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You should not take dabigatran if you are allergic to it, or if you have:

  • an artificial heart valve; or

  • any active bleeding from a surgery, injury, or other cause.

Dabigatran may cause you to bleed more easily, especially if:

  • you have a stomach ulcer;

  • you have recent or recurring bleeding in your stomach or intestines;

  • you have kidney disease (especially if you also take dronedarone or ketoconazole);

  • you take certain other medicines that can increase bleeding risk, such as aspirin, clopidogrel (Plavix), heparin, prasugrel, warfarin (Coumadin, Jantoven);

  • you take an NSAID (nonsteroidal anti-inflammatory drug) on a regular basis, such as ibuprofen (Advil, Motrin), naproxen (Aleve), diclofenac, indomethacin, meloxicam, and others; or

  • you are older than 75.

Dabigatran can cause a very serious blood clot around your spinal cord if you undergo a spinal tap or receive spinal anesthesia (epidural). This type of blood clot could cause long-term paralysis, and may be more likely to occur if:

  • you have a genetic spinal defect;

  • you have a spinal catheter in place;

  • you have a history of spinal surgery or repeated spinal taps;

  • you have recently had a spinal tap or epidural anesthesia;

  • you are taking an NSAID--Advil, Aleve, Motrin, and others; or

  • you are using other medicines to treat or prevent blood clots.

To make sure dabigatran is safe for you, tell your doctor if you have:

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  • if you are older than 75.

It is not known whether Pradaxa will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

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