Drugs › Direct thrombin inhibitor
Generic name
Dabigatran etexilate: adverse event reports filed with FDA
853 reports list it as a suspect or interacting product, 2007–2026. Class: Direct thrombin inhibitor.
- 853
- reports as suspect product
- 0% of all reports · about 44 a year
- 94
- reports, 12 months to June 2026
- 100 in the 12 months before
- 87%
- marked serious by the reporter
- 76.5% across the class
- 13.1%
- record death among outcomes, as reported
- 112 reports · not verified by FDA
853 adverse event reports received by FDA list dabigatran etexilate, a generic name as a suspect or interacting product, from February 2007 to June 2026. A further 563 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, 94 reports listed it, close to the 100 of 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 44 reports a year and 0% of the 20,646,523 reports in the database, and 1.3% 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 reactions recorded most often are drug interaction (15.7%), gastrointestinal haemorrhage (10.6%) and anaemia (5.4%). A report can list several reactions, so shares add to more than 100%; 303 different terms appear across these reports. Drug interaction is recorded in 15.7% of these reports, a larger share than in the median direct thrombin inhibitor drug (4.9%).
87% of the reports are marked serious by the reporter (76.5% across the class); 13.1% record death among the outcomes and 53.3% record hospitalisation, as reported. 35.8% of the reports came from physicians, and the largest patient age group is 75 and over (44.3%). 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 Dabigatran etexilate reports recording the termmedian drug in direct thrombin inhibitor
- Drug interactionan interaction between medicines15.7%134
- Gastrointestinal haemorrhagebleeding in the stomach or bowel10.6%90
- Anaemialow red blood cells5.4%46
- Haemorrhagebleeding5.2%44
- Melaenablack tarry stools4.7%40
- Hypotensionlow blood pressure4.6%39
- Deep vein thrombosisa blood clot in a deep vein3.5%30
- Drug ineffectivethe medicine did not work as expected3.3%28
- Pulmonary embolisma blood clot in the lung3.3%28
- Dizzinesslight-headedness or unsteadiness2.9%25
- Falla fall2.9%25
- Renal failure acute2.7%23
- Coagulopathy2.6%22
- Dyspnoeashortness of breath2.6%22
- Epistaxisnosebleed2.6%22
- Nauseafeeling sick2.5%21
- Haematuriablood in the urine2.3%20
- Rectal haemorrhage2.3%20
- Cerebral infarction2.1%18
- Dyspepsiaindigestion2.1%18
- Erythema multiformea skin reaction with target-shaped patches2.1%18
- Acute kidney injurysudden loss of kidney function2%17
- Haemoglobin decreasedlow haemoglobin2%17
- Chest painchest pain1.9%16
- Haematomaa collection of blood under the skin or in tissue1.9%16
- Off label useused for a purpose or in a way not on the label1.9%16
- Abdominal pain upperupper stomach pain1.8%15
- Atrial fibrillationan irregular heart rhythm1.8%15
- Cardiac failureheart failure1.8%15
- Fatiguetiredness1.8%15
Top 30 of 303 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. 38.2% 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 | 259 | 30.4% |
| Anticoagulant therapy | 95 | 11.1% |
| Thrombosis prophylaxis | 81 | 9.5% |
| Cerebrovascular accident prophylaxis | 20 | 2.3% |
| Deep vein thrombosis | 14 | 1.6% |
| Prophylaxis | 10 | 1.2% |
The indication field is filled in by the reporter and is often blank; shares are of all 853 reports.
In context
| Measure | Dabigatran etexilate | Direct thrombin inhibitor | All reports |
|---|---|---|---|
| Reports as suspect product | 853 | 65,690 | 20,646,523 |
| Share of that pool | — | 1.3% | 0% |
| Reports, latest 12 months | 94 | — | 1,332,454 |
| Marked serious | 87% | 76.5% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 131 | 153 | 91 |
| Hospitalisation recorded, per 1,000 reports | 533 | 518 | 213 |
| Consumer-filed share | 16.2% | 41.4% | 45.8% |
| Top term, share of reports | Drug interaction 15.7% | median 4.9% | 0.8% |
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 |
|---|---|---|---|---|
| Pradaxa | brand | 63,806 | 211 | 76.1% |
| Dabigatran etexilate mesylate | generic | 1,031 | 101 | 92% |
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 Dabigatran etexilate reports
How many adverse event reports has FDA received for Dabigatran etexilate?
853 reports list Dabigatran etexilate as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 94 of them arrived in the latest 12 months. Another 563 list it only as a concomitant medication.
What reactions are recorded in Dabigatran etexilate reports?
drug interaction (15.7%), gastrointestinal haemorrhage (10.6%), anaemia (5.4%), haemorrhage (5.2%) and melaena (4.7%). 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 Dabigatran etexilate was responsible.
How serious are the reports?
87% are marked serious by the reporter. Among the outcomes recorded, 13.1% of reports include death and 53.3% 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?
physician (35.8%), other health professional (32.7%) and consumer or non-health professional (16.2%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Dabigatran etexilate rising?
94 reports in the 12 months to June 2026, close to the 100 of 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 Dabigatran etexilate 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 Dabigatran etexilate?
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 Dabigatran etexilate as a suspect or interacting product; reports listing it only as a concomitant medication (563) 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.