The safety of DIFICID® was studied in 2 large pivotal trials1

Similar rates of adverse reactions versus vancomycin1

  • DIFICID is contraindicated in patients with hypersensitivity to fidaxomicin or to any of the excipients in the formulation
  • DIFICID should not be used for systemic infections
  • Only use DIFICID for infection proven or strongly suspected to be caused by C. difficile. Prescribing DIFICID in the absence of a proven or strongly suspected C. difficile infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria

 

Selected adverse reactions with an incidence of  ≥ 2% reported in
DIFICID patients in controlled trials1

Selected adverse reactions with an incidence of ? 2% reported in DIFICID<sup>®</sup> patients in controlled trials

 

Important Safety Information

  • DIFICID is contraindicated in patients with hypersensitivity to fidaxomicin
  • DIFICID should not be used for systemic infections
  • Acute hypersensitivity reactions (angioedema, dyspnea, pruritus, and rash) have been reported. In the event of a severe reaction, discontinue DIFICID.
  • Only use DIFICID for infection proven or strongly suspected to be caused by C. difficile.
    Prescribing DIFICID in the absence of a proven or strongly suspected C. difficile infection is unlikely to provide benefit to the patient and increases the risk of the development of drug- resistant bacteria.
  • The most common adverse reactions reported in clinical trials are nausea (11%), vomiting (7%), abdominal pain (6%), gastrointestinal hemorrhage (4%), anemia (2%), and neutropenia (2%)

 

Indications and Usage

  • DIFICID is a macrolide antibacterial drug indicated in adults ≥18 years of age for treatment of Clostridium difficile-associated diarrhea
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of DIFICID and other antibacterial drugs, DIFICID should be used only to treat infections that are proven or strongly suspected to be caused by Clostridium difficile

 

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