Pharmacologic class (EPC) · 3 drug pages

Direct thrombin inhibitor: adverse event reports filed with FDA

65,690 reports list a drug in this class as a suspect or interacting product, 2007–2026.

Read first · FDA's statement on these data

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. openFDA, FDA

FDA adds: "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 "cannot be used to estimate the incidence of these events."

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.

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

65,690
reports across the class: 0.3% of all reports; 406
reports, 12 months to June 2026: 526 in the 12 months before; 76.5%
marked serious by the reporter: 57.4% across all reports; 3
drugs with a page: brand and generic names counted separately

Direct thrombin inhibitor is a pharmacologic class (an FDA Established Pharmacologic Class) with 3 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 65,690 adverse event reports received by FDA, 0.3% of the database, from February 2007 to June 2026.

406 reports arrived in the 12 months to June 2026, down 23% from 526 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 76.5% of the class's reports are marked serious, 15.3% record death among the outcomes and 51.8% record hospitalisation, as reported.

Across the class the reactions recorded most often are gastrointestinal haemorrhage (12%), cerebrovascular accident (5.8%) and haemorrhage (4.5%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
PradaxaDabigatran etexilate	brand	63,806	211	76.1%	Gastrointestinal haemorrhage
Dabigatran etexilate mesylate	generic	1,031	101	92%	Cardiac tamponade
Dabigatran etexilate	generic	853	94	87%	Drug interaction

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Gastrointestinal haemorrhagebleeding in the stomach or bowel12%7,914
Cerebrovascular accidentstroke5.8%3,809
Haemorrhagebleeding4.5%2,971
Falla fall4%2,649
Anaemialow red blood cells3.8%2,484
Ischaemic stroke3.3%2,168
Rectal haemorrhage3%1,970
Deaththe patient died; cause not stated by this term2.8%1,814
Dizzinesslight-headedness or unsteadiness2.5%1,623
Dyspnoeashortness of breath2.3%1,518
Dyspepsiaindigestion2.3%1,486
Cerebral haemorrhage2.1%1,378
Astheniaweakness or lack of energy2%1,324
Atrial fibrillationan irregular heart rhythm2%1,303
Coagulopathy1.9%1,270
Melaenablack tarry stools1.9%1,254
Haemorrhagic anaemia1.9%1,244
Upper gastrointestinal haemorrhage1.9%1,225
Diarrhoealoose or frequent stools1.8%1,212
Epistaxisnosebleed1.8%1,192
Haematuriablood in the urine1.8%1,192
Headachehead pain1.8%1,188
Contusiona bruise1.8%1,179
Haemorrhage intracranial1.8%1,175
Lower gastrointestinal haemorrhage1.7%1,130

Solid bar: share of all class reports. Hollow bar: the median share across the 3 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death15.3%10,043

Life-threatening6.7%4,376

Hospitalisation (initial or prolonged)51.8%34,005

Disability2%1,309

Congenital anomaly0%11

Other serious27.3%17,901

Not serious23.5%15,418

Patient age

Under 20%11

2 to 110%18

12 to 170%18

18 to 441%673

45 to 647.9%5,185

65 to 7415.3%10,038

75 and over32.8%21,515

Age not given43%28,232

Who reported

Physician41.6%27,346

Pharmacist6.7%4,381

Other health professional9.7%6,401

Lawyer0%20

Consumer or non-health professional41.4%27,200

Not given0.5%342

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Direct thrombin inhibitor reports

Which drugs are in the Direct thrombin inhibitor class on this site?

Pradaxa, Dabigatran etexilate mesylate and Dabigatran etexilate. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

65,690 reports through June 2026, 406 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

gastrointestinal haemorrhage (12%), cerebrovascular accident (5.8%), haemorrhage (4.5%), fall (4%) and anaemia (3.8%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. 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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.