VEDOLIZUMAB for Immune-mediated enterocolitis: Side Effects & Safety Data

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There are 89 adverse event reports in the FDA FAERS database where VEDOLIZUMAB was used for Immune-mediated enterocolitis.

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