Does DABIGATRAN ETEXILATE Cause Off label use? 840 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 840 reports of Off label use have been filed in association with DABIGATRAN ETEXILATE (dabigatran etexilate). This represents 2.3% of all adverse event reports for DABIGATRAN ETEXILATE.
840
Reports of Off label use with DABIGATRAN ETEXILATE
2.3%
of all DABIGATRAN ETEXILATE reports
73
Deaths
334
Hospitalizations
How Dangerous Is Off label use From DABIGATRAN ETEXILATE?
Of the 840 reports, 73 (8.7%) resulted in death, 334 (39.8%) required hospitalization, and 57 (6.8%) 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 DABIGATRAN ETEXILATE. However, 840 reports have been filed with the FAERS database.
What Other Side Effects Does DABIGATRAN ETEXILATE Cause?
Gastrointestinal haemorrhage (4,081)
Cerebrovascular accident (2,175)
Fall (1,786)
Ischaemic stroke (1,581)
Anaemia (1,412)
Haemorrhage (1,324)
Death (1,025)
Rectal haemorrhage (964)
Cerebral haemorrhage (946)
Upper gastrointestinal haemorrhage (861)
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 DABIGATRAN ETEXILATE Alternatives Have Lower Off label use Risk?
DABIGATRAN ETEXILATE vs DABRAFENIB
DABIGATRAN ETEXILATE vs DABRAFENIB\TRAMETINIB
DABIGATRAN ETEXILATE vs DACARBAZINE
DABIGATRAN ETEXILATE vs DACLATASVIR
DABIGATRAN ETEXILATE vs DACLIZUMAB