Does VEDOLIZUMAB Cause Coma? 36 Reports in FDA Database

Q: Does VEDOLIZUMAB cause Coma?

36 reports of Coma have been filed with the FDA for VEDOLIZUMAB, representing 0.1% of all VEDOLIZUMAB adverse event reports.

Q: How dangerous is Coma from VEDOLIZUMAB?

Of 36 reports, 6 (16.7%) resulted in death and 34 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 36 reports of Coma have been filed in association with VEDOLIZUMAB (ENTYVIO). This represents 0.1% of all adverse event reports for VEDOLIZUMAB.

Reports of Coma with VEDOLIZUMAB

0.1%

of all VEDOLIZUMAB reports

Deaths

Hospitalizations

How Dangerous Is Coma From VEDOLIZUMAB?

Of the 36 reports, 6 (16.7%) resulted in death, 34 (94.4%) required hospitalization, and 3 (8.3%) were considered life-threatening.

Is Coma Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for VEDOLIZUMAB. However, 36 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) Haematochezia (5,215) Frequent bowel movements (4,527) Arthralgia (4,028)

What Other Drugs Cause Coma?

ACETAMINOPHEN (2,386) QUETIAPINE (2,267) DIAZEPAM (2,250) ALPRAZOLAM (2,042) PREGABALIN (1,941) TRAMADOL (1,708) ZOPICLONE (1,405) VENLAFAXINE (1,342) OXAZEPAM (1,256) BACLOFEN (1,133)

Which VEDOLIZUMAB Alternatives Have Lower Coma Risk?

VEDOLIZUMAB vs VELAGLUCERASE ALFA VEDOLIZUMAB vs VELCADE VEDOLIZUMAB vs VELETRI VEDOLIZUMAB vs VELIPARIB VEDOLIZUMAB vs VEMURAFENIB

VEDOLIZUMAB Full Profile All Coma Reports All Drugs Causing Coma VEDOLIZUMAB Demographics