Pradaxa Side Effects

Pradaxa (dabigatran) is a direct thrombin inhibitor. It helps keep the blood from coagulating (clotting).

Pradaxa is used to prevent blood clots and to reduce the risk of stroke in people with a certain type of heart rhythm disorder.

You should not take Pradaxa if you are allergic to dabigatran, or if you have any active bleeding from a surgery, injury, or other cause.

To make sure you can safely take Pradaxa, tell your doctor if you have any of these other conditions:

  • kidney disease;
  • mechanical heart valves;
  • a history of stomach ulcer or bleeding; or
  • if you are older than 75.

FDA pregnancy category C. It is not known whether Pradaxa will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using Pradaxa. It is not known whether dabigatran passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Get emergency medical help if you have any of these signs of an allergic reaction to Pradaxa: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using Pradaxa and call your doctor at once if you have a serious side effect such as:

  • any bleeding that will not stop;
  • weakness, feeling like you might pass out;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • blood in your urine or stools, black or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • pink or brown urine;
  • joint pain or swelling; or
  • heavy menstrual bleeding.

Less serious Pradaxa side effects may include:

  • nausea, diarrhea;
  • stomach pain or upset, indigestion, heartburn; or
  • mild skin rash or itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.