Dabigatran etexilate adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Dabigatran etexilate
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Generic name
Class: Direct thrombin inhibitor

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From February 2007 to June 2026, FDA received 853 adverse event reports that name Dabigatran etexilate. In these reports the drug is a suspect or interacting product.

In the same period, 563 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 94 reports in the 12 months to June 2026 and 100 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 94 (under 0.1%) name Dabigatran etexilate. Reports for patients 75 and over were 44.3% of the reports that name Dabigatran etexilate and 9.5% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Dabigatran etexilate is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 27 reports that name Dabigatran etexilate.
In January to March 2026, FDA received 22.
In April to June 2025, FDA received 31.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 122 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 844 of the 853 reports (98.9%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 122 terms.

Reaction terms in the reports that name Dabigatran etexilate, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 853 reports
Drug interactionan interaction between medicines	134	15.7%
Gastrointestinal haemorrhagebleeding in the stomach or bowel	90	10.6%
Anaemialow red blood cells	46	5.4%
Haemorrhagebleeding	44	5.2%
Melaenablack tarry stools	40	4.7%
Hypotensionlow blood pressure	39	4.6%
Deep vein thrombosisa blood clot in a deep vein	30	3.5%
Drug ineffectivethe medicine did not work as expected	28	3.3%
Pulmonary embolisma blood clot in the lung	28	3.3%
Dizzinesslight-headedness or unsteadiness	25	2.9%
Falla fall	25	2.9%
Renal failure acute	23	2.7%
Coagulopathy	22	2.6%
Dyspnoeashortness of breath	22	2.6%
Epistaxisnosebleed	22	2.6%
Nauseafeeling sick	21	2.5%
Haematuriablood in the urine	20	2.3%
Rectal haemorrhage	20	2.3%
Cerebral infarction	18	2.1%
Dyspepsiaindigestion	18	2.1%
Erythema multiformea skin reaction with target-shaped patches	18	2.1%
Acute kidney injurysudden loss of kidney function	17	2%
Haemoglobin decreasedlow haemoglobin	17	2%
Chest pain	16	1.9%
Haematomaa collection of blood under the skin or in tissue	16	1.9%
Off label useused for a purpose or in a way not on the label	16	1.9%
Abdominal pain upperupper stomach pain	15	1.8%
Atrial fibrillationan irregular heart rhythm	15	1.8%
Cardiac failureheart failure	15	1.8%
Fatiguetiredness	15	1.8%
Oedema peripheralswelling of the legs, ankles or hands	15	1.8%
Upper gastrointestinal haemorrhage	15	1.8%
Activated partial thromboplastin time prolonged	14	1.6%
Haematocheziablood in the stool	14	1.6%
Hypoglycaemialow blood sugar	14	1.6%
Overdosea dose above the recommended amount	14	1.6%
Abdominal discomfortstomach discomfort	13	1.5%
Arthralgiajoint pain	13	1.5%
Astheniaweakness or lack of energy	13	1.5%
Cerebrovascular accidentstroke	13	1.5%
Deaththe patient died; cause not stated by this term	13	1.5%
Headachehead pain	12	1.4%
Pneumonialung infection	12	1.4%
Pruritusitching	12	1.4%
Diarrhoealoose or frequent stools	11	1.3%
Haematemesis	11	1.3%
Malaisegeneral feeling of being unwell	11	1.3%
Product substitution issuea problem after switching products	11	1.3%
Subdural haematoma	11	1.3%
Bradycardiaslow heart rate	10	1.2%

Download all 122 terms of Dabigatran etexilate (CSV)

The counts add to more than 853 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Dabigatran etexilate with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Dabigatran etexilate (this page)	Generic name	853
Dabigatran etexilate mesylate	Generic name	1,031
Pradaxa	Brand name	63,806

Sum of the separately reported names: 65,690. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Dabigatran etexilate, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Other Serious (Important Medical Events)	Not serious
2007	7	7	1	1	7	0	2	0
2008	2	2	2	1	2	0	1	0
2010	26	26	3	2	16	0	10	0
2011	79	79	19	17	52	3	23	0
2012	131	130	32	21	73	3	56	1
2013	42	40	10	9	28	1	22	2
2014	28	28	3	3	16	0	22	0
2015	13	12	2	0	3	1	8	1
2016	18	18	3	0	13	1	7	0
2017	31	31	0	3	22	0	20	0
2018	25	23	0	3	18	0	11	2
2019	18	17	1	2	9	0	13	1
2020	43	42	3	3	19	0	29	1
2021	36	34	9	4	17	0	22	2
2022	63	56	14	4	27	4	37	7
2023	55	40	3	9	29	1	19	15
2024	77	50	0	5	40	0	14	27
2025	101	65	3	3	33	11	49	36
2026	58	42	4	6	31	2	25	16

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Dabigatran etexilate, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Dabigatran etexilate, by the year in which FDA received them
Year	Reports
2007	6
2008	3
2010	25
2011	80
2012	146
2013	33
2014	25
2015	16
2016	19
2017	31
2018	24
2019	16
2020	42
2021	46
2022	53
2023	58
2024	79
2025	102
2026	49

Reports that name Dabigatran etexilate, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Dabigatran etexilate
Age	Reports	Share
Under 2	0	0%
2 to 11	1	0.1%
12 to 17	1	0.1%
18 to 44	18	2.1%
45 to 64	99	11.6%
65 to 74	152	17.8%
75 and over	378	44.3%
Age not given	204	23.9%

Sex of the patient in the reports that name Dabigatran etexilate
Sex	Reports	Share
Female	322	37.7%
Male	419	49.1%
Unknown or not given	112	13.1%

Type of reporter in the reports that name Dabigatran etexilate
Reporter	Reports	Share
Physician	305	35.8%
Pharmacist	120	14.1%
Other health professional	279	32.7%
Lawyer	1	0.1%
Consumer or non-health professional	138	16.2%
Not given	10	1.2%

Age and sex are as the report gives them. The reporter is the primary source in the report. 38.2% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Dabigatran etexilate record
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 reporter fills in the indication, and the field is often empty. Each share is of all 853 reports.

Pages near this one

Dabigatran etexilate mesylate same ingredient
Pradaxa same ingredient
Dabigatran next in the A to Z list
Cytoxan next in the A to Z list
Dabrafenib next in the A to Z list
Cytotec next in the A to Z list
Dacarbazine next in the A to Z list
Cytosine Arabinoside next in the A to Z list
Daclatasvir next in the A to Z list
Cytosar next in the A to Z list
Daclatasvir dihydrochloride next in the A to Z list
Cytomel next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for Dabigatran etexilateThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Dabigatran etexilate: adverse event reports that FDA received. https://reportedreactions.com/drug/dabigatran-etexilate/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Dabigatran etexilate as a suspect or interacting product. The 563 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Dabigatran etexilate was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Dabigatran etexilate?

No. It is a count of what people reported to FDA: 853 reports from February 2007 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Physician (35.8%), other health professional (32.7%) and consumer or non-health professional (16.2%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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