PRADAXA safety and side effects banner treatment with PRADAXA banner

Safety & Side Effects

Some important considerations you’ll want to discuss with your doctor

There are different treatment options for your condition. One of these treatment options is PRADAXA. There is an overwhelming amount of information available regarding PRADAXA, and it can be confusing, but this site is here to help answer your questions. Be sure to discuss your questions with your doctor.

Important safety and side effects information

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 also be aware of possible serious side effects. Click on the links below as you read to learn more.

Discontinuation / bleeding

For people taking PRADAXA for atrial fibrillation (AFib) not caused by a heart valve problem:
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.

For people taking PRADAXA for deep vein thrombosis (DVT) and pulmonary embolism (PE):
PRADAXA treats blood clots in the veins of your legs (DVT) or lungs (PE) and reduces the risk of them occurring again.

Do not stop taking PRADAXA without talking to the doctor who prescribed it for you. Stopping PRADAXA increases your risk of a blood clot forming in your body.
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®)
    • if you have kidney problems and 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, 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 thrombotic event (the formation of a blood clot in a blood vessel).

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.

Spinal or epidural blood clots (hematoma). People who take PRADAXA and have medicine injected into their spinal and epidural area, or have a spinal puncture have a risk of forming a blood clot that can cause long-term or permanent loss of the ability to move (paralysis). Your risk of developing a spinal or epidural blood clot is higher if:

  • a thin tube called an epidural catheter is placed in your back to give you certain medicine
  • you take NSAIDs or a medicine to prevent blood from clotting
  • you have a history of difficult or repeated epidural or spinal punctures
  • you have a history of problems with your spine or have had surgery on your spine.

If you take PRADAXA and receive spinal anesthesia or have a spinal puncture, your doctor should watch you closely for symptoms of spinal or epidural blood clots. Tell your doctor right away if you have back pain, tingling, numbness, muscle weakness (especially in your legs and feet), loss of control of the bowels or bladder (incontinence).

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 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

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 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-10881-800-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.

download button PRADAXA and your other medications
Page revised 2/2015: PXD639317CONS-R1

Do you know how PRADAXA
compares to warfarin?

Discover the differences

Do you know how PRADAXA
compares to warfarin?

Discover the differences

IMPORTANT SAFETY INFORMATION AND USE OF PRADAXA

For people taking PRADAXA for atrial fibrillation: 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 prior to surgery or a medical or dental procedure. Your doctor will tell you when you should stop taking PRADAXA and when you may start taking it again. 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. Don’t take PRADAXA if you:

  • currently have abnormal bleeding;
  • have ever had an allergic reaction to it;
  • have had or plan to have a valve in your heart replaced

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

Spinal or epidural blood clots (hematoma). People who take PRADAXA and have medicine injected into their spinal and epidural area, or have a spinal puncture have a risk of forming a blood clot that can cause long-term or permanent loss of the ability to move (paralysis). Your risk of developing a spinal or epidural blood clot is higher if:

  • a thin tube called an epidural catheter is placed in your back to give you certain medicine
  • you take NSAIDs or a medicine to prevent blood from clotting
  • you have a history of difficult or repeated epidural or spinal punctures
  • you have a history of problems with your spine or have had surgery on your spine.

If you take PRADAXA and receive spinal anesthesia or have a spinal puncture, your doctor should watch you closely for symptoms of spinal or epidural blood clots. Tell your doctor right away if you have back pain, tingling, numbness, muscle weakness (especially in your legs and feet), loss of control of the bowels or bladder (incontinence).

Take PRADAXA exactly as prescribed. It is important to tell your doctors about all medicines, vitamins, and supplements you take. Some medicines may affect the way PRADAXA works.

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

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-10881-800-FDA-1088.

What is PRADAXA?

PRADAXA is a prescription blood thinner medicine that lowers the chance of blood clots forming in your body. PRADAXA is used to:

  • reduce the risk of stroke and blood clots in people who have a medical condition called 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 lead to blood clots forming and increase your risk of a stroke.
  • treat blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism) and reduce the risk of them occurring again.

PRADAXA is not for use in people with artificial (prosthetic) heart valves.

Please see full Prescribing Information and Medication Guide.

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.

Pradaxa® and PRADAXA with associated design ® are registered trademarks of Boehringer Ingelheim Pharma GmbH and Co. KG and used under license.

PradaxaLink™ and PradaxaLink™ with associated design are trademarks of Boehringer Ingelheim Pharmaceuticals, Inc.

The other brands listed above are trademarks of their respective owners, and are not trademarks of Boehringer Ingelheim Pharmaceuticals, Inc. The owners of these brands are not affiliated with and do not endorse Boehringer Ingelheim Pharmaceuticals, Inc., or its products.

This site is intended for U.S. residents only. Products discussed herein may have different names and labeling in different countries.

Use of this site is subject to the Internet Site Legal Notices and Disclaimers and Privacy Notice

Copyright © 2014 Boehringer Ingelheim Pharmaceuticals, Inc. All Rights Reserved. [12/14]

PXD639317CONS

SEE MORE

Important safety information and use of PRADAXA

For people taking PRADAXA for atrial fibrillation: 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 prior to surgery or a medical or dental procedure. Your doctor will tell you when you should stop taking PRADAXA and when you may start taking it again. 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. Don’t take PRADAXA if you:

  • currently have abnormal bleeding;
  • have ever had an allergic reaction to it;
  • have had or plan to have a valve in your heart replaced

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

Spinal or epidural blood clots (hematoma). People who take PRADAXA and have medicine injected into their spinal and epidural area, or have a spinal puncture have a risk of forming a blood clot that can cause long-term or permanent loss of the ability to move (paralysis). Your risk of developing a spinal or epidural blood clot is higher if:

  • a thin tube called an epidural catheter is placed in your back to give you certain medicine
  • you take NSAIDs or a medicine to prevent blood from clotting
  • you have a history of difficult or repeated epidural or spinal punctures
  • you have a history of problems with your spine or have had surgery on your spine.

If you take PRADAXA and receive spinal anesthesia or have a spinal puncture, your doctor should watch you closely for symptoms of spinal or epidural blood clots. Tell your doctor right away if you have back pain, tingling, numbness, muscle weakness (especially in your legs and feet), loss of control of the bowels or bladder (incontinence).

Take PRADAXA exactly as prescribed. It is important to tell your doctors about all medicines, vitamins, and supplements you take. Some medicines may affect the way PRADAXA works.

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

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-10881-800-FDA-1088

What is PRADAXA?

PRADAXA is a prescription blood thinner medicine that lowers the chance of blood clots forming in your body. PRADAXA is used to:

  • reduce the risk of stroke and blood clots in people who have a medical condition called 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 lead to blood clots forming and increase your risk of a stroke.
  • treat blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism) and reduce the risk of them occurring again.

PRADAXA is not for use in people with artificial (prosthetic) heart valves.

Please see full Prescribing Information and Medication Guide.

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.

Pradaxa® and PRADAXA with associated design ® are registered trademarks of Boehringer Ingelheim Pharma GmbH and Co. KG and used under license.

PradaxaLink™ and PradaxaLink™ with associated design are trademarks of Boehringer Ingelheim Pharmaceuticals, Inc.

The other brands listed above are trademarks of their respective owners, and are not trademarks of Boehringer Ingelheim Pharmaceuticals, Inc. The owners of these brands are not affiliated with and do not endorse Boehringer Ingelheim Pharmaceuticals, Inc., or its products.

This site is intended for U.S. residents only. Products discussed herein may have different names and labeling in different countries.

Use of this site is subject to the Internet Site Legal Notices and Disclaimers and Privacy Notice

Copyright © 2014 Boehringer Ingelheim Pharmaceuticals, Inc. All Rights Reserved. [12/14]

PXD639317CONS