Pradaxa is a brand-name prescription medication. It’s FDA-approved to decrease your risk of developing a blood clot, which can be dangerous if it’s in your legs or lungs. A blood clot that typically develops in your lower legs is known as a deep vein thrombosis (DVT). And a blood clot in your lungs is called a pulmonary embolism (PE).

Pradaxa is FDA-approved to:

  • Decrease the risk of stroke and blood clots in adults with nonvalvular atrial fibrillation (A-fib). This is an irregular heartbeat in the upper chambers of your heart. “Nonvalvular” means that faulty heart valves aren’t causing the condition.
  • Treat DVTs and PEs in adults who have taken a type of drug called an anticoagulant in injection form for 5 to 10 days. (Anticoagulants are sometimes called blood thinners.)
  • Decrease the risk of DVTs and PEs in adults who have already been treated for them.
  • Prevent DVTs and PEs in adults who have had a hip replacement.

Pradaxa contains the active drug dabigatran, which is part of a drug class called direct thrombin inhibitors. (A class of drugs is a group of medications that work in a similar way.) Pradaxa is a type of anticoagulant.

Pradaxa comes as a capsule that you swallow. You’ll usually take the drug once or twice a day. Pradaxa isn’t approved for use in children.

Effectiveness

Clinical studies looked at how well Pradaxa works to help prevent blood clots in people with nonvalvular A-fib. Blood clots can be very serious, and PEs or DVTs can sometimes result in death, so it’s very important to try to prevent them from occurring.

In one study, Pradaxa was compared with the drug warfarin (Coumadin). The rate of death from any cause was 3.6% a year for people who took Pradaxa compared with 4.1% a year for people who took warfarin. The rate of death due to vascular causes was also lower in the Pradaxa group: 2.3% compared with 2.7% in the warfarin group. “Vascular causes” are problems that occur in blood vessels or arteries and include heart attacks and strokes.

For more information about the effectiveness of Pradaxa, see the “Pradaxa uses” section below.

Pradaxa is available only as a brand-name medication. It’s not currently available in generic form.

A generic drug is an exact copy of the active drug in a brand-name medication. The generic is considered to be just as safe and effective as the original drug. Generics also tend to cost less than brand-name drugs.

Pradaxa contains the active drug dabigatran. (As the active drug, dabigatran is the ingredient that makes Pradaxa work.)

Pradaxa can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Pradaxa. These lists don’t include all possible side effects.

For more information on the possible side effects of Pradaxa, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs they have approved. If you would like to report to the FDA a side effect you’ve had with Pradaxa, you can do so through MedWatch.

Mild side effects

The mild side effects of Pradaxa that are more common* can include:

The mild side effects of Pradaxa that are less common** can include:

* occurred in more than 15% of people in clinical studies

** occurred in 15% or less of people in clinical studies

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Pradaxa aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

  • Increased risk of blood clots when stopping Pradaxa use.* Symptoms can include:
    • swelling
    • pain, warmth, or redness at the area of the clot
  • Blood clots in or around your spine.* Symptoms can include:
    • back pain
    • muscle weakness
    • numbness
    • tingling

Other serious side effects, explained in more detail below in “Side effect details,” include:

* Pradaxa has boxed warnings for the increased risk of blood clots when you stop taking Pradaxa as well as blood clots in and around your spinal column. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For more information, see “FDA warnings” at the beginning of this article.

Side effect details

You may wonder how often certain side effects occur with this drug. Here’s some detail on several of the side effects this drug may cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Pradaxa. In clinical trials, between 0% and 0.3% of people had allergic reactions to Pradaxa. It’s not known how common this side effect was in people who took other medications or a placebo (treatment with no active drug).

Symptoms of a mild allergic reaction can include:

  • skin rash
  • itchiness
  • flushing (warmth and redness in your skin)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have a severe allergic reaction to Pradaxa. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Side effects in older adults

Older adults may have more side effects from Pradaxa than younger people. However, it’s not known how often older adults have side effects. This group may bruise more easily than usual or have nosebleeds or bleeding gums. As you get older, the risk of bleeding or stroke occurring while taking Pradaxa increases. However, even with the additional risk of bleeding or stroke, sometimes this medication is the best choice for you.

If you’re taking Pradaxa and are bleeding often, can’t control bleeds, or feel dizzy, tell your doctor. They may switch you to a different medication or decrease the dose.

Bleeding

Pradaxa may increase your risk for bleeding. This is because the drug works by preventing your body from making clots. When your skin has an open wound or a wound that’s healing, your body usually forms a scab over that area. While you’re taking Pradaxa, it’s harder for your blood to clot and form a scab. You may have a higher risk for bleeding if you’re taking another medication that also increases the risk of bleeding.

Pradaxa was compared with warfarin (Coumadin) in studies. People took either drug to treat a blood clot in their legs called a deep vein thrombosis (DVT) or a blood clot in their lungs known as a pulmonary embolism (PE).

About 1.4% of people who took Pradaxa in the studies had a major bleeding event. Bleeding was considered a major bleeding event if it resulted in death, occurred in an organ, caused symptoms such as dizziness, or caused a decrease in the level of hemoglobin. (Hemoglobin is a protein found in red blood cells.)

Bleeding that was fatal occurred in 0.04% of people who took Pradaxa. In comparison, about 2% of people who took warfarin had a major bleeding event, and 0.1% of these people had bleeds that were fatal.

How often bleeding occurs may differ based on what condition you’re taking Pradaxa to help prevent or treat.

What to look for

It’s important to watch for symptoms of bleeding while you’re taking Pradaxa. Tell your doctor if you have any of the following:

  • fatigue (lack of energy)
  • joint pain
  • nosebleeds
  • bleeding gums
  • bruising
  • headaches

Symptoms of serious bleeds can include:

  • bleeding more easily than usual
  • vomiting blood or what looks like coffee grounds
  • coughing up blood or blood clots
  • bright red blood in your stool
  • black, tarry-looking stool
  • severe bleeding that you can’t stop

During your Pradaxa treatment, your doctor may monitor your blood to make sure your levels are normal and that you don’t have an increased risk for a bleed. If left untreated, serious bleeding can be fatal. So if you have any of the above symptoms while taking Pradaxa, see your doctor right away.

Heartburn

Heartburn is a side effect that may occur with Pradaxa. Heartburn can cause you to feel pain or burning in your chest. This is due to acid from your stomach moving into your esophagus, a tube that runs from your mouth to your stomach.

In four studies, 7.5% of people who took Pradaxa reported having heartburn. This was compared with 5.5% of people who took warfarin. Two of these studies looked at treating DVT or PE. The other two studies looked at people who took Pradaxa to prevent a DVT or PE from occurring again.

If you develop heartburn that’s bothersome to you while taking Pradaxa, tell your doctor. They may be able to recommend some ways to reduce the acid buildup and help ease your symptoms.

Increased risk of blood clots when you stop taking Pradaxa

Pradaxa is a type of drug called an anticoagulant. (Anticoagulants are sometimes called blood thinners.) Stopping the use of an anticoagulant such as Pradaxa sooner than advised may increase your risk for a blood clot. Pradaxa has a boxed warning for this. (A boxed warning is the most serious warning that the FDA requires.) It’s not known if anyone from clinical trials stopped taking Pradaxa and then had a blood clot.

Pradaxa works by stopping blood clots from forming. This helps prevent blood clots that can lead to heart attacks, strokes, and death. However, if you stop taking Pradaxa before your doctor tells you your treatment is complete, you’ll be at an increased risk of getting a blood clot.

It’s important to never stop taking Pradaxa without talking to your doctor first.

Blood clots in or around your spinal column

Pradaxa also has a boxed warning for a type of blood clot called a hematoma that’s spinal (in your spinal column) or epidural (in the area right around your spine). A boxed warning is the most serious warning that the FDA requires. During clinical trials, it wasn’t reported if anyone developed a spinal or epidural blood clot while taking Pradaxa.

This type of blood clot is possible only with spinal procedures such as spinal taps or if medication is injected into the spine column. This may cause a blood clot that can be very dangerous and even cause paralysis that’s long lasting or permanent.

You’re at an increased risk of developing a spinal or epidural blood clot if you:

  • are using other medications that affect blood clotting, which include nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, others), platelet inhibitors, and other anticoagulants
  • have had procedures in your spinal column that resulted in complications such as nerve damage
  • have a deformity of the spine
  • have a history of spinal surgery
  • have an indwelling epidural catheter (a tube that’s inserted into the area around your spine to give you medication, especially for pain)

Symptoms of a spinal or epidural blood clot may include back pain, tingling, weakness, and incontinence (loss of control of your bladder or bowels).

If you need any spinal procedures while you’re taking Pradaxa, your doctor will monitor you more carefully during and after the procedure.

The Pradaxa dosage your doctor prescribes will depend on several factors. These include:

  • the type and severity of the condition you’re using Pradaxa to treat
  • other medical conditions you may have, such as how well your kidneys are working
  • other medications that you’re taking

Typically, your doctor will start you on a low dosage. Then they’ll adjust it over time to reach the amount that’s right for you. Your doctor will ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Pradaxa comes as a capsule that you swallow. You’ll usually take the drug once or twice a day. Pradaxa is available in three strengths: 75 mg, 110 mg, and 150 mg.

Dosage for reducing the risk of stroke and systemic embolism in people with A-fib

The dose of Pradaxa to decrease the risk of stroke or a blood clot in people with nonvalvular atrial fibrillation (A-fib) is usually 150 mg twice a day.

However, your doctor may give you a different dose depending on factors such as whether you have kidney disease. If you have any questions about what dose is right for you, talk with your doctor.

Dosage for treating DVT and PE

The dose of Pradaxa to treat a current deep vein thrombosis (DVT) or pulmonary embolism (PE) is also 150 mg twice a day. A DVT is a blood clot that typically develops in your leg, and a PE is a blood clot that occurs in your lung. Pradaxa is used to treat a DVT or PE after you’ve already been treated with an anticoagulant in injection form for 5 to 10 days. (Anticoagulants are sometimes called blood thinners.)

However, your doctor may give you a different dose depending on factors such as whether you have kidney disease. If you have any questions about what dose is right for you, talk with your doctor.

Dosage for preventing DVT and PE

To prevent a deep vein thrombosis (DVT) or pulmonary embolism (PE) from occurring again, the dose of Pradaxa is 150 mg twice a day.

However, your doctor may give you a different dose depending on factors such as whether you have kidney disease. If you have any questions about what dose is right for you, talk with your doctor.

Dosage for preventing DVT and PE after a hip replacement

If you’re taking Pradaxa to prevent a deep vein thrombosis (DVT) or pulmonary embolism (PE) after a hip replacement, the starting dose would be 110 mg on day 1. Then the dose would increase to 220 mg once a day.

However, your doctor may give you a different dose depending on factors such as whether you have kidney disease. If you have any questions about what dose is right for you, talk with your doctor.

Dosage before surgery

Pradaxa works by stopping blood clots from forming. When your skin has an open wound or a wound that’s healing, your body usually forms a scab over that area. While you’re taking Pradaxa, it’s harder for your blood to clot and form a scab.

Your dose may need to be adjusted or you may need to stop taking Pradaxa for a few days before you have surgery. This helps prevent you from bleeding too much while you’re having surgery or healing afterward. Talk with your doctor about any surgeries that you plan to have and how to prevent bleeding.

If you need to have emergency surgery, sometimes you won’t have time to stop taking Pradaxa for a few days beforehand. In this case, there’s a medication that can be used to reverse bleeding from Pradaxa, if needed. See the section “Reversal of Pradaxa bleeds” for more information.

What if I miss a dose?

If you miss your scheduled dose of Pradaxa, be sure to take it as soon as you remember. If your next dose is less than 6 hours away, skip the missed dose and continue on your schedule with the next dose. If you have any questions about when to take your next dose after missing a dose, talk with your doctor or pharmacist.

To help make sure that you don’t miss a dose, try setting a reminder on your phone. A medication timer may be useful, too.

Will I need to use this drug long term?

Usually, Pradaxa is meant to be used as a long-term treatment. If you and your doctor determine that Pradaxa is safe and effective for you, you’ll likely take it long term.

However, in some cases, such as after a hip replacement, you may take Pradaxa for only a short period of time. Talk with your doctor about how long you should be using Pradaxa.

While you’re taking Pradaxa, you’re at an increased risk of bleeds. Some bleeds, such as stomach bleeds, may become serious. However, there is a medication called idarucizumab (Praxbind) that you may take if you develop a bleed. Idarucizumab is a reversal agent. This means it reverses the action of Pradaxa and helps your blood to clot normally again. It’s an injection that can be used in an emergency when you have uncontrollable bleeding.

Because Pradaxa stops your blood from clotting easily, you may be at an increased risk of bleeding if you have surgery while taking the medication.

Usually, your doctor will consider stopping your Pradaxa treatment 1 to 5 days before you have a major surgery. This is sometimes referred to as “holding your dose” because you’ll typically start taking Pradaxa again after your doctor says it’s fine.

The amount of time that you stop taking Pradaxa before a surgery depends on the procedure and your kidney function. Your doctor can tell you how long ahead of time you’ll need to stop taking Pradaxa before surgery.

However, sometimes emergency surgery is necessary. Idarucizumab can also be used in this case so that your body can clot blood again and you won’t develop a major bleed from the surgery.

Other drugs are available that can treat or help prevent a blood clot. Some may be a better fit for you than others. If you’re interested in finding an alternative to Pradaxa, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

Other medications that may be used to decrease your risk of blood clots, prevent blood clots occurring again, or prevent clotting after surgery include:

  • clopidogrel (Plavix)
  • apixaban (Eliquis)
  • enoxaparin (Lovenox)
  • fondaparinux (Arixtra)
  • rivaroxaban (Xarelto)
  • prasugrel (Effient)
  • warfarin (Coumadin)
  • heparin
  • ticagrelor (Brilinta)

You may wonder how Pradaxa compares with other medications that are prescribed for similar uses. Here we look at how Pradaxa and Eliquis are alike and different.

Ingredients

The active drug ingredient in Pradaxa is called dabigatran. The active drug ingredient in Eliquis is apixaban.

Uses

Pradaxa is used to decrease your risk of developing a blood clot, which can be dangerous if it’s in your legs or lungs. A blood clot that typically develops in your lower legs is known as a deep vein thrombosis (DVT). And a blood clot in your lungs is called a pulmonary embolism (PE).

The Food and Drug Administration (FDA) has approved Pradaxa to:

  • Decrease the risk of stroke and blood clots in adults with nonvalvular atrial fibrillation (A-fib). This is an irregular heartbeat in the upper chambers of your heart. “Nonvalvular” means that faulty heart valves aren’t causing the condition.
  • Treat DVTs and PEs in adults who have taken a type of drug called an injectable anticoagulant for 5 to 10 days. (Anticoagulants are sometimes called blood thinners.)
  • Decrease the risk of DVTs and PEs in adults who have already been treated for them.
  • Prevent DVTs and PEs in adults who have had a hip replacement.

Eliquis is FDA-approved for use in adults to:

  • reduce the risk of stroke and blood clots in nonvalvular A-fib
  • prevent DVT after a hip or knee replacement
  • treat DVT or PE
  • reduce the risk of DVT or PE occurring in people who have already had one

Drug forms and administration

Pradaxa comes as a capsule that you swallow. You’ll usually take the drug once or twice a day.

Eliquis comes as a tablet that you swallow. The tablet can also be crushed and dissolved in water, water and dextrose (sugar), or apple juice; or mixed with applesauce. In addition, the tablet can be dissolved in water and given through a nasogastric tube. (This is a tube that’s put up your nose and goes into your stomach.) You’ll usually take Eliquis tablets twice a day.

Side effects and risks

Pradaxa and Eliquis both contain anticoagulant (blood thinning) medications. Therefore, these medications can cause some similar side effects, but they can also cause some different ones. Below are examples of these side effects.

Mild side effects

These lists contain examples of mild side effects that can occur with Pradaxa, with Eliquis, or with both drugs (when taken individually).

Serious side effects

This list contains examples of serious side effects that can occur with both Pradaxa and Eliquis (when taken individually):

  • blood clots in or around your spine*
  • increased risk of blood clots when stopping Pradaxa or Eliquis use*
  • severe allergic reaction
  • serious bleeding

* Pradaxa and Eliquis have boxed warnings for the increased risk of blood clots when you stop taking the drug as well as blood clots in and around your spinal column. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For more information, see “FDA warnings” at the beginning of this article.

Effectiveness

Pradaxa and Eliquis are both FDA-approved to:

  • reduce the risk of stroke and blood clots in adults with nonvalvular A-fib
  • treat DVTs and PEs in adults
  • reduce the risk of DVT or PE in adults who have already had one
  • prevent DVT and PE from occurring after hip replacement surgery in adults

In addition, Eliquis is also FDA-approved to prevent a DVT or PE from occurring after knee replacement surgery.

These drugs haven’t been directly compared in clinical studies, but studies have found both Pradaxa and Eliquis to be effective for treating or preventing blood clots.

These drugs have been compared in a retrospective study on non-valvular A-fib. In this case, a retrospective study is one that looks back in time to compare data from people with A-fib who took either Pradaxa or Eliquis.

This study showed that the people who took Pradaxa had a 1.60% risk of major bleeding, compared with a 1.21% risk in people who took Eliquis. In the Pradaxa group, there was a 0.44% risk of a stroke occurring, compared with a 0.35% risk in the Eliquis group. This data doesn’t show a significant difference in major bleeding or stroke risk between Pradaxa and Eliquis.

Costs

Pradaxa and Eliquis are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics.

According to estimates on GoodRx.com, Pradaxa costs about the same as Eliquis. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Like Eliquis (above), the drug warfarin (Coumadin) has uses similar to those of Pradaxa. Here’s a comparison of how Pradaxa and warfarin are alike and different.

Ingredients

The active drug in Pradaxa is dabigatran. The active drug in warfarin is warfarin.

Uses

Pradaxa is used to decrease your risk of developing a blood clot, which can be dangerous if it’s in your legs or lungs. A blood clot that typically develops in your lower legs is known as a deep vein thrombosis (DVT). And a blood clot in your lungs is called a pulmonary embolism (PE).

The Food and Drug Administration (FDA) has approved Pradaxa to:

  • Decrease the risk of stroke and blood clots in adults with nonvalvular atrial fibrillation (A-fib). This is an irregular heartbeat in the upper chambers of your heart. “Nonvalvular” means that faulty heart valves aren’t causing the condition.
  • Treat DVTs and PEs in adults who have taken a type of drug called an anticoagulant in injection form for 5 to 10 days. (Anticoagulants are sometimes called blood thinners.)
  • Decrease the risk of DVTs and PEs in adults who have already been treated for them.
  • Prevent DVTs and PEs in adults who have had a hip replacement.

Warfarin is FDA-approved to:

  • prevent and treat blood clots due to A-fib in adults with or without a heart valve replacement
  • reduce the risk of blood clots, heart attacks, and death occurring after a stroke, blood clot, or heart attack has already occurred in adults
  • prevent and treat DVT and PE in adults

A major difference between Pradaxa and warfarin is that Pradaxa isn’t approved for use in people with heart valve replacements. Warfarin, on the other hand, can be used in people with heart valve replacements.

Drug forms and administration

Pradaxa comes as a capsule that you swallow. You’ll usually take the drug once or twice a day.

Warfarin comes as a tablet that you swallow. Your doctor may adjust your dosage based on blood tests. A small change in your warfarin dosage can greatly change how thin your blood is. So it’s important to get your levels checked often, as directed by your doctor. Sometimes your blood levels need to be checked every day until they’re stable and you know that your medication is working properly.

Side effects and risks

Pradaxa and warfarin both contain drugs that help prevent blood clots. Therefore, these medications can cause some similar side effects, but they can also cause some different ones. Below are examples of these side effects.

Mild side effects

These lists contain examples of mild side effects that can occur with Pradaxa, with warfarin, or with both drugs (when taken individually).

Serious side effects

These lists contain examples of serious side effects that can occur with Pradaxa, with warfarin, or with both drugs (when taken individually).

  • Can occur with Pradaxa:
    • increased risk of blood clots when stopping Pradaxa use*
    • blood clots in or around your spine*
  • Can occur with warfarin:
    • necrosis (tissue death)
    • clots made of cholesterol or plaquecalciphylaxis (calcium buildup in the body)
    • purple toes syndrome (a condition in which your toes can turn purple and become painful)
  • Can occur with both Pradaxa and warfarin:
    • serious bleeding**

* Pradaxa has boxed warnings for the increased risk of blood clots when you stop taking the drug as well as blood clots in and around your spinal column. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For more information, see “FDA warnings” at the beginning of this article.

** Warfarin has a boxed warning for the increased risk of major or fatal bleeding. A boxed warning is the most serious warning from the FDA.

Effectiveness

Pradaxa and warfarin are both FDA-approved to:

  • reduce the risk of stroke and blood clots in adults with nonvalvular A-fib
  • treat DVT and PE in adults
  • reduce the risk of DVT or PE occurring in adults after they’ve already had one

In addition, Pradaxa is also approved to prevent DVT or PE from occurring after hip replacement surgery. Warfarin is also approved to reduce the risk of blood clots in people with A-fib and heart valve replacements.

What the studies say

The use of Pradaxa and warfarin in treating nonvalvular A-fib has been directly compared in a clinical study. In the study, the rate of death from any cause was 3.6% a year in people who took Pradaxa compared with 4.1% a year in people who took warfarin. The rate of death due to vascular causes was also lower in the Pradaxa group: 2.3% compared with 2.7% in the warfarin group. “Vascular causes” are problems that occur in blood vessels or arteries and include heart attacks and strokes.

Pradaxa was also compared with warfarin in people being treated for a DVT or PE. In these studies, people took either warfarin or Pradaxa after being treated for 5 to 10 days with an anticoagulant in injection form. The results showed that 2.7% of people who took Pradaxa for a current DVT or PE had another DVT or PE while being treated. In comparison, 2.5% of people who took warfarin had another DVT or PE while being treated for their DVT or PE.

In another study, Pradaxa was compared with warfarin in people who had a past DVT or PE. These people had the clotting event 3 to 12 months ago and were treated for it. Then they took either Pradaxa or warfarin to help prevent another DVT or PE from occurring. In this study, 1.8% of people who took Pradaxa had another DVT or PE during treatment. In comparison, 1.3% of people who took warfarin had another DVT or PE during treatment.

Costs

Pradaxa is a brand-name medication. Warfarin is a generic medication called warfarin. It’s also available as a brand-name drug called Coumadin. Brand-name medications usually cost more than generics.

According to estimates on GoodRx.com, Pradaxa costs significantly more than warfarin and Coumadin. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

The Food and Drug Administration (FDA) approves prescription drugs such as Pradaxa to treat certain conditions. Pradaxa may also be used off-label for other conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

Pradaxa for reducing the risk of stroke and systemic embolism in people with A-fib

Pradaxa is approved to reduce the risk of stroke and blood clots in people with nonvalvular atrial fibrillation (A-fib). A-fib is a condition in which your heartbeat is irregular and can be faster than usual. And “nonvalvular” means that faulty heart valves aren’t the cause.

Symptoms of A-fib include sweating, heart palpitations, feeling tired, and trouble breathing. A-fib causes your heart to not pump blood properly, which can make blood gather and form a clot more easily.

Pradaxa works by thinning your blood and decreasing your body’s ability to form a blood clot. Strokes can be caused by blood clots that move to your brain. A blood clot in your lungs is called a pulmonary embolism (PE). And a blood clot that typically develops in your legs is known as a deep vein thrombosis (DVT). The risk of strokes as well as PEs and DVTs may be decreased by taking Pradaxa.

Clinical studies looked at how well Pradaxa works to help prevent blood clots in people with nonvalvular A-fib. Blood clots can be very serious, and PEs or DVTs can sometimes result in death, so it’s very important to try to prevent them from happening.

In one study, Pradaxa was compared with the drug warfarin (Coumadin). The rate of death from any cause was 3.6% a year in people who took Pradaxa compared with 4.1% a year in people who took warfarin. The rate of death due to vascular causes was also lower in the Pradaxa group: 2.3% compared with 2.7% in the warfarin group. “Vascular causes” are problems that occur in blood vessels or arteries and include heart attacks and strokes.

Pradaxa for treating DVT and PE

Pradaxa is also approved to treat deep venous thrombosis (DVT) and pulmonary embolism (PE) in adults. They must have taken an injectable form of a type of drug called an anticoagulant for 5 to 10 days. (Anticoagulants are sometimes called blood thinners.)

Pradaxa works by decreasing your body’s ability to form a blood clot. Pradaxa also decreases the risk of a blood clot occurring again because it lowers your body’s ability to form a clot.

Pradaxa was also compared with warfarin in people being treated for a DVT or PE. In these studies, people took either warfarin or Pradaxa after being treated for 5 to 10 days with a blood thinner in injection form. The results showed that 2.7% of people who took Pradaxa for a current DVT or PE had another DVT or PE while being treated. In comparison, 2.5% of people who took warfarin had another DVT or PE while being treated for their DVT or PE.

Pradaxa for preventing DVT and PE

Pradaxa is approved to prevent a deep venous thrombosis (DVT) and pulmonary embolism (PE) from occurring in adults who were treated for a past DVT or PE.

Pradaxa works by decreasing your blood’s ability to clot. By decreasing clotting, Pradaxa reduces the risk of DVT and PE from occurring again.

In a study, Pradaxa was compared with warfarin in people who had a past DVT or PE. These people had the clotting event 3 to 12 months ago and were treated for it. Then they took either Pradaxa or warfarin to help prevent another DVT or PE from occurring. In this study, 1.8% of people who took Pradaxa had another DVT or PE during treatment. In comparison, 1.3% of people who took warfarin had another DVT or PE during treatment.

In another study, Pradaxa was compared with a placebo (treatment with no active drug) to help prevent DVT or PE in people who had one in the past. These people were treated with a different anticoagulant drug for 6 to 18 months and then started taking Pradaxa or a placebo to prevent another DVT or PE. Researchers found that 0.4% of people who took Pradaxa had a DVT or PE. In comparison, 5.6% of people who took a placebo had a DVT or PE.

Pradaxa for preventing DVT and PE after a hip replacement

After a hip replacement, you’re at a higher risk for developing a blood clot, such as a deep vein thrombosis (DVT) or a pulmonary embolism (PE). This is because you’re unable to move for a time after surgery, which means your blood is flowing more slowly and can clot easier. You’re also at a higher risk due to the surgery itself, in which your hip joint is replaced.

Pradaxa was studied to help prevent blood clots in people who had just had hip replacement surgery. Researchers compared Pradaxa with enoxaparin (Lovenox), which is an anticoagulant in injection form. DVTs occurred in 7.6% of people who took Pradaxa. In comparison, DVTs occurred in 8.5% of people who took enoxaparin. PEs occurred in 0.1% of people who took Pradaxa and in 0.2% of people who took enoxaparin.

Off-label uses for Pradaxa

In addition to the uses listed above, Pradaxa may be used off-label. Off-label drug use is when a drug that’s approved for one use is used for a different one that’s not approved.

Pradaxa for heparin-induced thrombocytopenia

Heparin-induced thrombocytopenia (HIT) is a condition that can occur after you take an anticoagulant called heparin. HIT causes thrombocytopenia, which is a decrease in the level of platelets in your blood. HIT is dangerous because it can lead to an increased risk of developing a blood clot.

The FDA hasn’t approved Pradaxa to decrease the risk of clotting after HIT, but the drug may be used off-label for this use. Some studies show that Pradaxa may decrease the risk of clotting in people with HIT and may be safe to take when you have a low platelet count.

In the study, platelet counts returned to normal in about 95% of people who took Pradaxa after developing HIT. This means that platelet counts were normal in 38 of 40 people. The other two people had other conditions that may have caused a decrease in platelet counts. Pradaxa wasn’t compared with a different drug or a placebo.

Here are answers to some frequently asked questions about Pradaxa.

Is Pradaxa a blood thinner or an anticoagulant?

Pradaxa is a type of drug called an anticoagulant, which is often referred to as a blood thinner. However, Pradaxa doesn’t actually thin your blood. “Blood thinner” is just a name used by healthcare providers to make discussing the drugs easier.

Pradaxa belongs to a class of medications called direct-acting oral anticoagulants, or DOACs. (A medication class is a group of drugs that work in a similar way.) DOACs are anticoagulants, and they work by blocking thrombin. This is an enzyme in your blood that helps blood clot. (An enzyme is a protein that aids chemical changes in your body.) Pradaxa doesn’t thin your blood. Instead, the drug blocks thrombin so that your blood doesn’t clot as easily as it normally would.

Are there any foods to avoid during Pradaxa treatment?

No, there are no foods that are known to interact with Pradaxa. With some other medications, such as warfarin (Coumadin), there are foods that you need to watch out for. Certain foods can make warfarin not work as well and may put you at risk for blood clots. Examples of these foods include broccoli, spinach, and black licorice. However, you don’t need to avoid any foods while taking Pradaxa.

But if you have kidney problems, you may have to avoid grapefruit while you’re taking Pradaxa. This is because the grapefruit can increase the level of Pradaxa in your body, which may increase your risk of having a bleed. If you have kidney problems, ask your doctor if there’s a safe amount of grapefruit you can eat during your Pradaxa treatment.

How do I stop taking Pradaxa?

Never stop taking Pradaxa without first talking with your doctor. Stopping Pradaxa use before your doctor advises you to can increase your risk of blood clots or stroke.*

You may need to stop taking Pradaxa if you’re having surgery. Ask your doctor if and when you should stop taking Pradaxa before having surgery. They may prescribe a different medication to help prevent blood clots from forming while you’re not taking Pradaxa.

In certain situations, such as switching from Pradaxa to warfarin (Coumadin), you may have to start taking warfarin a few days before stopping Pradaxa treatment. So if you’re switching from Pradaxa to another medication to prevent blood clots, first talk with your doctor or pharmacist. They can help you determine when to take your last dose of Pradaxa and your first dose of the new medication.

And if you’re taking Pradaxa for a short time to prevent a blood clot after a hip replacement, your doctor will discuss the right way and time to stop taking your medication. In this situation, you’ll usually stop taking Pradaxa after 28 to 35 days.

* Pradaxa has boxed warnings for the increased risk of blood clots when you stop taking the drug as well as blood clots in and around your spinal column. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For more information, see “FDA warnings” at the beginning of this article.

Can I take Tylenol or NSAIDs with Pradaxa?

You can take acetaminophen (Tylenol) to relieve pain or a fever while you’re taking Pradaxa. There are no interactions between Tylenol and Pradaxa.

However, you shouldn’t take any nonsteroidal anti-inflammatory drugs (NSAIDs) while you’re taking Pradaxa, unless your doctor advises you to. These medications are usually used to ease swelling and pain, and taking them with Pradaxa may increase your risk for bleeding. (For more about NSAIDs, see the “Pradaxa interactions” section below.)

If you have a fever, pain, or swelling while taking Pradaxa, ask your doctor or pharmacist to recommend a treatment.

Do I need to stop taking Pradaxa if I’m having a dental extraction?

Not usually. The American Dental Association suggests that there’s no need for most people to stop taking Pradaxa if they’re having a tooth removed. However, if you’re at a higher risk of bleeding, your dentist may want you to stop taking Pradaxa for a few days before the dental procedure. This may help prevent you from bleeding too much during and afterward. Your dentist and doctor will discuss a safe length of time for you to stop taking Pradaxa. However, usually this isn’t necessary.

Why can’t I keep Pradaxa in my pill organizer?

Storing Pradaxa in your pill box may expose the medication to moisture. This can cause it to not work properly and be dangerous to you. So you should keep Pradaxa in its original bottle or blister package so the drug stays dry.

Will I need to have my blood tested while taking Pradaxa?

No, you don’t have to have your blood tested regularly while taking Pradaxa. Unlike other blood-thinning medications, such as warfarin, your doctor doesn’t typically need to monitor your blood levels during your Pradaxa treatment. This makes Pradaxa much more convenient to take.

There are no major interactions between alcohol and Pradaxa. However, Pradaxa helps prevent blood clots, and alcohol can also prevent clotting from occurring. So drinking alcohol while you’re taking Pradaxa may increase your risk of bleeding. Talk with your doctor about how much alcohol is safe to drink while you’re taking Pradaxa.

Pradaxa can interact with several other medications. It can also interact with certain supplements as well as certain foods.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase the number of side effects or make them more severe.

Pradaxa and other medications

Below is a list of medications that can interact with Pradaxa. This list doesn’t contain all drugs that may interact with Pradaxa.

Before taking Pradaxa, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Pradaxa and primidone

You shouldn’t take primidone (Mysoline) if you’re taking Pradaxa. This is because primidone can decrease the level of Pradaxa in your body, which puts you at an increased risk for getting a blood clot.

If you’re taking primidone, talk with your doctor before using Pradaxa. They may suggest different medications.

Pradaxa and Plavix

You shouldn’t usually take Pradaxa along with other medications that slow blood flow or stop your blood from clotting, unless advised to do so by your doctor. Clopidogrel (Plavix) is a medication that works by preventing the platelets in your blood from clotting. So when you take clopidogrel with Pradaxa, you’re at an increased risk of bleeding and side effects from these medications. (For more about Pradaxa side effects, see the “Pradaxa side effects” section above.)

Talk with your doctor about the best way to switch from one medication to another, if needed.

Pradaxa and NSAIDs

You shouldn’t take a nonsteroidal anti-inflammatory drug (NSAID) while using Pradaxa, unless your doctor advises you to. This is because it may increase your risk for bleeding. NSAIDs are medications that are usually used to ease fever, swelling, and pain.

Examples of NSAIDs include:

  • ibuprofen (Advil)
  • aspirin
  • naproxen (Aleve)
  • meloxicam (Mobic)
  • celecoxib (Celebrex)
  • diclofenac (Voltaren)
  • ketorolac (Acular)
  • etodolac
  • indomethacin (Indocin)

If you’re taking Pradaxa and want to ease pain, a fever, or swelling, ask your doctor or pharmacist what treatments may help.

Pradaxa and dronedarone

The drug dronedarone (Multaq) can increase the level of Pradaxa in your body if you have kidney problems such as chronic kidney disease. This can be dangerous, because if you have more Pradaxa in your body, you may have more severe side effects and an increased risk for bleeding. (For more about Pradaxa side effects, see the “Pradaxa side effects” section above.)

If you’re taking Pradaxa along with dronedarone and have kidney problems, your doctor will decrease your dose of Pradaxa to make sure that you aren’t getting too much medication.

Pradaxa and antifungal medications

If you have kidney problems such as chronic kidney disease, you may need to avoid taking certain oral medications that treat fungal infections while using Pradaxa. Oral medications are drugs in pill, capsule, or liquid form that you swallow. Taking an antifungal medication with Pradaxa may increase the level of Pradaxa in your body if you have kidney problems. And this rise in the Pradaxa level may increase the risk of bleeding or side effects. (For more about Pradaxa side effects, see the “Pradaxa side effects” section above.)

Examples of antifungal medications that people with kidney problems should avoid while taking Pradaxa include:

  • ketoconazole (Nizoral)
  • itraconazole (Sporanox)
  • voriconazole (Vfend)

If you have kidney problems and need to take an oral antifungal medication while you’re using Pradaxa, first talk with your doctor. They may advise you to use an antifungal cream instead. If that’s not an option, they may decrease your dose of Pradaxa while you’re taking the antifungal medication so that you aren’t exposed to too much Pradaxa.

Pradaxa and rifampin

You shouldn’t take rifampin (Rifadin) if you’re using Pradaxa. Rifampin can decrease the level of Pradaxa in your body. This means that Pradaxa won’t work as well and you may develop a blood clot.

If you need to take rifampin while you’re using Pradaxa, first talk with your doctor. They may be able to prescribe a different medication for you that won’t interact with Pradaxa.

Pradaxa and other blood thinner medications

You usually shouldn’t take Pradaxa with other anticoagulant medications, unless you’re switching from one drug to another. The effects of Pradaxa and other anticoagulants will combine and may increase the risk for side effects and bleeding. (For more about Pradaxa side effects, see the “Pradaxa side effects” section above.)

Examples of anticoagulants that shouldn’t be taken at the same time as Pradaxa include:

  • apixaban (Eliquis)
  • rivaroxaban (Xarelto)
  • heparin
  • enoxaparin (Lovenox)
  • dalteparin (Fragmin)
  • warfarin (Coumadin)

It’s important that when you switch from one medication to another, you first talk with your doctor about when to stop taking the old medication.

Pradaxa and herbs and supplements

There aren’t any herbs or supplements that have been specifically reported to interact with Pradaxa. However, you should still check with your doctor or pharmacist before using any of these products while taking Pradaxa.

Using more than the recommended dosage of Pradaxa can lead to serious side effects. Because this medication makes it harder for your blood to clot, taking too much can make you bleed and be very serious. There’s a medication called idarucizumab (Praxbind) that binds (attaches) to Pradaxa, which makes Pradaxa inactive. This helps decrease your risk of having serious side effects from Pradaxa. If you take too much Pradaxa, it’s important that you call your doctor right away so they can determine if you need idarucizumab.

Don’t use more Pradaxa than your doctor recommends.

Overdose symptoms

Symptoms of an overdose can include:

  • bleeding more easily than usual
  • being unable to stop a cut or wound from bleeding
  • bruising
  • nosebleeds
  • bleeding gums

What to do in case of overdose

If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

As with all medications, the cost of Pradaxa can vary. To find current prices for Pradaxa in your area, check out GoodRx.com:

The cost you find on GoodRx.com is what you may pay without insurance. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Your insurance plan may require you to get prior authorization before approving coverage for Pradaxa. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the request and let you and your doctor know if your plan will cover Pradaxa.

If you’re not sure if you’ll need to get prior authorization for Pradaxa, contact your insurance company.

Financial assistance

If you need financial support to pay for Pradaxa, help is available. Boehringer Ingelheim Pharmaceuticals Inc., the manufacturer of Pradaxa, offers the Pradaxa Savings Card as part of a program called SolutionsPlus. For more information and to find out if you’re eligible for support, call 877-481-5332 or visit the program website.

You should take Pradaxa according to your doctor’s or healthcare provider’s instructions.

Pradaxa comes as a capsule that you swallow with a full glass of water.

When to take

You’ll take Pradaxa once or twice a day as directed by your doctor. If you’re taking capsules twice a day, it’s best to take them about 12 hours apart. You should take Pradaxa at the same time each day.

To help make sure that you don’t miss a dose, try setting a reminder on your phone. A medication timer may be useful, too.

Taking Pradaxa with food

You can take Pradaxa with or without food. Take the capsules with a full glass of water.

Can Pradaxa be crushed, split, or chewed?

No, you should swallow Pradaxa capsules whole. Never break, crush, chew, or open them. Your body will absorb the medication too quickly if you open or chew the capsules. This means you’ll get too much of the drug and be at an increased risk of bleeding or side effects from the medication. (For more about side effects, see the “Pradaxa side effects” section above.)

Pradaxa is approved to reduce the risk of stroke and blood clots in people with nonvalvular atrial fibrillation (A-fib). A-fib is a condition in which your heartbeat is irregular. And “nonvalvular” means that faulty heart valves aren’t the cause. People with A-fib may have heart palpitations (feeling of skipped or extra heartbeats), a fast heart rate, or feel tired or short of breath. If you have A-fib , you’re at an increased risk for developing a blood clot or having a heart attack or stroke.

Pradaxa can also be used to treat people with blood clots. Certain situations may increase your risk for a blood clot. These include:

  • smoking
  • not being able to move for a long time
  • having a traumatic event such as a fall or a car accident
  • having certain surgeries such as a hip replacement

Pradaxa can also be used to help prevent blood clots in people having a hip replacement or in people who have had a deep vein thrombosis (DVT) or pulmonary embolism (PE) in the past. A DVT is a blood clot in a large vein in your body, usually in your lower legs, and a PE is a blood clot in the lungs.

What Pradaxa does

Pradaxa works by decreasing the risk of a blood clot forming. The drug blocks an enzyme in your blood called thrombin. (An enzyme is a protein that aids chemical changes in your body.) Thrombin is responsible for clotting in your blood. By blocking thrombin, Pradaxa helps prevent your body from forming blood clots.

How long does it take to work?

Pradaxa starts working to help prevent or treat blood clots within hours after taking the medication. However, you need to take it once or twice a day, every day, to make sure that you always have enough medication in your body to help prevent or treat a blood clot.

It’s not known if Pradaxa is safe to take during pregnancy. During labor, Pradaxa may increase the risk of blood clots in certain women. The drug may also increase the risk of bleeding in the baby. Pradaxa may also make it less likely for a fertilized egg to be implanted in the uterus.

In an animal study, pregnant animals who were given Pradaxa had increased bleeding in their vagina and uterus. They were also less able to have a fertilized egg implanted in their uterus. The babies had an increased risk of delayed or irregular bone formation and death. However, animal studies don’t indicate what will happen in humans who take Pradaxa.

If you’re pregnant or planning to become pregnant, talk with your doctor before taking Pradaxa. They can help you determine the best treatment plan.

It’s not known if Pradaxa is safe to take during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Pradaxa.

It’s not known if Pradaxa is present in human breast milk or if it affects a breastfed child. In an animal study, the medication and its metabolites were found in breast milk. (When Pradaxa breaks down in your body, it turns into substances called metabolites.) Therefore, it’s not recommended that women breastfeed while taking Pradaxa.

If you’re breastfeeding, talk with your doctor before taking Pradaxa. They can discuss your treatment options and the best way to feed your child.

This drug comes with several precautions.

FDA warnings

This drug has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous.

  • Increased risk of a blood clot forming when you stop taking Pradaxa. Pradaxa is a type of drug called an anticoagulant, and it works by preventing your blood from clotting. Blood clots can cause heart attacks, strokes, and other serious conditions. If you stop taking an anticoagulant such as Pradaxa before you’re supposed to, you may increase your risk of developing a blood clot. Be sure to talk with your doctor before you stop taking Pradaxa, even if it’s just for a few days. They may have you take a different medication to help prevent your body from forming blood clots.
  • Blood clots in or around your spine. If you have a spinal tap (a procedure to test fluid in your spinal cord) or medication injected near your spine while taking Pradaxa, a type of blood clot called a hematoma may develop. The blood clot may be spinal (in your spine ) or epidural (in the area right around your spine). This can cause paralysis that’s long lasting or even permanent. If you do need a spinal procedure while you’re taking Pradaxa, your doctor will monitor you for symptoms of blood clots and treat you right away, if needed. These symptoms include back pain, tingling, weakness, and incontinence (loss of control of your bladder or bowels).

Other precautions

Before taking Pradaxa, talk with your doctor about your health history. Pradaxa may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

  • Upcoming surgery. If you’re having surgery, talk with your doctor about Pradaxa. Depending on the surgery, your doctor may have you stop taking Pradaxa for a couple of days before your procedure. This is done to help prevent bleeding and allow your body to clot so that the wound can heal after surgery.
  • Kidney problems. If you have kidney problems such as chronic kidney disease, talk with your doctor before taking Pradaxa. Kidney problems can cause the level of the drug to build up in your body. And too much Pradaxa can lead to more side effects or increase your risk for bleeding. (For more about side effects, see the “Pradaxa side effects” section above.) If you have any kidney problems, be sure to talk with your doctor before you start taking Pradaxa. They may prescribe a lower dose or have you stop taking the medication.
  • Bleeding problems or active bleeding. If you have any bleeding problems or conditions such as anemia (decreased level of red blood cells), be sure to tell your doctor before you start taking Pradaxa. One of the side effects of Pradaxa is an increased risk of bleeding. So if you already have an increased risk due to a bleeding condition, your doctor may recommend that you take a different medication instead of Pradaxa.
  • Stomach ulcers. If you have a history of stomach ulcers, talk with your doctor before taking Pradaxa. The drug may cause you to bleed more easily than usual. So if you have a stomach ulcer, you may bleed more from the ulcer while you’re taking Pradaxa. This can be dangerous and can cause severe bleeding. Your doctor may recommend a drug other than Pradaxa.
  • Bioprosthetic or mechanical heart valves. If you have a heart valve replacement, you shouldn’t take Pradaxa. The drug causes more clotting events (such as strokes or heart attacks) to occur in people with heart valve replacements. Pradaxa can also increase the risk of bleeding. If you have a heart valve replacement, talk with your doctor about what medication is best for you.
  • Antiphospholipid syndrome. If you have an immune disorder called triple-positive antiphospholipid syndrome, you may have a greater risk for blood clots with Pradaxa. If you have this disorder, talk with your doctor to find out if Pradaxa is safe for you.
  • Pregnancy. It’s not known if Pradaxa is safe to take during pregnancy. For more information, please see the “Pradaxa and pregnancy” section above.
  • Breastfeeding. Breastfeeding while taking Pradaxa isn’t recommended. For more information, please see the “Pradaxa and breastfeeding” section above.
  • Allergic reactions. If you have an allergic reaction to Pradaxa or any of its ingredients, you shouldn’t take this medication. Ask your doctor what other treatments are better options for you.

Note: For more information about the potential negative effects of Pradaxa, see the “Pradaxa side effects” section above.

When you get Pradaxa from the pharmacy, the pharmacist will add an expiration date to the label on the bottle or blister package. This date is typically 1 year from the date they dispensed the medication.

The expiration date helps guarantee that the medication is effective during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk with your pharmacist about whether you might still be able to use it.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

You should store Pradaxa capsules at room temperature, between 68°F and 77°F (20°C to 25°C) in their original container away from light. Avoid storing this medication in areas where it could get damp or wet, such as in bathrooms. These capsules must be kept dry and away from moisture for them to remain effective. Always keep your bottle tightly closed after taking your dose.

Disposal

If you no longer need to take Pradaxa and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

The FDA website provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication.

Pradaxa is only good for 4 months after opening the bottle. Throw away any medication that you don’t use within 4 months of opening the bottle.

The following information is provided for clinicians and other healthcare professionals.

Indications

Pradaxa is indicated to:

Mechanism of action

Pradaxa belongs to the class of medications known as direct oral anticoagulants (DOACs). It works by directly blocking thrombin. The usual action of thrombin is to convert fibrinogen to fibrin during coagulation. By blocking thrombin, fibrin is not produced and a thrombus does not develop. Fibrin that’s free in the blood or bound to a clot is inhibited by Pradaxa as well.

Pharmacokinetics and metabolism

The maximum concentration of Pradaxa occurs at about 1-hour post-dose in a fasted patient. Taking Pradaxa along with a high-fat meal can delay the maximum concentration reached by about 2 hours post-dose. However, a high-fat meal has no effect on the bioavailability of Pradaxa. Therefore, this medication can be taken with or without food.

Pradaxa is approximately 35% plasma protein bound. It is converted from dabigatran etexilate to dabigatran by hydrolysis. It is not a substrate, inducer, or inhibitor of the cytochrome p450 enzymes. Dabigatran is then conjugated and forms four acyl glucuronides.

Pradaxa is eliminated via urine, with renal clearance accounting for about 80% of total clearance after the drug is given intravenously. However, after oral administration, 7% is recovered in urine and 86% in feces. The half-life of dabigatran is 12 to 17 hours.

Contraindications

Pradaxa is contraindicated in people with:

  • active bleeding
  • history of serious allergic or anaphylactic reaction to Pradaxa
  • mechanical prosthetic heart valves

Storage

Pradaxa should be stored at room temperature between 68°F and 77°F (20°C to 25°C). It should always be stored in its original container.

Disclaimer: Medical News Today 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.