FIBRINOGEN HUMAN\THROMBIN HUMAN for Haemorrhage: Side Effects & Safety Data
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There are 7 adverse event reports in the FDA FAERS database where FIBRINOGEN HUMAN\THROMBIN HUMAN was used for Haemorrhage.
Most Reported Side Effects for FIBRINOGEN HUMAN\THROMBIN HUMAN
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Off label use | 225 | 22.4% | 11 | 30 |
| Drug ineffective | 132 | 13.2% | 5 | 14 |
| Product use in unapproved indication | 95 | 9.5% | 3 | 10 |
| Cerebrospinal fluid leakage | 57 | 5.7% | 2 | 23 |
| Haemorrhage | 50 | 5.0% | 8 | 3 |
| Seroma | 49 | 4.9% | 0 | 5 |
| Drug ineffective for unapproved indication | 42 | 4.2% | 3 | 7 |
| Product physical consistency issue | 31 | 3.1% | 0 | 0 |
| Wound infection | 29 | 2.9% | 0 | 3 |
| Post procedural complication | 26 | 2.6% | 1 | 8 |
| Haematoma | 23 | 2.3% | 1 | 2 |
| Graft complication | 22 | 2.2% | 0 | 0 |
| Procedural complication | 19 | 1.9% | 2 | 5 |
| Product adhesion issue | 19 | 1.9% | 0 | 2 |
| Product quality issue | 19 | 1.9% | 1 | 3 |
Other Indications for FIBRINOGEN HUMAN\THROMBIN HUMAN
Tissue sealing (226)
Haemostasis (171)
Product used for unknown indication (146)
Off label use (39)
Prophylaxis (33)
Hernia repair (28)
Surgery (26)
Pterygium operation (25)
Abdominal hernia repair (19)
Cerebrospinal fluid leakage (19)
Other Drugs Used for Haemorrhage
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT (751)
COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTEIN C\PROTEIN S HUMAN\PROTHROMBIN (318)
COAGULATION FACTOR IX RECOMBINANT HUMAN\ISOPROPYL ALCOHOL (273)
TRANEXAMIC ACID (247)
EFMOROCTOCOG ALFA (219)
ANTI-INHIBITOR COAGULANT COMPLEX (116)
EFTRENONACOG ALFA (109)
COAGULATION FACTOR VIIA RECOMBINANT HUMAN (92)
ANDEXANET ALFA (85)
IDARUCIZUMAB (83)