Does VEDOLIZUMAB Cause Urticaria? 805 Reports in FDA Database

Q: Does VEDOLIZUMAB cause Urticaria?

805 reports of Urticaria have been filed with the FDA for VEDOLIZUMAB, representing 1.1% of all VEDOLIZUMAB adverse event reports.

Q: How dangerous is Urticaria from VEDOLIZUMAB?

Of 805 reports, 345 (42.9%) resulted in death and 363 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 805 reports of Urticaria have been filed in association with VEDOLIZUMAB (ENTYVIO). This represents 1.1% of all adverse event reports for VEDOLIZUMAB.

805

Reports of Urticaria with VEDOLIZUMAB

1.1%

of all VEDOLIZUMAB reports

345

Deaths

363

Hospitalizations

How Dangerous Is Urticaria From VEDOLIZUMAB?

Of the 805 reports, 345 (42.9%) resulted in death, 363 (45.1%) required hospitalization, and 262 (32.5%) were considered life-threatening.