BOSENTAN\BOSENTAN for Scleroderma: Side Effects & Safety Data
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There are 6 adverse event reports in the FDA FAERS database where BOSENTAN\BOSENTAN was used for Scleroderma.
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)
Scleroderma associated digital ulcer (38)
Systemic sclerosis (16)
Skin ulcer (15)
Portopulmonary hypertension (10)
Raynaud's phenomenon (8)
Heart disease congenital (7)
Other Drugs Used for Scleroderma
AMBRISENTAN (1,547)
RITUXIMAB (252)
METHOTREXATE (145)
MYCOPHENOLATE MOFETIL (144)
LETAIRIS (120)
TOCILIZUMAB (117)
PREDNISONE (83)
SILDENAFIL (78)
BOSENTAN (52)
HYDROXYCHLOROQUINE (49)