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Pradaxa- Adverse Events Overview

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Lisa Jennings6 years ago

Pradaxa (dabigatran) is a blood-thinning (anticoagulant) drug approved to prevent blood clotting and strokes in patients with atrial fibrillation (abnormal heart rhythm). Since its approval in 2010, the U.S. Food and Drug Administration (FDA) has received thousands of reports of adverse events, including fatal bleeding events, in Pradaxa users. 

Nearly 10,000 Adverse Events Reported  

According to, the U.S. Food and Drug Administration's Adverse Event Reporting System has received 9,215 adverse events reports for Pradaxa. The most commonly reported events fall into the following categories: 

  • Gastrointestinal
  • Gastrointestinal Hemorrhages
  • Gastrointestinal Motility And Defecation Conditions
  • Neurological
  • Respiratory
  • Epidermal And Dermal Conditions
  • Hematology Investigations
  • Injuries
  • Headaches
  • Musculoskeletal and Connective Tissue  
  • Central Nervous System Vascular

Most Common Side-Effects Reported 

  • Indigestion  (792 events reported)
  • Dizziness (741 events reported)
  • Gastrointestinal Hemorrhage/Bleeding (596 events reported)
  • Diarrhea (522 events reported)
  • Headache (520 events reported)
  • Nausea (477 events reported)
  • Abdominal Discomfort (426 events reported)
  • Upper Abdominal Pain (426 events reported)
  • Shortness Of Breath (423 events reported)
  • Weakness (392 events reported)
  • Fatigue (384 events reported)
Contact an Experienced Pradaxa Attorney

Thomas J. Henry are leaders in the area of drug and product liability litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. The Defective Drug and Products Division represent a multitude of people who are battling against manufacturers of medical devices and/ or defective pharmaceuticals.

If you or a loved one have been injured by or have developed serious side-effects from the use of Pradaxa, contact Thomas J. Henry immediately. We are available 24/7, nights and weekends.


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