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U.S. Department of Health and Human Services

Safety

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Dificid (Fidaxomicin) Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2013

Summary View

 

CONTRAINDICATIONS

  • Hypersensitivity
 

WARNINGS AND PRECAUTIONS

  • Acute Hypersensitivity Reactions: Acute hypersensitivity reactions, including dyspnea, rash, pruritus, and angioedema of the mouth, throat, and face have been reported with Fidaxomicin…