BOSENTAN
Generic: BOSENTAN
Actavis PharmaManufacturer
ORALRoute
BOSENTANActive Substance
2019-04-26Original Approval
BOSENTAN is FDA application ANDA207110, sponsored by WATSON LABS INC. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.
Top Reported Reactions
1
DYSPNOEA
1,011 reports
2
OFF LABEL USE
802 reports
3
DEATH
729 reports
4
FATIGUE
640 reports
5
PRODUCT DOSE OMISSION ISSUE
627 reports
6
HEADACHE
536 reports
7
DIARRHOEA
464 reports
8
DRUG INEFFECTIVE
381 reports
9
MALAISE
377 reports
10
NAUSEA
374 reports