ECULIZUMAB for Prophylaxis: Side Effects & Safety Data
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There are 41 adverse event reports in the FDA FAERS database where ECULIZUMAB was used for Prophylaxis.
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)
Off label use (3,550)
Thrombotic microangiopathy (1,312)
Neuromyelitis optica spectrum disorder (1,097)
C3 glomerulopathy (267)
Transplant rejection (176)
Other Drugs Used for Prophylaxis
PEGFILGRASTIM (7,424)
HUMAN C1-ESTERASE INHIBITOR (5,950)
DENOSUMAB (4,541)
SULFAMETHOXAZOLE\TRIMETHOPRIM (3,197)
ASPIRIN (2,083)
VALACYCLOVIR (1,574)
PANTOPRAZOLE (1,502)
VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN (1,444)
CLOPIDOGREL BISULFATE (1,296)
ENOXAPARIN (1,278)