Pradaxa can cause you to bleed more easily. Call your doctor at once if you have: bleeding gums, nosebleeds, heavy menstrual periods or abnormal vaginal bleeding, blood in your urine, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.
Many other drugs can increase your risk of bleeding when used with dabigatran. Tell your doctor about all medicines you have recently used.
Pradaxa can cause a very serious blood clot around your spinal cord if you undergo a spinal tap or receive spinal anesthesia (epidural), especially if you have a genetic spinal defect, if you have a spinal catheter in place, if you have a history of spinal surgery or repeated spinal taps, or if you are also using other drugs that can affect blood clotting. This type of blood clot can lead to long-term or permanent paralysis.
Get emergency medical help if you have symptoms of a spinal cord blood clot such as back pain, numbness or muscle weakness in your lower body, or loss of bladder or bowel control.
Do not stop taking Pradaxa without first talking to your doctor. Stopping suddenly can increase your risk of blood clot or stroke.
Before taking this medicine
You should not take Pradaxa if you are allergic to dabigatran, or if you have:
an artificial heart valve; or
active bleeding from a surgery, injury, or other cause.
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.
Pradaxa may cause you to bleed more easily, especially if:
you have a stomach ulcer or 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.
To make sure Pradaxa is safe for you, tell your doctor if you have:
kidney disease;
a bleeding disorder that is inherited or caused by disease;
antiphospholipid syndrome (also called Hughes syndrome or "sticky blood syndrome"), an immune system disorder that increases the risk of blood clots;
a stomach ulcer; or
if you have been taking rifampin.
Tell your doctor if you are pregnant or if you become pregnant. Taking Pradaxa during pregnancy may cause bleeding in the mother or the newborn baby. However, the risk of blood clots is higher during pregnancy. The benefit of preventing a blood clot may outweigh any risks to the baby.
You should not breast-feed while using dabigatran.
