FACTOR XIII CONCENTRATE for Factor xiii deficiency: Side Effects & Safety Data

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There are 57 adverse event reports in the FDA FAERS database where FACTOR XIII CONCENTRATE was used for Factor xiii 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