VEDOLIZUMAB for Colitis ulcerative: Side Effects & Safety Data
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There are 33,987 adverse event reports in the FDA FAERS database where VEDOLIZUMAB was used for Colitis ulcerative.
Most Reported Side Effects for VEDOLIZUMAB
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Off label use | 21,017 | 28.5% | 637 | 5,998 |
| Colitis ulcerative | 13,455 | 18.2% | 155 | 3,107 |
| Crohn's disease | 9,759 | 13.2% | 227 | 3,122 |
| Drug ineffective | 8,424 | 11.4% | 180 | 2,439 |
| Diarrhoea | 7,493 | 10.2% | 399 | 2,536 |
| Abdominal pain | 6,401 | 8.7% | 117 | 2,324 |
| Fatigue | 5,477 | 7.4% | 394 | 1,730 |
| Haematochezia | 5,215 | 7.1% | 8 | 1,046 |
| Frequent bowel movements | 4,527 | 6.1% | 103 | 1,188 |
| Arthralgia | 4,028 | 5.5% | 308 | 1,164 |
| Malaise | 3,684 | 5.0% | 262 | 1,565 |
| Nausea | 3,582 | 4.9% | 304 | 1,456 |
| Headache | 3,574 | 4.8% | 355 | 1,237 |
| Inappropriate schedule of product administration | 3,259 | 4.4% | 70 | 828 |
| Product dose omission issue | 3,078 | 4.2% | 47 | 859 |
Other Indications for VEDOLIZUMAB
Crohn's disease (28,718)
Product used for unknown indication (8,955)
Inflammatory bowel disease (1,342)
Colitis (805)
Colitis microscopic (286)
Proctitis ulcerative (146)
Deep vein thrombosis (139)
Immune-mediated enterocolitis (89)
Pouchitis (86)
Graft versus host disease (71)
Other Drugs Used for Colitis ulcerative
ADALIMUMAB (34,530)
INFLIXIMAB (21,373)
INFLIXIMAB-DYYB (6,767)
TOFACITINIB (6,358)
MESALAMINE (6,347)
UPADACITINIB (4,800)
USTEKINUMAB (3,872)
GOLIMUMAB (3,637)
HUMIRA (2,707)
AZATHIOPRINE (1,951)