dabigatran
Dabigatran etexilate mesylate, also known by its brand name, Pradaxa, is a type of anticoagulant blood thinner that treats and prevents certain types of blood clots in people ages 8 years and older. It's also used to lower the risk of stroke and blood clots in people with atrial fibrillation (AFib). The dosing can differ based on why you need the medication, but it's typically taken by mouth twice a day. Side effects include stomach upset and bleeding. For people who experience serious bleeding with this medication, there's an antidote medication called Praxbind (idarucizumab) that reverses its effects.
What is Dabigatran (Pradaxa)?
What is Dabigatran (Pradaxa) used for?
Adults:
- Lowering the risk of stroke or blood clots in people with atrial fibrillation (AFib) that isn't caused by a heart valve problem
- Treating blood clots in the legs (deep vein thrombosis (DVT)) or lungs (pulmonary embolism (PE)) - only after receiving an injectable blood thinner for 5-10 days
- Lowering the risk of blood clots from happening again in the legs (DVT) or lungs (PE) in people with a history of blood clots
- Preventing blood clots in the legs (DVT) or lungs (PE) after hip replacement surgery
Children 8 years and older:
- Treating blood clots - only after receiving an injectable blood thinner
- Lowering the risk of blood clots from happening again in children with a history of blood clots
How Dabigatran (Pradaxa) works
Dabigatran (Pradaxa) is an anticoagulant known as a direct thrombin inhibitor. It works by blocking thrombin, a protein that's needed for blood clots to form. By stopping thrombin from working, it prevents blood clots from forming. This lowers the risk of stroke, and treats and prevents clots in your arms or legs.
Drug facts
Side effects of Dabigatran (Pradaxa)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Upset stomach
- Nausea
- Stomach pain
- Bleeding
Less Common Side Effects
- Stomach ulcers
- Low blood cell counts
- Hair loss
Dabigatran (Pradaxa) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Severe bleeding: bleeding that doesn't stop, blood in the urine, vomiting or coughing up blood, bloody or dark-colored stools, severe stomach pain or discomfort
- Bleeding around spinal cord (after spinal procedures only): pain, tingling, a burning sensation, numbness, weakness, unable to use the bathroom
- Serious allergic reaction: swelling in the face or throat, hives, trouble breathing
More on Dabigatran (Pradaxa) side effects
The following Dabigatran (Pradaxa) side effects have also been reported
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
indigestion
pain or burning in the throat
stomach discomfort, upset, burning, or pain
vomiting
vomiting of blood or material that looks like coffee grounds
Rare
Chest pain or discomfort
difficulty with swallowing
dizziness
fainting or loss of consciousness
fast heartbeat
fast or irregular breathing
pain or discomfort in the arms, jaw, back or neck
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
sweating
tightness in the chest
trouble breathing
unusual tiredness or weakness
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
Hair loss or thinning of the hair
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.
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Pros and cons of Dabigatran (Pradaxa)
Pros
- Good option for preventing and treating blood clots in many people
- Doesn't require regular blood tests, frequent dose changes, or diet changes
- Has an antidote called Praxbind for people who experience a serious bleed
- Can be taken with or without food
Cons
- Typically taken twice a day
- Not for people who have atrial fibrillation with heart valve problems
- Can cause serious bleeding and bruising
- Common causes stomach-related side effects like nausea, vomiting, and diarrhea
Pharmacist tips for Dabigatran (Pradaxa)
- If you get more than one bottle of dabigatran (Pradaxa) from the pharmacy, only open one bottle at a time. Keep the bottle tightly closed when you aren't using it to protect the medication from moisture. Once a bottle is opened, the medication is only good for 4 months. Throw away any unused capsules after 4 months.
- You can take dabigatran (Pradaxa) with or without food. If it's hurting your stomach, taking it with food can help.
- Take your dabigatran (Pradaxa) doses at about the same time every day. This helps to make sure the levels of the medication in your body are consistent.
- If you accidentally miss a dose of dabigatran (Pradaxa), take it as soon as you can that same day. But if it’s less than 6 hours before your next dose, skip the missed dose. Don’t double up to make up for it.
- Swallow dabigatran (Pradaxa) capsules whole with a full glass of water. Don't open, chew, break, or crush them. This can cause your body to absorb too much medication and raise your risk of bleeding.
- Dabigatran (Pradaxa) can make you bleed and bruise more easily. Get medical help right away if you feel lightheaded, dizzy, are vomiting or coughing up blood, or have blood in your stool. These are signs of bleeding that might be happening inside your body.
- If you're going to have a dental procedure or surgery, make sure your healthcare care team knows you're taking dabigatran (Pradaxa). Depending on the surgery, you might need to temporarily stop taking this medication for a couple days before to lower your risk for severe bleeding.
- Get medical help if you fall and hit your head while taking dabigatran (Pradaxa). You should be urgently seen to make sure you don't have any brain bleeds.
- Dabigatran (Pradaxa) can interact with many commonly-used supplements, over-the-counter (OTC) products, and prescription medications. Make sure to tell your care team about all of the medications you're taking or planning on taking with dabigatran (Pradaxa). They can make sure your medications are as safe for you as possible.
Common questions about Dabigatran (Pradaxa)
Yes, dabigatran (Pradaxa) is a blood thinner. More specifically, it's classified as a direct thrombin inhibitor.
Pradaxa capsules are already available as a generic as of 2022. Speak to your prescriber or pharmacist if you have questions about the generic.
No blood tests are used to monitor how well dabigatran (Pradaxa) is working. But you'll know it works if you don't experience any signs or symptoms of blood clots. Your prescriber will regularly check in to see how well you're tolerating the medication. Seek medical help right away if you notice leg swelling, shortness of breath, sharp chest pain, back pain, slurred speech, or drooping of the face. These are signs of different types of blood clot problems, and typically require urgent treatment.
A single dose of dabigatran (Pradaxa) can stay in your system for about 2.5 to 3.5 days, though it might take longer for people with kidney problems. This time frame is estimated based on its half-life of dabigatran (Pradaxa), which is the time it takes for half of the medication to leave the body. Even though a dose can stay in the body for up to a few days, dabigatran (Pradaxa) must be taken twice per day to keep medication levels high enough for it to work properly.
No, don't break, chew, open, or crush the dabigatran (Pradaxa) capsules. Doing so can affect how much of the medication is absorbed, which can raise the risk for bleeding and side effects. Contact your prescriber if you're having trouble swallowing dabigatran (Pradaxa) whole because you might need to take a different blood thinner.
There isn't a set amount of time for which you must stop taking dabigatran (Pradaxa). There are typical lengths of treatment with blood thinners like dabigatran (Pradaxa), depending on why you need the medication. But things like your medical history, other medications, and risk for bleeding are also taken into consideration. Sometimes, people take dabigatran (Pradaxa) for life. Talk to your prescriber if you have questions about how long you should be taking this medication.
For invasive surgery, dabigatran (Pradaxa) should be stopped 1 to 5 days before the procedure in order to lower the risk of bleeding. But depending on your bleeding risk, your care team might recommend a different time frame. Ask your prescriber if you should stop taking this medication for dental surgery. Don't stop taking it unless a healthcare professional specifically tells you to do so.
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Risks and warnings for Dabigatran (Pradaxa)
Dabigatran (Pradaxa) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Higher risk of blood clots from stopping too early
- Risk factors: Stopping dabigatran (Pradaxa) too early
Don't stop taking dabigatran (Pradaxa) unless a healthcare professional specifically tells you it's safe to do so. Stopping the medication too early can cause blood clots to form in your body.
Let your prescriber know if you experience symptoms of blood clots, such as:
- Stroke: sudden numbness or weakness on one side of the body, feeling confused, trouble speaking or understanding speech, dizziness, trouble keeping balance
- Blood clot in the leg or arm: swelling or redness in arms or legs, skin that's warm to touch
- Blood clot in the lungs: trouble breathing, chest pain, cough, irregular heartbeat
Possible risk of paralysis (only in certain spinal procedures)
- Risk factors: Spinal puncture (spinal tap) | Getting anesthesia in the spine (epidural anesthesia) | History of spinal surgery | Taking other medications that raise the risk for bleeds
If you're having certain types of spinal procedures, taking dabigatran (Pradaxa) can raise your risk for getting a hematoma (pooling of blood) around the spinal cord. Sometimes, hematomas can lead to serious complications, such as paralysis. If you're getting a spinal procedure, a member of your care team might ask you to temporarily stop taking dabigatran (Pradaxa) to lower your risk of spinal hematomas. Let your care team know right away if you notice symptoms such as numbness or weakness of your legs, or bowel or bladder problems - these can be signs of problems with your spine.
Risk of bleeding
- Risk factors: Older than age 75 | Kidney problems | Stomach bleeding or ulcer | Taking other medications that raise the risk for bleeding (e.g., antiplatelets, anticoagulants, NSAIDs, corticosteroids)
Taking dabigatran (Pradaxa) can raise your risk for bleeding. Your risk is higher if you're also taking other medications that can cause bleeding. If you end up with a life-threatening bleed, your prescriber will consider giving you a medication called Praxbind (idarucizumab) to reverse the effects of dabigatran (Pradaxa). Let your prescriber know if you have a fall, head injury, or other kinds of physical injury - they might need to check you for bleeding inside your body. Get medical help right away if you have dark or tarry stool or bleeds that are difficult to stop.
Interactions with other medications
There are certain medications that can change the amount of dabigatran (Pradaxa) in your body. Some interactions can cause more bleeding and side effects, while others can stop dabigatran (Pradaxa)) from working as well. Let your prescriber and pharmacist know about other prescriptions, over-the-counter medications, vitamins, and herbal supplements you're taking or have stopped recently.
Not for use in people with mechanical heart valves
People who have artificial heart valves should avoid taking dabigatran (Pradaxa) since it can raise their risk of experiencing stroke, heart attack, blood clots, and life-threatening bleeding. If you need to take a blood thinner but have an artificial heart valve, talk to your prescriber about other options.
Not for use in people with antiphospholipid syndrome
Dabigatran (Pradaxa) shouldn't be used in people with antiphospholipid syndrome because it hasn't been shown to work well.
Dabigatran (Pradaxa) dosage
Capsule| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 75mg | 60 capsules | $42.06 | $0.70 |
| 150mg | 60 capsules | $55.37 | $0.92 |
| 110mg | 60 capsules | $55.37 | $0.92 |
Typical dosage for Dabigatran (Pradaxa)
Adults
- Lowering the risk of stroke or blood clots in AFib: The typical dose is 150 mg by mouth twice daily.
- Treating DVT or PE: The typical dose is 150 mg by mouth twice daily.
- Lowering the risk of DVT or PE in those with a history of blood clots: The typical dose is 150 mg by mouth twice daily.
- Preventing DVT or PE after hip replacement surgery: The typical dose is 110 mg by mouth as a single dose right after surgery, then 220 mg by mouth once daily.
Children ages 8 and older
- Treating blood clots and preventing blood clots in those with a history of blood clots: The typical dose depends on your child's weight.
- 24 lbs to under 35 lbs: The typical dose is 75 mg by mouth twice daily.
- 35 lbs to under 57 lbs: The typical dose is 110 mg by mouth twice daily.
- 57 lbs to under 90 lbs: The typical dose is 150 mg by mouth twice daily.
- 90 lbs to under 134 lbs: The typical dose is 185 mg by mouth twice daily.
- 134 lbs to under 178 lbs: The typical dose is 220 mg by mouth twice daily.
- 178 lbs or more: The typical dose is 260 mg by mouth twice daily.
Your dose might differ if you have kidney problems or if you take a medication that interacts with dabigatran (Pradaxa).
Note: Dabigatran (Pradaxa) is also available as pellets for children ages 3 months to under 12 years.
Interactions between Dabigatran (Pradaxa) and other drugs
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.
- Defibrotide
- Itraconazole
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.
- Abciximab
- Aceclofenac
- Acemetacin
- Acenocoumarol
- Alipogene Tiparvovec
- Alteplase, Recombinant
- Amiodarone
- Amtolmetin Guacil
- Anagrelide
- Anistreplase
- Apalutamide
- Apixaban
- Argatroban
- Aspirin
- Bemiparin
- Betrixaban
- Bivalirudin
- Bromfenac
- Bufexamac
- Cangrelor
- Caplacizumab-yhdp
- Capmatinib
- Carbamazepine
- Carvedilol
- Celecoxib
- Choline Salicylate
- Cilostazol
- Clarithromycin
- Clonixin
- Clopidogrel
- Cobicistat
- Collagenase, Clostridium histolyticum
- Conivaptan
- Cyclosporine
- Dalteparin
- Danaparoid
- Darunavir
- Desirudin
- Desvenlafaxine
- Dexibuprofen
- Dexketoprofen
- Diclofenac
- Diflunisal
- Dipyridamole
- Dipyrone
- Dronedarone
- Drotrecogin Alfa
- Droxicam
- Edoxaban
- Enoxaparin
- Epoprostenol
- Eptifibatide
- Erythromycin
- Escitalopram
- Etodolac
- Etofenamate
- Etoricoxib
- Felbinac
- Fenoprofen
- Fepradinol
- Feprazone
- Flibanserin
- Floctafenine
- Flufenamic Acid
- Fluoxetine
- Flurbiprofen
- Fondaparinux
- Fosphenytoin
- Heparin
- Ibrutinib
- Ibuprofen
- Iloprost
- Indomethacin
- Inotersen
- Ketoconazole
- Ketoprofen
- Ketorolac
- Lapatinib
- Lasmiditan
- Lepirudin
- Levomilnacipran
- Lornoxicam
- Lovastatin
- Loxoprofen
- Lumiracoxib
- Meclofenamate
- Mefenamic Acid
- Meloxicam
- Morniflumate
- Nabumetone
- Nadroparin
- Naproxen
- Nepafenac
- Niflumic Acid
- Nimesulide
- Nimesulide Beta Cyclodextrin
- Nintedanib
- Omadacycline
- Orlistat
- Oxaliplatin
- Oxaprozin
- Oxyphenbutazone
- Parecoxib
- Paroxetine
- Pentosan Polysulfate Sodium
- Phenindione
- Phenobarbital
- Phenprocoumon
- Phenylbutazone
- Phenytoin
- Piketoprofen
- Piracetam
- Piroxicam
- Pranoprofen
- Prasugrel
- Primidone
- Proglumetacin
- Propyphenazone
- Proquazone
- Protein C
- Quinidine
- Ranolazine
- Reteplase, Recombinant
- Rifampin
- Ritonavir
- Rivaroxaban
- Rofecoxib
- Sarecycline
- Selexipag
- Simvastatin
- St John's Wort
- Streptokinase
- Sulfinpyrazone
- Sulindac
- Telaprevir
- Tenecteplase
- Tenoxicam
- Tiaprofenic Acid
- Ticagrelor
- Ticlopidine
- Tinzaparin
- Tipranavir
- Tirofiban
- Tolfenamic Acid
- Tolmetin
- Trazodone
- Treprostinil
- Urokinase
- Valdecoxib
- Vemurafenib
- Venetoclax
- Venlafaxine
- Verapamil
- Vilazodone
- Vorapaxar
- Vortioxetine
- Warfarin
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.
- Sodium Zirconium Cyclosilicate
How much does Dabigatran (Pradaxa) cost?
Dabigatran (Pradaxa) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Dabigatran (Pradaxa) will not be safe for you to take.
- Active bleeding
- Mechanical heart valve
What are alternatives to Dabigatran (Pradaxa)?
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