Drugs › Direct thrombin inhibitor
Brand name · Dabigatran etexilate
Pradaxa: adverse event reports filed with FDA
63,806 reports list it as a suspect or interacting product, 2009–2026. Class: Direct thrombin inhibitor. Also reported as Pradaxa 110mg, Pradaxa 150.
- 63,806
- reports as suspect product
- 0.3% of all reports · about 3,736 a year
- 211
- reports, 12 months to June 2026
- 302 in the 12 months before
- 76.1%
- marked serious by the reporter
- 76.5% across the class
- 15.4%
- record death among outcomes, as reported
- 9,823 reports · not verified by FDA
63,806 adverse event reports received by FDA list the brand name Pradaxa (dabigatran etexilate) as a suspect or interacting product, from June 2009 to June 2026. A further 7,285 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 211 reports listed it, down 30% from 302 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 3,736 reports a year and 0.3% of the 20,646,523 reports in the database, and 97.1% of the reports for the direct thrombin inhibitor class. How many people take it is not in the data, so a count is not a rate of occurrence.
The MedDRA terms listed most often are gastrointestinal haemorrhage (12.2%), cerebrovascular accident (5.9%) and haemorrhage (4.5%). A report can list several reactions, so shares add to more than 100%; 2,293 different terms appear across these reports. Gastrointestinal haemorrhage is recorded in 12.2% of these reports, about the same share as in the median direct thrombin inhibitor drug (10.6%).
76.1% of the reports are marked serious by the reporter (76.5% across the class); 15.4% record death among the outcomes and 51.8% record hospitalisation, as reported. 42.4% of the reports came from consumers, and the largest patient age group is 75 and over (32.3%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Pradaxa reports recording the termmedian drug in direct thrombin inhibitor
- Gastrointestinal haemorrhagebleeding in the stomach or bowel12.2%7,764
- Cerebrovascular accidentstroke5.9%3,784
- Haemorrhagebleeding4.5%2,858
- Falla fall4%2,583
- Anaemialow red blood cells3.8%2,424
- Ischaemic stroke3.4%2,148
- Rectal haemorrhage3%1,905
- Deaththe patient died; cause not stated by this term2.8%1,801
- Dizzinesslight-headedness or unsteadiness2.5%1,591
- Dyspnoeashortness of breath2.3%1,491
- Dyspepsiaindigestion2.3%1,468
- Cerebral haemorrhage2.1%1,347
- Astheniaweakness or lack of energy2%1,306
- Atrial fibrillationan irregular heart rhythm2%1,275
- Haemorrhagic anaemia1.9%1,242
- Coagulopathy1.9%1,223
- Upper gastrointestinal haemorrhage1.9%1,204
- Diarrhoealoose or frequent stools1.9%1,196
- Melaenablack tarry stools1.9%1,196
- Contusiona bruise1.8%1,174
- Headachehead pain1.8%1,173
- Epistaxisnosebleed1.8%1,155
- Haematuriablood in the urine1.8%1,141
- Haemorrhage intracranial1.8%1,138
- Lower gastrointestinal haemorrhage1.8%1,124
- Off label useused for a purpose or in a way not on the label1.7%1,081
- Nauseafeeling sick1.7%1,074
- Fatiguetiredness1.6%1,046
- Pulmonary embolisma blood clot in the lung1.5%976
- Renal failure acute1.5%961
Top 30 of 2,293 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 3 drugs in the direct thrombin inhibitor class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 65,690 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 58.3% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Atrial fibrillation | 31,352 | 49.1% |
| Cerebrovascular accident prophylaxis | 3,275 | 5.1% |
| Anticoagulant therapy | 1,721 | 2.7% |
| Thrombosis prophylaxis | 1,357 | 2.1% |
| Deep vein thrombosis | 491 | 0.8% |
| Pulmonary embolism | 367 | 0.6% |
The indication field is filled in by the reporter and is often blank; shares are of all 63,806 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Pradaxa reports |
|---|---|---|
| Aspirin | 5,081 | 8% |
| Lasix | 3,499 | 5.5% |
| Lisinopril | 3,163 | 5% |
| Furosemide | 3,108 | 4.9% |
| Metoprolol | 2,930 | 4.6% |
| Digoxin | 2,678 | 4.2% |
| Simvastatin | 2,619 | 4.1% |
| Lipitor | 2,103 | 3.3% |
| Omeprazole | 1,800 | 2.8% |
| Metformin | 1,541 | 2.4% |
Other products listed in reports where Pradaxa is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Pradaxa | Direct thrombin inhibitor | All reports |
|---|---|---|---|
| Reports as suspect product | 63,806 | 65,690 | 20,646,523 |
| Share of that pool | — | 97.1% | 0.3% |
| Reports, latest 12 months | 211 | — | 1,332,454 |
| Marked serious | 76.1% | 76.5% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 154 | 153 | 91 |
| Hospitalisation recorded, per 1,000 reports | 518 | 518 | 213 |
| Consumer-filed share | 42.4% | 41.4% | 45.8% |
| Top term, share of reports | Gastrointestinal haemorrhage 12.2% | median 10.6% | 0.4% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the direct thrombin inhibitor class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Dabigatran etexilate mesylate | generic | 1,031 | 101 | 92% |
| Dabigatran etexilate | generic | 853 | 94 | 87% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Pradaxa reports
How many adverse event reports has FDA received for Pradaxa?
63,806 reports list Pradaxa as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 211 of them arrived in the latest 12 months. Another 7,285 list it only as a concomitant medication.
What reactions are recorded in Pradaxa reports?
gastrointestinal haemorrhage (12.2%), cerebrovascular accident (5.9%), haemorrhage (4.5%), fall (4%) and anaemia (3.8%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Pradaxa was responsible.
How serious are the reports?
76.1% are marked serious by the reporter. Among the outcomes recorded, 15.4% of reports include death and 51.8% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (42.4%), physician (41.6%) and other health professional (9.1%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Pradaxa rising?
211 reports in the 12 months to June 2026, down 30% from 302 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Pradaxa was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Pradaxa?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Pradaxa as a suspect or interacting product; reports listing it only as a concomitant medication (7,285) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.