Dabigatran

Pronunciation: da-BIG-a-tran.

Generic name
dabigatran etexilate
Drug class
Anticoagulant (direct oral thrombin/factor IIa inhibitor)
Form
Capsule (75 mg, 110 mg, 150 mg); coated granules also authorised in some markets for patients who cannot swallow capsules
Route
Oral
Legal status
Prescription-only

Availability and supply rules vary by country

Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand

Australia: Pradaxa (5), ARX-Dabigatran (generic) (5) · Full directory

What dabigatran etexilate is and how it works

Dabigatran is an oral anticoagulant (blood thinner) that works by directly blocking thrombin, a key clotting enzyme. It is used to prevent stroke in people with a certain type of irregular heartbeat (non-valvular atrial fibrillation), to treat blood clots in the veins or lungs (DVT/PE), to help prevent these clots from recurring, and to prevent blood clots after hip replacement surgery. (1) (2)

Dabigatran carries two genuine, serious boxed-warning risks: stopping it early (without your prescriber's guidance) can increase your risk of a stroke or blood clot, and taking it around the time of spinal or epidural anesthesia or a spinal puncture carries a risk of a spinal blood clot that can cause long-term or permanent paralysis. Unlike some other blood thinners, dabigatran must never be used if you have a mechanical heart valve -- studies found it increased the risk of both blood clots and bleeding in that specific group. A dedicated reversal medicine (idarucizumab/Praxbind) exists for emergencies but is only given by medical staff.

Mechanism of action: how dabigatran etexilate works

Dabigatran is a direct, reversible, competitive inhibitor of thrombin (activated factor IIa), both free and clot-bound thrombin. By inhibiting thrombin, dabigatran prevents the conversion of fibrinogen to fibrin during the coagulation cascade, reducing thrombus formation. It is administered as the prodrug dabigatran etexilate, which is rapidly converted to active dabigatran by esterase-catalysed hydrolysis; it is not metabolised by the cytochrome P450 system. (1) (2) (6)

What dabigatran etexilate is used for

Stroke and systemic embolism prevention in non-valvular atrial fibrillation

Used to reduce the risk of stroke and blood clots travelling to other parts of the body in adults with non-valvular atrial fibrillation (an irregular heart rhythm not caused by a heart valve problem), typically alongside other stroke-risk factors such as prior stroke, heart failure, or older age. (1) (6)

Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrence

Used to treat a blood clot in a deep vein (DVT) or in the lungs (PE) after at least 5-10 days of initial injectable (parenteral) anticoagulant treatment, and, after an initial treatment course, to reduce the risk of these clots happening again. (1) (6)

Prevention of blood clots after hip replacement surgery

Used to prevent venous thromboembolism (blood clots in the veins) in adults who have had elective total hip replacement surgery (and, in some markets including Canada, total knee replacement surgery). (1) (4)

Before taking dabigatran etexilate

Do not take / not appropriate for

  • Do not take dabigatran if you have a mechanical (prosthetic) heart valve -- this is a specific, genuine contraindication, not a general caution; a clinical trial found dabigatran increased both blood clot and bleeding risk in this group. (all countries) (1) (2)
  • Do not take dabigatran if you have active, clinically significant bleeding. (all countries) (1) (2)
  • Do not take dabigatran if you have severe kidney impairment (creatinine clearance below 30 mL/min). (all countries) (2) (4)
  • Do not take dabigatran together with strong P-glycoprotein inhibitors, such as ketoconazole, dronedarone, itraconazole, ciclosporin, or glecaprevir/pibrentasvir. (United Kingdom, and consistent with US labeling reviewed) (2)
  • Do not take dabigatran if you have a history of a serious allergic reaction to it. (United States) (1)

Tell your clinician about

  • Whether you have a mechanical heart valve -- dabigatran must not be used in this situation.
  • Any history of bleeding problems or stomach ulcers.
  • Your kidney function, since dosing and eligibility depend heavily on it.
  • Any planned surgery, dental work, spinal or epidural anesthesia, or spinal puncture, so timing around your dabigatran dose can be planned safely.
  • All other medicines you take, especially other anticoagulants, antiplatelet medicines, NSAIDs, and medicines affecting P-glycoprotein (such as ketoconazole, verapamil, amiodarone, or rifampicin).
  • Whether you are pregnant, planning pregnancy, or breastfeeding.
  • Your age -- dosing may be reduced starting at age 75-80 depending on your individual risk, and is routinely reduced at age 80 and above.
(1) (2) (6)

How to take dabigatran etexilate

  • Take dabigatran exactly as prescribed, at the dose and frequency for your specific condition.
  • Swallow capsules whole with a full glass of water -- do not open, chew, or break the capsule, as this can significantly increase how much drug is absorbed.
  • Never stop taking dabigatran on your own, even briefly, without talking to your prescriber first -- stopping early increases your risk of a stroke or blood clot.
  • If you have surgery, a dental procedure, or a spinal/epidural procedure planned, your care team will tell you exactly when to stop and restart dabigatran around it.
(1) (2) (6)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6)

Missed dose

If you miss a dose, take it as soon as you remember, unless it is within 6 hours of your next scheduled dose -- in that case, skip the missed dose and continue your normal schedule. Do not take a double dose to make up for a missed one. If unsure, contact your prescriber or pharmacist for guidance rather than guessing.

Overdose

Seek urgent medical attention for a suspected overdose. Signs of too much anticoagulant effect include unusual bruising, nosebleeds, blood in urine or stool, or unusually heavy bleeding. Unlike some other anticoagulants, dabigatran has a specific, dedicated reversal agent (idarucizumab/Praxbind) available in hospital settings for life-threatening bleeding or urgent surgery, and dabigatran can also be removed from the blood by dialysis in some circumstances, though clinical experience with dialysis for this purpose is limited. (1) (2) (6)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Stomach upset, indigestion, or gastritis-like symptoms (the most common adverse reactions reported, alongside bleeding).

What to notice: Stomach upset, indigestion, or gastritis-like symptoms (the most common adverse reactions reported, alongside bleeding).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Gastrointestinal bleeding, nosebleeds (epistaxis), bruising, and anaemia.

What to notice: Gastrointestinal bleeding, nosebleeds (epistaxis), bruising, and anaemia.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)

Gastroesophageal reflux and abdominal pain.

What to notice: Gastroesophageal reflux and abdominal pain.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (2)

Serious warnings

Signs of a spinal or epidural blood clot (hematoma) — boxed_warning

Symptoms: New or worsening back pain, numbness, tingling, weakness in the legs, or loss of control of bowel or bladder function, especially after spinal or epidural anesthesia or a spinal puncture.

Action: Seek emergency medical help immediately -- this can indicate a spinal or epidural blood clot pressing on the spinal cord, which can cause long-term or permanent paralysis if not treated urgently. (1) (2)

Risk of stroke or blood clot from stopping this medicine early — boxed_warning

Symptoms: Not applicable -- this is a warning about the danger of unsupervised discontinuation, not a symptom to watch for.

Action: Never stop taking dabigatran on your own. If you need to stop for any reason, including before a procedure or because of bleeding, this must be planned with your prescriber. (1)

Signs of serious bleeding — boxed_warning_adjacent_serious

Symptoms: Unusual bruising, nosebleeds that won't stop, blood in urine or stool, coughing up blood, severe headache, vomiting blood, or bleeding from the gums.

Action: Contact your clinician or seek emergency care immediately -- a specific reversal agent (idarucizumab) is available in hospital settings for serious or life-threatening bleeding. (1) (2)

Risks specific to mechanical heart valves — contraindication

Symptoms: Not applicable -- this is about who should never take this medicine.

Action: Dabigatran must not be used if you have a mechanical prosthetic heart valve; tell every prescriber and pharmacist about any heart valve replacement you have had. (1) (2)

Signs of a serious allergic reaction — emergency

Symptoms: Swelling of the face, lips, tongue, or throat; difficulty breathing; widespread rash, hives, or urticaria.

Action: Seek emergency medical help immediately. (1) (2)

Interactions

  • Strong P-glycoprotein inhibitors -- ketoconazole, dronedarone, itraconazole, ciclosporin, and glecaprevir/pibrentasvir -- must not be combined with dabigatran; they significantly increase dabigatran blood levels and bleeding risk. (2)
  • Milder P-glycoprotein inhibitors, such as verapamil, amiodarone, and quinidine, require caution and sometimes a dose adjustment or specific dose timing. (2)
  • P-glycoprotein inducers -- rifampicin, St John's Wort, carbamazepine, and phenytoin -- significantly reduce dabigatran's effectiveness and should generally be avoided. (2)
  • Other medicines that affect bleeding or clotting -- including NSAIDs, aspirin and other antiplatelet medicines, and other anticoagulants -- increase bleeding risk and increase the spinal/epidural hematoma risk if combined around the time of a spinal procedure. (1) (2)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Dabigatran's safety has not been established for use during pregnancy; use is generally avoided unless a clinician determines it is clearly necessary. (1) (2) (3) (4) (5) (6)

Breastfeeding

Breastfeeding should generally be discontinued during dabigatran treatment, based on clinician guidance. (1) (2) (3) (4) (5) (6)

Children

Safety and efficacy have not been established in patients under 18 years of age; dabigatran is not indicated for this population for stroke prevention in atrial fibrillation. (1) (2) (3) (4) (5) (6)

Elderly

Dose is routinely reduced to 110 mg twice daily at age 80 and above, and may be reduced at age 75-80 depending on individual thromboembolic and bleeding risk; older age is generally associated with increased drug exposure and bleeding risk. (1) (2) (3) (4) (5) (6)

Hepatic_impairment

Use with caution; dabigatran has not been extensively studied in significant hepatic impairment or liver disease associated with coagulopathy. (1) (2) (3) (4) (5) (6)

Renal_impairment

Contraindicated in severe renal impairment (creatinine clearance below 30 mL/min). Dose reduction to 110 mg twice daily may be considered in moderate impairment (creatinine clearance 30-50 mL/min) if bleeding risk is high and clot risk is low. Kidney function must be assessed before starting and monitored at least annually during treatment (more often if it may decline). (1) (2) (3) (4) (5) (6)

Source_ids

US-DAILYMED-PRADAXA-2026,UK-EMC-PRADAXA-SMPC-2026,NZ-MEDSAFE-PRADAXA-2026 (1) (2) (3) (4) (5) (6)

Monitoring

Before starting

  • Kidney function (estimated creatinine clearance)
  • Baseline bleeding risk assessment
  • Confirmation the patient does not have a mechanical heart valve
  • Review of other medicines affecting P-glycoprotein or bleeding/clotting
  • Review of any planned spinal/epidural procedure or surgery

During treatment

  • Kidney function reassessed at least annually, and more often if it may be compromised (such as during acute illness) or in moderate renal impairment.
  • Ongoing monitoring for signs of bleeding at every visit.
  • Close monitoring for neurological signs (back pain, numbness, weakness, bowel/bladder changes) around the time of any spinal or epidural procedure.
(6) (1)

Storage

Store in the original blister pack or bottle, protected from moisture -- do not repackage into pill organisers, as dabigatran capsules are moisture-sensitive and this can reduce their effectiveness. Keep out of reach of children.

Study the drug class: Direct oral anticoagulants

Professional information

Clinician-facing context only, sourced from the current US FDA, UK EMC, and Health Canada labels reviewed for this dossier; verify against the current full label before prescribing.

United States

Indication: Non-valvular atrial fibrillation

Dose summary: 150 mg twice daily (CrCl >30 mL/min); 75 mg twice daily (CrCl 15-30 mL/min).

Renal context: Dose-reduced at CrCl 15-30 mL/min; not established below 15 mL/min or in dialysis for this indication. (1)

United Kingdom, New Zealand

Indication: Non-valvular atrial fibrillation

Dose summary: 150 mg twice daily standard; 110 mg twice daily at age >=80 (or age 75-80 with low thrombotic/high bleeding risk); 110 mg twice daily may be considered at CrCl 30-50 mL/min with high bleeding risk.

Renal context: Contraindicated at CrCl <30 mL/min; reassess renal function at least annually in moderate impairment. (2) (6)

Mechanism of action

Hepatic guidance

Limited clinical data in significant hepatic impairment; use with caution and clinical judgement.

Overdose note

Idarucizumab (Praxbind) is a specific, monoclonal-antibody-fragment reversal agent indicated for rapid reversal of dabigatran's anticoagulant effect in emergency surgery/urgent procedures or life-threatening/uncontrolled bleeding; not established in paediatric patients. Dabigatran can also be removed by dialysis, though clinical experience with this approach is limited. (1) (2) (6)

Frequently asked questions

Why can't I take dabigatran if I have a mechanical heart valve?

A clinical trial (RE-ALIGN) found that patients with mechanical prosthetic heart valves who took dabigatran had more blood clots AND more bleeding than those on warfarin, so dabigatran is specifically contraindicated in this group -- it is not simply a general caution. Always tell every prescriber and pharmacist if you have had a heart valve replacement. (1) (2)

Is there an emergency reversal medicine for dabigatran?

Yes -- idarucizumab (brand name Praxbind) is a specific reversal agent approved for dabigatran in emergency surgery or life-threatening bleeding. It is given only by medical staff in a hospital setting; it is not something you can request or use yourself, and it does not change how you take your regular dabigatran dose day to day. (2) (3)

Can I open the capsule or crush it if I have trouble swallowing?

No -- do not open, chew, or crush dabigatran capsules. Doing so can significantly increase how much of the drug your body absorbs, raising your bleeding risk. If you have difficulty swallowing capsules, tell your prescriber; a coated-granule formulation exists in some markets for this situation. (1)

What is the mechanism of action of dabigatran etexilate?

Dabigatran is a direct, reversible, competitive inhibitor of thrombin (activated factor IIa), both free and clot-bound thrombin. By inhibiting thrombin, dabigatran prevents the conversion of fibrinogen to fibrin during the coagulation cascade, reducing thrombus formation. It is administered as the prodrug dabigatran etexilate, which is rapidly converted to active dabigatran by esterase-catalysed hydrolysis; it is not metabolised by the cytochrome P450 system. (1) (2) (6)

What is the generic name of Dabigatran?

The generic name is dabigatran etexilate. (1) (3)

What class of drug is dabigatran etexilate?

Dabigatran is classed as: Anticoagulant (direct oral thrombin/factor IIa inhibitor). (1) (3)

References

  1. PRADAXA (dabigatran etexilate mesylate) capsules -- full prescribing informationU.S. Food and Drug Administration / DailyMed (NIH), full prescribing information, Boehringer Ingelheim Pharmaceuticals, Inc. · United States · accessed 2026-07-31 · source 1
  2. Pradaxa 150 mg hard capsules -- Summary of Product Characteristicselectronic medicines compendium (emc), United Kingdom -- Boehringer Ingelheim Ltd · United Kingdom · accessed 2026-07-31 · source 2
  3. Pradaxa, INN-dabigatran etexilate -- EPAREuropean Medicines Agency (EMA) -- centralised EU marketing authorisation, EPAR · European Union · accessed 2026-07-31 · source 3
  4. PRADAXA (dabigatran etexilate capsules) -- Product MonographHealth Canada product monograph, Boehringer Ingelheim Canada Ltd. · Canada · accessed 2026-07-31 · source 4
  5. PRADAXA dabigatran etexilate tablets -- ARTG entries 137832 (75 mg), 138402 (110 mg), 168211 (150 mg)Therapeutic Goods Administration (TGA), Australia · Australia · accessed 2026-07-31 · source 5
  6. PRADAXA (dabigatran etexilate) hard capsules -- New Zealand Data Sheet (v08)Medsafe (New Zealand Medicines and Medical Devices Safety Authority) · New Zealand · accessed 2026-07-31 · source 6

Brand names by country

Single-ingredient dabigatran etexilate names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • Pradaxa75 mg, 110 mg, 40 mg, 150 mg, 30 mg, 20 mg, 50 mg · boehringer ingelheim pharmaceuticals inc.

United Kingdom

  • Pradaxa (2)MHRA licensed emc smpc confirmed · 75 mg, 110 mg, 150 mg · Boehringer Ingelheim Ltd

Canada

  • PRADAXA

Australia

  • Pradaxa (5)TGA ARTG registered confirmed · 75 mg, 110 mg, 150 mg · Boehringer Ingelheim Pty Ltd
  • ARX-Dabigatran (generic) (5)TGA ARTG registered confirmed · 110 mg · not specified in source

New Zealand

  • Pradaxa (plus generic Pharmacor Dabigatran Etexilate) (6)Medsafe data sheet confirmed current version v08 · 75 mg, 110 mg, 150 mg · Boehringer Ingelheim (NZ) Ltd
View brands in additional countries.

European Union

Pradaxa (3), Dabigatran etexilate Teva (generic) (3)

This page provides general reference information about dabigatran (Pradaxa) and is not a substitute for advice from the clinician managing your treatment. All dosing, timing around procedures, and treatment-continuation decisions should be made with your prescriber or care team -- never stop, start, or change this medicine on your own.

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