Drug Database: Fidaxomicin

What is fidaxomicin? What is fidaxomicin?

What is fidaxomicin?

Fidaxomicin is an antibacterial prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of diarrhea caused by enteric infection with the bacterium Clostridioides difficile.

Certain bacterial enteric infections can be opportunistic infections (OIs) of HIV. An OI is an infection that occurs more frequently or is more severe in people with weakened immune systems —such as people with HIV—than in people with healthy immune systems.

To learn more about OIs, read the HIVinfo What is an Opportunistic Infection? fact sheet.

How is fidaxomicin used in people with HIV? How is fidaxomicin used in people with HIV?

How is fidaxomicin used in people with HIV?

The Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV include recommendations on the use of fidaxomicin in people with HIV to treat bacterial enteric infection caused by Clostridioides difficile.

The recommended uses may not always be consistent with FDA-approved uses of fidaxomicin. See the Guidelines for complete information on recommended uses of fidaxomicin in adults and adolescents with HIV. Fidaxomicin may have other recommended uses not listed above.

What should I tell my health care provider before taking fidaxomicin? What should I tell my health care provider before taking fidaxomicin?

What should I tell my health care provider before taking fidaxomicin?

Before taking fidaxomicin, tell your health care provider:

• If you are allergic to fidaxomicin, macrolide antibiotics (such as azithromycin or clarithromycin), or any other medicines.
• About any medical conditions you have or have had.
• About anything that could affect your ability to take medicines, such as difficulty swallowing or remembering to take pills. A liquid form of fidaxomicin is available for people who have difficulty swallowing pills.
• If you are pregnant or plan to become pregnant. Talk to your health care provider about the risks and benefits of taking fidaxomicin during pregnancy.
• If you are breastfeeding or plan to breastfeed. For mothers with HIV in the United States, the Guideline recommends speaking with your health care provider to discuss options for feeding your baby. Mothers with suppressed viral load have a less than 1% chance of transmitting HIV to their baby via their own milk. Although most medicines are safe to use while breastfeeding, some medicines should be avoided. Always let your health care provider know about all the medicines and supplements you are using before you start breastfeeding.
• About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Fidaxomicin may affect the way other medicines or products work, and other medicines or products may affect how fidaxomicin works. Ask your health care provider if there are interactions between fidaxomicin and the other medicines you take.

How should I take fidaxomicin? How should I take fidaxomicin?

How should I take fidaxomicin?

Take fidaxomicin according to your health care provider’s instructions. Your health care provider will tell you how much fidaxomicin to take and when to take it. 

It is important to complete the full prescribed course of treatment with fidaxomicin, even if you begin to feel better. If you stop using fidaxomicin too soon or skip doses, your infection may not be fully treated, and the bacteria may become harder to treat (resistant).

Before you start fidaxomicin and each time you get a refill, read any printed information that comes with your medicine.

What side effects can fidaxomicin cause? What side effects can fidaxomicin cause?

What side effects can fidaxomicin cause?

Fidaxomicin may cause side effects that can be mild or serious. To learn about possible side effects of fidaxomicin, see the FDA drug label or talk to your health care provider or pharmacist. Tell your health care professional if you have any side effect that bothers you or that does not go away. Your health care professional may be able to tell you about ways to prevent or reduce some side effects.

You may report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online.

How should fidaxomicin be stored? How should fidaxomicin be stored?

How should fidaxomicin be stored?

• Store fidaxomicin tablets at room temperature, 68°F to 77°F (20°C to 25°C).
• Store reconstituted fidaxomicin oral suspension in a refrigerator at 36°F to 46°F (2°C to 8°C) for up to 12 days. Throw away any unused portion by the date written on the bottle.
• Keep fidaxomicin in the container that it came in and keep the container tightly closed.
• Do not use fidaxomicin if the original seal over the container opening is broken or missing.
• Throw away fidaxomicin that is no longer needed or expired (out of date). Follow FDA Guidelines on how to safely dispose of unused medicine.
• Keep fidaxomicin and all medicines out of reach of children.

Where can I find more information about fidaxomicin? Where can I find more information about fidaxomicin?

Where can I find more information about fidaxomicin?

• Recommendations on the HIV-related uses of fidaxomicin, from the Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV.
• This Patient Version drug summary is based on the following FDA label(s): Tablet (film coated), granule (for suspension). The Patient Package Insert includes information for people taking fidaxomicin.
• The American Hospital Formulary Service (AHFS) Patient Medication Information for fidaxomicin available from MedlinePlus.
• Fidaxomicin-related research studies, from ClinicalTrials.gov. (The ClinicalTrials.gov search can be modified so that you can get results that better match your interests.)