Dabigatran is used to prevent stroke and harmful blood clots (such as in your legs or lungs) if you have a certain type of irregular heartbeat (atrial fibrillation). Dabigatran is also used to treat blood clots in the veins of your legs (deep
vein thrombosis) or lungs (pulmonary embolism) and to reduce the risk of them occurring again. This medication may also be used to prevent these blood clots from forming after hip replacement surgery. Dabigatran is an
anticoagulant that works by blocking a certain substance (a clotting protein called thrombin) in your blood. This helps to keep blood flowing smoothly in your body.
Dabigatran should not be used to prevent blood clots from forming after artificial heart valve replacement. If you have had heart valve surgery, talk to your doctor about the best medication for you. Do not stop taking any medication,
including dabigatran, without talking to your doctor first.
POSSIBLE SIDE EFFECTS
Easy bruising or minor bleeding (such as nosebleed, bleeding from cuts) may occur. If either of these effects persists or worsens, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
This medication can cause serious bleeding if it affects your blood clotting proteins too much. Tell your doctor right away if you have any signs of serious bleeding, including: unusual pain/swelling/discomfort, unusual/easy bruising,
prolonged bleeding from cuts or gums, persistent/frequent nosebleeds, unusually heavy/prolonged menstrual flow, pink/dark urine, coughing up blood, vomit that is bloody or looks like coffee grounds, severe headache,
dizziness/fainting, unusual or persistent tiredness/weakness, bloody/black/tarry stools.
Tell your doctor right away if you have any serious side effects, including: stomach/abdominal pain, severe heartburn/nausea/vomiting.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness,
trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
PRECAUTIONS
Before taking dabigatran, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your
pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: mechanical heart valve, kidney disease, bleeding problems (such as bleeding of the stomach/intestines, bleeding in the brain), blood
disorders (such as anemia, hemophilia, thrombocytopenia), liver disease, recent major injury/surgery, stroke, frequent falls/injuries.
It is important that all your doctors and dentists know that you take dabigatran. Before having surgery or any medical/dental procedures, tell your doctor or dentist that you are taking this medication and about all the products you use
(including prescription drugs, nonprescription drugs, and herbal products). Your doctor may tell you to stop this medication before surgery. Follow your doctor's directions carefully.
Avoid getting injections into the muscles. If you must have an injection into the muscle (for example, a flu shot), ask for it to be given in the arm. This way, it will be easier to check for bleeding and/or apply pressure bandages.
This medication may cause stomach bleeding. Daily use of alcohol while using this medicine may increase your risk for stomach bleeding. Limit alcoholic beverages. Ask your doctor or pharmacist about how much alcohol you may
safely drink.
This medication can cause heavy bleeding. To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports. Use an electric razor when
shaving and a soft toothbrush when brushing your teeth. If you fall or injure yourself, especially if you hit your head, call your doctor right away. Your doctor may need to check you.
Older adults may be at greater risk for bleeding while using this drug.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
PRECAUTIONS
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including
prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Some products that may interact with this drug include: mifepristone, other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, "blood thinners" such as warfarin, enoxaparin), certain
antidepressants (including SSRIs such as fluoxetine, SNRIs such as venlafaxine).
Other medications can affect the removal of apixaban from your body, which may affect how apixaban works. Examples include certain azole antifungals (such as itraconazole, ketoconazole, posaconazole), clarithromycin, conivaptan,
HIV protease inhibitors (such as lopinavir, ritonavir), rifamycins (such as rifabutin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.
Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (aspirin, NSAIDs such as ibuprofen, naproxen) that may increase your risk for bleeding if taken together
with this medication. However, if your doctor has directed you to take low-dose aspirin to prevent heart attack or stroke (usually at dosages of 81-325 milligrams a day), you should continue taking the aspirin unless your doctor
instructs you otherwise. Ask your doctor or pharmacist for more details.
INTERACTIONS
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including
prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Some products that may interact with this drug include: mifepristone.
Other medications can affect the removal of dabigatran from your body, which may affect how dabigatran works. Examples include cobicistat, cyclosporine, dronedarone, ketoconazole, rifampin, and St. John's wort, among others.
Aspirin, aspirin-like drugs (salicylates), and nonsteroidal anti-inflammatory drugs (NSAIDs such as ibuprofen, naproxen, celecoxib) may have effects similar to dabigatran. These drugs may increase the risk of bleeding problems if
taken during treatment with dabigatran. Carefully check all prescription/nonprescription product labels (including drugs applied to the skin such as pain-relieving creams) since the products may contain NSAIDs or salicylates. Talk to
your doctor about using a different medication (such as acetaminophen) to treat pain/fever. If you have been prescribed low-dose aspirin and related drugs (such as clopidogrel, ticlopidine) for specific medical reasons such as heart
attack or stroke prevention, ask your doctor if you should continue taking them or if your prescription should be changed. Consult your doctor or pharmacist for more details.