Using Pradaxa - Side effects

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Pradaxa has a well-characterized safety profile and is usually well tolerated. For a full list of known adverse events, please see the Pradaxa Summary of Product Characteristics.1

The most common and potentially serious adverse event with any anticoagulant is bleeding. The risk of bleeding with Pradaxa has been shown to be comparable to warfarin in real-world analyses.2-6

Core regulatory bodies, including the FDA and US Department of Defense, support Pradaxa safety in real-world use,2-6 - the FDA study being one of the largest real-world data analyses of its kind.2

For further real-world evidence on bleeding in patients treated with Pradaxa click here.

For information about how to manage patients treated with Pradaxa in cases of bleeding, see the emergencies section.

Managing dyspepsia

Dyspepsia can be managed in almost all patients who experience it using these simple measures:7

An image showing information on managing dyspepsia when taking Pradaxa (Dabigatran)

*Based on a sub analysis of RE-LY and RELY-ABLE.

  1. Pradaxa Summary of Product Characteristics 2016. Boehringer Ingelheim.
  2. Graham DJ et al. Circulation 2015;131:157–164.
  3. Seeger JD et al. Presented at AHA 2014.
  4. Villines TC et al. Presented at AHA 2014.
  5. Larsen TB et al. Am J Med 2014;127:650-656.
  6. Larsen TB et al. Am J Med 2014;127:329-336.
  7. Nieuwlaat R et al. Poster presented at the 35th Congress of the ESC 2013, Amsterdam, The Netherlands.