Does ODEVIXIBAT Cause Off label use? 33 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 33 reports of Off label use have been filed in association with ODEVIXIBAT (BYLVAY). This represents 14.8% of all adverse event reports for ODEVIXIBAT.
33
Reports of Off label use with ODEVIXIBAT
14.8%
of all ODEVIXIBAT reports
3
Deaths
6
Hospitalizations
How Dangerous Is Off label use From ODEVIXIBAT?
Of the 33 reports, 3 (9.1%) resulted in death, 6 (18.2%) required hospitalization, and 1 (3.0%) 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 ODEVIXIBAT. However, 33 reports have been filed with the FAERS database.
What Other Side Effects Does ODEVIXIBAT Cause?
Diarrhoea (65)
Pruritus (55)
Drug ineffective (26)
Abdominal pain (17)
Abdominal pain upper (17)
Product dose omission issue (16)
Vomiting (14)
Blood bilirubin increased (10)
Hepatic enzyme increased (10)
Nausea (10)
What Other Drugs Cause Off label use?
RITUXIMAB (39,751)
INFLIXIMAB (34,801)
DENOSUMAB (34,612)
METHOTREXATE (24,020)
VEDOLIZUMAB (21,017)
ETANERCEPT (20,178)
TOCILIZUMAB (18,256)
PREDNISONE (17,867)
LENALIDOMIDE (17,017)
ADALIMUMAB (16,417)
Which ODEVIXIBAT Alternatives Have Lower Off label use Risk?
ODEVIXIBAT vs OFATUMUMAB
ODEVIXIBAT vs OFLOXACIN
ODEVIXIBAT vs OLANZAPINE
ODEVIXIBAT vs OLANZAPINE\SAMIDORPHAN L-MALATE
ODEVIXIBAT vs OLAPARIB