hepatotoxicity). Symptoms may include:
    • loss of appetite or weight loss (anorexia)
    • nausea or vomiting
    • fatigue
    • stomach pain or tenderness
    • dark-colored urine or light-colored stools
    • yellowing of the skin or whites of the eyes
    • fever
    • skin irritation

Ketoconazole interactions can cause changes in the electrical activity of your heart called QT prolongation. QT prolongation can cause irregular heartbeats that can be fatal.

This can happen if you use ketoconazole tablets with certain drugs such as dofetilide, quinidine, pimozide, cisapride, methadone, disopyramide, dronedarone, and ranolazine.

Talk to your doctor about any other medicines you are taking before you start taking ketoconazole tablets.

Tell your doctor right away if you feel weak, dizzy, lightheaded, or experience an irregular or fast heartbeat. These could be symptoms associated with QT interval prolongation.

The dose of ketoconazole that your doctor prescribes will depend on several factors. That includes:

  • the type and severity of the condition for which you are using ketoconazole
  • your age
  • the form of ketoconazole you are taking
  • other medical conditions you may have

Your doctor will usually start you on a low dose and adjust it over time to reach a dose that works for you. Eventually they will prescribe the lowest dose that produces the desired effect.

The following information shows the most used or recommended doses.However, be sure to take the dosage prescribed by your doctor.Your doctor will determine the best dosage to meet your needs.

shape and strength

Generic:ketoconazole

  • Form:tableta oral
  • Force:200 milligrams

Dosage for fungal infections

Adult dosage (18 years and older)

  • Usual dose:200 mg once a day for up to 6 months.
  • Dose increase:Your doctor may increase the dose to 400 mg once a day if necessary.

Dose for children (2 to 17 years)

Your doctor will determine the dose based on your child's weight. The dose ranges from 3.3 to 6.6 mg/kg of body weight once daily.

Infant dose (0 to 1 year)

Ketoconazole has not been confirmed to be safe and effective for use in people younger than 2 years of age. In general, ketoconazole tablets should not be used in young children.

Ketoconazole is used for short-term treatment. However, sometimes it is necessary to take it for several months. Ketoconazole has risks if you do not take it as prescribed.

If you stop taking the medicine or do not take it

Your infection or skin condition will not improve.

If you miss a dose or do not take the medicine on time

Your medicine may not work as well or may stop working altogether. For this medicine to work well, a certain amount must be in your body at all times.

if you drink too much

You may have dangerous levels of the drug in your body. Symptoms of an overdose of this medication may include:

  • nausea
  • to vomit
  • diarrhea

If you think you have taken too much of this medicine, call your doctor or local poison control center. If your symptoms are severe, call 911 or go to the nearest emergency room right away.

What to do if you miss a dose

Take your dose as soon as you remember. But if you remember only a few hours before your next scheduled dose, take only one dose. Never try to hit it by firing two shots at once. This can lead to dangerous side effects.

How to tell if the medicine is working

Your skin condition or infection should improve.

This medication comes with several warnings.

FDA Warnings

  • This medication has black box warnings. These are the most serious warnings from the Food and Drug Administration (FDA). A black box warning alerts doctors and patients to the potentially dangerous effects of drugs.
  • Liver failure.This medicine can cause liver failure. Your doctor will monitor your liver function while you are taking this medicine.
  • It should not be used as the first treatment.This medication should only be used when other treatments are not an option or when the potential benefits outweigh the risks. These serious risks include liver failure and heart rhythm problems.
  • QT prolongation and drug interactions leading to QT prolongation: Taking ketoconazole with certain medications can cause changes in the electrical activity of your heart called QT prolongation. QT prolongation can cause irregular heartbeats that can be fatal. These medications include dofetilide, quinidine, pimozide, cisapride, methadone, disopyramide, dronedarone, ranolazine, and should not be used with ketoconazole, due to increased risk of life-threatening heartbeat or heart rhythm problems.
  • appropriate use: Because ketoconazole tablets can cause serious side effects, ketoconazole tablets should not be used to treat onychomycosis, dermatophyte skin infections, or Candida infections. Use ketoconazole only when other effective antifungal therapy is not available or tolerated and if the potential benefits are considered to outweigh the potential risks.
  • Liver problems (hepatotoxicity): Hepatic failure, requiring liver transplantation, occurred during the use of oral ketoconazole. Taking this medication increases the risk of liver damage, so your doctor should closely monitor your liver function.

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Warnings for hormonal problems

High doses of this medication can affect your body's ability to secrete hormones in response to stress.

Symptoms can include extreme thirst, weight loss, darkening of the skin, unusual fatigue, joint pain, and loss of appetite. If you have these symptoms, call your doctor.

allergies

Ketoconazole tablets can cause a severe allergic reaction. Symptoms may include:

  • heavy breathing
  • tos
  • wheezing
  • fever
  • shaking chills
  • the beat of your heart or your ears
  • swelling of the eyelids, face, mouth, neck, or any other part of the body
  • rash, hives, blistering, or peeling skin

If you have an allergic reaction, call your doctor or local poison control center right away. If your symptoms are severe, call 911 or go to the nearest emergency room.

Do not take this medicine again if you have already had an allergic reaction.Taking it again can be fatal (cause death).

Interaction with alcohol

You should not drink alcohol while taking ketoconazole. Drinking alcohol can increase the risk of liver damage while you are taking this medicine. If you drink alcohol, consult your doctor.

Notifications for specific groups

For pregnant women:Ketoconazole is a category C pregnancy drug. This means two things:

  1. Animal studies have shown negative effects on the fetus when the mother takes the drug.
  2. There have not been enough human studies to be sure how the drug might affect an unborn baby.

Talk to your doctor if you are pregnant or plan to become pregnant. This drug should be used only if the potential benefit justifies the potential risk to the fetus.

For women who are breastfeeding:Ketoconazole passes into breast milk and may cause side effects in a nursing infant. Talk to your doctor if you are breastfeeding your baby. Ketoconazole has been shown to be excreted in milk. The manufacturer does not recommend breastfeeding.

For children:Ketoconazole has not been confirmed to be safe and effective for use in people younger than 2 years of age. In general, ketoconazole tablets should not be used in children.

Ketoconazole can interact with several other medications. Different interactions can cause different effects. For example, some may affect the effect of the drug, while others may cause increased side effects.

Below is a list of drugs that can interact with ketoconazole. This list does not contain all drugs that may interact with ketoconazole.

Before taking ketoconazole, be sure to tell your doctor and pharmacist about all prescription, over-the-counter, and other medicines you are taking. Also tell them about the vitamins, herbs, and supplements you are using. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that could affect you, ask your doctor or pharmacist.

Drugs you should not use with ketoconazole

Certain medications should not be taken with ketoconazole.This can cause dangerous effects in the body. Examples of these drugs include:

  • Antiarrhythmics such as dofetilide, quinidine, and dronedarone.Taking these medicines with ketoconazole can cause a heart problem called QT prolongation. This is a change in electrical activity in the heart. It can cause irregular heartbeat and be fatal.
  • Methadone.Taking these medicines together can cause a heart condition called QT prolongation. This is a change in electrical activity in the heart. It can cause irregular heartbeat and be fatal.
  • Ranolazina.Taking these medicines together can cause a heart condition called QT prolongation. This is a change in electrical activity in the heart. It can cause irregular heartbeat and be fatal.
  • Simvastatin or lovastatin.Taking ketoconazole with these medicines can cause muscle problems.
  • Triazolam, midazolam or alprazolam.Taking these medicines together can make you very sleepy for a long time.
  • Eplerenona.Taking these drugs together can cause low blood pressure and low potassium levels.
  • Dofetilide, quinidine, pimozide, cisapride, methadone, disopyramide, dronedarone and ranolazine: Taking ketoconazole with these medicines can cause changes in the electrical activity of your heart called QT prolongation. QT prolongation can cause irregular heartbeats that can be fatal.

Interactions that increase the risk of side effects

Taking certain drugs with ketoconazole increases the risk of side effects.

  • Ketoconazole Side Effects:Taking ketoconazole with certain medications increases the risk of ketoconazole side effects. This is because the amount of ketoconazole in your body increases. Examples of these drugs include:
    • ritonavir
    • atorvastatin
  • Side effects of other medications:Taking ketoconazole with certain medications increases the risk of side effects from those medications. Examples of these drugs include:
    • Pain medications such as buprenorphine, fentanyl, and oxycodone.Taking these medicines with ketoconazole can cause slow breathing.
    • Anticoagulants such as rivaroxaban, dabigatran, and warfarin.Taking these medicines with ketoconazole can increase the risk of bleeding.
    • Heart medications such as felodipine and nisoldipine.Taking these medicines with ketoconazole can cause swelling of the legs or arms and heart failure.
    • Tamsulosina.Taking these medicines together can cause headache, dizziness, and orthostatic hypotension (low blood pressure when you stand up from sitting or lying down).
    • digoxin. Taking these medications together may cause dizziness, headache, and upset stomach. Your doctor can check the levels of digoxin in your blood.
    • Eletriptan.Taking these drugs together can cause weakness, nausea, dizziness, and drowsiness.
    • Antipsychotics such as aripiprazole, buspirone, haloperidol, quetiapine, and risperidone.Taking these medications with ketoconazole may cause dizziness, drowsiness, and headache.
    • Ramelteon.Taking these drugs together can cause dizziness, drowsiness, and fatigue.
    • Antiviral drugs such as indinavir, maraviroc, and saquinavir.Taking these medicines with ketoconazole can cause stomach upset, nausea, and headache.
    • Blood pressure medications, such as verapamil and aliskiren.Taking these medicines with ketoconazole can cause low blood pressure, slow heart rate, and dizziness.
    • Erectile dysfunction medications such as sildenafil, tadalafil, and vardenafil.Taking these medicines with ketoconazole can cause headaches, stomach aches, and muscle pain.
    • Medicines for urinary problems, such as solifenacin and tolterodine.Taking these medicines with ketoconazole can cause dry mouth, headaches, and dizziness.

Interactions that can make your medications less effective

  • When ketoconazole is less effective:When ketoconazole is used with certain medications, it may not work as well to treat your condition. This is because the amount of ketoconazole in your body may be reduced. Examples of these drugs include:
    • Famotidine, cimetidine, pantoprazole, omeprazole, and rabeprazole.You should take ketoconazole with an acidic drink, such as a non-diet soda, if you take these medications together.
    • Aluminum hydroxide.You should take this medicine 1 hour before or 2 hours after taking ketoconazole.
    • Antibiotics, such as isoniazid and rifabutin
    • Anticonvulsants, such as carbamazepine and phenytoin.
    • Antiviral drugs, such as efavirenz and nevirapine
    • carbamazepine.Your doctor may monitor your carbamazepine levels.

Keep this in mind if your doctor prescribes ketoconazole for you.

In general

Ketoconazole tablets should be taken with a meal..

Store

  • Store this medicine between 20°C and 25°C (68°F and 77°F).
  • Protect this medication from light.
  • Do not store this medication in wet or damp areas, such as bathrooms.

filling in

The prescription for this medication is refillable. You should not need a new prescription to refill this medication. Your doctor will write the number of authorized refills on your prescription.

A trip

When traveling with your medication:

  • Always carry your medication with you. When you fly, never put it in your checked baggage. Keep it in your hand luggage.
  • Don't worry about the X-ray machines at the airport. They can't harm your medicines.
  • You may need to show the pharmacy label on your medication to the airport staff. Always carry the original labeled box of the prescription medication with you.
  • Do not put this medication in the glove compartment or leave it in the car. Avoid doing this when the weather is too hot or too cold.

clinical monitoring

Your doctor may carry out tests during treatment with this medicine. These tests can help make sure the medicine is working and that you are safe during treatment. Tests your doctor may do include:

  • Liver function tests.Your doctor may perform blood tests to check how well your liver is working. If your liver is not working well, your doctor may ask you to stop taking this medicine.
  • Heart rate monitoring (ECG).Your doctor can do this test to see if your heart rhythm is normal. Otherwise, your doctor may prevent you from taking this medicine.

The cost of these tests will depend on your insurance.

sun sensitivity

Ketoconazole can make your skin more sensitive to the sun. This increases the risk of sunburn. Stay out of the sun if you can while taking this medicine. If you must go outside, wear protective clothing and sunscreen.

There are other medications available to treat your condition. Some may be more suitable for you than others. Talk to your doctor about other medication options that may be right for you.

Exemption:Healthline has made every effort to ensure that all information is factually accurate, complete, and up-to-date. However, this article should not be used as a substitute for the knowledge and experience of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information in this document is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or side effects. The absence of warnings or other information for a particular drug does not mean that the drug or drug combination is safe, effective, or appropriate for all patients or for all specific uses.

fact box

Your symptoms may begin to improve within 24 hours of starting this medicine. If your symptoms do not improve after using this medicine for several days, call your doctor.

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