Does VEDOLIZUMAB Cause Off label use? 21,017 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 21,017 reports of Off label use have been filed in association with VEDOLIZUMAB (ENTYVIO). This represents 28.5% of all adverse event reports for VEDOLIZUMAB.
21,017
Reports of Off label use with VEDOLIZUMAB
28.5%
of all VEDOLIZUMAB reports
637
Deaths
5,998
Hospitalizations
How Dangerous Is Off label use From VEDOLIZUMAB?
Of the 21,017 reports, 637 (3.0%) resulted in death, 5,998 (28.5%) required hospitalization, and 256 (1.2%) were considered life-threatening.
Is Off label use Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for VEDOLIZUMAB. However, 21,017 reports have been filed with the FAERS database.
What Other Side Effects Does VEDOLIZUMAB Cause?
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)
Malaise (3,684)
What Other Drugs Cause Off label use?
RITUXIMAB (39,751)
INFLIXIMAB (34,801)
DENOSUMAB (34,612)
METHOTREXATE (24,020)
ETANERCEPT (20,178)
TOCILIZUMAB (18,256)
PREDNISONE (17,867)
LENALIDOMIDE (17,017)
ADALIMUMAB (16,417)
HYDROXYCHLOROQUINE (15,318)
Which VEDOLIZUMAB Alternatives Have Lower Off label use Risk?
VEDOLIZUMAB vs VELAGLUCERASE ALFA
VEDOLIZUMAB vs VELCADE
VEDOLIZUMAB vs VELETRI
VEDOLIZUMAB vs VELIPARIB
VEDOLIZUMAB vs VEMURAFENIB