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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 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

Related Pages

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