82/100 · Critical
Manufactured by Boehringer Ingelheim Pharmaceuticals, Inc.
Significant Safety Concerns with Dabigatran Etexilate
111,048 FDA adverse event reports analyzed
Last updated: 2026-05-12
DABIGATRAN ETEXILATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Boehringer Ingelheim Pharmaceuticals, Inc.. Based on analysis of 111,048 FDA adverse event reports, DABIGATRAN ETEXILATE has a safety score of 82 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for DABIGATRAN ETEXILATE include GASTROINTESTINAL HAEMORRHAGE, CEREBROVASCULAR ACCIDENT, FALL, HAEMORRHAGE, ANAEMIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DABIGATRAN ETEXILATE.
Dabigatran Etexilate has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 111,048 adverse event reports for this medication, which is primarily manufactured by Boehringer Ingelheim Pharmaceuticals, Inc..
The most commonly reported adverse events include Gastrointestinal Haemorrhage, Cerebrovascular Accident, Fall. Of classified reports, 77.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Gastrointestinal hemorrhage and cerebral hemorrhage are the most frequent serious adverse events.
A high percentage of reports involve hemorrhagic events, indicating a significant risk. The majority of adverse events are serious, with a serious event rate of 77.3%.
Patients taking Dabigatran Etexilate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Dabigatran etexilate can interact with other anticoagulants and may increase the risk of bleeding. Patients should avoid certain drugs known to affect coagulation. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Dabigatran Etexilate received a safety concern score of 82/100 (high concern). This is based on a 77.3% serious event ratio across 76,732 classified reports. The score accounts for 111,048 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Male: 36,052, Female: 32,993, Unknown: 883. The most frequently reported age groups are age 80 (1,967 reports), age 75 (1,809 reports), age 78 (1,803 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 76,732 classified reports for DABIGATRAN ETEXILATE:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Dabigatran etexilate can interact with other anticoagulants and may increase the risk of bleeding. Patients should avoid certain drugs known to affect coagulation.
If you are taking Dabigatran Etexilate, here are important things to know. The most commonly reported side effects include gastrointestinal haemorrhage, cerebrovascular accident, fall, haemorrhage, anaemia. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Be cautious when taking dabigatran etexilate and avoid potential drug interactions. Report any unusual bleeding or signs of stroke to your healthcare provider immediately. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor the safety of dabigatran etexilate and has not issued any additional warnings beyond those already in place.
The FDA has received approximately 111,048 adverse event reports associated with Dabigatran Etexilate. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Dabigatran Etexilate include Gastrointestinal Haemorrhage, Cerebrovascular Accident, Fall, Haemorrhage, Anaemia. By volume, the top reported reactions are: Gastrointestinal Haemorrhage (8,257 reports), Cerebrovascular Accident (4,058 reports), Fall (3,228 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Dabigatran Etexilate.
Out of 76,732 classified reports, 59,286 (77.3%) were classified as serious and 17,446 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Dabigatran Etexilate break down by patient sex as follows: Male: 36,052, Female: 32,993, Unknown: 883. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Dabigatran Etexilate adverse events are: age 80: 1,967 reports, age 75: 1,809 reports, age 78: 1,803 reports, age 81: 1,753 reports, age 77: 1,738 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Dabigatran Etexilate adverse event reports is Boehringer Ingelheim Pharmaceuticals, Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Dabigatran Etexilate include: Dyspnoea, Ischaemic Stroke, Dizziness, Death, Rectal Haemorrhage. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Dabigatran Etexilate to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Dabigatran Etexilate has a safety concern score of 82 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Gastrointestinal hemorrhage and cerebral hemorrhage are the most frequent serious adverse events.
Key safety signals identified in Dabigatran Etexilate's adverse event data include: Gastrointestinal hemorrhage. Cerebrovascular accident. Fall. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Dabigatran etexilate can interact with other anticoagulants and may increase the risk of bleeding. Patients should avoid certain drugs known to affect coagulation. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Dabigatran Etexilate.
Be cautious when taking dabigatran etexilate and avoid potential drug interactions. Report any unusual bleeding or signs of stroke to your healthcare provider immediately.
Dabigatran Etexilate has 111,048 adverse event reports on file with the FDA. A high percentage of reports involve hemorrhagic events, indicating a significant risk. The volume of reports for Dabigatran Etexilate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of dabigatran etexilate and has not issued any additional warnings beyond those already in place. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by Boehringer Ingelheim Pharmaceuticals, Inc. and compare their safety profiles:
The following drugs share commonly reported adverse reactions with DABIGATRAN ETEXILATE:
Drugs related to DABIGATRAN ETEXILATE based on therapeutic use, drug class, or shared indications: