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Fidaxomicin (Dificid): Uses, Side Effects and Dosage

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Status:
Prescription (Rx)
Strength:
200 mg
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Fidaxomicin

What are fidaxomicin tablets?

Fidaxomicin tablets are an antibiotic medicine used to treat an infection called Clostridioides difficile-associated diarrhea (CDAD) in adults. Clostridioides difficile (C-diff) is a bacterium that can cause an infection that can damage your colon and cause stomach pain and severe diarrhea.

  • Fidaxomicin tablets are not to be used to treat other types of infections in the body.
  • Sometimes infections are caused by viruses rather than bacteria. Antibiotic medicines, including fidaxomicin tablets, do not kill viruses.

It is not known if fidaxomicin tablets are safe and effective in children under 6 months old.

Who should not take fidaxomicin tablets?

Do not take fidaxomicin tablets if you are allergic to fidaxomicin, or any other ingredient in fidaxomicin tablets. See the end of this Patient Information for a complete list of ingredients in fidaxomicin tablets.

What should I tell my doctor before taking fidaxomicin tablets?

Pregnancy

  • If you are pregnant or plan to become pregnant, tell your doctor before you take fidaxomicin tablets.
  • It is not known if fidaxomicin tablets will harm your baby while you are pregnant.
  • If you are pregnant, you and your doctor should decide together if you will take fidaxomicin tablets.

Breastfeeding

  • If you are breastfeeding or plan to breastfeed, tell your doctor before you take fidaxomicin tablets.
  • It is not known if fidaxomicin passes into breast milk.
  • If you are breastfeeding, you and your doctor should decide together if you will take fidaxomicin tablets.

Other Medicines

  • Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal and dietary supplements.
  • Know the medicines you take. Keep a list of your medicines to show your doctor and pharmacist when you get a new medicine.

Allergic Reactions

  • See “Who should not take fidaxomicin tablets?”
  • If you are allergic to other kinds of antibiotics called macrolides (for example: azithromycin (Zithromax) or clarithromycin (Biaxin)) or any other ingredient in fidaxomicin tablets, tell your doctor. See the end of this Patient Information for a complete list of ingredients in fidaxomicin tablets.

How do I take fidaxomicin tablets?

  • Take fidaxomicin tablets exactly as prescribed by your doctor.
  • Take fidaxomicin tablets twice a day (approximately every 12 hours). For example, if you take your first dose at 8:00 a.m. you should take your second dose at 8:00 p.m.

  • You can take fidaxomicin tablets with or without food.

  • Do not skip any doses or stop taking fidaxomicin tablets until you finish your prescribed treatment, even if you begin to feel better, unless you have a serious allergic reaction (see “What are the possible side effects of fidaxomicin tablets?”). This will lower the chance that the bacteria will become resistant to fidaxomicin tablets. If this happens, fidaxomicin tablets and other antibiotic medicines may not work in the future.

What are the possible side effects of fidaxomicin tablets?

Fidaxomicin tablets can cause serious side effects, including:

  • Allergic reaction. If you get a severe allergic reaction while taking fidaxomicin tablets, including problems breathing or shortness of breath, rash, itching or hives, or swelling of the mouth, throat, or face, stop taking fidaxomicin tablets and get emergency medical help right away.

Common side effects of fidaxomicin tablets include:

The most common side effects of fidaxomicin tablets in adults include:

  • nausea
  • bleeding in the stomach or intestines
  • vomiting
  • low red blood cell count (anemia)
  • stomach pain
  • low white blood cell count (neutropenia)

Other less common side effects of fidaxomicin tablets may include:

  • swelling of any body part (such as your face, lips, tongue or around your eyes)
  • itching
  • hives
  • passing gas
  • bloating
  • intestinal blockage
  • stomach tenderness
  • serious bowel inflammation (toxic megacolon)
  • heartburn
  • problems swallowing
  • low platelet count (important for clotting and to control bleeding)
  • high blood sugar (hyperglycemia)
  • abnormal liver tests
  • high levels of acid in your blood (metabolic acidosis)
  • low levels of blood bicarbonate

If you have any side effect that bothers you or does not go away, tell your doctor.

There may be other side effects to fidaxomicin tablets that are not listed. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store fidaxomicin tablets?

  • Store fidaxomicin tablets at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep fidaxomicin tablets in its original bottle until you are ready to take it.

Keep fidaxomicin tablets and all medicines out of the reach of children.

General information about the safe and effective use of fidaxomicin tablets.

Medicines are sometimes prescribed for purposes other than those listed in the Patient Information. Do not take fidaxomicin tablets for a condition for which it was not prescribed. Do not give fidaxomicin tablets to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or doctor for information about fidaxomicin tablets that is written for health professionals.

What if I have questions?

  • Call your doctor.
  • Call Sandoz Inc., the company that makes fidaxomicin tablets, at 1-800-525-8747.
  • Go to the website – www.us.sandoz.com.
  • You can also find the full prescribing information written for doctors at www.us.sandoz.com

What are the ingredients in fidaxomicin tablets?

Active ingredient: fidaxomicin

Inactive ingredients: butylated hydroxytoluene, hydroxypropyl cellulose, lecithin (soy), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, sodium starch glycolate, talc, and titanium dioxide.

Pediatric use information is approved for Cubist Pharmaceuticals LLC's DIFICID® (fidaxomicin) tablets. However, due to Cubist Pharmaceuticals LLC's marketing exclusivity rights, this drug product is not labeled with that information.

Manufactured by Aizant Drug Research Solutions Pvt. Ltd., India for

Sandoz Inc., Princeton, NJ 08540

This Patient Information has been approved by the U.S. Food and Drug Administration Revised: 05/2026

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 220465 · View the label on DailyMed

Revision date stated in the text: May 2026

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Fidaxomicin

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Macrolide Antibacterial
Active ingredient Fidaxomicin 200 mg
Dosage form Tablet, film coated
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) SANDOZ
FDA approval ANDA 220465Abbreviated New Drug Application (ANDA) – generic drug Approved August 13, 2026
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Generics Dificid with the same TE code
Manufacturers 5 labelers list this drug on DailyMed
Packages (NDC)
Package
200 mg – 20 in 1 bottle NDC 0781-5194-20

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.