Does VEDOLIZUMAB Cause Headache? 3,574 Reports in FDA Database

Q: Does VEDOLIZUMAB cause Headache?

3,574 reports of Headache have been filed with the FDA for VEDOLIZUMAB, representing 4.8% of all VEDOLIZUMAB adverse event reports.

Q: How dangerous is Headache from VEDOLIZUMAB?

Of 3,574 reports, 355 (9.9%) resulted in death and 1,237 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 3,574 reports of Headache have been filed in association with VEDOLIZUMAB (ENTYVIO). This represents 4.8% of all adverse event reports for VEDOLIZUMAB.

3,574

Reports of Headache with VEDOLIZUMAB

4.8%

of all VEDOLIZUMAB reports

355

Deaths

1,237

Hospitalizations

How Dangerous Is Headache From VEDOLIZUMAB?

Of the 3,574 reports, 355 (9.9%) resulted in death, 1,237 (34.6%) required hospitalization, and 271 (7.6%) were considered life-threatening.