What is itraconazole?
Itraconazole is an antifungal prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of certain fungal infections, including histoplasmosis (also known as Histoplasma capsulatum infection), esophageal candidiasis, oropharyngeal candidiasis, and others.
Esophageal candidiasis (infection of the esophagus) and oropharyngeal candidiasis (infection of part of the throat) are examples of a fungal infection called mucocutaneous candidiasis (also called mucosal candidiasis). Mucocutaneous candidiasis and histoplasmosis are all opportunistic infections. An opportunistic infection is an infection that occurs more frequently or is more severe in people with weakened immune systems—such as those infected with HIV—than in people with healthy immune systems.
Itraconazole can also be used “off-label” to prevent and treat other opportunistic infections of HIV infection. “Off-label” use refers to use of an FDA-approved medicine in a manner different from that described on the medicine label. Good medical practice and the best interests of a patient sometimes require that a medicine be used “off-label.”
What HIV-related opportunistic infections is itraconazole used for?
The Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents, prepared by the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and the HIV Medicine Association of the Infectious Diseases Society of America (IDSA-HIVMA), includes recommendations on the HIV-related uses of itraconazole to:
- Coccidioidomycosis from recurring (called secondary prophylaxis or maintenance therapy). (This is an “off-label” use.)
- Histoplasmosis from occurring the first time (called primary prophylaxis) and from recurring. (This is an “off-label” use.)
- Oropharyngeal candidiasis from recurring. (This is an “off-label” use.)
- Penicilliosis marneffei from occurring the first time and from recurring. (This is an “off-label” use.)
- Esophageal candidiasis and oropharyngeal candidiasis.
- Coccidioidomycosis. (This is an “off-label” use.)
- Cryptococcosis. (This is an "off-label" use.)
- Microsporidiosis, specifically disseminated infection caused by certain types of microsporidia. (This is an "off-label" use.)
- Uncomplicated vulvovaginal candidiasis (a type of mucocutaneous candidiasis). (This is an “off-label” use.)
- Penicilliosis marneffei. (This is an “off-label” use.)
The above list may not include all of the HIV-related uses of itraconazole recommended in the Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents
. Some recommended uses, such as uses in certain rare circumstances, may have been omitted.
What should I tell my health care provider before taking itraconazole?
Before taking itraconazole, tell your health care provider:
- If you are allergic to itraconazole or any other medicines.
- About any medical conditions you have or have had, for example, diabetes or liver problems.
- About anything that could affect your ability to take medicines, such as difficulty swallowing or remembering to take pills.
- If you are pregnant or plan to become pregnant. For systemic fungal infections, itraconazole should be used during pregnancy only if the benefit outweighs the potential risk. Itraconazole should not be used for fungal nail infections during pregnancy or by someone planning to become pregnant within 2 months of treatment. Talk to your health care provider about possible risks with taking itraconazole when pregnant.
- If you are breastfeeding or plan to breastfeed. Do not breastfeed if you are infected with HIV.
- About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Itraconazole may affect the way other medicines or products work, and other medicines or products may affect how itraconazole works. Ask your health care provider if there are interactions between itraconazole and the other medicines you take.
Ask your health care provider about possible side effects from itraconazole. Your health care provider will tell you what to do if you have side effects.
How should I take itraconazole?
Take itraconazole according to your health care provider’s instructions. Your health care provider will tell you how much itraconazole to take and when to take it. Before you start itraconazole and each time you get a refill, read any printed information that comes with your medicine.
How should itraconazole be stored?
- Store itraconazole capsules at room temperature, 59°F to 77°F (15°C to 25°C). Protect the capsules from light and moisture.
- Store itraconazole oral solution at or below 77°F (25°C). Do not freeze the oral solution.
- Do not use itraconazole if the original seal over the bottle opening is broken or missing.
- Throw away itraconazole that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
- Keep itraconazole and all medicines out of reach of children.
Where can I find more information about itraconazole?
More information about itraconazole is available:
The above Patient Version drug summary is based on the following FDA label(s): Capsule
Last Reviewed: January 20, 2016