PRADAXA for Atrial fibrillation: Side Effects & Safety Data

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There are 2,325 adverse event reports in the FDA FAERS database where PRADAXA was used for Atrial fibrillation.

Most Reported Side Effects for PRADAXA

Side Effect	Reports	%	Deaths	Hosp.
Gastrointestinal haemorrhage	907	24.5%	224	813
Anaemia	332	9.0%	69	312
Haemorrhage	311	8.4%	122	191
Haemorrhagic anaemia	286	7.7%	47	281
Cerebrovascular accident	218	5.9%	37	131
Coagulopathy	215	5.8%	56	211
Renal failure acute	193	5.2%	59	184
Lower gastrointestinal haemorrhage	135	3.7%	22	130
Fall	127	3.4%	44	100
Cerebral haemorrhage	125	3.4%	79	98
Epistaxis	125	3.4%	28	103
Ischaemic stroke	124	3.4%	19	89
Rectal haemorrhage	124	3.4%	33	100
Off label use	122	3.3%	8	35
Upper gastrointestinal haemorrhage	119	3.2%	28	111