Precautions and Warnings With Dabigatran

Before taking dabigatran, it's important to understand that this medication may not be safe for certain people, such as those who have a bleeding disorder, kidney disease, or stomach ulcers. Safety precautions to be aware of with dabigatran also include warnings of potential drug interactions and allergic reactions. Do not take this drug if you have active bleeding, such as bleeding in the brain.

What Should I Tell My Healthcare Provider Before Taking Dabigatran?

You should talk with your healthcare provider prior to taking dabigatran etexilate mesylate (Pradaxa®) 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 Dabigatran Precautions and Warnings

Some warnings and precautions to be aware of prior to taking this drug include the following:
 
  • One of the most serious dabigatran 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. Dabigatran 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.
 
  • Dabigatran should be stopped ahead of time for elective surgery. However, stopping dabigatran for too long (for any reason) increases your risk for a stroke. Ask your healthcare provider when you should stop and restart dabigatran.
 
  • Studies show that warfarin (Coumadin®, an older anticoagulant) works better and is safer than dabigatran in one particular group of people (those with mechanical prosthetic heart valves). In fact, dabigatran should not be used in people with mechanical prosthetic heart valves for this particular reason. 
 
  • Dabigatran may interact with a number of different medications (see Drug Interactions With Dabigatran).
     
  • A lower dabigatran dosage may be recommended for people with poorly functioning kidneys.
     
  • Dabigatran 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 dabigatran 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).
     
Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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