Does BOSENTAN Cause Stomatitis? 21 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 21 reports of Stomatitis have been filed in association with BOSENTAN (Tracleer). This represents 0.1% of all adverse event reports for BOSENTAN.
21
Reports of Stomatitis with BOSENTAN
0.1%
of all BOSENTAN reports
1
Deaths
17
Hospitalizations
How Dangerous Is Stomatitis From BOSENTAN?
Of the 21 reports, 1 (4.8%) resulted in death, 17 (81.0%) required hospitalization.
Is Stomatitis Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for BOSENTAN. However, 21 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 Stomatitis?
METHOTREXATE (7,245)
TOCILIZUMAB (4,761)
ADALIMUMAB (4,500)
LEFLUNOMIDE (4,492)
ABATACEPT (4,481)
ETANERCEPT (4,338)
RITUXIMAB (4,335)
CERTOLIZUMAB PEGOL (3,760)
INFLIXIMAB (3,713)
PREDNISONE (3,656)