ECULIZUMAB for Off label use: Side Effects & Safety Data
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There are 3,550 adverse event reports in the FDA FAERS database where ECULIZUMAB was used for Off label use.
Most Reported Side Effects for ECULIZUMAB
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Fatigue | 4,858 | 11.0% | 91 | 944 |
| Off label use | 4,228 | 9.6% | 577 | 658 |
| Haemoglobin decreased | 3,028 | 6.9% | 127 | 1,045 |
| Headache | 2,699 | 6.1% | 56 | 700 |
| Death | 2,221 | 5.0% | 2,221 | 540 |
| Pyrexia | 1,948 | 4.4% | 128 | 1,129 |
| Dyspnoea | 1,819 | 4.1% | 97 | 737 |
| Asthenia | 1,732 | 3.9% | 95 | 627 |
| Drug ineffective | 1,644 | 3.7% | 164 | 472 |
| Nausea | 1,579 | 3.6% | 47 | 516 |
| Malaise | 1,562 | 3.5% | 91 | 591 |
| Platelet count decreased | 1,502 | 3.4% | 111 | 659 |
| Haemolysis | 1,476 | 3.3% | 87 | 557 |
| Hospitalisation | 1,345 | 3.0% | 75 | 1,336 |
| Blood lactate dehydrogenase increased | 1,290 | 2.9% | 79 | 420 |
Other Indications for ECULIZUMAB
Paroxysmal nocturnal haemoglobinuria (12,054)
Haemolytic uraemic syndrome (8,500)
Product used for unknown indication (6,808)
Atypical haemolytic uraemic syndrome (5,848)
Myasthenia gravis (5,715)
Thrombotic microangiopathy (1,312)
Neuromyelitis optica spectrum disorder (1,097)
C3 glomerulopathy (267)
Transplant rejection (176)
Antiphospholipid syndrome (126)
Other Drugs Used for Off label use
LENALIDOMIDE (5,767)
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)
LACOSAMIDE (842)