Ketoconazole

Ketoconazole can cause serious (possibly fatal) side effects and drug interactions. It should only be used when other treatments have not worked, are not available, or cannot be taken by you. Discuss the risks and benefits of this medication, as well as other effective and possibly safer treatments for fungal infections, with your doctor.

Ketoconazole has rarely caused very serious (possibly fatal) liver problems. Get medical help right away if you develop symptoms of liver problems, including nausea/vomiting that doesn't stop, stomach/abdominal pain, dark urine, yellowing eyes/skin, loss of appetite, or light colored stools. To reduce your risk for liver problems, your doctor should obtain liver function tests every week while you are taking this medication. Do not drink alcoholic beverages while taking ketoconazole because alcohol increases the risk of serious liver problems. See also Notes section.

Ketoconazole must not be used with certain other medications because a serious, possibly fatal, drug interaction may occur. Ketoconazole interacts with drugs such as disopyramide, dofetilide, dronedarone, methadone, pimozide, quinidine, ranolazine, among others. These interactions may increase the risk of a certain condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away. Tell your doctor and pharmacist about all the medications and products you may be taking before you start ketoconazole treatment. See also Precautions section.

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used for advanced prostate cancer.

Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless your doctor tells you to.

When treating pityriasis, this medication may not cause an immediate return to normal skin color. It may take several months after treatment is completed for your natural skin color to return.

Store at room temperature. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Before using ketoconazole, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungals such as clotrimazole, econazole, or miconazole; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

This medication should be used only if clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Use this medication on the skin only. Clean and thoroughly dry the area to be treated. Apply this medication to the affected skin, usually once or twice a day or as directed by your doctor. Dosage and length of treatment depends on the type of infection being treated. Do not apply this more often than prescribed. Your condition will not clear faster, but side effects may be increased.

Apply enough medication to cover the affected skin and some of the surrounding skin. After applying this medication, wash your hands. Do not wrap, cover or bandage the area unless directed to do so by your doctor.

Do not apply this medication in the eyes, nose, mouth, or vagina. If this medication gets in the eyes (for example, when used to treat dandruff), rinse thoroughly with water.

Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time(s) each day.

Continue to use this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection.

Tell your doctor if your condition lasts after the prescribed amount of treatment or if it gets worse at any time.

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Stinging, swelling, irritation, or redness of the treated skin may occur. If any of these effects last or get worse, notify your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: blistering, open sores.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.