ALTEPLASE for Prophylaxis: Side Effects & Safety Data

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There are 8 adverse event reports in the FDA FAERS database where ALTEPLASE was used for Prophylaxis.

Most Reported Side Effects for ALTEPLASE

Side Effect	Reports	%	Deaths	Hosp.
No adverse event	2,456	19.4%	0	17
Off label use	1,752	13.8%	137	135
Gingival bleeding	1,018	8.0%	18	44
Cerebral haemorrhage	819	6.5%	357	232
Death	818	6.5%	818	58
Haemorrhage intracranial	615	4.9%	247	143
Angioedema	603	4.8%	37	192
Haemorrhage	536	4.2%	172	107
Drug ineffective	524	4.1%	69	99
Haemorrhagic transformation stroke	496	3.9%	168	127
Product storage error	371	2.9%	1	2
Intercepted medication error	244	1.9%	0	0
Hypotension	242	1.9%	48	80
Intercepted product storage error	227	1.8%	0	0
Vomiting	224	1.8%	25	76