Dabigatran (Pradaxa®): A Deep Dive

What is it?

Dabigatran, also known as Pradaxa®, is a prescribed medication called an anticoagulant (sometimes called a blood thinner). It’s part of a class of medications called direct oral anticoagulants (DOACs).

Dabigatran is used to treat blood clots—or prevent new ones from forming—in patients with:

Dabigatran should be taken twice a day (every 12 hours) by mouth.

How does it work?

Dabigatran is a direct thrombin inhibitor, meaning that it works to block a clotting agent known as thrombin. “When a blood clot forms, one of the main ingredients for it is fibrin. Fibrin forms when it’s converted from its precursor, fibrinogen. Another entity called thrombin needs to be activated for the conversion to take place,” explained Dr. Azhar Ahmad, the Executive Director of Clinical Development and Medical Affairs at Boehringer Ingelheim. “Dabigatran inhibits what the thrombin is doing, stops the fibrinogen from forming fibrin, and prevents the blood from clotting.”

What are the benefits?

  • Dabigatran is an effective and safe alternative to warfarin. When compared with warfarin in some clinical trials, dabigatran significantly reduced the risk of stroke in patients with NVAF. Likewise, dabigatran had a lower risk of bleeding and was just as effective as warfarin in treating venous thromboembolism (VTE, which includes DVT and PE).
  • Dabigatran can be used in infants and children. The dosage varies based on a child’s weight and age.
  • Dabigatran doesn’t require routine blood tests or dietary restrictions.

What are the risks?

  • Patients on dabigatran may have a higher risk of bleeding (especially if they’re 75 years old or older), have kidney problems, or have had recent stomach/intestinal bleeding or stomach ulcers.
    • However, in the event of major or life-threatening bleeding, dabigatran can be reversed with a medication called idarucizumab (Praxbind®).

Safety considerations

You can help further manage your bleeding risk while on dabigatran by: 

  • Taking your medicine as directed. You should never stop your medication or change your dosage without talking to your healthcare provider first. 
  • Telling your healthcare providers about all medicines or supplements that you take—including over-the-counter medications, natural products, and vitamins—to avoid drug interactions. 
  • Avoiding certain anti-infectives (antibiotics and/or antiviral/antifungal medications), other blood thinners (heparin, warfarin), aspirin, ibuprofen, and some seizure medications or antidepressants, unless recommended by your healthcare provider.
  • Limiting or avoiding alcohol use.
  • Making sure to talk to your healthcare provider before having any type of surgical procedure.

Pregnancy or breastfeeding considerations

Dabigatran is unsafe to use in pregnancy and is also not recommended for use in patients who are breastfeeding.

For more information about dabigatran, please see our Anticoagulant Comparison Chart!

References

Dabigatran: Drug Information. UpToDate. 2022.

FDA Prescribing Information. 2011.

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