BOSENTAN for Scleroderma associated digital ulcer: Side Effects & Safety Data
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There are 246 adverse event reports in the FDA FAERS database where BOSENTAN was used for Scleroderma associated digital ulcer.
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)
Skin ulcer (211)
Systemic scleroderma (120)
Heart disease congenital (65)
Connective tissue disorder (62)
Cor pulmonale chronic (60)
Raynaud's phenomenon (59)
Scleroderma (52)