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Some important considerations you’ll want to discuss with your doctor
Because PRADAXA is available only by prescription, the decision to prescribe it is made by a healthcare professional after discussing a range of important considerations with the individual patient. These considerations include both the risks and benefits of PRADAXA, and any other conditions you may have or other medications you may be taking. When taking PRADAXA, you should be aware of possible serious side effects. Click on the links below as you read to learn more.
- Discontinuation/Bleeding (click to expand)
PRADAXA lowers your chance of having a stroke by helping to prevent clots from forming. If you stop taking PRADAXA, you may have increased risk of forming a clot in your blood.
Do not stop taking PRADAXA without talking to the doctor who prescribes it for you. Stopping PRADAXA increases your risk of having a stroke.
PRADAXA may need to be stopped, if possible, prior to surgery or a medical or dental procedure. Ask the doctor who prescribed PRADAXA for you when you should stop taking it. Your doctor will tell you when you may start taking PRADAXA again after your surgery or procedure. If you have to stop taking PRADAXA, your doctor may prescribe another medicine to help prevent a blood clot from forming.
PRADAXA can cause bleeding which can be serious, and sometimes lead to death. This is because PRADAXA is a blood thinner medicine that lowers the chance of blood clots forming in your body.
You may have a higher risk of bleeding if you take PRADAXA and:
- Are 75 years old or older
- Have kidney problems
- Have stomach or intestine bleeding that is recent or keeps coming back, or you have a stomach ulcer
- Take other medicines that increase your risk of bleeding, including:
- Aspirin or aspirin-containing products
- Long-term (chronic) use of non-steroidal anti-inflammatory drugs (NSAIDs)
- Warfarin sodium (Coumadin®, Jantoven®)
- A medicine that contains heparin
- Clopidogrel bisulfate (Plavix®)
- Prasugrel (Effient®)
- Have kidney problems and also take dronedarone (Multaq®) or ketoconazole tablets (Nizoral®).
Tell your doctor if you take any of these medicines. Ask your doctor or pharmacist if you are not sure if your medicine is one listed above.
PRADAXA can increase your risk of bleeding because it lessens the ability of your blood to clot. While you take PRADAXA:
- You may bruise more easily.
- It may take longer for any bleeding to stop.
Call your doctor or seek immediate medical care if you have any of the following signs or symptoms of bleeding:
- Any unexpected, severe, or uncontrollable bleeding; or bleeding that lasts a long time.
- Unusual or unexpected bruising.
- Coughing up or vomiting blood; or vomit that looks like coffee grounds.
- Pink or brown urine; red or black stools (looks like tar).
- Unexpected pain, swelling, or joint pain.
- Headaches and feeling dizzy or weak.
Take PRADAXA exactly as prescribed. Do not stop taking PRADAXA without first talking to the doctor who prescribes it for you. Stopping PRADAXA may increase your risk of a stroke.
PRADAXA may need to be stopped, if possible, for one or more days before any surgery, or medical or dental procedure. If you need to stop taking PRADAXA for any reason, talk to the doctor who prescribed PRADAXA for you to find out when you should stop taking it. Your doctor will tell you when to start taking PRADAXA again after your surgery or procedure.
- Allergic reactions (click to expand)
In some people, PRADAXA can cause symptoms of an allergic reaction, including hives, rash, and itching. Tell your doctor or get medical help right away if you get any of the following symptoms of a serious allergic reaction to PRADAXA:
- Chest pain or chest tightness
- Swelling of your face or tongue
- Trouble breathing or wheezing
- Feeling dizzy or faint
- Most common side effects (click to expand)
Most common side effects of PRADAXA include:
- Indigestion, upset stomach, or burning
- Stomach pain
Be sure to tell your doctor if you have any side effect that bothers you or does not go away.
These are not all of the possible side effects of PRADAXA. For more information, ask your doctor or pharmacist and be sure to also access the Medication Guide.
Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
If you or a loved one would like to find out more about PRADAXA as a possible treatment option, take time to review the PRADAXA Safety Information. Then use the Doctor Discussion Guide for an easy way to get the conversation started during your next office visit.Next: Free Information Kit »