VEDOLIZUMAB for Proctitis ulcerative: Side Effects & Safety Data
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There are 146 adverse event reports in the FDA FAERS database where VEDOLIZUMAB was used for Proctitis 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
Colitis ulcerative (33,987)
Crohn's disease (28,718)
Product used for unknown indication (8,955)
Inflammatory bowel disease (1,342)
Colitis (805)
Colitis microscopic (286)
Deep vein thrombosis (139)
Immune-mediated enterocolitis (89)
Pouchitis (86)
Graft versus host disease (71)
Other Drugs Used for Proctitis ulcerative
MESALAMINE (162)
ADALIMUMAB (124)
OZANIMOD (57)
INFLIXIMAB (56)
TOFACITINIB (35)
USTEKINUMAB (29)
AZATHIOPRINE (22)
UPADACITINIB (20)
BUDESONIDE (14)
GOLIMUMAB (14)