This article describes possible side effects of Pradaxa. You can explore this overview article to learn more about Pradaxa, including the drug’s uses, ways to save on cost, and more.
Pradaxa is a brand-name medication that comes as an oral capsule. It’s available in a generic version called dabigatran. This article describes possible side effects of Pradaxa.
Pradaxa has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “Side effects of Pradaxa in detail” section below.
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More common side effects of Pradaxa
Pradaxa may cause mild or serious side effects. Below are some of the more common side effects of this medication.
Commonly reported side effects of Pradaxa include:
- bruising or bleeding more easily than usual
- indigestion
- serious bleeding*
- stomach pain or discomfort
- upset stomach
* To learn more about this side effect, see the “Side effects of Pradaxa in detail” section below.
Mild side effects of Pradaxa
Pradaxa may cause certain mild side effects. Usually, mild side effects are temporary and can be easily managed. Tell your doctor or pharmacist if you have side effects that don’t go away or become bothersome.
Mild side effects of Pradaxa that occurred in studies include:
- bruising or bleeding more easily than usual
- indigestion
- stomach pain or discomfort
- upset stomach
- nausea
- vomiting
- diarrhea
Pradaxa may cause more mild side effects than those listed above. For details, see the drug’s prescribing information.
Serious side effects of Pradaxa
Pradaxa may cause certain serious side effects. If you have any serious side effects from Pradaxa, call your doctor right away. But if you think you’re having a medical emergency or your side effects feel life threatening, take immediate action. Call 911 or a local emergency number, or go to the nearest emergency room.
After the FDA approves a drug, it tracks and reviews side effects of the medication. Visit MedWatch’s website if you’d like to notify the FDA about a side effect you’ve had with Pradaxa.
Serious side effects of Pradaxa that occurred in studies include:
- increased risk of blood clots if treatment is stopped early*†
- blood clots in or around the spine after certain medical procedures*†
- serious bleeding*
* To learn more about this side effect, see the “Side effects of Pradaxa in detail” section below.
† Pradaxa has a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA. To learn more, see the “Side effects of Pradaxa in detail” section below.
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For some people, Pradaxa can cause an allergic reaction. Reports of allergic reactions were rare in studies of people taking Pradaxa.
In general, symptoms of an allergic reaction can be mild or serious. You can learn more about possible symptoms in this article.
Ways to manage
For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.
For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Pradaxa, your doctor may recommend taking a different medication instead.
Common questions about side effects of Pradaxa
Here are answers to some common questions about side effects of Pradaxa. If you have other questions, talk with your doctor or pharmacist.
Are there different Pradaxa side effects in older adults?
No, the side effects of Pradaxa aren’t different for older adults compared with younger adults. But the risk of bleeding may be higher in adults over age 75 years. In studies, risk of bleeding or stroke increased with age. Despite this, Pradaxa may still be the best choice for you.
Do Pradaxa side effects include fatigue?
No, fatigue wasn’t reported in studies of Pradaxa. But fatigue can be a symptom of bleeding, which is a common side effect of Pradaxa. To learn more, see the “Side effects of Pradaxa in detail” section below.
If you experience fatigue while taking Pradaxa, tell your doctor. They can determine the most likely cause and recommend ways to manage it.
Do Pradaxa side effects include hair loss?
It’s possible that Pradaxa may cause hair loss. This side effect wasn’t reported in studies of the drug, but it has occurred in people taking Pradaxa after the drug was approved for use.
Tell your doctor if you have hair loss while taking Pradaxa. They can determine the most likely cause and recommend ways to manage it.
Side effects of Pradaxa in detail
Below you’ll find details on some of the side effects of Pradaxa.
This drug has boxed warnings about risk of blood clots if Pradaxa is stopped early and risk of spinal blood clots from certain medical procedures. A boxed warning is the most serious warning from the FDA.
Increased risk of blood clots when stopping Pradaxa early
Stopping treatment with any anticoagulant, including Pradaxa, too soon raises the risk of blood clots. Due to this risk, do not stop taking Pradaxa without talking with your doctor. If they agree you should stop taking Pradaxa, they might prescribe a different anticoagulant to help continue lowering your risk of blood clots.
Blood clots in or around the spine after certain procedures
People taking Pradaxa are at risk of developing a blood clot in or around the spine from certain procedures. This includes spinal or epidural injections and lumbar puncture (spinal tap). Spinal blood clots can cause problems with the ability to move, which may be permanent.
Certain factors can increase the risk of spinal blood clots with Pradaxa. These include:
- having an epidural catheter (a thin tube inserted into your spinal column) to deliver medication to your spine
- having past problems with your spine
- having spinal surgery in the past or having spinal procedures that caused complications
- taking other medications that affect blood clotting, such as nonsteroidal anti-inflammatory drugs (NSAIDs)
Ways to manage
If you have concerns about these boxed warnings, tell your doctor. They will monitor you closely if you need to stop Pradaxa or have a spinal procedure. If you have to stop Pradaxa, your doctor may recommend a different medication.
Serious bleeding
In studies, serious bleeding was common in people taking Pradaxa. This side effect may be serious or even fatal.
Pradaxa makes your blood less likely to clot. This is how it treats and prevents blood clots. But this effect can also lead to bleeding or bruising more easily than usual. It can also lead to serious bleeding.
Symptoms of serious bleeding may include:
- bleeding that lasts a long time
- bleeding that is severe or that you can’t control
- coughing up blood or blood clots
- bruises that keep growing larger
- dark stools that look like tar or that have red blood in them
- dizziness or lightheadedness
- fatigue
- headaches that may be severe
- joint pain, swelling, or warmth without an injury or other obvious cause
- pink, red, or brown urine
- vomiting blood or a dark material that looks like coffee grounds
Certain factors can increase the risk of serious bleeding with Pradaxa. These include:
- being over age 75 years
- having kidney problems
- having a stomach ulcer
- having stomach or intestinal bleeding in the past
- taking other medications that increase the risk of bleeding, such as NSAIDs
Ways to manage
If you experience symptoms of serious bleeding, get emergency medical care or call 911.
Warnings for Pradaxa
Below are some factors you may want to discuss with your doctor before taking Pradaxa.
Boxed warnings
Pradaxa has boxed warnings. A boxed warning is the most serious warning from the FDA.
For details, see the “Side effects of Pradaxa in detail” section above.
Other warnings
It may not be safe for you to take Pradaxa if you have specific health conditions. These are sometimes called drug-condition interactions. Other things may also affect whether Pradaxa is a safe treatment option for you.
Before taking Pradaxa, tell your doctor about your health and any medications you take. Things to consider include:
Pradaxa and pregnancy
It’s not known whether Pradaxa should be taken during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before taking this medication.
Pradaxa and breastfeeding
It’s not known whether Pradaxa should be taken while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before taking this medication.
Pradaxa isn’t known to interact with alcohol.
But drinking alcohol can affect your blood’s ability to clot. This may increase the risk of bleeding while taking Pradaxa.
If you drink alcohol, talk with your doctor about whether it’s safe to consume it during your treatment with Pradaxa.
Disclaimer: Optum Perks 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.
