FACTOR XIII CONCENTRATE for Haemorrhage prophylaxis: Side Effects & Safety Data

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There are 5 adverse event reports in the FDA FAERS database where FACTOR XIII CONCENTRATE was used for Haemorrhage 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