SAFETY & SIDE EFFECTS

Safety & Side Effects

  • FOR PRADAXA PATIENTS
  • HOW TO TAKE PRADAXA
  • SAFETY & SIDE EFFECTS
  • JOIN THE PRADAXA SUPPORT PROGRAM
  • MEDICATON REMINDERS

When you’re taking PRADAXA, you’ll need to be aware of possible side effects and what to do if you experience any signs or symptoms of these side effects.

PRADAXA can cause serious side effects. Click on the links below to learn more:

BLEEDING

PRADAXA can cause bleeding, which can be serious and sometimes lead to death. This is because PRADAXA is a blood-thinning medicine (anticoagulant) 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 (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

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 with PRADAXA:

  • Chest pain or chest tightness.
  • Swelling of your face or tongue.
  • Trouble breathing or wheezing.
  • Feeling dizzy or faint.

MOST COMMON SIDE EFFECTS

Common side effects of PRADAXA include:

  • Indigestion, upset stomach, or burning.
  • Stomach pain.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of PRADAXA. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088, or by visiting www.fda.gov/medwatch.


Please note: This information is for people who have already been prescribed PRADAXA by their doctor. If you or a loved one would like to learn more about PRADAXA as a possible treatment option, review PRADAXA safety information here 

NEXT: Join The New Housecall™ support program

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Join The New Housecall™ support program for helpful information and resources. Plus, save on your prescription with the PRADAXA Savings Card.*

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Medication reminders make it easy to know when to take PRADAXA. Sign up now to get reminders by:

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* Pay no more than $30 if you have commercial insurance, with a maximum benefit of $100 on your monthly prescription over a 12-month period. If you are covered by a government-funded insurance, or are cash paying, or live in the state of Massachusetts, you are eligible for one FREE 30-day supply of PRADAXA.

WHAT IS PRADAXA?

PRADAXA is a prescription blood-thinning medicine used to reduce the risk of stroke and blood clots in people with atrial fibrillation not caused by a heart valve problem. With atrial fibrillation, part of the heart does not beat the way it should. This can cause blood clots to form, increasing your risk of a stroke. PRADAXA lowers the chance of blood clots forming in your body.

 

IMPORTANT SAFETY INFORMATION ABOUT PRADAXA

PRADAXA can cause bleeding which can be serious and sometimes lead to death. Don’t take PRADAXA if you currently have abnormal bleeding or if you have ever had an allergic reaction to it.

Your risk of bleeding with PRADAXA may be higher if you:

  • • 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, like aspirin products, non-steroidal anti-inflammatory drugs (NSAIDs) and blood thinners
  • • have kidney problems and take dronedarone (Multaq®) or ketoconazole tablets (Nizoral®)

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

It is important to tell your doctor about all medicines, vitamins and supplements you take. Some of your other medicines may affect the way PRADAXA works.

Take PRADAXA exactly as prescribed by your doctor. Don’t stop taking PRADAXA without talking to your doctor as your risk of stroke may increase.

Tell your doctor if you are planning to have any surgery, or medical or dental procedure, because you may have to stop taking PRADAXA for a short time.

PRADAXA can cause indigestion, stomach upset or burning, and stomach pain.

Click here for full Prescribing Information including Medication Guide

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.

The health information contained in this Website is provided for educational purposes only and is not intended to replace discussions with a healthcare professional. All decisions regarding patient care must be made with a healthcare professional, considering the unique characteristics of the patient.

IMPORTANT SAFETY INFORMATION ABOUT PRADAXA

PRADAXA can cause bleeding which can be serious and sometimes lead to death. Don’t take PRADAXA if you currently have abnormal bleeding or if you have ever had an allergic reaction to it.


Your risk of bleeding with PRADAXA may be higher if you:

  • • 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, like aspirin products, non-steroidal anti-inflammatory drugs (NSAIDs) and blood thinners
  • • have kidney problems and take dronedarone (Multaq®) or ketoconazole tablets (Nizoral®)

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

It is important to tell your doctor about all medicines, vitamins and supplements you take. Some of your other medicines may affect the way PRADAXA works.


Take PRADAXA exactly as prescribed by your doctor. Don’t stop taking PRADAXA without talking to your doctor as your risk of stroke may increase.


Tell your doctor if you are planning to have any surgery, or medical or dental procedure, because you may have to stop taking PRADAXA for a short time.


PRADAXA can cause indigestion, stomach upset or burning, and stomach pain.



WHAT IS PRADAXA?


PRADAXA is a prescription blood-thinning medicine used to reduce the risk of stroke and blood clots in people with atrial fibrillation not caused by a heart valve problem. With atrial fibrillation, part of the heart does not beat the way it should. This can cause blood clots to form, increasing your risk of a stroke. PRADAXA lowers the chance of blood clots forming in your body.


Click here for full Prescribing Information including Medication Guide.


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.


The health information contained in this Website is provided for educational purposes only and is not intended to replace discussions with a healthcare professional. All decisions regarding patient care must be made with a healthcare professional, considering the unique characteristics of the patient.



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PRADAXA® (DABIGATRAN ETEXILATE MESYLATE) CAPSULES:
IMPORTANT STORAGE AND HANDLING INFORMATION
PRADAXA must be kept dry. To protect it from moisture, PRADAXA comes in either a bottle with a special cap that contains a drying agent or a blister pack with each capsule sealed separately.

When taking PRADAXA, please follow these instructions carefully:
  • Always store PRADAXA in its original container.
    • Never put PRADAXA into any other container, such as a pill box or pill organizer.
    • Store PRADAXA at room temperature between 59°F to 86°F (15°C to 30°C).
  • If your PRADAXA came in a bottle:
    • Be sure the closure tape, which indicates that the bottle has not been opened, is intact when you receive your prescription. Do not remove the closure tape until you are ready to open the bottle. Open your new bottle only after finishing your current bottle.
    • Once the bottle is opened, you must use PRADAXA within 30 days.
      • As soon as you open the bottle, write the date on the label. PRADAXA will expire 30 days after the date you opened the bottle.
      • Do not alter the child-proof cap.
      • Safely throw away any unused PRADAXA after 30 days.
      • If your pharmacist or other healthcare provider gave you more than one bottle of PRADAXA, be sure to open only one bottle at a time.
    • Each time you take PRADAXA:
      • Remove only one capsule from the opened bottle.
      • Immediately and tightly close the bottle.
  • If your PRADAXA came in a blister pack, remove only one capsule from the pack at a time.
  • Always read the Medication Guide included with each of your PRADAXA prescriptions. There may be information that is new or that has changed since your last prescription.
  • Remember to keep PRADAXA, and all medicines, out of the reach of children.
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