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