82/100 · Critical
Manufactured by Boehringer Ingelheim Pharmaceuticals Inc.
High Safety Concerns with Dabigatran Etexilate Mesylate: Significant Hemorrhagic Events
101,632 FDA adverse event reports analyzed
Last updated: 2026-05-12
DABIGATRAN ETEXILATE MESYLATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Boehringer Ingelheim Pharmaceuticals Inc.. Based on analysis of 101,632 FDA adverse event reports, DABIGATRAN ETEXILATE MESYLATE 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 MESYLATE 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 MESYLATE.
Dabigatran Etexilate Mesylate 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 101,632 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, 76.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Hemorrhagic events, including gastrointestinal and intracranial hemorrhage, are the most frequent and serious adverse reactions.
The drug is associated with a high rate of serious adverse events, particularly hemorrhagic and cardiovascular issues. Atrial fibrillation, a common indication for this drug, is also frequently reported, indicating potential efficacy but increased risk.
Patients taking Dabigatran Etexilate Mesylate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Dabigatran etexilate mesylate can interact with other anticoagulants and antiplatelet agents, leading to increased bleeding risk. Patients should avoid these drugs unless medically necessary. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Dabigatran Etexilate Mesylate received a safety concern score of 82/100 (high concern). This is based on a 76.4% serious event ratio across 71,902 classified reports. The score accounts for 101,632 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: 33,233, Female: 31,294, Unknown: 863. The most frequently reported age groups are age 80 (1,849 reports), age 78 (1,682 reports), age 75 (1,651 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 71,902 classified reports for DABIGATRAN ETEXILATE MESYLATE:
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 mesylate can interact with other anticoagulants and antiplatelet agents, leading to increased bleeding risk. Patients should avoid these drugs unless medically necessary.
If you are taking Dabigatran Etexilate Mesylate, 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. Inform your healthcare provider about all medications and supplements you are taking to avoid potential drug interactions. Be cautious of signs of bleeding, such as unusual bruising, persistent headaches, or changes in vision, and seek medical attention immediately if they occur. 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 profile of dabigatran etexilate mesylate and has issued warnings regarding the risk of serious hemorrhagic events. Healthcare providers should carefully weigh the benefits against the risks.
The FDA has received approximately 101,632 adverse event reports associated with Dabigatran Etexilate Mesylate. 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 Mesylate include Gastrointestinal Haemorrhage, Cerebrovascular Accident, Fall, Haemorrhage, Anaemia. By volume, the top reported reactions are: Gastrointestinal Haemorrhage (7,864 reports), Cerebrovascular Accident (3,930 reports), Fall (3,010 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 Mesylate.
Out of 71,902 classified reports, 54,927 (76.4%) were classified as serious and 16,975 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 Mesylate break down by patient sex as follows: Male: 33,233, Female: 31,294, Unknown: 863. 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 Mesylate adverse events are: age 80: 1,849 reports, age 78: 1,682 reports, age 75: 1,651 reports, age 82: 1,610 reports, age 81: 1,595 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 Mesylate 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 Mesylate include: Ischaemic Stroke, Death, Dyspnoea, Rectal Haemorrhage, Dizziness. 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 Mesylate 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 Mesylate 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. Hemorrhagic events, including gastrointestinal and intracranial hemorrhage, are the most frequent and serious adverse reactions.
Key safety signals identified in Dabigatran Etexilate Mesylate's adverse event data include: Hemorrhage (7864 reports). Cerebrovascular accident (3930 reports). Death (2106 reports). These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Dabigatran etexilate mesylate can interact with other anticoagulants and antiplatelet agents, leading to increased bleeding risk. Patients should avoid these drugs unless medically necessary. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Dabigatran Etexilate Mesylate.
Inform your healthcare provider about all medications and supplements you are taking to avoid potential drug interactions. Be cautious of signs of bleeding, such as unusual bruising, persistent headaches, or changes in vision, and seek medical attention immediately if they occur.
Dabigatran Etexilate Mesylate has 101,632 adverse event reports on file with the FDA. The drug is associated with a high rate of serious adverse events, particularly hemorrhagic and cardiovascular issues. The volume of reports for Dabigatran Etexilate Mesylate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety profile of dabigatran etexilate mesylate and has issued warnings regarding the risk of serious hemorrhagic events. Healthcare providers should carefully weigh the benefits against the risks. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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