A VigiBase Descriptive Study of Fidaxomicin Adverse Events

SUMMARY. Fidaxomicin is a macrocyclic antibiotic used for the treatment of Clostridium difficile infection in adults. Fidaxomicin’s most frequent side effects included nausea, vomiting, abdominal pain, gastrointestinal bleeding, and anemia. The present descriptive study that was conducted to describe the most reported adverse events of fidaxomicin using VigiBase. During the study period, 1289 reports were submitted to the World Health Organization. The most reported events were general disorders and administration site conditions (29%), infections and infestations (16%), gastrointestinal disorders (16%), and injury, poisoning, and proce-dural complications (9%). It is necessary to continue and systematically monitor the safety of fidaxomicin to optimize the management of Clostridium difficile infection.