Does DEFIBROTIDE Cause Off label use? 1,323 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 1,323 reports of Off label use have been filed in association with DEFIBROTIDE (DEFITELIO). This represents 35.4% of all adverse event reports for DEFIBROTIDE.
1,323
Reports of Off label use with DEFIBROTIDE
35.4%
of all DEFIBROTIDE reports
375
Deaths
180
Hospitalizations
How Dangerous Is Off label use From DEFIBROTIDE?
Of the 1,323 reports, 375 (28.3%) resulted in death, 180 (13.6%) required hospitalization, and 50 (3.8%) 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 DEFIBROTIDE. However, 1,323 reports have been filed with the FAERS database.
What Other Side Effects Does DEFIBROTIDE Cause?
Venoocclusive disease (576)
Death (463)
Multiple organ dysfunction syndrome (372)
Venoocclusive liver disease (355)
Intentional product use issue (201)
Hypotension (169)
Haemorrhage (156)
Sepsis (143)
Acute graft versus host disease (140)
Gastrointestinal haemorrhage (125)
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 DEFIBROTIDE Alternatives Have Lower Off label use Risk?
DEFIBROTIDE vs DEFLAZACORT
DEFIBROTIDE vs DEGARELIX
DEFIBROTIDE vs DELAFLOXACIN MEGLUMINE
DEFIBROTIDE vs DELAMANID
DEFIBROTIDE vs DELANDISTROGENE MOXEPARVOVEC-ROKL