FACTOR XIII CONCENTRATE for Haemorrhage: Side Effects & Safety Data
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There are 6 adverse event reports in the FDA FAERS database where FACTOR XIII CONCENTRATE was used for Haemorrhage.
Most Reported Side Effects for FACTOR XIII CONCENTRATE
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Drug ineffective | 25 | 16.1% | 4 | 6 |
| No adverse event | 20 | 12.9% | 0 | 0 |
| Haemorrhage | 12 | 7.7% | 1 | 1 |
| Device issue | 9 | 5.8% | 0 | 0 |
| Off label use | 8 | 5.2% | 0 | 2 |
| Product preparation issue | 8 | 5.2% | 0 | 0 |
| Product use in unapproved indication | 8 | 5.2% | 1 | 0 |
| Abortion spontaneous | 7 | 4.5% | 0 | 0 |
| Exposure during pregnancy | 7 | 4.5% | 0 | 3 |
| Factor xiii inhibition | 7 | 4.5% | 0 | 2 |
| Deep vein thrombosis | 5 | 3.2% | 0 | 1 |
| Drug ineffective for unapproved indication | 5 | 3.2% | 0 | 0 |
| Dyspnoea | 5 | 3.2% | 0 | 3 |
| Epistaxis | 5 | 3.2% | 0 | 0 |
| Hypersensitivity | 5 | 3.2% | 0 | 1 |
Other Indications for FACTOR XIII CONCENTRATE
Factor xiii deficiency (57)
Product used for unknown indication (19)
Prophylaxis (18)
Coagulation factor deficiency (9)
Abnormal clotting factor (5)
Haemorrhage prophylaxis (5)
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)