Fidaxomicin warnings and precautions

Warnings And Precautions

Not for Systemic Infections

Since there is minimal systemic absorption of fidaxomicin, DIFICID is not effective for treatment of systemic infections.

Hypersensitivity Reactions

Acute hypersensitivity reactions, including dyspnea, rash pruritus, and angioedema of the mouth, throat, and face have been reported with Fidaxomicin. If a severe hypersensitivity reaction occurs, DIFICID should be discontinued and appropriate therapy should be instituted.

Some patients with hypersensitivity reactions also reported a history of allergy to other macrolides. Physicians prescribing DIFICID to patients with a known macrolide allergy should be aware of the possibility of hypersensitivity reactions.

Development of Drug-Resistant Bacteria

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.