DABIGATRAN ETEXILATE for Prophylaxis: Side Effects & Safety Data

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There are 185 adverse event reports in the FDA FAERS database where DABIGATRAN ETEXILATE was used for Prophylaxis.

Most Reported Side Effects for DABIGATRAN ETEXILATE

Side Effect	Reports	%	Deaths	Hosp.
Gastrointestinal haemorrhage	4,081	11.0%	1,013	3,611
Cerebrovascular accident	2,175	5.9%	216	1,192
Fall	1,786	4.8%	315	1,312
Ischaemic stroke	1,581	4.3%	147	1,054
Anaemia	1,412	3.8%	240	1,244
Haemorrhage	1,324	3.6%	397	735
Death	1,025	2.8%	1,025	284
Rectal haemorrhage	964	2.6%	200	751
Cerebral haemorrhage	946	2.6%	483	633
Upper gastrointestinal haemorrhage	861	2.3%	205	794
Atrial fibrillation	858	2.3%	79	538
Off label use	840	2.3%	73	334
Acute kidney injury	805	2.2%	218	658
Lower gastrointestinal haemorrhage	757	2.0%	141	702
Procoagulant therapy	737	2.0%	4	621