Does VEDOLIZUMAB Cause Stomatitis? 436 Reports in FDA Database

Q: Does VEDOLIZUMAB cause Stomatitis?

436 reports of Stomatitis have been filed with the FDA for VEDOLIZUMAB, representing 0.6% of all VEDOLIZUMAB adverse event reports.

Q: How dangerous is Stomatitis from VEDOLIZUMAB?

Of 436 reports, 289 (66.3%) resulted in death and 299 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 436 reports of Stomatitis have been filed in association with VEDOLIZUMAB (ENTYVIO). This represents 0.6% of all adverse event reports for VEDOLIZUMAB.

436

Reports of Stomatitis with VEDOLIZUMAB

0.6%

of all VEDOLIZUMAB reports

289

Deaths

299

Hospitalizations

How Dangerous Is Stomatitis From VEDOLIZUMAB?

Of the 436 reports, 289 (66.3%) resulted in death, 299 (68.6%) required hospitalization, and 255 (58.5%) were considered life-threatening.

Is Stomatitis Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for VEDOLIZUMAB. However, 436 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 Stomatitis?

METHOTREXATE (7,245) TOCILIZUMAB (4,761) ADALIMUMAB (4,500) LEFLUNOMIDE (4,492) ABATACEPT (4,481) ETANERCEPT (4,338) RITUXIMAB (4,335) CERTOLIZUMAB PEGOL (3,760) INFLIXIMAB (3,713) PREDNISONE (3,656)

Which VEDOLIZUMAB Alternatives Have Lower Stomatitis Risk?

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

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