Does VEDOLIZUMAB Cause Infection? 1,095 Reports in FDA Database

Q: Does VEDOLIZUMAB cause Infection?

1,095 reports of Infection have been filed with the FDA for VEDOLIZUMAB, representing 1.5% of all VEDOLIZUMAB adverse event reports.

Q: How dangerous is Infection from VEDOLIZUMAB?

Of 1,095 reports, 367 (33.5%) resulted in death and 670 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 1,095 reports of Infection have been filed in association with VEDOLIZUMAB (ENTYVIO). This represents 1.5% of all adverse event reports for VEDOLIZUMAB.

1,095

Reports of Infection with VEDOLIZUMAB

1.5%

of all VEDOLIZUMAB reports

367

Deaths

670

Hospitalizations

How Dangerous Is Infection From VEDOLIZUMAB?

Of the 1,095 reports, 367 (33.5%) resulted in death, 670 (61.2%) required hospitalization, and 259 (23.7%) were considered life-threatening.