TRACLEER for Scleroderma associated digital ulcer: Side Effects & Safety Data
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There are 8 adverse event reports in the FDA FAERS database where TRACLEER was used for Scleroderma associated digital ulcer.
Most Reported Side Effects for TRACLEER
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Death | 382 | 20.5% | 382 | 85 |
| Dyspnoea | 229 | 12.3% | 64 | 201 |
| Pulmonary arterial hypertension | 127 | 6.8% | 85 | 70 |
| Pneumonia | 121 | 6.5% | 41 | 109 |
| Condition aggravated | 86 | 4.6% | 46 | 55 |
| Fall | 79 | 4.2% | 16 | 65 |
| Fluid retention | 65 | 3.5% | 20 | 60 |
| Dizziness | 63 | 3.4% | 10 | 57 |
| Cardiac failure congestive | 60 | 3.2% | 23 | 48 |
| Aspartate aminotransferase increased | 59 | 3.2% | 8 | 35 |
| Fatigue | 59 | 3.2% | 10 | 50 |
| Alanine aminotransferase increased | 57 | 3.1% | 8 | 33 |
| Malaise | 57 | 3.1% | 16 | 49 |
| Disease progression | 54 | 2.9% | 47 | 21 |
| Syncope | 54 | 2.9% | 11 | 48 |
Other Indications for TRACLEER
Pulmonary arterial hypertension (1,472)
Pulmonary hypertension (116)
Cor pulmonale chronic (101)
Product used for unknown indication (86)
Skin ulcer (14)
Systemic lupus erythematosus (6)
Connective tissue disorder (5)
Scleroderma (5)
Systemic sclerosis (5)