Does PRADAXA Cause Off label use? 122 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 122 reports of Off label use have been filed in association with PRADAXA. This represents 3.3% of all adverse event reports for PRADAXA.
122
Reports of Off label use with PRADAXA
3.3%
of all PRADAXA reports
8
Deaths
35
Hospitalizations
How Dangerous Is Off label use From PRADAXA?
Of the 122 reports, 8 (6.6%) resulted in death, 35 (28.7%) required hospitalization, and 7 (5.7%) 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 PRADAXA. However, 122 reports have been filed with the FAERS database.
What Other Side Effects Does PRADAXA Cause?
Gastrointestinal haemorrhage (907)
Anaemia (332)
Haemorrhage (311)
Haemorrhagic anaemia (286)
Cerebrovascular accident (218)
Coagulopathy (215)
Renal failure acute (193)
Lower gastrointestinal haemorrhage (135)
Fall (127)
Cerebral 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 PRADAXA Alternatives Have Lower Off label use Risk?
PRADAXA vs PRALATREXATE
PRADAXA vs PRALSETINIB
PRADAXA vs PRAMIPEXOLE
PRADAXA vs PRAMIPEXOLE\PRAMIPEXOLE
PRADAXA vs PRAMLINTIDE