"Nov. 4, 2011 -- The FDA has approved Janssen's Xarelto to prevent stroke in patients with an abnormal heart rhythm called atrial fibrillation -- with a strong "black box" warning.
A black box warning is the FDA's strongest warning."...
Pradaxa Patient Information Including Side Effects
Brand Names: Pradaxa
Generic Name: dabigatran (Pronunciation: da BIG a tran)
- What is dabigatran (Pradaxa)?
- What are the possible side effects of dabigatran (Pradaxa)?
- What is the most important information I should know about dabigatran (Pradaxa)?
- What should I discuss with my healthcare provider before taking dabigatran (Pradaxa)?
- How should I take dabigatran (Pradaxa)?
- What happens if I miss a dose (Pradaxa)?
- What happens if I overdose (Pradaxa)?
- What should I avoid while taking dabigatran (Pradaxa)?
- What other drugs will affect dabigatran (Pradaxa)?
- Where can I get more information?
What is dabigatran (Pradaxa)?
Dabigatran keeps the platelets in your blood from coagulating (clotting).
Dabigatran is used to prevent blood clots and to reduce the risk of stroke in people with a certain type of heart rhythm disorder.
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:
- 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 side effects may include:
- stomach pain or upset, indigestion, heartburn;
- nausea, diarrhea; 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. You may report side effects to FDA at 1-800-FDA-1088.
Read the Pradaxa (dabigatran etexilate mesylate) Side Effects Center for a complete guide to possible side effects
What is the most important information I should know about dabigatran (Pradaxa)?
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 such as a fall or a bump on the head. 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.
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.
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 taking dabigatran for a short time before you have surgery or other medical procedures.
Do not stop taking the medicine without first talking to your doctor.
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.
Before taking dabigatran, tell your doctor if you have kidney disease, a history of stomach ulcer or bleeding, if you are older than 75, or if you are using a blood thinner such as heparin or warfarin (Coumadin, Jantoven).
Do not crush, chew, break, or open a dabigatran capsule. Swallow the pill whole.
Additional Pradaxa Information
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