Uses
What is dabigatran used for?
Dabigatran is commonly used to prevent complications in any of the following situations.
- To reduce your chances of stroke and blood clots if you have atrial fibrillation, which is a type of irregular heartbeat
- To treat blood clots in your legs (deep vein thrombosis, also called DVT) and lungs (pulmonary embolism, also called PE)
- You have a history of DVT and PE, and you are at high risk for blood clots
- Prevention of DVT and PE following hip replacement surgery
Dabigatran may also be used for other conditions as determined by your healthcare provider.
How does dabigatran work (mechanism of action)?
Dabigatran is an anticoagulant that works by blocking a clotting protein called thrombin in the blood. This helps to stop clots from forming and keeps blood flowing smoothly in the body.
How is dabigatran supplied (dosage forms)?
Brands and other names
- Pradaxa
Dosage forms and strengths
- 75 mg, 110 mg, 150 mg oral capsules
- 20 mg, 30 mg, 40 mg, 50 mg, 110 mg, 150 mg oral pellets
How should I store dabigatran?
Oral Capsules. Dabigatran oral capsules should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place, tightly closed in the original bottle. Do not put dabigatran capsules in pill boxes or pill organizers. Use within the first four months of opening, then safely throw away any remaining medicine. Do not remove capsules from blister packs until ready to take.
Oral Pellets. Dabigatran oral pellets should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Keep oral pellet packets in the original silver packaging to keep them dry. Do not open until you are ready to use them. Use within 6 months of opening, then safely throw away any remaining medicine.
Side Effects
What are the most common side effects of dabigatran?
The most common side effects of dabigatran are listed below. Tell your healthcare provider if you have any of these side effects that bother you.
- Indigestion
- Upset stomach
- Heartburn
- Stomach pain
- Nausea
- Vomiting
- Diarrhea
There may be other side effects of dabigatran that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of dabigatran?
While less common, the most serious side effects of dabigatran are described below, along with what to do if they happen.
Severe Allergic Reactions. Dabigatran may cause allergic reactions, which can be serious. Stop taking dabigatran and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching, skin rash, or pale red bumps on the skin called hives
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Severe Bleeding. Dabigatran can increase your risk of severe bleeding that can lead to death. Some patients with serious bleeding may need a blood transfusion or surgery. Call your healthcare provider right away if you have any of the following signs of severe bleeding while taking dabigatran.
- Pink, red, or brown urine (pee)
- Vomit with blood that looks like coffee grounds
- Red or black stools (looks like tar)
- Coughing up blood or blood clots
Warnings & Precautions
Who should not use dabigatran?
Allergies to Ingredients. People who are allergic to any of the following should not use dabigatran.
- Pradaxa
- Dabigatran
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in the specific dabigatran products they stock.
Active Bleeding Problems. Dabigatran should not be used if you have active bleeding, such as bleeding of the brain, stomach, or intestines.
Mechanical Heart Valves. Dabigatran should not be used if you have a mechanical prosthetic valve.
What should I know about dabigatran before using it?
Do not take dabigatran unless it has been prescribed to you by a healthcare provider. Take it as prescribed.
Do not share dabigatran with other people, even if they have the same condition as you. It may harm them.
Keep dabigatran out of the reach of children.
Do not stop taking dabigatran without talking to your healthcare provider. Stopping dabigatran increases your risk of having blood clots or a stroke.
Do not chew, cut, or crush dabigatran capsules. This may increase your exposure to dabigatran.
Make sure that you or a caregiver understands how to properly prepare and use dabigatran pellets. If you have any questions, talk to your healthcare provider.
Do not run out of dabigatran. Refill your prescription before you run out.
People who are 75 and older can be at greater risk for some side effects from dabigatran. Talk to your healthcare provider about your risks if you are in this age group.
You may take dabigatran capsules with food if you have an upset stomach while taking it.
Swallow capsules whole with a full glass of water.
Do not give dabigatran oral pellets with a syringe or through a feeding tube.
What should I tell my healthcare provider before using dabigatran?
Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if dabigatran is right for you.
In particular, make sure that you discuss any of the following.
Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.
- Kidney problems
- Recent stomach or intestine bleeding
- Stomach ulcer
- Antiphospholipid syndrome
Other Medicines and Supplements. Dabigatran may interact with other medicines and supplements. Before using dabigatran, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.
Surgery. Tell your healthcare provider and dentist you are taking dabigatran before any planned surgeries or dental procedures. Your healthcare provider may tell you to stop taking dabigatran before the procedure to decrease your risk of bleeding. Follow the instructions from your healthcare provider about when to stop dabigatran and when you can start taking it again.
Pregnancy. It is not known if or how dabigatran could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. Ask your healthcare provider about your risk for bleeding while taking dabigatran. Your healthcare provider will advise you if you should take dabigatran while you are pregnant or trying to get pregnant.
Breastfeeding. It is not known if dabigatran passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should stop breastfeeding or stop dabigatran.
Interactions
Does dabigatran interact with foods or drinks?
There are no known interactions between dabigatran capsules and foods or drinks. Dabigatran pellets can be mixed with apple juice, mashed carrots, apple sauce, or bananas. Do not mix the pellets with any other food or liquid, such as milk or foods containing milk.
It is unknown if drinking alcohol will affect dabigatran, but both dabigatran and alcohol can increase your risk of bleeding. It is best to limit the amount of alcohol you drink.
Does dabigatran interact with other medicines (drug interactions)?
Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
In particular, make sure that you discuss if you are using any of the following before taking dabigatran.
- Aspirin, which is in many prescription and OTC products, including those for pain, swelling, and fever
- A blood thinner, which is a medicine used to treat or prevent blood clots
- An antiplatelet medicine, such as clopidogrel (Plavix), ticagrelor (Brilinta), prasugrel (Effient), aspirin/dipyridamole, or cilostazol, which is a medicine used to prevent blood clots
- A non-steroidal anti-inflammatory drug (NSAID), such as ibuprofen, naproxen, and others, which are contained in many prescription and OTC products for pain, swelling, and fever
- Rifampin, which is a medicine commonly used to treat an infection called tuberculosis
- Ketoconazole, which is a medicine used for fungal infections
- Dronedarone (Multaq), which is a medicine used to help keep a normal heart rhythm in people who have had atrial fibrillation
Some other medicines may alter the blood levels of dabigatran. Tell your healthcare provider about all medicines that you take or have recently taken.
This may not be a complete list of medicines that can interact with dabigatran. Always check with your healthcare provider.
Overdose/Missed Dose
What should I do if I accidentally use too much dabigatran?
If you or someone else has used too much dabigatran, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of dabigatran?
If a dose of dabigatran capsules is not taken at the scheduled time, the dose should be taken as soon as possible on the same day. The missed dose should be skipped if it cannot be taken at least six hours before the next scheduled dose. Do not take double or extra doses.
Are you currently using Dabigatran (Pradaxa)?
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