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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

PRADAXA: 3,701 Adverse Event Reports & Safety Profile

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3,701
Total FAERS Reports
761 (20.6%)
Deaths Reported
2,379
Hospitalizations
3,701
As Primary/Secondary Suspect
209
Life-Threatening
84
Disabilities

First Report: 2009 · Latest Report: 20140626

What Are the Most Common PRADAXA Side Effects?

#1 Most Reported
Gastrointestinal haemorrhage
907 reports (24.5%)
#2 Most Reported
Anaemia
332 reports (9.0%)
#3 Most Reported
Haemorrhage
311 reports (8.4%)

All PRADAXA Side Effects by Frequency

Side Effect Reports % of Total 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
Haematuria 100 2.7% 21 83
Contusion 92 2.5% 14 58
Myocardial infarction 88 2.4% 33 62
Respiratory failure 87 2.4% 44 82
Haemorrhage intracranial 74 2.0% 45 55

Who Reports PRADAXA Side Effects? Age & Gender Data

Average age: 74.4 years. Most reports from: US. View detailed demographics →

Is PRADAXA Getting Safer? Reports by Year

YearReportsDeathsHosp.
2009 5 2 1
2010 32 4 25
2011 388 94 332
2012 509 115 405
2013 637 117 385
2014 758 110 421

View full timeline →

What Is PRADAXA Used For?

IndicationReports
Atrial fibrillation 2,325
Product used for unknown indication 692
Anticoagulant therapy 418
Cerebrovascular accident prophylaxis 286
Thrombosis prophylaxis 155
Atrial flutter 31
Deep vein thrombosis 25
Pulmonary embolism 19
Arrhythmia 17
Cerebrovascular accident 17

PRADAXA vs Alternatives: Which Is Safer?

PRADAXA vs PRALATREXATE PRADAXA vs PRALSETINIB PRADAXA vs PRAMIPEXOLE PRADAXA vs PRAMIPEXOLE\PRAMIPEXOLE PRADAXA vs PRAMLINTIDE PRADAXA vs PRASTERONE PRADAXA vs PRASUGREL PRADAXA vs PRAVASTATIN PRADAXA vs PRAVASTATIN\PRAVASTATIN PRADAXA vs PRAZAXA

Official FDA Label for PRADAXA

Official prescribing information from the FDA-approved drug label.