Adverse effects are not addressed in the approval letter.

Adverse Event Profile and Monitoring

The document does not describe side effects, contraindications, or adverse event monitoring for Fidaxomicin Tablets. Clinicians must extrapolate safety data from the RLD, which includes nausea, vomiting, and anemia as common adverse reactions. Severe risks, such as hypersensitivity or hepatic toxicity, are not mentioned here. Post-marketing pharmacovigilance and REMS compliance (if applicable) are critical for identifying generic-specific safety signals. Patients should be monitored per Dificid’s prescribing guidelines until further data emerge.