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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

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

Related Pages

PRADAXA Full Profile All Off label use Reports All Drugs Causing Off label use PRADAXA Demographics