Pradaxa Warnings and Precautions

You should not take Pradaxa if you have active bleeding, such as an intestinal ulcer or bleeding in the brain. Other warnings and precautions with Pradaxa involve possible drug interactions and allergic reactions. Make sure your healthcare provider has a list of any other medications, herbs, or vitamins you are taking before beginning treatment. Also, make sure to tell your healthcare provider if you are pregnant or breastfeeding.

What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to taking Pradaxa® (dabigatran etexilate mesylate) if you have:
  • A bleeding disorder
  • Intestinal or stomach ulcers or bleeding
  • Bleeding in the brain
  • An aneurysm
  • A prosthetic heart valve
  • Kidney disease, such as kidney failure (renal failure)
  • Any allergies, including allergies to foods, dyes, or preservatives.
Also, let your healthcare provider know if you:
  • Have an upcoming surgery
  • Are pregnant or thinking of becoming pregnant
  • Are breastfeeding.
Make sure to tell your healthcare provider about any other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Specific Precautions and Warnings With Pradaxa

Some warnings and precautions to be aware of prior to taking this drug include the following:
  • One of the most serious Pradaxa side effects is bleeding, including potentially fatal internal bleeding. People who have the highest risk for serious bleeding with this medication include those who are taking other medications that increase the bleeding risk and women in labor and delivery. Pradaxa should not be given to any individual with active bleeding.


  • Let your healthcare provider know if you develop any signs of bleeding, such as:
    • Easy bruising
    • Cuts or scrapes that are slow to stop bleeding
    • Black, tarry stools; bright-red blood in the stool; or vomiting of blood (signs of gastrointestinal bleeding)
    • Signs of bleeding in the brain, such as vision or speech changes, weakness or numbness in an arm or leg, or a severe headache.
  • Studies show that warfarin (Coumadin®, an older anticoagulant) works better and is safer than Pradaxa in one particular group of people (those with mechanical prosthetic heart valves). In fact, Pradaxa should not be used in people with mechanical prosthetic heart valves for this particular reason.  
  • Pradaxa should be stopped ahead of time for elective surgery. However, stopping Pradaxa for too long (for any reason) increases your risk for a stroke. Ask your healthcare provider when you should stop and restart Pradaxa.
  • Pradaxa may interact with a number of different medications (see Pradaxa Drug Interactions).
  • A lower Pradaxa dosage may be recommended for people with poorly functioning kidneys.
  • Pradaxa is a pregnancy Category C medication, meaning that it may not be safe for use during pregnancy, although the full risks are currently unknown (see Pradaxa and Pregnancy for more information).
  • At this time, it is unknown if Pradaxa passes through breast milk in humans. If you are breastfeeding or plan to start breastfeeding, discuss this with your healthcare provider prior to taking the drug (see Pradaxa and Breastfeeding for more information).
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Pradaxa Medication Information

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