SOLIRIS for Paroxysmal nocturnal haemoglobinuria: Side Effects & Safety Data
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There are 1,478 adverse event reports in the FDA FAERS database where SOLIRIS was used for Paroxysmal nocturnal haemoglobinuria.
Most Reported Side Effects for SOLIRIS
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Fatigue | 341 | 14.2% | 14 | 95 |
| Haemoglobin decreased | 254 | 10.6% | 12 | 122 |
| Transfusion | 183 | 7.6% | 8 | 67 |
| Abdominal pain | 141 | 5.9% | 8 | 69 |
| Unevaluable event | 140 | 5.8% | 17 | 129 |
| Dyspnoea | 129 | 5.4% | 10 | 57 |
| Headache | 126 | 5.3% | 3 | 49 |
| Aplastic anaemia | 120 | 5.0% | 4 | 27 |
| Death | 118 | 4.9% | 118 | 38 |
| Platelet count decreased | 106 | 4.4% | 12 | 60 |
| Haemolysis | 103 | 4.3% | 2 | 53 |
| Pyrexia | 103 | 4.3% | 11 | 78 |
| Haemoglobinuria | 100 | 4.2% | 5 | 34 |
| Off label use | 96 | 4.0% | 26 | 22 |
| Vomiting | 95 | 4.0% | 8 | 54 |
Other Indications for SOLIRIS
Haemolytic uraemic syndrome (811)
Off label use (102)
Product used for unknown indication (30)
Neuromyelitis optica (17)
Thrombotic microangiopathy (10)
Transplant rejection (8)
Glomerulonephritis membranoproliferative (5)
Other Drugs Used for Paroxysmal nocturnal haemoglobinuria
ECULIZUMAB (12,054)
RAVULIZUMAB-CWVZ (2,175)
PEGCETACOPLAN (559)
IPTACOPAN (291)
DANICOPAN (89)
CYCLOSPORINE (50)
RAVULIZUMAB (50)
CROVALIMAB-AKKZ (36)
PREDNISOLONE (17)
PREDNISONE (8)