Medications and Drugs
Brand Names: Pradaxa
Generic Name: dabigatran (Pronunciation: da BIG a tran)
What is dabigatran (Pradaxa)?
Dabigatran keeps the platelets in your blood from coagulating (clotting).
Dabigatran may also be used for purposes not listed in this medication guide.
What are the possible side effects of dabigatran (Pradaxa)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using dabigatran and call your doctor at once if you have a serious side effect such as:
Less serious side effects may include:
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is the most important information I should know about dabigatran (Pradaxa)?
You should not take dabigatran if you are allergic to it, or if you have any active bleeding from a surgery, injury, or other cause.
Tell your doctor if you have recently used or received any other medications to treat or prevent blood clots.
Do not crush, chew, break, or open a dabigatran capsule. Swallow the pill whole.
If you need surgery, dental work, or any type of medical test or treatment, tell the doctor or dentist ahead of time if you have taken dabigatran within the past 12 hours. You may need to stop using the medicine for a short time for surgery or other medical procedures. Do not stop taking this medication without first talking to your doctor.
Because dabigatran keeps your blood from coagulating (clotting) to prevent unwanted blood clots, this medicine can also make it easier for you to bleed, even from a minor injury. Avoid activities that may increase your risk of bleeding or injury. Contact your doctor or seek emergency medical attention if you have bleeding that will not stop.
Stop taking dabigatran and call your doctor at once if you have any signs of bleeding such as weakness, feeling like you might pass out, easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin, pink or brown urine, bloody or tarry stools, coughing up blood, joint pain or swelling, or heavy menstrual bleeding.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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