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PRADAXA (dabigatran etexilate mesylate) is a prescription blood-thinning medicine used to reduce the risk of stroke and blood clots in people with atrial fibrillation (AFib) not caused by a heart valve problem. With AFib, the heart doesn’t beat the way it should. This can cause blood clots to form, increasing the risk of stroke. PRADAXA lowers the chance of blood clots forming in your body and putting you at risk of a stroke.

Important safety information about Pradaxa

PRADAXA can cause bleeding which can be serious and sometimes lead to death. Don’t take PRADAXA if you currently have abnormal bleeding or if you have ever had an allergic reaction to it.

To find the right dose for you, your doctor should test your kidney function before you start PRADAXA and in some cases yearly thereafter.

Your risk of bleeding with PRADAXA may be higher if you:

  • Are 75 years old or older
  • Have kidney problems
  • Have stomach or intestine bleeding that is recent or keeps coming back or you have a stomach ulcer
  • Take other medicines that increase your risk of bleeding, like aspirin products, non-steroidal anti-inflammatory drugs (NSAIDs) and blood thinners
  • Have kidney problems and take dronedarone (Multaq®) or ketoconazole tablets (Nizoral®)

Call your doctor or seek immediate medical care if you have any of the following signs or symptoms of bleeding:

  • Any unexpected, severe, or uncontrollable bleeding; or bleeding that lasts a long time
  • Unusual or unexpected bruising
  • Coughing up or vomiting blood; or vomit that looks like coffee grounds
  • Pink or brown urine; red or black stools (looks like tar)
  • Unexpected pain, swelling, or joint pain
  • Headaches and feeling dizzy or weak

It is important to tell your doctor about all medicines, vitamins and supplements you take. Some of your other medicines may affect the way PRADAXA works.

Take PRADAXA exactly as prescribed by your doctor. Don’t stop taking PRADAXA without talking to your doctor as your risk of stroke may increase.

Tell your doctor if you are planning to have any surgery, or medical or dental procedure, because you may have to stop taking PRADAXA for a short time.

PRADAXA can cause indigestion, stomach upset or burning, and stomach pain.

Click here for full Prescribing Information including Patient Medication Guide

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088.

The health information contained in this Website is provided for educational purposes only and is not intended to replace discussions with a healthcare professional. All decisions regarding patient care must be made with a healthcare professional, considering the unique characteristics of the patient.