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.

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.

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

Acid or sour stomach

belching

black, tarry stools

bloody stools

constipation

diarrhea

heartburn

indigestion

nausea

pain or burning in the throat

stomach discomfort, upset, burning, or pain

vomiting

vomiting of blood or material that looks like coffee grounds

Rare

Cough

difficulty with swallowing

dizziness

fainting or loss of consciousness

fast heartbeat

fast or irregular breathing

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness of the skin

skin rash, hives, welts, or itching skin

tightness in the chest

trouble breathing

unusual tiredness or weakness

Incidence not known

Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

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.

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.

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.