FACTOR XIII CONCENTRATE for Prophylaxis: Side Effects & Safety Data
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There are 18 adverse event reports in the FDA FAERS database where FACTOR XIII CONCENTRATE was used for Prophylaxis.
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)
Coagulation factor deficiency (9)
Haemorrhage (6)
Abnormal clotting factor (5)
Haemorrhage prophylaxis (5)
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)