Pradaxa (Dabigatran) – Oral

Warning:

The Food and Drug Administration (FDA) has issued a boxed warning for Pradaxa. Boxed warnings are the agency’s strongest warnings for serious and potentially life-threatening risks.

The boxed warning:

Premature discontinuation of Pradaxa increases the chance of thrombotic events (when blood clots block veins or arteries): Premature discontinuation of any oral anticoagulant (blood thinner) increases the risk of thrombotic events. To reduce this risk, consider treatment with another anticoagulant if Pradaxa is discontinued for a reason other than bleeding or completion of a course of therapy.

Spinal/epidural hematoma: Epidural or spinal hematomas (a serious bruise) may occur in people treated with Pradaxa who are receiving neuraxial (placing a needle between the vertebrae) anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis.

What Is Pradaxa?

Pradaxa (dabigatran) is an orally administered prescription anticoagulant (blood thinner), specifically a direct thrombin inhibitor (DTI), available in capsule form for people 8 and older.

Pradaxa is an alternative to warfarin (a blood thinner used to treat blot clots) used to reduce the risk of stroke in atrial fibrillation (AFib, a heart rhythm disorder that increases the chance of clots) not caused by a heart valve problem.

It is also approved to treat deep vein thrombosis (DVT, blood clots in the veins of your legs) or pulmonary embolism (PE, blood clots in the lungs) in adults who have been treated with blood thinner injections and to reduce the risk of them reoccurring.

In general, anticoagulant medicines are used to prevent blood clots in high-risk people. A blood clot is a mass of blood that has coagulated (become thickened).

Pradaxa works by preventing blood clots from forming in the body.

This medication is also available as a generic product called dabigatran. However, as the focus of this article, Pradaxa is a brand-name drug available in capsule form to be consumed orally (by mouth).

Drug Facts

Generic Name: Dabigatran
Brand Name: Pradaxa
Drug Availability: Prescription
Administration Route: Oral
Therapeutic Classification: Anticoagulant
Available Generically: Yes
Controlled Substance: N/A
Active Ingredient: Dabigatran etexilate mesylate

Dosage Form(s): Capsule

What Is Pradaxa Used For?

The FDA approved Pradaxa for the following:

  • To reduce the risk of stroke and systemic embolism (a serious complication after heart transplantation) in adults with non-valvular AFib (AFib not caused by an issue with a heart valve).
  • For the treatment of DVT and PE in adults who have been treated with a parenteral anticoagulant (drugs used to treat DVT and PE) for five to 10 days.
  • To reduce the risk of recurrence of DVT and PE in adults who have been previously treated.
  • For the prophylaxis (method of treatment to stop the reoccurrence of a condition) of DVT and PE in adults who have undergone hip replacement surgery.
  • For the treatment of venous thromboembolism (VTE; a blood clot in a vein) in children 8 to 18 years old who have been treated with a parenteral anticoagulant for at least five days.
  • To reduce the risk of recurrence of VTE in children 8 to 18 who have been previously treated.

When blood clots occur in the veins or arteries, they can be dangerous and even life-threatening. 

How to Take Pradaxa

Take Pradaxa exactly as prescribed by your healthcare provider.

The capsules are taken twice a day (or once daily for VTE prophylaxis after hip or knee replacement) and should be taken whole without chewing or breaking. Take Pradaxa with a full glass of water, with or without food.

When it is used to prevent a DVT or PE after hip replacement surgery, it is usually taken one to four hours after surgery and then once a day for another 28 to 35 days.

Your Pradaxa dose may have to be adjusted if you have kidney disease. Make sure you tell your healthcare provider what other medications you are taking since Pradaxa can interact with other drugs. 

Storage

Pradaxa capsules are sensitive to moisture, which can cause the medication to break down and become less effective.

For that reason, it is important to keep the capsules in the bottle they came in. Do not store Pradaxa in other containers, such as pill boxes or organizers.

Only open one bottle at a time, and close the bottle tightly after use. Avoid storing the capsules in the bathroom.

Once you have opened a bottle, finish it within four months.

Off-Label Uses

Sometimes, healthcare providers prescribe Pradaxa for off-label uses.

Off-label use means that a healthcare provider prescribes the drug to treat a different medical condition than the FDA-approved if they feel it will benefit the person. 

Potential off-label indications for which healthcare providers may prescribe Pradaxa include:

How Long Does Pradaxa Take to Work?

Pradaxa begins to reduce blood clotting within a few hours after taking the first dose. If you stop taking it, however, its effect on clotting begins to wear off within 24 hours for most people.

What Are the Side Effects of Pradaxa?

This is not a complete list of side effects, and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 1-800-FDA-1088.

Common Side Effects

As with all anticoagulants, Pradaxa increases your risk of bleeding.

You might notice that you bruise more easily or that bleeding takes longer to stop. Because Pradaxa reduces your blood’s ability to clot, contact your healthcare provider if you fall or hurt yourself, especially if you hit your head.

Dyspepsia (upset stomach) is a common side effect of Pradaxa and can limit the medication’s use in some people.

Severe Side Effects

The FDA has issued a boxed warning for Pradaxa. Boxed warnings are the agency’s strongest warnings for serious and potentially life-threatening risks.

The boxed warning:

Premature discontinuation of Pradaxa increases the chance of thrombotic events: Premature discontinuation of any oral anticoagulant increases the risk of thrombotic events. To reduce this risk, consider treatment with another anticoagulant if Pradaxa is discontinued for a reason other than bleeding or completion of a course of therapy.

Spinal/epidural hematoma: Epidural or spinal hematomas may occur in people treated with Pradaxa who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis.

Call your healthcare provider right away if you have:

Fortunately, a drug called idarucizumab can quickly reverse the effects of Pradaxa and be given in a hospital in the event of severe bleeding.

Do not stop taking Pradaxa until you have spoken to your healthcare provider or have been seen in an emergency room.

Make sure your healthcare team knows that you are on Pradaxa if you are about to undergo a medical or dental procedure, particularly a lumbar puncture (spinal tap) or epidural anesthesia. Pradaxa has been associated with bleeding around the spinal cord after such a procedure.

Like most medications, it is possible to be allergic to Pradaxa's active ingredient, dabigatran. Let your healthcare provider know if you have symptoms like hives, rash, or itching. 

Signs of a severe allergic reaction include:

  • Swelling of the lips and tongue
  • Dyspnea (trouble breathing)
  • Chest pain
  • Dizziness

Seek medical help right away if you experience any signs of a severe reaction. 

Report Side Effects

Pradaxa may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your healthcare provider may send a report to the FDA's MedWatch Adverse Event Reporting Program or by phone (800-332-1088).

Dosage: How Much Pradaxa Should I Take? 

Drug Content Provided and Reviewed by IBM Micromedex®

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (capsules):
    • For prevention of stroke and blood clots in patients with nonvalvular atrial fibrillation:
      • Adults—75 to 150 milligrams (mg) 2 times a day.
      • Children—Use and dose must be determined by your doctor.
    • For prevention of blood clots after hip replacement surgery:
      • Adults—110 milligrams (mg) taken 1 to 4 hours after hip surgery. Then, 220 mg taken once a day for 28 to 35 days.
      • Children—Use and dose must be determined by your doctor.
    • For treatment and prevention of blood clots from occurring again:
      • Adults—150 milligrams (mg) 2 times a day.
      • Children 8 years of age and older—Dose is based on body weight and must be determined by your doctor.
        • Weighing more than 81 kilograms (kg)—260 milligrams (mg) 2 times a day (one 150 mg capsule plus one 110 mg capsule 2 times a day or one 110 mg capsule plus two 75 mg capsules two times a day).
        • Weighing 61 to less than 81 kg—220 mg 2 times a day (two 110 mg capsules 2 times a day).
        • Weighing 41 to less than 61 kg—185 mg 2 times a day (one 110 mg capsule plus one 75 mg capsule 2 times a day).
        • Weighing 26 to less than 41 kg—150 mg 2 times a day (one 150 mg capsule or two 75 mg capsules 2 times a day).
        • Weighing 16 to less than 26 kg—110 mg 2 times a day (one 110 mg capsule 2 times a day).
        • Weighing 11 to less than 16 kg—75 mg 2 times a day (one 75 mg capsule 2 times a day).
      • Children younger than 8 years of age—Use and dose must be determined by your doctor.
  • For oral dosage form (pellets):
    • For treatment and prevention of blood clots from occurring again:
      • Children 2 to 12 years of age—Dose is based on body weight and must be determined by your doctor.
        • Weighing more than 41 kilograms (kg)—260 milligrams (mg) 2 times a day (one 110 mg packet plus one 150 mg packet 2 times a day).
        • Weighing 21 to less than 41 kg—220 mg 2 times a day (two 110 mg packets 2 times a day).
        • Weighing 16 to less than 21 kg—170 mg 2 times a day (one 20 mg packet plus one 150 mg packet 2 times a day).
        • Weighing 13 to less than 16 kg—140 mg 2 times a day (one 30 mg packet plus one 110 mg packet 2 times a day).
        • Weighing 11 to less than 13 kg—110 mg 2 times a day (one 110 mg packet 2 times a day).
        • Weighing 9 to less than 11 kg—90 mg 2 times a day (one 40 mg packet plus one 50 mg packet 2 times a day).
        • Weighing 7 to less than 9 kg—70 mg 2 times a day (one 30 mg packet plus one 40 mg packet 2 times a day).
      • Children younger than 2 years of age—Dose is based on body weight and must be determined by your doctor.
        • Children 18 to less than 24 months of age weighing 21 to less than 26 kilograms (kg)—180 milligrams (mg) 2 times a day (one 30 mg packet plus one 150 mg packet 2 times a day).
        • Children 12 to less than 24 months of age weighing 16 to less than 21 kg—140 mg 2 times a day (one 30 mg packet plus one 110 mg packet 2 times a day).
        • Weighing 13 to less than 16 kg—
          • Children 11 to less than 24 months of age—140 mg 2 times a day (one 30 mg packet plus one 110 mg packet 2 times a day).
          • Children 10 to less than 11 months of age—100 mg 2 times a day (two 50 mg packets 2 times a day).
        • Weighing 11 to less than 13 kg—
          • Children 18 to less than 24 months of age—110 mg 2 times a day (one 110 mg packet 2 times a day).
          • Children 8 to less than 18 months of age—100 mg 2 times a day (two 50 mg packets 2 times a day).
        • Weighing 9 to less than 11 kg—
          • Children 11 to less than 24 months of age—90 mg 2 times a day (one 40 mg packet plus one 50 mg packet 2 times a day).
          • Children 6 to less than 11 months of age—80 mg 2 times a day (two 40 mg packets 2 times a day).
          • Children 5 to less than 6 months of age—60 mg 2 times a day (two 30 mg packets 2 times a day).
        • Weighing 7 to less than 9 kg—
          • Children 9 to less than 24 months of age—70 mg 2 times a day (one 30 mg packet plus one 40 mg packet 2 times a day).
          • Children 4 to less than 9 months of age—60 mg 2 times a day (two 30 mg packets 2 times a day).
          • Children 3 to less than 4 months of age—50 mg 2 times a day (one 50 mg packet 2 times a day).
        • Weighing 5 to less than 7 kg—
          • Children 5 to less than 24 months of age—50 mg 2 times a day (one 50 mg packet 2 times a day).
          • Children 3 to less than 5 months of age—40 mg 2 times a day (one 40 mg packet 2 times a day).
        • Children 3 to less than 10 months of age weighing 4 to less than 5 kg—40 mg 2 times a day (one 40 mg packet 2 times a day).
        • Children 3 to less than 6 months of age weighing 3 to less than 4 kg—30 mg 2 times a day (one 30 mg packet 2 times a day).

Modifications

Talk to your healthcare provider about appropriate dosing in these situations:

Dosage: Your dose may need to be adjusted if you have kidney disease. Certain drugs (e.g., ketoconazole, verapamil, and particular antibiotics) may increase the blood thinning effect of Pradaxa in people with kidney disease. Your dose may need to be adjusted or certain drug combinations avoided.

Pregnancy: There is not enough data regarding the use of Pradaxa in pregnant people to make a recommendation on the risk of birth defects, miscarriage, or adverse outcomes. The medicine does get transferred from the pregnant person to the fetus in small amounts, which can potentially harm the fetus, but the effect is not well established.

Breastfeeding: There is no data on the presence of dabigatran in human milk, the effects on the breastfed child, or milk production. However, Pradaxa was present in rat milk. Therefore, breastfeeding is not recommended during treatment with Pradaxa. 

Children: The capsules can be used in adolescents 8 to 18 years old who can swallow the capsules whole. 

Adults Over 65: Per clinical studies, the risk of stroke and bleeding increases with age, but the risk-benefit profile is favorable in all age groups.

Missed Dose

If you forget a dose, take it as soon as you remember, unless your next scheduled dose is less than six hours away. In that case, skip the missed dose. Don’t take two doses at once.

Overdose: What Happens If I Take Too Much Pradaxa?

Call your healthcare provider if you accidentally take a larger than prescribed dose.

Too much dabigatran in your system can increase your risk for bleeding complications.

What Happens If I Overdose on Pradaxa?

If you think you or someone else may have overdosed on Pradaxa, call a healthcare provider or the Poison Control Center (1-800-222-2222).

If someone collapses or isn’t breathing after taking Pradaxa, call 911 immediately.

Precautions

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It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

It is important to tell your doctor if you are pregnant or planning to become pregnant before using this medicine. Using this medicine while you are pregnant may increase the risk of severe bleeding from your uterus.

Make sure any doctor who treats you knows that you are using this medicine. You may need to stop using this medicine for several days before having surgery, including dental procedures.

You may bleed and bruise more easily while you are using this medicine. Be extra careful to avoid injuries. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Gently brush and floss your teeth. Be careful when using sharp objects, including razors and fingernail clippers. Avoid picking your nose. If you need to blow your nose, blow it gently.

Check with your doctor right away if you have any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, headache, dizziness, or weakness, pain, swelling, or discomfort in a joint, pinpoint red spots on your skin, unusual nosebleeds, or unusual vaginal bleeding that is heavier than normal. These may be signs of bleeding problems.

Do not suddenly stop using this medicine without asking first your doctor. Doing so may increase risk of blood clots and stroke.

This medicine may increase your risk of developing spinal or epidural blood clot. This usually occurs if you have an epidural catheter placed in your back to give you certain medicine, are taking NSAIDs or medicine to prevent blood clotting, or have a history of spinal problems or have had surgery on your spine. Check with your doctor if you have midline back pain, loss of bladder or bowel control, or numbness, tingling, or weakness of your legs or feet while you are using this medicine.

Check with your doctor right away if you have stomach pain or upset, nausea, heartburn, or indigestion while you are taking this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

What Are Reasons I Shouldn’t Take Pradaxa?

Potential users should note the following before starting treatment:

Anticoagulant therapy, bleeding: You should not take Pradaxa if you have certain bleeding conditions, have had a serious allergic reaction to dabigatran, or have a replaced heart valve.

Surgery: Pradaxa should be used with extreme caution in those undergoing surgery and interventions due to the risk of bleeding.

Dialysis, kidney issues: Use Pradaxa with caution in people with kidney impairment.

Intramuscular injections: Subcutaneous (intramuscular) injections of other medications should not be administered to people receiving Pradaxa.

What Other Medications Interact With Pradaxa?

Many drugs may interact with Pradaxa.

Before starting treatment, tell your healthcare provider about other medications, vitamins, or supplements you are taking. 

The following medications can increase your risk of bleeding while taking Pradaxa:

  • Other anticoagulants: Avoid combining Pradaxa with another blood thinner.
  • Anti-inflammatory drugs (e.g., Durlaza [aspirin]): People on a combination of anti-inflammatory drugs and Pradaxa should be monitored.
  • Certain antifungals (e.g., ketoconazole and fluconazole): Your Pradaxa dose may need to be adjusted.
  • Vitamin E: People should be monitored with this combination.

Medications containing rifampin can reduce dabigatran’s anticoagulant effect, and the combination should be avoided. 

What Medications Are Similar?

Dabigatran is a member of the “direct thrombin inhibitor” class of anticoagulants. They work by interfering with the action of thrombin, a protein important in blood clotting. 

Dabigatran is the only available direct thrombin inhibitor you can take by mouth.

The introduction of an oral direct thrombin inhibitor was an important advance over warfarin, the previous first choice for oral anticoagulation.

Dabigatran is easier to use and does not require periodic blood testing like warfarin.

Angiomax (bivalirudin) and argatroban are other direct thrombin inhibitors given through an intravenous (IV) route.

Xarelto (rivaroxaban), Eliquis (apixaban), and Savaysa (edoxaban) are other oral anticoagulants that work by interfering with another protein in the clotting process, called factor Xa.

Antiplatelet drugs like aspirin, Plavix (clopidogrel), and ticlopidine may also be referred to as blood thinners.

Plavix and ticlopidine have different mechanisms of action, interfering with the action of platelets (blood cells) to start the clotting process, in comparison to Pradaxa.

Antiplatelet drugs tend to be used for slightly different indications than true anticoagulants.

Frequently Asked Questions

  • What is Pradaxa used for?

    Pradaxa is an oral anticoagulant used for the treatment of blood clots in the case of DVT or PE. It is also used to prevent strokes in people with AFib and prevent VTE following total hip replacement.

    Pradaxa is not appropriate for those with mechanical heart valves.

  • How does Pradaxa work?

    Pradaxa interferes with the action of thrombin, a protein in the blood that is important in clotting. Blocking the action of thrombin reduces the ability of blood to clot.

  • What drugs should not be taken with Pradaxa?

    Drugs containing the antibiotic rifampin may decrease the effectiveness of Pradaxa. This combination is generally avoided.

    There is a long list of medications that may interact with Pradaxa.

    Make sure your prescribing healthcare provider knows what drugs, vitamins, and herbal supplements you are taking.

  • What are the side effects of Pradaxa?

    Like with any anticoagulant, Pradaxa can increase your risk for bleeding. Tell your healthcare provider if you have an abnormal predisposition to bleeding.

    You may notice that you bruise more easily or that bleeding takes longer to stop. Dyspepsia is the next most common side effect.

  • Are there any dietary restrictions with Pradaxa?

    Unlike warfarin, Pradaxa has no specific dietary restrictions.

How Can I Stay Healthy While Taking Pradaxa?

It’s scary to learn that you have a blood clot that could spread to your lungs or a heart arrhythmia that increases your risk of stroke.

But these diagnoses don’t need to define you. We are lucky to have widely available, convenient oral anticoagulant treatments which help your body’s natural mechanisms against blood clots.

Drugs like Pradaxa don’t require frequent blood tests like older anticoagulants and don’t require dietary restrictions.

Use common sense while on blood thinners, such as avoiding activities that place you at risk of falls or injury. 

Medical Disclaimer

Verywell Health's drug information is meant for educational purposes only and is not intended as a replacement for medical advice, diagnosis, or treatment from a healthcare provider. Consult your healthcare provider before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.

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Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
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By Rony Kampalath, MD
Rony Kampalath, MD, is board-certified in diagnostic radiology and previously worked as a primary care physician. He is an assistant professor at the University of California at Irvine Medical Center, where he also practices. Within the practice of radiology, he specializes in abdominal imaging.