• Pradaxa can cause bleeding which can be serious, and sometimes lead to death. This is because Pradaxa is a blood thinner medicine that lowers the chance of blood clots forming in your body.
• You may have a higher risk of bleeding if you take Pradaxa and:
  • are over 75 years old
  • 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, including:
    • aspirin or aspirin containing products
    • long-term (chronic) use of non-steroidal anti-inflammatory drugs (NSAIDs)
    • warfarin sodium (Coumadin, Jantoven)
    • a medicine that contains heparin
    • clopidogrel (Plavix)
    • prasugrel (Effient)
  • have certain kidney problems and also take the medicines dronedarone (Multaq) or ketoconazole tablets (Nizoral).
  • Pradaxa can increase your risk of bleeding because it lessens the ability of your blood to clot. While you take Pradaxa:
    • you may bruise more easily
    • it may take longer for any bleeding to stop
  • Call your doctor or get medical help right away if you have any of these signs or symptoms of bleeding:
    • unexpected bleeding or bleeding that lasts a long time, such as:
      • unusual bleeding from the gums
      • nose bleeds that happen often
      • menstrual bleeding or vaginal bleeding that is heavier than normal
    • bleeding that is severe or you cannot control
    • pink or brown urine
    • red or black stools (looks like tar)
    • bruises that happen without a known cause or get larger
    • cough up blood or blood clots
    • vomit blood or your vomit looks like "coffee grounds"
    • unexpected pain, swelling, or joint pain
    • headaches, feeling dizzy or weak

Take Pradaxa exactly as prescribed. Do not stop taking Pradaxa without first talking to the doctor who prescribes it for you. Stopping Pradaxa may increase your risk of a stroke.

Pradaxa may need to be stopped, if possible, for one or more days before any surgery, or medical or dental procedure. If you need to stop taking Pradaxa for any reason, talk to the doctor who prescribed Pradaxa for you to find out when you should stop taking it. Your doctor will tell you when to start taking Pradaxa again after your surgery or procedure.

Do not take Pradaxa if you:

• currently have certain types of abnormal bleeding. Talk to your doctor, before taking Pradaxa if you currently have unusual bleeding.
• if you have a mechanical heart valve, also known as a mechanical prosthetic heart valve.
• have had a serious allergic reaction to Pradaxa.