Dabigatran etexilate mesylate: adverse event reports filed with FDA

1,031

reports as suspect product

0% of all reports · about 84 a year

101

reports, 12 months to June 2026

124 in the 12 months before

92%

marked serious by the reporter

76.5% across the class

10.5%

record death among outcomes, as reported

108 reports · not verified by FDA

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 mesylate reports recording the termmedian drug in direct thrombin inhibitor

1. Cardiac tamponade9.1%94
2. Haemorrhagebleeding6.7%69
3. Gastrointestinal haemorrhagebleeding in the stomach or bowel5.8%60
4. Drug interactionan interaction between medicines4.9%51
5. Rectal haemorrhage4.4%45
6. Subdural haematoma4.2%43
7. Falla fall4%41
8. Acute kidney injurysudden loss of kidney function3.4%35
9. Haemorrhage intracranial3.2%33
10. Activated partial thromboplastin time prolonged3.1%32
11. Haematuriablood in the urine3%31
12. Cerebral haemorrhage2.6%27
13. Overdosea dose above the recommended amount2.5%26
14. Subarachnoid haemorrhage2.5%26
15. Coagulopathy2.4%25
16. Shock haemorrhagic2.3%24
17. Drug ineffectivethe medicine did not work as expected2.2%23
18. Drug level increaseda raised blood level of the medicine2.2%23
19. Cerebral infarction2.1%22
20. Melaenablack tarry stools1.7%18
21. Traumatic intracranial haemorrhage1.7%18
22. Pericardial effusionfluid around the heart1.6%17
23. Aortic dissection1.6%16
24. Procoagulant therapy1.6%16
25. Surgeryan operation1.6%16
26. Epistaxisnosebleed1.5%15
27. Hypotensionlow blood pressure1.5%15
28. Anaemialow red blood cells1.4%14
29. Atrial fibrillationan irregular heart rhythm1.3%13
30. Haematomaa collection of blood under the skin or in tissue1.3%13

Top 30 of 203 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

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 13.7% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 1,031 reports.

Drugs most often listed in the same reports

Other products listed in reports where Dabigatran etexilate mesylate 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

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

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.

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 mesylate as a suspect or interacting product; reports listing it only as a concomitant medication (193) 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.