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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

Does VEDOLIZUMAB Cause Colitis? 1,077 Reports in FDA Database

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According to the FDA Adverse Event Reporting System (FAERS), 1,077 reports of Colitis have been filed in association with VEDOLIZUMAB (ENTYVIO). This represents 1.5% of all adverse event reports for VEDOLIZUMAB.

1,077
Reports of Colitis with VEDOLIZUMAB
1.5%
of all VEDOLIZUMAB reports
9
Deaths
461
Hospitalizations

How Dangerous Is Colitis From VEDOLIZUMAB?

Of the 1,077 reports, 9 (0.8%) resulted in death, 461 (42.8%) required hospitalization, and 4 (0.4%) were considered life-threatening.

Is Colitis Listed in the Official Label?

Yes, Colitis is listed as a known adverse reaction in the official FDA drug label for VEDOLIZUMAB.

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 Colitis?

ADALIMUMAB (3,043) NIVOLUMAB (2,123) IPILIMUMAB (1,988) PEMBROLIZUMAB (1,638) INFLIXIMAB (1,254) METHOTREXATE (1,166) PREDNISONE (1,100) CARBOPLATIN (993) MESALAMINE (839) RITUXIMAB (740)

Which VEDOLIZUMAB Alternatives Have Lower Colitis Risk?

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

Related Pages

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