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5 Pradaxa Side Effects You Should Know About

Austin Ulrich, PharmD, BCACPChristina Aungst, PharmD
Published on December 15, 2022

Key takeaways:

  • The most common side effects of Pradaxa (dabigatran) are stomach upset and bleeding.

  • Stomach pain can often be managed by taking Pradaxa with food. But if it continues, talk to your healthcare provider. They may recommend a medication to help treat gastrointestinal side effects.

  • Bleeding from Pradaxa can be mild or severe. If you have any signs of bleeding (including bleeding from your gums or nosebleeds), contact your healthcare provider. If bleeding is severe, including any bleeding that won’t stop or coughing or vomiting blood, seek emergency care.

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A woman suffers from stomach pain.
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Dabigatran (Pradaxa) is an anticoagulant. It helps prevent unwanted blood clots in people who have a high risk of developing clots. This includes people with atrial fibrillation, deep vein thrombosis, and pulmonary embolism.

Pradaxa belongs to a group of medications called direct oral anticoagulants (DOACs). DOACs are different from the older, well-known anticoagulant warfarin (Coumadin, Jantoven). In many situations, DOACs have been found to be more effective and safer than warfarin.

Like all anticoagulants, Pradaxa can have side effects. Below, we’ll discuss five of the most notable side effects and how you might manage them.

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1. Gastrointestinal side effects

Gastrointestinal (GI) effects are some of the most common Pradaxa side effects. This includes:

  • Upset stomach

  • Abdominal pain

  • Heartburn

  • Diarrhea

  • Nausea and vomiting

GI side effects from Pradaxa are often mild. But if they’re bothersome, taking Pradaxa with food may provide some relief. If taking Pradaxa with food doesn’t work, your healthcare provider may recommend a medication to relieve your symptoms. This might include medications like antacids, histamine-2 antagonists, and proton pump inhibitors.

If you have GI symptoms that won’t go away or become severe, let your healthcare provider know right away. This may indicate that something more serious, like an ulcer or stomach inflammation, is present.

2. Bleeding

Pradaxa works by making it harder for your blood to clot. So it’s no surprise that one of the most common side effects is bleeding. When compared to warfarin, Pradaxa is more likely to cause a GI bleed but less likely to cause a brain bleed.

Your risk of bleeding with Pradaxa increases in certain situations. This includes if you:

  • Take other medications that can also cause bleeding, including antiplatelet medications like clopidogrel (Plavix) and nonsteroidal anti-inflammatory drugs (NSAIDs).

  • Have a mechanical heart valve

  • Are over 75 years old

  • Have kidney problems

  • Have a history of stomach bleeds or ulcers

Some signs of bleeding may be obvious. But some are harder to spot. Signs of bleeding include:

  • Unusual bleeding from your gums

  • A heavier menstrual period

  • Frequent nosebleeds

  • Blood in your urine

  • Red or black stools

  • Coughing up blood

  • Vomiting blood

  • Bruising that happens without a known cause or gets larger

  • Low hemoglobin or hematocrit levels on a blood test

  • Headaches, dizziness, and weakness (may indicate bleeding in the brain)

If you experience any signs of bleeding or bruising, contact your healthcare provider immediately. If the amount of blood loss is severe or you feel ill, seek emergency care. If you have a life-threatening bleed, you may receive a medication called Praxbind (idarucizumab) in the hospital. This medication reverses the effects of Pradaxa.

3. Mouth ulcers

Ulcers are another possible side effect of Pradaxa. This may include ulcers in the mouth or esophagus (a tube that connects your mouth and stomach). These ulcers are thought to be caused by incorrect administration of Pradaxa. Taking Pradaxa incorrectly can cause severe irritation to the mouth or esophagus, resulting in ulcers.

Pradaxa capsules should be swallowed whole with a full glass of water. This will help make sure it doesn’t get stuck in the throat or esophagus. Pradaxa capsules shouldn’t be opened, broken, or chewed.

4. Blood clots

If you take Pradaxa, you’re taking it to prevent blood clots. But this doesn’t mean Pradaxa is always effective. Unfortunately, clots can sometimes still happen. And there are a few situations where blood clots are more likely to occur. These include:

  • If you stop Pradaxa too early. If you stop taking Pradaxa too early, you’re more likely to experience a blood clot. This can lead to life-threatening events like a heart attack or stroke. In fact, the medication label for Pradaxa has a boxed warning for an increased risk of blood clots when stopping Pradaxa too early. A boxed warning is the most serious warning the FDA can assign to a medication.

  • If you have triple-positive antiphospholipid syndrome (APS). APS is a rare autoimmune condition where a person has excessive clotting. People with APS shouldn’t use DOACs like Pradaxa. This is because DOACs don’t work as well as warfarin in people with APS. You’re more likely to develop a blood clot taking Pradaxa versus warfarin if you have this medical condition.

  • If you have a mechanical heart valve. If you have a mechanical heart valve, taking Pradaxa can increase your risk of bleeding. But it can also increase your risk of blood clots. In studies, Pradaxa has led to clot-related events like heart attack and stroke in people with mechanical heart valves. You shouldn’t use Pradaxa if you have a mechanical heart valve. Pradaxa hasn’t been well-studied in people with bioprosthetic heart valves (tissue valves), so it’s not recommended.

If you’re prescribed Pradaxa, it’s important to take it for as long as your healthcare provider recommends. For some people, Pradaxa may be a lifelong medication. But others might not need it forever. You’ll always want to get your healthcare provider’s OK before stopping Pradaxa.

5. Spinal problems

Certain procedures involving the spine may be risky if you take Pradaxa, including:

  • Epidural anesthesia. This involves placing a small tube (catheter) into the lower part of your spinal cord (epidural space). Pain medication can then be injected through this catheter. It is usually needed for childbirth and procedures of the belly, legs, or feet. 

  • Lumbar puncture. This may be needed to diagnose or treat certain medical conditions. This involves inserting a needle into the spine. Some situations where a lumbar puncture is needed include diagnosing brain infections and checking for bleeding in the brain.

Pradaxa makes it more likely to develop bleeding in your spine from these procedures. Serious consequences like long-term or permanent paralysis are possible. Pradaxa’s medication label has a boxed warning for this risk.

To avoid this complication, your healthcare provider or surgeon may recommend stopping Pradaxa before your procedure. If this is recommended, you’ll want to confirm specific instructions for how to do this. Don’t stop Pradaxa without talking to your healthcare team. How long before a procedure to stop Pradaxa depends on the procedure and your individual situation.

When should I contact my healthcare provider about side effects from Pradaxa?

If you’re experiencing mild GI side effects from Pradaxa, you may be able to manage this at home by taking Pradaxa with food. If this doesn’t help, talk to your healthcare provider about what to do next. If you experience any signs of bleeding, contact your provider right away. If you have excessive bleeding or feel really sick, seek emergency care. This may include vomiting or coughing up blood, severe headaches, or any type of bleeding that won’t stop.

The bottom line

Pradaxa is a blood thinner that helps prevent unwanted blood clots. Common Pradaxa side effects include GI side effects like stomach pain, heartburn, and diarrhea. Bleeding is also a common side effect of Pradaxa, and in some situations it can be severe.

If you experience signs of bleeding, contact your provider right away. This might include unusual nosebleeds or bleeding from the gums. If you have excessive bleeding or are especially ill, seek emergency care. This includes any type of bleeding that won’t stop.

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Why trust our experts?

Austin Ulrich, PharmD, BCACP
Austin Ulrich, PharmD, BCACP, is a board-certified ambulatory care clinical pharmacist. In his early career, he provided direct patient care in a variety of settings, including hospital and community pharmacies, and in a primary care clinic as a clinical pharmacist.
Amy B. Gragnolati, PharmD, BCPS
Amy Gragnolati, PharmD, BCPS, is a pharmacy editor for GoodRx. Amy currently holds her pharmacist license in Georgia and California.
Christina Aungst, PharmD
Christina Aungst, PharmD, is a pharmacy editor for GoodRx. She began writing for GoodRx Health in 2019, transitioning from freelance writer to editor in 2021.

References

A-S Medication Solutions. (2022). Pradaxa [package insert].

American Heart Association. (2021). Types of replacement heart valves.

View All References (7)

Hernandez, I., et al. (2014). Risk of bleeding with dabigatran in atrial fibrillation. JAMA.

Julia, S., et al. (2017). Direct oral anticoagulants: A quick guide. European Cardiology Review.

Kuno, Y., et al. (2018). Oral ulcer due to dabigatran capsule. British Medical Journal.

MedlinePlus. (2021). Spinal and epidural anesthesia.

National Organization for Rare Disorders. (n.d.). Antiphospholipid syndrome.

Wood, M., et al. (2015). Pradaxa-induced esophageal ulcer. British Medical Journal Case Reports.

Yamashita, T., et al. (2014). Observational study of the effects of dabigatran on gastrointestinal symptoms in patients with non-valvular atrial fibrillation. Journal of Arrhythmia.

GoodRx Health has strict sourcing policies and relies on primary sources such as medical organizations, governmental agencies, academic institutions, and peer-reviewed scientific journals. Learn more about how we ensure our content is accurate, thorough, and unbiased by reading our editorial guidelines.

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