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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.

DABIGATRAN: 2,080 Adverse Event Reports & Safety Profile

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2,080
Total FAERS Reports
251 (12.1%)
Deaths Reported
1,309
Hospitalizations
2,080
As Primary/Secondary Suspect
184
Life-Threatening
53
Disabilities

First Report: 20010101 · Latest Report: 20250829

What Are the Most Common DABIGATRAN Side Effects?

#1 Most Reported
Gastrointestinal haemorrhage
210 reports (10.1%)
#2 Most Reported
Hypotension
167 reports (8.0%)
#3 Most Reported
Atrial fibrillation
150 reports (7.2%)

All DABIGATRAN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Gastrointestinal haemorrhage 210 10.1% 44 157
Hypotension 167 8.0% 11 139
Atrial fibrillation 150 7.2% 3 110
Drug interaction 143 6.9% 7 95
Haemorrhage 141 6.8% 21 84
Anaemia 131 6.3% 12 113
Dizziness 123 5.9% 6 97
Acute kidney injury 120 5.8% 14 99
Drug ineffective 118 5.7% 10 88
Fall 117 5.6% 3 97
Gastric haemorrhage 111 5.3% 0 94
Melaena 100 4.8% 5 90
Haematuria 85 4.1% 2 62
Cardiac failure 79 3.8% 7 65
Dyspnoea 76 3.7% 7 61
Nausea 76 3.7% 2 44
Cerebrovascular accident 75 3.6% 4 47
Haemoglobin decreased 75 3.6% 8 52
Syncope 72 3.5% 4 61
Coagulopathy 69 3.3% 5 62

Who Reports DABIGATRAN Side Effects? Age & Gender Data

Gender: 36.3% female, 63.7% male. Average age: 71.7 years. Most reports from: US. View detailed demographics →

Is DABIGATRAN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 1 0 1
2005 1 0 1
2010 4 0 4
2011 18 1 6
2012 41 1 19
2013 66 9 37
2014 126 11 81
2015 122 18 83
2016 246 30 169
2017 106 14 80
2018 108 5 74
2019 64 3 43
2020 61 3 41
2021 67 1 51
2022 40 3 32
2023 15 2 11
2024 13 1 8
2025 11 0 3

View full timeline →

What Is DABIGATRAN Used For?

IndicationReports
Atrial fibrillation 997
Product used for unknown indication 478
Anticoagulant therapy 127
Deep vein thrombosis 58
Cerebrovascular accident prophylaxis 48
Pulmonary embolism 43
Cerebrovascular accident 35
Thrombosis prophylaxis 32
Prophylaxis 23
Atrial flutter 17

DABIGATRAN vs Alternatives: Which Is Safer?

DABIGATRAN vs DABIGATRAN ETEXILATE DABIGATRAN vs DABRAFENIB DABIGATRAN vs DABRAFENIB\TRAMETINIB DABIGATRAN vs DACARBAZINE DABIGATRAN vs DACLATASVIR DABIGATRAN vs DACLIZUMAB DABIGATRAN vs DACOMITINIB DABIGATRAN vs DACTINOMYCIN DABIGATRAN vs DALBAVANCIN DABIGATRAN vs DALFAMPRIDINE

Official FDA Label for DABIGATRAN

Official prescribing information from the FDA-approved drug label.