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Dabigatran (Oral)

Generic name: dabigatran [ da-bi-GAT-ran-e-TEX-i-late-MES-i-late ]
Brand name: Pradaxa
Drug class: Thrombin inhibitors

Medically reviewed by Last updated on Oct 1, 2023.

Oral route(Capsule;Pellet)

Premature Discontinuation Increases The Risk Of Thrombotic Events

Premature discontinuation of any oral anticoagulant, including dabigatran etexilate, increases the risk of thrombotic events. If anticoagulation with dabigatran etexilate is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant.

Spinal/Epidural Hematoma

Epidural or spinal hematomas may occur in patients treated with dabigatran etexilate who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: use of indwelling epidural catheters; concomitant use of other drugs that affect hemostasis, such as NSAIDs, platelet inhibitors, other anticoagulants; a history of traumatic or repeated epidural or spinal punctures; a history of spinal deformity or spinal surgery; optimal timing between administration of dabigatran etexilate and neuraxial procedures is not known. Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Consider the risks and benefits before neuraxial intervention in patients anticoagulated or to be anticoagulated .

Uses for dabigatran

Dabigatran is used to decrease the risk of stroke and blood clots in patients with a serious heart rhythm problem called nonvalvular atrial fibrillation. Dabigatran is also used to treat and prevent blood clots (eg, deep vein thrombosis, pulmonary embolism) from occurring again in patients who already have received other medicines. It is also used to prevent deep vein thrombosis and pulmonary embolism after hip replacement surgery. It works by preventing harmful clots from forming in the blood vessels.

This medicine is available only with your doctor's prescription.

Before using dabigatran

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Appropriate studies have not been performed on the relationship of age to the effects of dabigatran capsules or oral pellets in children with heart rhythm problems or who had hip replacement surgery. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of dabigatran capsules in children 8 years of age and older or dabigatran oral pellets in children younger than 12 years of age with blood clotting problems. Safety and efficacy have been established.


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dabigatran in the elderly. However, elderly patients are more likely to have age-related stroke, bleeding, or kidney problems, which may require caution and an adjustment in the dose for patients receiving dabigatran.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Proper use of dabigatran

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects. Also, do not stop using this medicine without checking first with your doctor.

This medicine comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor if you have any questions.

You may take this medicine with or without food.

Swallow the capsule whole with a full glass of water. Do not crush, break, chew, or open it.

If you are taking another medicine to thin the blood, (eg, heparin, warfarin, Coumadin®), your doctor will give you very specific instructions about how to switch to dabigatran. Carefully follow the instructions and ask your doctor if you have any questions.

To use the oral pellets:

If you are taking this medicine 2 times a day, take one dose in the morning and one dose in the evening, at least 12 hours apart. Take it at the same time everyday.


The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you have less than 6 hours before your next scheduled dose, skip the missed dose and go back to your regular dosing schedule.

If you have only taken a part of your dose of the oral pellets, do not take another dose right away. Take your next dose at your regular dosing schedule, at least 12 hours after.


Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep your medicine in the original package (blister package or bottle for the capsules or aluminum bag for the packets of oral pellets) until you are ready to use it. Do not store the capsules in any other container (eg, pill boxes or pill organizers). After you open a bottle for the first time, you must take all of the capsules within 4 months. If you have not used the capsules within 4 months, you must dispose of the remaining capsules and start a new bottle.

Use each packet of oral pellets within 6 months of opening the aluminum bag. Throw away any unused medicine. Do not store and reuse any leftover mixture.

Precautions while using dabigatran

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

It is important to tell your doctor if you are pregnant or planning to become pregnant before using this medicine. Using this medicine while you are pregnant may increase the risk of severe bleeding from your uterus.

Make sure any doctor who treats you knows that you are using this medicine. You may need to stop using this medicine for several days before having surgery, including dental procedures.

You may bleed and bruise more easily while you are using this medicine. Be extra careful to avoid injuries. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Gently brush and floss your teeth. Be careful when using sharp objects, including razors and fingernail clippers. Avoid picking your nose. If you need to blow your nose, blow it gently.

Check with your doctor right away if you have any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, headache, dizziness, or weakness, pain, swelling, or discomfort in a joint, pinpoint red spots on your skin, unusual nosebleeds, or unusual vaginal bleeding that is heavier than normal. These may be signs of bleeding problems.

Do not suddenly stop using this medicine without asking first your doctor. Doing so may increase risk of blood clots and stroke.

This medicine may increase your risk of developing spinal or epidural blood clot. This usually occurs if you have an epidural catheter placed in your back to give you certain medicine, are taking NSAIDs or medicine to prevent blood clotting, or have a history of spinal problems or have had surgery on your spine. Check with your doctor if you have midline back pain, loss of bladder or bowel control, or numbness, tingling, or weakness of your legs or feet while you are using this medicine.

Check with your doctor right away if you have stomach pain or upset, nausea, heartburn, or indigestion while you are taking this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of dabigatran

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common


Incidence not known

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Commonly used brand name(s)

In the U.S.

Available Dosage Forms:

Therapeutic Class: Anticoagulant

Pharmacologic Class: Dabigatran Etexilate

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.