BOSENTAN for Pulmonary veno-occlusive disease: Side Effects & Safety Data
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There are 5 adverse event reports in the FDA FAERS database where BOSENTAN was used for Pulmonary veno-occlusive disease.
Most Reported Side Effects for BOSENTAN
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Dyspnoea | 2,492 | 12.7% | 501 | 1,640 |
| Death | 2,388 | 12.2% | 2,384 | 689 |
| Pneumonia | 1,064 | 5.4% | 264 | 946 |
| Fatigue | 1,025 | 5.2% | 116 | 449 |
| Headache | 962 | 4.9% | 94 | 467 |
| Hospitalisation | 915 | 4.7% | 105 | 913 |
| Malaise | 894 | 4.6% | 130 | 445 |
| Diarrhoea | 840 | 4.3% | 132 | 484 |
| Product dose omission issue | 798 | 4.1% | 18 | 174 |
| Pulmonary arterial hypertension | 778 | 4.0% | 358 | 506 |
| Nausea | 765 | 3.9% | 98 | 428 |
| Condition aggravated | 739 | 3.8% | 239 | 464 |
| Dizziness | 721 | 3.7% | 95 | 376 |
| Cough | 705 | 3.6% | 100 | 400 |
| Off label use | 659 | 3.4% | 100 | 272 |
Other Indications for BOSENTAN
Pulmonary arterial hypertension (12,387)
Product used for unknown indication (3,679)
Pulmonary hypertension (2,337)
Scleroderma associated digital ulcer (246)
Skin ulcer (211)
Systemic scleroderma (120)
Heart disease congenital (65)
Connective tissue disorder (62)
Cor pulmonale chronic (60)
Raynaud's phenomenon (59)
Other Drugs Used for Pulmonary veno-occlusive disease
TREPROSTINIL (22)
EPOPROSTENOL (20)
AMBRISENTAN (17)
SILDENAFIL (14)
IMATINIB (13)
MACITENTAN (11)
DEFIBROTIDE (8)
SELEXIPAG (5)
TADALAFIL (5)