BOSENTAN\BOSENTAN for Scleroderma associated digital ulcer: Side Effects & Safety Data
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There are 38 adverse event reports in the FDA FAERS database where BOSENTAN\BOSENTAN was used for Scleroderma associated digital ulcer.
Most Reported Side Effects for BOSENTAN\BOSENTAN
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Death | 543 | 15.6% | 542 | 118 |
| Dyspnoea | 443 | 12.7% | 104 | 384 |
| Pulmonary arterial hypertension | 245 | 7.0% | 149 | 143 |
| Pneumonia | 220 | 6.3% | 62 | 202 |
| Fall | 182 | 5.2% | 22 | 160 |
| Condition aggravated | 161 | 4.6% | 84 | 95 |
| Fluid retention | 125 | 3.6% | 30 | 117 |
| Syncope | 115 | 3.3% | 17 | 97 |
| Nausea | 113 | 3.2% | 20 | 95 |
| Fatigue | 111 | 3.2% | 15 | 87 |
| Dizziness | 106 | 3.0% | 11 | 90 |
| Disease progression | 99 | 2.8% | 84 | 49 |
| Malaise | 98 | 2.8% | 22 | 82 |
| Cardiac failure congestive | 97 | 2.8% | 37 | 77 |
| Cough | 97 | 2.8% | 10 | 74 |
Other Indications for BOSENTAN\BOSENTAN
Pulmonary arterial hypertension (2,673)
Cor pulmonale chronic (238)
Pulmonary hypertension (238)
Product used for unknown indication (187)
Systemic sclerosis (16)
Skin ulcer (15)
Portopulmonary hypertension (10)
Raynaud's phenomenon (8)
Heart disease congenital (7)
Scleroderma (6)