Pradaxa (dabigatran etexilate mesylate) is a prescription blood thinner which lowers the chances of blood clots forming in your body.  

Important Information   

Because it acts as an anti-clotting agent to prevent unwanted blood clots, Pradaxa also increases the risk of serious or fatal bleeding.  Even minor injuries, such as a bump to the head or fall, can lead to serious bleeding in patients.  A specific reversal agent for this medication is not available.   

Furthermore, a study released in January 2012 from Cleveland Clinic researchers Ken Uchino, MD, and Adrian V. Hernandez, MD, PhD, found that users of Pradaxa have a 33 percent higher chance of heart attack or severe heart disease symptoms than patients taking warfarin.  Warfarin is among the most popular anticoagulant drugs prescribed in North America and it does have a reversal agent.  The researchers’ findings were based on data from seven previous clinical trials. 

Side Effects of Pradaxa

Patients taking Pradaxa are warned that bruising may occur more easily and it may take longer for any type of bleeding to stop.  Individuals are instructed to seek immediate care from a doctor if any of the following signs or symptoms of bleeding are noticed:

  • Unexplained bleeding from the gums

  • Frequent nose bleeds 

  • Heavier than normal menstrual or vaginal bleeding 

  • Severe or uncontrollable bleeding 

  • Unexplained bruises that grow in size

  • Coughing up blood or blood clots

  • Vomiting blood or vomit that looks like coffee grounds

  • Urine that is pink or brown 

  • Stools that are red or black and look like tar

Other, less serious side effects of Pradaxa may include:

  • Nausea

  • Diarrhea

  • Upset stomach, stomach pain, indigestion, or heartburn

  • Skin rash or itching

Before Taking Pradaxa

Because Pradaxa is eliminated through the kidneys, renal function should be assessed before taking this medication in order to determine the appropriate dose.  Renal function should be reassessed during treatment, if it is clinically indicated there are problems, and the dose should be adjusted.  Patients should also disclose all other medications, vitamins, and herbal supplements they are taking to their doctor before taking Pradaxa.   

Patients should not take Pradaxa if they are allergic to dabigatran.  Furthermore, patients who have active bleeding due to surgery, injury, or another cause should not take this medication.  Patients need to tell their doctor if they have kidney disease, a history of stomach ulcer or bleeding, or if they are using another blood thinner.  Patients should also tell their doctor if they are older than 75.

Patients need to inform their doctor if they are pregnant or plan on becoming pregnant because it is not yet known if Pradaxa will harm unborn infants.  Patients who are breastfeeding or plan to breastfeed should also tell their doctor, as it is uncertain whether Pradaxa passes into breast milk. 

When Taking Pradaxa

When taking Pradaxa, patients are instructed to avoid activities that may increase the risk of bleeding or injury.  Users are also instructed to take extra care to prevent bleeding while shaving or brushing their teeth.

Follow your doctor’s instructions for taking Pradaxa and report any falls or injuries you experience immediately.  This is particularly true if you hit your head, as life-threatening bleeding may occur.      

Other Pradaxa Information

This direct thrombin inhibitor was approved by the U.S. Food and Drug Administration (FDA) in October 2010 for the treatment of patients with an abnormal heart rhythm (atrial fibrillation).  Atrial fibrillation is one of the most common types of abnormal heart rhythm, affecting over 2 million Americans.  Pradaxa is available in 75 mg. and 150 mg. capsules.