SOLIRIS for Off label use: Side Effects & Safety Data
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There are 102 adverse event reports in the FDA FAERS database where SOLIRIS was used for Off label use.
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
Paroxysmal nocturnal haemoglobinuria (1,478)
Haemolytic uraemic syndrome (811)
Product used for unknown indication (30)
Neuromyelitis optica (17)
Thrombotic microangiopathy (10)
Transplant rejection (8)
Glomerulonephritis membranoproliferative (5)
Other Drugs Used for Off label use
LENALIDOMIDE (5,767)
ECULIZUMAB (3,550)
CERTOLIZUMAB PEGOL (2,256)
ABOBOTULINUMTOXINA (2,170)
LEVETIRACETAM (2,161)
APREMILAST (1,995)
PROPRANOLOL (1,576)
CETIRIZINE (1,416)
HUMAN IMMUNOGLOBULIN G (1,129)
THALIDOMIDE (1,033)