ANDEXANET ALFA for Procoagulant therapy: Side Effects & Safety Data
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There are 272 adverse event reports in the FDA FAERS database where ANDEXANET ALFA was used for Procoagulant therapy.
Most Reported Side Effects for ANDEXANET ALFA
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Death | 175 | 16.3% | 175 | 5 |
| Cerebral infarction | 139 | 12.9% | 35 | 41 |
| Off label use | 64 | 6.0% | 41 | 6 |
| Cerebral haemorrhage | 50 | 4.7% | 33 | 11 |
| Thrombosis | 43 | 4.0% | 15 | 4 |
| Acute myocardial infarction | 42 | 3.9% | 27 | 14 |
| Myocardial infarction | 42 | 3.9% | 26 | 7 |
| Cerebrovascular accident | 40 | 3.7% | 19 | 9 |
| Ischaemic stroke | 38 | 3.5% | 17 | 11 |
| Pulmonary embolism | 38 | 3.5% | 21 | 10 |
| Heparin resistance | 37 | 3.5% | 4 | 11 |
| Haemorrhage | 33 | 3.1% | 10 | 8 |
| Embolism | 28 | 2.6% | 9 | 6 |
| No adverse event | 25 | 2.3% | 5 | 0 |
| Pneumonia | 24 | 2.2% | 19 | 3 |
Other Indications for ANDEXANET ALFA
Cerebral haemorrhage (99)
Haemorrhage (85)
Subdural haematoma (68)
Haemorrhage intracranial (44)
Product used for unknown indication (44)
Subarachnoid haemorrhage (41)
Gastrointestinal haemorrhage (33)
Thalamus haemorrhage (28)
Putamen haemorrhage (20)
Anticoagulant therapy (14)
Other Drugs Used for Procoagulant therapy
IDARUCIZUMAB (1,040)
PROTAMINE (152)
COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTEIN C\PROTEIN S HUMAN\PROTHROMBIN (128)
COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN (97)
TRANEXAMIC ACID (40)
PHYTONADIONE (18)
ANTI-INHIBITOR COAGULANT COMPLEX (16)
EPLERENONE (14)
AMINOCAPROIC ACID (9)
FACTOR IX COMPLEX (7)