EMICIZUMAB for Factor viii deficiency: Side Effects & Safety Data
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There are 315 adverse event reports in the FDA FAERS database where EMICIZUMAB was used for Factor viii deficiency.
Most Reported Side Effects for EMICIZUMAB
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Off label use | 101 | 13.8% | 7 | 11 |
| Haemarthrosis | 77 | 10.5% | 0 | 15 |
| No adverse event | 77 | 10.5% | 0 | 0 |
| Haemorrhage | 72 | 9.8% | 2 | 16 |
| Haematoma | 30 | 4.1% | 1 | 7 |
| Fall | 23 | 3.1% | 0 | 6 |
| Headache | 23 | 3.1% | 2 | 3 |
| Arthralgia | 22 | 3.0% | 2 | 1 |
| Drug ineffective | 21 | 2.9% | 5 | 3 |
| Head injury | 21 | 2.9% | 0 | 5 |
| Muscle haemorrhage | 19 | 2.6% | 0 | 7 |
| Pyrexia | 18 | 2.5% | 2 | 9 |
| Drug specific antibody present | 17 | 2.3% | 0 | 0 |
| Injection site reaction | 16 | 2.2% | 0 | 0 |
| Haematuria | 13 | 1.8% | 0 | 5 |
Other Indications for EMICIZUMAB
Product used for unknown indication (99)
Acquired haemophilia (93)
Haemophilia a with anti factor viii (70)
Haemophilia a without inhibitors (64)
Haemophilia (47)
Von willebrand's disease (25)
Prophylaxis (22)
Haemorrhage prophylaxis (6)
Other Drugs Used for Factor viii deficiency
EMICIZUMAB-KXWH (6,532)
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT (4,268)
EFMOROCTOCOG ALFA (832)
--BLOOD-COAGULATION FACTOR VIII FUSION PROTEIN WITH IMMUNOGLOBULIN G1 , ,-BIS WITH IMMUNOGLOBULIN G1 (722)
ANTIHEMOPHILIC FACTOR, PEGYLATED HUMAN SEQUENCE RECOMBINANT (352)
ANTI-INHIBITOR COAGULANT COMPLEX (317)
DAMOCTOCOG ALFA PEGOL (310)
EFANESOCTOCOG ALFA (292)
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT RESIDUES 743-1636 DELETED (180)
ANTIHEMOPHILIC FACTOR HUMAN (161)