Generic Name: dabigatran, Oral capsule

Generic Name:

dabigatran, Oral capsule

Pradaxa

All Brands

  • Pradaxa
SECTION 1 of 5

Highlights for dabigatran

Oral capsule
1

Dabigatran is an oral drug used to prevent and treat blood clots.

2

The usual dose of dabigatran is one 150-mg capsule taken by mouth two times per day. Take each dose 12 hours apart with a full glass of water.

3

Dabigatran can cause serious bleeding, which can sometimes be fatal. This is because dabigatran is a blood thinner drug that lowers the chance of blood clots forming in your body.

4

Your doctor may do a blood test to check how well your kidneys are working before and during dabigatran treatment. If you have reduced kidney function, more dabigatran may stay in your body. This puts you at an increased risk for side effects, such as bleeding.

5

Common side effects include upset stomach, heartburn, indigestion, and stomach pain.

IMPORTANT INFORMATION

FDA Warning

This drug has a Black Box Warning. This is the most serious warning from the Food and Drug Administration (FDA). A black box warning alerts doctors and patients to potentially dangerous effects.

Warning for stopping treatment.Dabigatran is used to prevent or treat blood clots. Stopping it before you finish your treatment will increase your risk of blood clots. This raises your risk for stroke or heart attack. If you need to stop this medication, before you complete your treatment, your doctor may prescribe another drug to help prevent a clot from forming.

This medication may be stopped before you complete your treatment due to active bleeding, conversion to another blood thinner, development of acute renal failure, or a medical or dental procedure.

Risk of permanent paralysis. People who take dabigatran and have another medicine injected into their spinal and epidural area, or have a spinal puncture, have a risk of forming a severe blood clot. This type of blood clot can cause long-term or permanent paralysis (loss of the ability to move). Your risk is higher if:

  • a thin tube called an epidural catheter is placed into your back to give you medicine
  • you take this drug in addition to nonsteroidal anti-inflammatory drugs (NSAIDs) or another 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 you’ve had surgery on your spine

If you take dabigatran and receive spinal anesthesia or have a spinal puncture, your doctor should watch you for signs of spinal or epidural blood clots. Tell your doctor right away if you have these symptoms:

  • back pain
  • tingling, numbness, or muscle weakness, especially in your legs and feet
  • loss of control of your bladder or bowels (incontinence)

Risk of bleeding

Dabigatran can cause serious bleeding which can sometimes be fatal. This is because dabigatran is a blood thinner drug that decreases the chance of blood clots forming in your body. You may have a higher risk of bleeding if you:

  • are over 75 years old
  • have kidney problems, especially if you take the drug dronedarone or ketoconazole
  • have a history of stomach or intestinal bleeding or a stomach ulcer
  • take other medicines that increase your risk of bleeding, such as aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs)
  • undergo invasive or surgical procedures

Call your doctor or get medical help right away if you have any of these signs of bleeding:

  • unexpected bleeding or bleeding that lasts a long time, such as:
    • unusual bleeding from your gums
    • frequent nosebleeds
    • heavier than normal menstrual bleeding
  • severe bleeding that you can’t control
  • pink or brown-colored urine
  • red or black-colored, tarry stools
  • unexplained bruises
  • coughing up blood
  • vomiting blood or vomit that looks like coffee grounds
  • unexpected pain or swelling
  • headaches
  • weakness
  • dizziness

Artificial heart valve risk

Don’t take dabigatran if you have an artificial (prosthetic) heart valve. If you have this condition, this drug may not protect you from blood clots and strokes. It may also increase your risk of bleeding.

Drug Features

Dabigatran is a prescription drug. It’s available as an oral capsule.

Why It's Used

Dabigatran is used to:

  • reduce the risk of stroke and blood clots in people with atrial fibrillation.
  • treat blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism)
  • reduce the risk of additional blood clots in people with a history of blood clots in the veins of their legs (deep vein thrombosis) or lungs (pulmonary embolism)

How It Works

Dabigatran is a blood thinner that decreases the chance of blood clots forming in your body. It belongs to a class of medications known as direct thrombin inhibitors.

Thrombin is a substance in your blood that’s needed to form clots. Thrombin also causes platelets in your blood to stick to one another, causing clots to form. Dabigatran blocks thrombin and then prevents a clot (thrombus) from forming in your body.

SECTION 2 of 5

dabigatran Side Effects

Oral capsule

Most Common Side Effects

The most common side effects that occur with dabigatran include:

  • stomach pain

  • upset stomach, heartburn, or indigestion

Serious Side Effects

If you experience any of these serious side effects, call your doctor right away. If your symptoms are potentially life threatening, or if you think you’re experiencing a medical emergency, call 9-1-1.

  • serious bleeding: Symptoms may include:

    • bruising more easily
    • taking longer to stop bleeding
    • unexpected bleeding or bleeding that lasts a long time, such as:
      • unusual bleeding from your gums
      • frequent nosebleeds
      • heavier than normal menstrual bleeding
    • severe bleeding or bleeding that you can’t control
    • pink or brown-colored urine
    • red or black-colored, tarry stools
    • unexplained bruises
    • coughing up blood or blood clots
    • vomiting blood or vomit that looks like coffee grounds
    • unexpected pain or swelling
    • headaches
    • weakness
    • dizziness
  • spinal or epidural blood clots (hematoma). People who take dabigatran and have another medicine injected into their spinal and epidural area, or have a spinal puncture, are at risk of forming a severe blood clot. This can cause long-term or permanent paralysis (loss of the ability to move). Symptoms may include:

    • back pain
    • tingling, numbness, or muscle weakness, especially in your legs and feet
    • loss of control of your bladder or bowels (incontinence)
  • allergic reactions. Symptoms may include:

    • hives
    • skin rash
    • itching
    • feeling faint or dizzy
    • chest pain or tightness
    • trouble breathing or wheezing
    • swelling of your tongue or face
Pharmacist's Advice
Healthline Pharmacist Editorial Team

Dabigatran does not cause drowsiness.

Mild side effects may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.
SECTION 3 of 5

dabigatran May Interact with Other Medications

Oral capsule

Dabigatran can interact with other medications, herbs, or vitamins you might be taking. That’s why your doctor should manage all of your medications carefully. If you’re curious about how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

Note: You can reduce your chances of drug interactions by having all of your prescriptions filled at the same pharmacy. That way, a pharmacist can check for possible drug interactions.

Medications That Might Interact with This Drug

Rifampin
  • rifampin (Rifater, Rifamate, Rimactane, Rifadin)

This medicine may reduce the blood levels of dabigatran. This may stop dabigatran from working as well, which would raise your risk for blood clots and stroke. These drugs shouldn’t be taken together.

Nonsteroidal anti-inflammatory drugs (NSAIDs)

Examples of NSAIDs include:

  • diclofenac (Cataflam)
  • etodolac
  • fenoprofen (Nalfon)
  • flurbiprofen
  • ibuprofen (Motrin)
  • indomethacin (Indocin)
  • ketoprofen
  • ketorolac (Sprix, Toradol)
  • meclofenamate
  • mefenamic acid (Ponstel)
  • meloxicam (Mobic)
  • nabumetone
  • naproxen (Naprosyn)
  • oxaprozin (Daypro)
  • piroxicam (Feldene)
  • sulindac (Clinoril)
  • tolmetin

Use caution when taking dabigatran with NSAIDs. Taking NSAIDs with dabigatran may increase your chance for bleeding.

Blood thinners and antiplatelet drugs
  • aspirin or products that contain aspirin
  • warfarin sodium (Coumadin, Jantoven)
  • heparin
  • clopidogrel (Plavix)
  • prasugrel (Effient)

Taking dabigatran with these drugs increases your risk for bleeding.

Protein pump blockers
  • dronedarone (Multaq)
  • ketoconazole (Nizoral)

These medications increase levels of dabigatran in your blood. This may raise your risk for bleeding. Your doctor may reduce your dose of dabigatran or decide not give you the drug at all.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.

People with bleeding problems

Dabigatran can cause serious bleeding, which can sometimes be fatal. This is because dabigatran is a blood thinner drug that decreases the chance of blood clots forming in your body. You may have a higher risk of bleeding if you:

  • are over 75 years old
  • have kidney problems, especially if you take the drug dronedarone or ketoconazole
  • have a history of stomach or intestinal bleeding or a stomach ulcer
  • take other medicines that increase your risk of bleeding, such as aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs)

People with a history of stomach ulcers

Dabigatran is a blood thinner drug, which may put you at an increased risk of bleeding. This may make your stomach ulcer worse.

People with kidney problems

This drug is cleared by your kidneys. If your kidneys don’t work well, dabigatran may build up in your body and cause more side effects. Your doctor may reduce your dose depending on how well your kidneys are working. People who are on dialysis shouldn’t take this drug.

Pregnant women

Dabigatran is a category C pregnancy drug. That means two things:

  1. Research in animals has shown adverse effects to the fetus when the mother takes the drug.
  2. There haven’t been enough studies done in humans to be certain how the drug might affect the fetus.

Tell your doctor if you’re pregnant or plan to become pregnant. Dabigatran should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Women who are nursing

It isn’t known if dabigatran passes through breastmilk. If it does, it may cause serious effects in a breastfeeding child.

You and your doctor may need to decide if you will take dabigatran or breastfeed.

For Seniors

In general, the risk of stroke and bleeding increases with age. You may be more likely to have bleeding while you take this drug.

For Children

The safety and effectiveness of dabigatran haven’t been established in people under the age of 18 years.

Keep this medicine out of the reach of children.

When to call the doctor

Call your doctor right away if you fall or hurt yourself, especially if you hit your head. Your doctor may need to check you for bleeding that might be happening inside your body.

If you plan to have surgery or a medical or a dental procedure, tell your doctor or dentist that you’re taking dabigatran. You may have to stop taking dabigatran for a short time.

Allergies

Dabigatran can cause a severe allergic reaction. Symptoms may include:

  • feeling faint or dizzy
  • chest pain or tightness
  • trouble breathing or wheezing
  • swelling of your tongue or face

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal.

SECTION 4 of 5

How to Take dabigatran (Dosage)

Oral capsule

All possible dosages and forms may not be included here. Your dose, form, and how often you take it will depend on:

  • your age
  • the condition being treated
  • how severe your condition is
  • other medical conditions you have
  • how you react to the first dose

What Are You Taking This Medication For?

Reduce the risk of stroke and blood clots
Form: Oral capsule
Strengths: 75 mg and 150 mg
Adult Dosage (ages 18 years and older)
  • The standard dose is 150 mg taken two times per day.
  • Doses should be spaced 12 hours apart.
Child Dosage (ages 0-17 years)

A safe and effective dose hasn’t been established in people younger than 18 years old.

Special Considerations

Kidney problems: Creatinine clearance (CrCl) is laboratory test that measures how well your kidneys are working. Your dose of dabigatran depends on how well your kidneys are working.

  • CrCl less than 15 mL/min or people who are on dialysis: Don’t take this medication.
  • CrCl 15–30 mL/min: The dose is 75 mg taken two times per day. Doses should be spaced 12 hours apart.
  • CrCl 30–50 mL/min if you take the drug with dronedarone or ketoconazole: 75 mg taken two times per day. Doses should be spaced 12 hours apart.
  • You shouldn’t use dabigatran if your CrCl is less than 50 mL/min and you take dronedarone or ketoconazole.

Warnings

You’re at increased risk of blood clots if you stop taking dabigatran before you’re supposed to.

Deep vein thrombosis and pulmonary embolism
Form: Oral capsule
Strengths: 75 mg and 150 mg
Adult Dosage (ages 18 years and older)
  • The standard dose is 150 mg taken two times per day.
  • Doses should be spaced 12 hours apart.
Child Dosage (ages 0-17 years)

A safe and effective dose hasn’t been established in people younger than 18 years old.

Special Considerations

Kidney problems: Creatinine clearance (CrCl) is laboratory test that measures how well your kidneys are working. Your dose of dabigatran depends on how well your kidneys are working.

  • CrCl less than or equal to 30 mL/min or people who are on dialysis: Don’t take this medication.
  • You shouldn’t use dabigatran if your CrCl is less than 50 mL/min and you take dronedarone or ketoconazole.

Warnings

You’re at increased risk of blood clots if you stop taking dabigatran before you’re supposed to.

Reduce the risk of additional blood clots
Form: Oral capsule
Strengths: 75 mg and 150 mg
Adult Dosage (ages 18 years and older)
  • The standard dose is 150 mg taken two times per day daily.
  • Doses should be spaced 12 hours apart.
Child Dosage (ages 0-17 years)

A safe and effective dose hasn’t been established in people younger than 18 years old.

Special Considerations

Kidney problems: Creatinine clearance (CrCl) is laboratory test that measures how well your kidneys are working. Your dose of dabigatran depends on how well your kidneys are working.

  • CrCl less than or equal to 30 mL/min or people who are on dialysis: Dosing recommendations are not provided.
  • You shouldn’t use dabigatran if your CrCl is less than 50 mL/min and you take dronedarone or ketoconazole.

Warnings

You’re at increased risk of blood clots if you stop taking dabigatran before you’re supposed to.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always to speak with your doctor or pharmacist about dosages that are right for you.
Pharmacist's Advice
Healthline Pharmacist Editorial Team

Dabigatran comes with serious risks if you don’t take it as prescribed.

If You Miss a Dose

If you miss a dose, take it as soon as you remember. If your next dose is less than 6 hours away, skip the missed dose and take one dose at your scheduled time. Don’t take two doses at the same time to try to make up for this missed dose.

If You Stop Taking It or Don’t Take It On Schedule

Don’t stop taking it without talking to your doctor first. Stopping the drug may increase your risk of having a stroke or forming blood clots. Don’t run out of dabigatran. Refill your prescription before you run out.

If You Take Too Much

You will have serious complications from bleeding. If you think that you have taken too much dabigatran, call your doctor or go to the emergency room right away. It’s important to take your medication every day as directed by your doctor even though you may not know if the medication is helping you.

How to Tell the Drug is Working

If you’re taking it to reduce the risk of stoke or blood clots, you may not be able to tell it’s working.

If you’re taking the drug to treat deep vein thrombosis or pulmonary embolism, you may be able to tell it’s working if your symptoms from the blood clots go away or get better.

Dabigatran can be used for both short-term and long-term treatment.

Your doctor will decide how long you should take dabigatran.

Important Considerations for Taking Dabigatran

Don’t cut or crush the capsules

Swallow dabigatran capsules whole. Don’t break or chew it. Don’t empty the pellets from the capsule.

Store in temperatures from 59–86°F (15–30°C)

Dabigatran comes in a bottle or in a blister package. If your medication comes in a bottle, you should only open one bottle at time. Once the bottle is opened, you should use it all within four months.

Keep the drug in its original package to protect it.

Keep this drug away from moisture. Don’t store it in your bathroom or any other damp location.

Travel

When traveling with your medication:

  • Always carry it with you or in your carry-on bag.
  • Don’t worry about airport X-ray machines. They can’t hurt this medication.
  • You may need to show your pharmacy’s label to clearly identify the medication. Keep the original prescription-labeled with you when traveling.
  • Be sure that you have enough medicine before you leave on your trip. It may be difficult to refill your prescription while traveling. It’s important that you don’t run out of dabigatran. Refill your prescription before you run out of medicine.

Clinical Monitoring

Your doctor may check the following during your treatment with dabigatran:

  • kidney function. Your doctor may do a blood test to check how well your kidneys are working. If you have kidney problems, your body won’t be able to clear out the drug as well. This could cause more dabigatran to stay in your body, putting you at an increased risk for side effects, such as bleeding. Your dose of dabigatran may need to be decreased, or your doctor may switch you to a different drug.
  • signs of bleeding. Your doctor may do blood tests to check for symptoms of bleeding.

Insurance

Many insurance companies will require a prior authorization before they approve the prescription and pay for dabigatran.

Are There Any Alternatives?

There are several drugs that work to treat or prevent blood clots. Some may be more suitable for you than others. Talk to your doctor about possible alternatives.

SECTION 5 of 5

How Much Does dabigatran Cost?

Oral capsule
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Lowest price for dabigatran

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Content developed in collaboration with University of Illinois-Chicago, Drug Information Group

Medically reviewed by Creighton University, Center for Drug Information and Evidence-Based Practice on June 11, 2015

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

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