Does VEDOLIZUMAB Cause Malaise? 3,684 Reports in FDA Database

Q: Does VEDOLIZUMAB cause Malaise?

3,684 reports of Malaise have been filed with the FDA for VEDOLIZUMAB, representing 5.0% of all VEDOLIZUMAB adverse event reports.

Q: How dangerous is Malaise from VEDOLIZUMAB?

Of 3,684 reports, 262 (7.1%) resulted in death and 1,565 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 3,684 reports of Malaise have been filed in association with VEDOLIZUMAB (ENTYVIO). This represents 5.0% of all adverse event reports for VEDOLIZUMAB.

3,684

Reports of Malaise with VEDOLIZUMAB

5.0%

of all VEDOLIZUMAB reports

262

Deaths

1,565

Hospitalizations

How Dangerous Is Malaise From VEDOLIZUMAB?

Of the 3,684 reports, 262 (7.1%) resulted in death, 1,565 (42.5%) required hospitalization, and 227 (6.2%) were considered life-threatening.