Does VEDOLIZUMAB Cause Cerebral infarction? 25 Reports in FDA Database

Q: Does VEDOLIZUMAB cause Cerebral infarction?

25 reports of Cerebral infarction have been filed with the FDA for VEDOLIZUMAB, representing 0.0% of all VEDOLIZUMAB adverse event reports.

Q: How dangerous is Cerebral infarction from VEDOLIZUMAB?

Of 25 reports, 5 (20.0%) resulted in death and 16 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 25 reports of Cerebral infarction have been filed in association with VEDOLIZUMAB (ENTYVIO). This represents 0.0% of all adverse event reports for VEDOLIZUMAB.

Reports of Cerebral infarction with VEDOLIZUMAB

0.0%

of all VEDOLIZUMAB reports

Deaths

Hospitalizations

How Dangerous Is Cerebral infarction From VEDOLIZUMAB?

Of the 25 reports, 5 (20.0%) resulted in death, 16 (64.0%) required hospitalization, and 2 (8.0%) were considered life-threatening.

Is Cerebral infarction Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for VEDOLIZUMAB. However, 25 reports have been filed with the FAERS database.

What Other Side Effects Does VEDOLIZUMAB Cause?

Off label use (21,017) Colitis ulcerative (13,455) Crohn's disease (9,759) Drug ineffective (8,424) Diarrhoea (7,493) Abdominal pain (6,401) Fatigue (5,477)