DEFIBROTIDE for Prophylaxis: Side Effects & Safety Data

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There are 1,073 adverse event reports in the FDA FAERS database where DEFIBROTIDE was used for Prophylaxis.

Most Reported Side Effects for DEFIBROTIDE

Side Effect	Reports	%	Deaths	Hosp.
Off label use	1,323	35.4%	375	180
Venoocclusive disease	576	15.4%	125	79
Death	463	12.4%	463	148
Multiple organ dysfunction syndrome	372	10.0%	337	125
Venoocclusive liver disease	355	9.5%	272	73
Intentional product use issue	201	5.4%	39	31
Hypotension	169	4.5%	134	72
Haemorrhage	156	4.2%	60	35
Sepsis	143	3.8%	110	56
Acute graft versus host disease	140	3.7%	69	56
Gastrointestinal haemorrhage	125	3.3%	71	48
Septic shock	113	3.0%	107	61
Renal failure	111	3.0%	68	47
Drug ineffective	106	2.8%	72	27
Disease progression	100	2.7%	78	16