Pradaxadabigatran etexilate
According to the FDA label: Dabigatran etexilate capsules are a direct thrombin inhibitor indicated: • To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation ( 1.1 ) • For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days ( 1.2 ) • To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated ( 1.3 ) • For the prophylaxis of…
73,377 adverse event reports submitted to the FDA (2007–2026)
Top Reported Adverse Events
The most frequently reported events in association with Pradaxa in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Gastrointestinal Haemorrhage 7,962 reports
Bleeding somewhere in the digestive tract, such as the stomach or intestines. Also spelled hemorrhage in American English.
Full definition in the glossary →Cerebrovascular Accident 3,956 reports
The medical term for a stroke, which happens when blood flow to part of the brain is interrupted.
Full definition in the glossary →Fall 3,064 reports
A report that the person fell down. Falls are tracked because they can signal issues like dizziness, weakness, or balance problems.
Full definition in the glossary →Haemorrhage 3,043 reports
Bleeding, particularly heavy or uncontrolled bleeding. Also spelled hemorrhage in American English.
Full definition in the glossary →Anaemia 2,650 reports
A condition where there are too few healthy red blood cells to carry enough oxygen, often causing tiredness and paleness. Also spelled anemia in American English.
Full definition in the glossary → See all drugs reporting this event →- Ischaemic Stroke 2,194 reports
Death 2,136 reports
A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Full definition in the glossary →Dyspnoea 2,073 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →- Rectal Haemorrhage 2,004 reports
Dizziness 1,973 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Atrial Fibrillation 1,789 reports
An irregular, often rapid heart rhythm.
Full definition in the glossary →Diarrhoea 1,678 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Asthenia 1,676 reports
Physical weakness or lack of strength.
Full definition in the glossary →Dyspepsia 1,543 reports
The medical term for indigestion, meaning discomfort or pain in the upper belly, often after eating.
Full definition in the glossary → See all drugs reporting this event →Fatigue 1,524 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Male | 33,980 |
| Female | 31,857 |
| Unknown | 867 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 777 |
| 18-34 | 267 |
| 35-49 | 1,013 |
| 50-64 | 5,576 |
| 65-74 | 11,695 |
| 75+ | 23,848 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Pradaxa. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Hospitalization | 37,304 |
| Other Serious | 21,305 |
| Non-Serious | 17,136 |
| Death | 10,925 |
| Life-Threatening | 4,673 |
| Disability | 1,525 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Pradaxa. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2007 | 5 |
| 2008 | 3 |
| 2009 | 4 |
| 2010 | 410 |
| 2011 | 11,548 |
| 2012 | 9,132 |
| 2013 | 7,940 |
| 2014 | 7,200 |
| 2015 | 4,610 |
| 2016 | 5,590 |
| 2017 | 6,566 |
| 2018 | 5,564 |
| 2019 | 3,958 |
| 2020 | 2,994 |
| 2021 | 2,513 |
| 2022 | 2,217 |
| 2023 | 1,166 |
| 2024 | 975 |
| 2025 | 830 |
| 2026 (partial) | 152 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Pradaxa
In FDA adverse event reports that mention Pradaxa, these medications appeared most often in the same report.
- Furosemide (8,467 reports)
- Aspirin (6,157 reports)
- Metoprolol (5,807 reports)
- Simvastatin (4,016 reports)
- Lisinopril (3,980 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026