Does BOSENTAN Cause Off label use? 659 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 659 reports of Off label use have been filed in association with BOSENTAN (Tracleer). This represents 3.4% of all adverse event reports for BOSENTAN.
659
Reports of Off label use with BOSENTAN
3.4%
of all BOSENTAN reports
100
Deaths
272
Hospitalizations
How Dangerous Is Off label use From BOSENTAN?
Of the 659 reports, 100 (15.2%) resulted in death, 272 (41.3%) required hospitalization, and 22 (3.3%) 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 BOSENTAN. However, 659 reports have been filed with the FAERS database.
What Other Side Effects Does BOSENTAN Cause?
Dyspnoea (2,492)
Death (2,388)
Pneumonia (1,064)
Fatigue (1,025)
Headache (962)
Hospitalisation (915)
Malaise (894)
Diarrhoea (840)
Product dose omission issue (798)
Pulmonary arterial hypertension (778)
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 BOSENTAN Alternatives Have Lower Off label use Risk?
BOSENTAN vs BOSENTAN\BOSENTAN
BOSENTAN vs BOSUTINIB
BOSENTAN vs BOTOX
BOSENTAN vs BOTOX COSMETIC
BOSENTAN vs BOTULINUM TOXIN NOS