
dabigatran
Dabigatran (Pradaxa) is an anticoagulant (blood thinner) used to help prevent and treat blood clots in adults and children. It's approved for certain conditions, including atrial fibrillation (AFib), where it lowers the risk of stroke. The medication comes as oral capsules and oral pellets that you take by mouth once or twice a day, depending on your condition. Common side effects include stomach upset and bleeding. If serious bleeding occurs, another medication called Praxbind (idarucizumab) can quickly reverse its blood-thinning effects.
What is Dabigatran (Pradaxa)?
What is Dabigatran (Pradaxa) used for?
Adults:
- Lower the risk of stroke and blood clots in certain people with atrial fibrillation (AFib)
- Treat blood clots in the legs (deep vein thrombosis, DVT) or lungs (pulmonary embolism, PE) - after 5 to 10 days of treatment with an injectable blood thinner
- Lower the risk of DVT and PE from happening again in those who finished treatment
- Prevent DVT or PE after hip replacement surgery
Children (3 months and older):
- Treat blood clots - after 5 days of treatment with an injectable blood thinner
- Lower the risk of blood clots from happening again in those who finished treatment
How Dabigatran (Pradaxa) works
Dabigatran (Pradaxa) is an anticoagulant known as a direct thrombin inhibitor. It works by blocking thrombin, a protein your body needs to form blood clots.
By blocking thrombin, dabigatran (Pradaxa) helps prevent new blood clots from forming and keeps existing blood clots from getting larger.
Drug facts
| Common Brands | Pradaxa |
|---|---|
| Drug Class | Anticoagulant |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | Lower-cost generic available |
| Availability | Prescription only |
More on Dabigatran (Pradaxa) essentials
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): pain, tingling, a burning sensation, numbness, weakness, unable to use the bathroom
- Serious allergic reaction: chest pain, swelling in the face or throat, trouble breathing, feeling dizzy or faint, hives, rash, itching
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
- Doesn't require regular blood tests, frequent dose changes, or diet changes
- Has a specific reversal agent (Praxbind) for emergency situations
- Approved for both adults and children
Cons
- Most commonly taken twice a day
- Can raise the risk of serious bleeding
- Commonly causes stomach-related side effects like stomach upset and nausea
Pharmacist tips for Dabigatran (Pradaxa)
- Take your dabigatran (Pradaxa) at about the same times every day. This helps keep a steady amount of medication in your body.
- If you miss a dose of dabigatran (Pradaxa), take it as soon as you remember. But if your next scheduled dose is less than 6 hours away, just skip the missed one. Whatever you do, never take two doses at the same time to make up for a forgotten one.
- Tell all of your healthcare professionals, including your dentist, that you're taking dabigatran (Pradaxa) before any procedure or surgery. You might need to temporarily stop the medication.
- Dabigatran (Pradaxa) commonly causes stomach upset, heartburn, nausea, or stomach pain. Tell your care team if these symptoms become bothersome or don't go away.
- Dabigatran (Pradaxa) can raise your risk of bleeding and bruising. Get medical help right away if you feel dizzy, cough up or vomit blood, or notice blood in your stool or urine.
- Get medical help if you fall and hit your head while taking dabigatran (Pradaxa), even if you feel okay. You could have bleeding inside your brain.
- Dabigatran (Pradaxa) can interact with many commonly-used supplements, over-the-counter (OTC) products, and prescription medications. Taking these together can increase your risk of bleeding or affect how dabigatran (Pradaxa) works.
- Pregnancy: Tell your prescriber right away if you become pregnant or plan to become pregnant while taking dabigatran (Pradaxa). It's not known whether this medication is safe during pregnancy.
- Breastfeeding: Don't breastfeed while taking dabigatran (Pradaxa) since it's not known if the medication is safe during this time.
Oral capsules:
- You can take the capsules with or without food. If they upset your stomach, try taking them with food to help.
- Swallow the 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.
- Storage: Store the capsules in their original bottle or blister package to protect them from moisture. If using the bottle, use the capsules within 4 months after opening and keep the lid tightly closed.
Oral pellets:
- Give the pellets twice a day, about 12 hours apart. Try to give each dose at the same times every day.
- The pellets can be sprinkled on mashed carrots, applesauce, or mashed banana, or may be taken with approximately 1-2 ounces of apple juice. Once mixed, use the mixture within 30 minutes.
- Don't mix the pellets with milk or foods that contain milk, such as yogurt or pudding. This can affect how well the medication works.
- Storage: Keep the pellet packets sealed until you're ready to use them. Use all packets within 6 months after opening the aluminum bag. Throw away the desiccant once the package is opened.
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 tells you to. Stopping this medication too soon can raise your risk of serious blood clots in your body, including a stroke.
Get medical help right away if you have any of these symptoms:
- 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
Early treatment can help prevent serious complications.
Bleeding around the spine (after 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 taking dabigatran (Pradaxa) and need spinal or epidural anesthesia (numbing around your spine) or a spinal tap, you might have a higher risk of bleeding around your spinal cord. Though rare, this type can cause permanent nerve damage or paralysis.
Tell every healthcare professional that you're taking dabigatran (Pradaxa) before any spinal procedure. Get medical help right away if you have severe back pain, numbness or tingling in your legs, leg weakness, or trouble controlling your bladder or bowels after the procedure. These can be signs of bleeding around the spinal cord and need emergency treatment.
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 also take other medications that can cause bleeding, such as NSAIDs, aspirin, or other blood thinners.
Get medical help right away if you have unusual bleeding or bruising, cough up or vomit blood, notice blood in your urine or stool, or feel dizzy or faint. If you have life-threatening bleeding or need emergency surgery, adults can receive a reversal medication called Praxbind (idarucizumab) to quickly reverse the effects of dabigatran (Pradaxa).
Not for people with mechanical heart valves
Don't take dabigatran (Pradaxa) if you have a mechanical artificial heart valve. This medication can raise your risk of stroke, heart attack, blood clots, and serious bleeding. If you have an artificial heart valve and need a blood thinner, talk with your prescriber about safer treatment options.
Interactions with other medications
Dabigatran (Pradaxa) can interact with certain medications that affect how your body processes it. Some medications, such as rifampin, can make dabigatran (Pradaxa) work less well. Others, such as dronedarone or ketoconazole, can increase the amount of dabigatran (Pradaxa) in your body and raise your risk of bleeding, especially if you have kidney problems.
Tell your care team and pharmacist about all the medications, vitamins, and supplements you take before starting dabigatran (Pradaxa) or any new medication. Your prescriber might need to adjust your dose or recommend a different treatment to help keep you safe.
Not for people with antiphospholipid syndrome
Dabigatran (Pradaxa) isn't recommended if you have triple-positive antiphospholipid syndrome (APS), a condition that raises your risk of blood clots. Tell your prescriber if you have APS before starting this medication. They can help choose the safest blood thinner for you.
Dabigatran (Pradaxa) dosage
| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 75mg | 60 capsules | $42.23 | $0.70 |
| 150mg | 60 capsules | $43.29 | $0.72 |
| 110mg | 60 capsules | $44.37 | $0.74 |
Typical dosage for Dabigatran (Pradaxa)
Adults (oral capsules)
- Lower risk of stroke and blood clots in AFib: The typical dose is 150 mg by mouth twice a day.
- Treat DVT or PE: The typical dose is 150 mg by mouth twice a day.
- Lower the risk of another DVT or PE: The typical dose is 150 mg by mouth twice a day.
- Prevent 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 a day.
Children
- 3 months to less than 12 years old (oral pellets):
- The dose depends on your child's age and weight and ranges from 30 mg to 180 mg by mouth twice a day. Your child's prescriber will determine the correct dose.
- 8 years and older (oral capsules):
- The dose depends on your child's weight and ranges from 75 mg to 260 mg by mouth twice a day. Your child's prescriber will determine the correct dose.
Your dose might differ if you have kidney problems or if you take a medication that interacts with dabigatran (Pradaxa).
More on Dabigatran (Pradaxa) dosage
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 artificial heart valve
What are alternatives to Dabigatran (Pradaxa)?
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