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Important Safety Information

  • Do not take DIFICID if you are allergic to fidaxomicin, or any other ingredient in DIFICID.
  • Tell your doctor before you take DIFICID if you are pregnant or plan to become pregnant, are breastfeeding or plan to breastfeed. It is not known if DIFICID will harm your baby while you are pregnant or if DIFICID passes into breast milk. You and your doctor should decide together if you will take DIFICID if you are pregnant or breastfeeding.
  • Know the medicines you take. Keep a list of your medicines to show your doctor and pharmacist when you get a new medicine.
  • DIFICID can cause serious side effects, including allergic reaction. If you get a severe allergic reaction while taking DIFICID, including problems breathing or shortness of breath, rash, itching or hives, or swelling of the mouth, throat, or face, stop taking DIFICID and get emergency help right away.
  • The most common side effects of DIFICID in adults include nausea, vomiting, stomach pain, bleeding in the stomach or intestines, low red blood cell count (anemia), and low white blood cell count (neutropenia).
  • The most common side effects of DIFICID in children include fever, vomiting, diarrhea, stomach pain, constipation, rash, and high levels of enzymes called aminotransferases in the blood which may indicate liver damage.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit, or call 1-800-FDA-1088.

Please read the accompanying Patient Information for DIFICID and discuss it with your health care professional. The physician Prescribing Information also is available.

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