Pradaxa (dabigatran etexilate) is a brand-name prescription medication. The Food and Drug Administration (FDA) has approved it for the following uses in certain situations:

Pradaxa may be taken on a short-term basis or a long-term basis. This depends on what use it’s being prescribed for.

Here are some fast facts about Pradaxa:

  • Active ingredient: dabigatran etexilate
  • Drug class: direct thrombin inhibitor (sometimes called an anticoagulant or blood thinner)
  • Drug form: oral capsule

Pradaxa also comes as oral pellets for use in children ages 3 months to less than 12 years. However, this article will focus on the oral capsule form of Pradaxa.

As with other drugs, Pradaxa can cause side effects. Read on to learn about potential common, mild, and serious side effects. For a general overview of Pradaxa, including details about its uses, see this article.

Pradaxa can cause certain side effects (also called adverse effects), some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

These are just a few of the more common side effects reported by people who took Pradaxa in clinical trials:

  • bruising more easily
  • upper abdominal pain
  • mild bleeding*
  • upset stomach*
  • heartburn*

* For more information about this side effect, see “Side effect specifics” below.

Mild side effects can occur with Pradaxa. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Pradaxa’s prescribing information.

Mild side effects that have been reported with Pradaxa include:

These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks side effects of the medication. If you develop a side effect while taking Pradaxa and want to tell the FDA about it, visit MedWatch.

* For more information about this side effect, see “Side effect specifics” below.

Pradaxa may cause serious side effects. These serious side effects are not common, though they are possible. The list below may not include all possible serious side effects of the drug. For more information, you can refer to Pradaxa’s prescribing information.

If you develop serious side effects while taking Pradaxa, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Serious side effects that have been reported include:

* For more information about this side effect, see ”Side effect specifics” below.
† Pradaxa has a boxed warning for this side effect. This is a serious warning from the Food and Drug Administration (FDA). To learn more, see the “Side effect specifics” section below.

In clinical trials, the side effects of Pradaxa in children were similar to those seen in adults. However, vomiting was a common side effect in clinical trials of children taking Pradaxa. This side effect was not reported in trials by adults taking Pradaxa.

If you’re concerned about your child experiencing side effects during Pradaxa treatment, talk with their doctor.

Pradaxa may cause several side effects. Here are some frequently asked questions about the drug’s side effects and their answers.

Does Pradaxa cause certain side effects in older adults?

Older adults (ages 65 years and over) may have an increased risk of bleeding during Pradaxa treatment. They may bruise or bleed more easily due to this side effect. Older adults may also have an increased risk of stroke while taking Pradaxa.

Despite the increased risk of bleeding and stroke in older adults, the benefits of taking Pradaxa are typically thought to outweigh the risks.

If you’re an older adult and are concerned about whether Pradaxa is safe for you, talk with your doctor. They can discuss with you the risks and benefits of taking this medication for your condition.

What side effects can I expect with the higher strengths of Pradaxa (110 mg and 150 mg)?

The side effects of Pradaxa’s 110-milligram (mg) and 150-mg strengths are the same as the side effects of the lower strengths.

However, you may have an increased risk of side effects with higher strengths of Pradaxa. This is due to having more of the drug in your system.

If you have questions about what side effects to expect with your Pradaxa dosage, talk with your doctor or pharmacist.

Can Pradaxa cause hair loss?

It’s not likely for Pradaxa to cause hair loss. This side effect didn’t occur in clinical trials. However, there have been reports of hair loss after Pradaxa became available for use. It’s not known whether Pradaxa directly caused the hair loss in those who reported it or how common it may be.

Other medications, including anticoagulants such as warfarin, may cause hair loss. If you’re experiencing hair loss or are concerned about hair loss, talk with your doctor. Tell them about all of the medications you take. They can check whether any of these medications are causing your hair loss. They can also determine whether factors unrelated to treatment are causing it.

Is weight gain a side effect of Pradaxa treatment?

No, weight gain was not a reported side effect of Pradaxa in clinical trials.

However, keep in mind that you may have weight gain due to the condition you’re taking Pradaxa to treat. For example, if you’re taking Pradaxa to help prevent blood clots after a hip or knee replacement surgery, you may not be able to move around as much as you typically would. This may lead to weight gain.

If you are concerned about weight gain, talk with your doctor. They can suggest ways to maintain a weight that’s healthy for you.

Learn more about some of the side effects that Pradaxa may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Pradaxa.

Bleeding

Pradaxa can cause some people to bleed more easily. Bleeding was one of the most common side effects of the drug in clinical trials. This is because Pradaxa works to help prevent blood clots. So your blood will have a harder time forming a clot than it typically would. For example, your blood may not clot well enough to help heal a wound.

Symptoms of mild bleeding can include:

Symptoms of serious bleeding can include:

In rare cases, serious bleeding events can occur, and they can be fatal.

What you can do

If you have any symptoms of serious bleeding, seek immediate medical care or call 911 or your local emergency number. For milder symptoms, talk with your doctor right away. They can recommend whether you need immediate medical attention.

It’s important to watch for symptoms of bleeding while taking Pradaxa. Bleeding can happen without any known injury or wound, including inside your body. If bleeding is not treated immediately, it can become very serious and even fatal.

Talk with your doctor to learn about your risk of bleeding. Tell them of all the prescription and over-the-counter treatments or supplements that you take. They can recommend ways to lower your risk of bleeding.

Upset stomach

Upset stomach can occur during Pradaxa treatment. This side effect was commonly reported in clinical trials of the drug.

Symptoms can include:

  • a burning feeling in your stomach
  • stomach discomfort
  • nausea
  • pain in the upper part of your abdomen

What you can do

Talk with your doctor if you have an upset stomach while taking Pradaxa. They’ll likely suggest taking Pradaxa with a snack or meal to help reduce your discomfort.

Heartburn

Heartburn is a common side effect that occurred in clinical trials of Pradaxa. It’s typically caused by stomach acid or stomach contents that have traveled back into your esophagus.

Symptoms can include indigestion or a burning, painful feeling in your lower chest.

What you can do

If you experience heartburn while taking Pradaxa, talk with your doctor. They can recommend ways to reduce the risk of this side effect. They can also suggest ways to help relieve any discomfort you’re having.

Increased risk of blood clots after stopping Pradaxa

Pradaxa has a boxed warning describing an increased risk of blood clots after stopping the drug. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).

It’s not known how often blood clots occurred after stopping Pradaxa in clinical trials. However, blood clots can lead to serious complications, such as heart attack or stroke. So it’s important to be aware of symptoms of this side effect while taking Pradaxa.

Symptoms can include:

  • swelling or severe pain in your leg, ankle, or foot
  • pain in the jaw, neck, shoulder, or chest
  • trouble breathing
  • coughing up blood
  • trouble speaking

Stopping Pradaxa treatment without your doctor’s recommendation can increase your risk of blood clots with any oral anticoagulant, including Pradaxa. (Anticoagulants are also called blood thinners.)

What you can do

If you have symptoms of a blood clot, call 911 or your local emergency number immediately. A healthcare professional can determine whether you’re having a heart attack, stroke, or another medical emergency. They’ll provide any treatment necessary.

Due to this risk, it’s important that you do not stop Pradaxa without first talking with your doctor. If you are concerned about how long you’ll take Pradaxa, talk with your doctor. They can discuss with you the risks and benefits of continuing or stopping treatment.

Risk of blood clots in or near your spinal column

Pradaxa has a boxed warning for the risk of a blood clot forming in or near your spinal column after certain spinal procedures. A boxed warning is the most serious warning from the FDA.

While taking Pradaxa, there’s an increased risk of hematoma (a type of blood clot) forming after spinal procedures, such as spinal taps. This risk is also increased if you take Pradaxa and receive an injection of medication into your spinal column or in your spinal area. An example is an epidural injection. A hematoma in your spinal column can be very serious and long lasting, possibly causing paralysis.

What you can do

Before any spinal procedure or injection, talk with your doctor to make sure they’re aware that you’re taking Pradaxa. They can discuss with you whether the benefits of the procedure or injection will outweigh the risks.

Allergic reaction

As with most drugs, Pradaxa can cause an allergic reaction in some people. This was a rare side effect in clinical trials.

Symptoms can be mild or serious and can include:

  • skin rash
  • itching
  • flushing
  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your mouth, tongue, or throat, which can make it hard to breathe

What you can do

For mild symptoms of an allergic reaction, call your doctor right away. They may recommend ways to ease your symptoms and determine whether you should keep taking Pradaxa. However, if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Pradaxa has several warnings and precautions that you and your doctor should consider before you take the drug.

Boxed warnings

This drug has boxed warnings about an increased risk of blood clots after stopping Pradaxa and a risk of blood clots in or near your spinal column. These are serious warnings from the Food and Drug Administration (FDA). For details, see the “Side effect specifics” section above.

Other precautions

Be sure to talk with your doctor about your health history before you take Pradaxa. This drug may not be the right treatment option for you if you have certain medical conditions or other factors that affect your health. These are known as drug-condition or drug-factor interactions. The conditions and factors to consider include:

Mechanical prosthetic heart valve. There’s an increased risk of blood clots and serious bleeding in people taking Pradaxa who have a bileaflet mechanical prosthetic heart valve. Due to this risk, your doctor will not recommend Pradaxa if you have this type of heart valve.

Serious active bleed. Pradaxa is not safe to take if you have serious bleeding or bleeding problems, such as hemophilia. Before starting Pradaxa, tell your doctor if you’re bleeding or have ever had bleeding that didn’t stop. Also, tell them if you have a bleeding or blood disorder.

Antiphospholipid syndrome. People with triple-positive antiphospholipid syndrome have an increased risk of having blood clots with Pradaxa. If you have this condition, your doctor may not recommend Pradaxa for your condition.

Kidney problems. If you have kidney problems, talk with your doctor before starting Pradaxa treatment. Pradaxa can build up to an unsafe level in people with kidney problems. This increases the risk of serious side effects, such as severe bleeding. If you have kidney problems, your doctor may lower your Pradaxa dose, or they may not recommend this drug for your condition.

Upcoming surgeries or procedures. If you’re taking Pradaxa and have an upcoming surgery or procedure, including a dental procedure, tell your doctor. They may recommend that you temporarily stop taking Pradaxa to decrease your risk of serious bleeding during the procedure.

Allergic reaction. If you’ve had an allergic reaction to Pradaxa or any of its ingredients, your doctor will likely not prescribe Pradaxa. Ask your doctor what other medications may be better options for you.

Alcohol with Pradaxa

There are no known interactions between Pradaxa and alcohol. However, both can increase your risk of bleeding by preventing your blood from clotting as it typically would.

If you’re interested in drinking alcohol while taking Pradaxa, talk with your doctor to find out how much alcohol, if any, is safe for you to consume.

Pregnancy and breastfeeding while taking Pradaxa

It’s not known whether Pradaxa is safe to take during pregnancy. In animal studies, Pradaxa increased bleeding in the reproductive organs of animals given the drug. And Pradaxa made it harder for the animal to become pregnant. However, animal studies do not always reflect what may occur in humans.

In humans, Pradaxa may increase the risk of bleeding in both the pregnant person and the developing fetus. And during labor, pregnant people who receive an epidural have an increased risk of a spinal hematoma (a type of blood clot). Pradaxa also increases the risk of blood clots in or near the spine as a side effect,* so taking the drug while you’re pregnant may increase this further.

Pregnancy can also increase the risk of blood clots. And this risk is even higher in pregnant people with health conditions that make blood clots more likely. These conditions include:

If you’re considering becoming pregnant or have become pregnant while taking Pradaxa, talk with your doctor right away. They can discuss with you the risks and benefits of taking the drug during pregnancy.

It’s not known whether it’s safe to breastfeed while taking Pradaxa. Pradaxa passed into milk in animal studies. If you’re taking Pradaxa, your doctor will likely recommend you do not breastfeed.

If you have questions about breastfeeding during Pradaxa treatment, talk with your doctor.

* Pradaxa has a boxed warning for this side effect. This is a serious warning from the FDA. To learn more, see the “Side effect specifics” section above.

Pradaxa can cause several side effects. The most common side effects are bleeding and stomach problems. It’s important to watch for symptoms of bleeding, as this side effect can become serious and even fatal.

If you’d like to learn more about Pradaxa, talk with your doctor or pharmacist. They can help answer any questions you have about side effects from taking the drug.

Besides talking with your doctor, you can do some research on your own. These articles might help:

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 another 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.