Dabigatran Etexilate Viatris

Oral anticoagulant (direct thrombin inhibitor) for stroke prevention and blood clot treatment

Prescription Only (Rx) B01AE07 Direct Thrombin Inhibitor
Active Ingredient
Dabigatran etexilate mesilate
Dosage Forms
Hard capsule
Available Strengths
75 mg, 110 mg, 150 mg
Administration
Oral
Reviewed by iMedic Medical Board
Evidence Level 1A

Dabigatran Etexilate Viatris is a generic oral anticoagulant containing dabigatran etexilate, a direct thrombin inhibitor. It is primarily used to prevent stroke and systemic embolism in adults with non-valvular atrial fibrillation, and to treat and prevent deep vein thrombosis (DVT) and pulmonary embolism (PE). It belongs to the class of direct oral anticoagulants (DOACs) and is bioequivalent to the originator product. Dabigatran is available as hard capsules in 75 mg, 110 mg, and 150 mg strengths and requires a prescription.

Quick Facts

Active Ingredient
Dabigatran etexilate
Drug Class
Direct Thrombin Inhibitor (DOAC)
ATC Code
B01AE07
Common Uses
Stroke Prevention, DVT/PE
Available Forms
Hard capsule 75/110/150 mg
Prescription Status
Rx Only

Key Takeaways

  • Dabigatran Etexilate Viatris is a generic direct thrombin inhibitor used to prevent stroke in non-valvular atrial fibrillation and to treat/prevent venous thromboembolism (DVT and PE).
  • Unlike warfarin, dabigatran does not require routine blood monitoring (INR testing) and has fewer dietary interactions, making daily management simpler for most patients.
  • Capsules must be swallowed whole — never opened, crushed, or chewed — as this can dramatically increase drug absorption and risk of serious bleeding.
  • A specific reversal agent, idarucizumab (Praxbind), is available to rapidly neutralise the anticoagulant effect in life-threatening bleeding or emergency surgery.
  • Kidney function must be assessed before starting treatment and monitored regularly, as dabigatran is primarily eliminated by the kidneys and dose adjustments are required in renal impairment.

What Is Dabigatran Etexilate Viatris and What Is It Used For?

Quick Answer: Dabigatran Etexilate Viatris is a prescription oral anticoagulant (blood thinner) that works by directly inhibiting thrombin, a key enzyme in the blood clotting cascade. It is used to prevent stroke in atrial fibrillation, treat blood clots, and prevent clots after joint replacement surgery.

Dabigatran etexilate is a prodrug that is rapidly converted to its active form, dabigatran, by esterase enzymes in the plasma and liver after oral administration. Dabigatran is a potent, direct, competitive, and reversible inhibitor of thrombin (also known as coagulation factor IIa). By inhibiting thrombin, dabigatran prevents the conversion of fibrinogen to fibrin, thereby interrupting the final common pathway of the coagulation cascade and reducing thrombus (blood clot) formation.

The Viatris formulation is a generic version of the originator product and is bioequivalent, meaning it delivers the same amount of active substance at the same rate. It is approved by the European Medicines Agency (EMA) and other regulatory authorities worldwide for the same indications as the reference product.

Dabigatran Etexilate Viatris is indicated for the following therapeutic uses in adults:

  • Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF) who have one or more risk factors such as prior stroke or transient ischaemic attack (TIA), age 75 years or older, heart failure (NYHA Class II or above), diabetes mellitus, or hypertension.
  • Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults, following initial treatment with a parenteral anticoagulant for at least 5 days.
  • Prevention of venous thromboembolism (VTE) in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.

The landmark RE-LY trial (Randomized Evaluation of Long-Term Anticoagulation Therapy), published in the New England Journal of Medicine in 2009, demonstrated that dabigatran 150 mg twice daily was superior to warfarin in preventing stroke and systemic embolism in patients with atrial fibrillation, while dabigatran 110 mg twice daily was non-inferior to warfarin with significantly lower rates of major bleeding. These findings established dabigatran as a cornerstone of modern anticoagulation therapy.

Dabigatran belongs to the class of direct oral anticoagulants (DOACs), which also includes rivaroxaban, apixaban, and edoxaban. The DOACs have largely replaced warfarin as first-line anticoagulation for most indications due to their predictable pharmacokinetics, lack of need for routine coagulation monitoring, and more favourable safety profiles in many patient populations.

What Should You Know Before Taking Dabigatran Etexilate Viatris?

Quick Answer: You should not take dabigatran if you have a mechanical heart valve, severe kidney impairment (CrCl <30 mL/min), active clinically significant bleeding, or if you are taking certain strong P-glycoprotein inhibitors. Kidney function testing is required before and during treatment.

Contraindications

Dabigatran Etexilate Viatris must not be used in the following situations. These are absolute contraindications, meaning the drug should never be prescribed or taken under these circumstances:

  • Known hypersensitivity to dabigatran etexilate, dabigatran, or any of the excipients listed in the formulation.
  • Severe renal impairment with a creatinine clearance (CrCl) below 30 mL/min. Dabigatran is approximately 80% eliminated renally, and severe kidney impairment leads to dangerous drug accumulation.
  • Active clinically significant bleeding, including gastrointestinal haemorrhage, intracranial haemorrhage, or any other major bleeding event.
  • Lesions or conditions considered a significant risk factor for major bleeding, such as current or recent gastrointestinal ulceration, malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal, or ophthalmic surgery, recent intracranial haemorrhage, or known or suspected oesophageal varices.
  • Concomitant treatment with systemic ketoconazole, cyclosporine, itraconazole, dronedarone, or any other strong P-glycoprotein (P-gp) inhibitor as determined by the prescribing information for the specific market.
  • Hepatic impairment or liver disease expected to have any impact on survival.
  • Prosthetic heart valves requiring anticoagulant treatment. The RE-ALIGN trial was terminated early due to increased thromboembolic and bleeding events in patients with mechanical heart valves treated with dabigatran compared to warfarin.

Warnings and Precautions

Several important warnings and precautions should be carefully considered before initiating and during treatment with dabigatran:

Bleeding risk: As with all anticoagulants, dabigatran increases the risk of bleeding. Any signs or symptoms of bleeding or anaemia should prompt investigation, including a decrease in haemoglobin or blood pressure with no clear cause. Risk factors for bleeding include age 75 years or older, moderate renal impairment (CrCl 30–50 mL/min), concomitant use of antiplatelet agents or NSAIDs, low body weight (<50 kg), and conditions associated with increased bleeding risk.

Renal function monitoring: Because dabigatran is primarily eliminated via the kidneys, renal function (as estimated by creatinine clearance using the Cockcroft-Gault method) must be assessed before starting treatment. During treatment, renal function should be assessed at least once per year in patients over 75 years of age, or more frequently if clinical circumstances suggest that renal function might decline (such as dehydration, concurrent nephrotoxic medication use, or hypovolaemia).

Surgical and invasive procedures: Dabigatran should be temporarily discontinued before surgical or invasive procedures due to the increased risk of bleeding. The duration of preoperative discontinuation depends on the patient's renal function and the bleeding risk of the procedure. For procedures with a high bleeding risk and normal renal function, dabigatran should be stopped at least 48 hours beforehand. For procedures with a standard bleeding risk, stopping 24 hours beforehand is generally sufficient. In patients with impaired renal function, longer discontinuation times are necessary.

Spinal/epidural anaesthesia or puncture: As with all anticoagulants, there is a risk of spinal or epidural haematoma with neuraxial anaesthesia. Specific timing guidelines must be followed for catheter insertion and removal in relation to dabigatran dosing.

Pregnancy and Breastfeeding

There are limited data from the use of dabigatran in pregnant women. Animal studies have shown reproductive toxicity, and therefore dabigatran should not be used during pregnancy unless clearly necessary and only if the potential benefit outweighs the potential risk to the foetus. Women of childbearing potential should avoid pregnancy during treatment with dabigatran, and effective contraception should be used.

It is not known whether dabigatran is excreted in human breast milk. No clinical data on the effect of dabigatran on infants during breastfeeding are available. As a precautionary measure, breastfeeding should be discontinued during treatment with dabigatran. A decision must be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.

How Does Dabigatran Etexilate Viatris Interact with Other Drugs?

Quick Answer: Dabigatran is a substrate of the P-glycoprotein (P-gp) transporter. Strong P-gp inhibitors (ketoconazole, dronedarone, cyclosporine) are contraindicated. P-gp inducers (rifampicin, St John's Wort, carbamazepine) significantly reduce dabigatran levels and should be avoided. Antiplatelet agents and NSAIDs increase bleeding risk.

Drug interactions with dabigatran are primarily mediated through the P-glycoprotein (P-gp) efflux transporter. Dabigatran etexilate (the prodrug) is a substrate of P-gp, and drugs that inhibit or induce P-gp can significantly affect dabigatran plasma concentrations. Unlike warfarin, dabigatran is not metabolised by the cytochrome P450 (CYP) enzyme system, which substantially reduces the number of potential drug interactions.

Understanding these interactions is essential for safe prescribing and patient safety. The following table summarises the most clinically significant interactions:

Major Interactions

Major Drug Interactions — Contraindicated or Require Dose Adjustment
Interacting Drug Mechanism Effect Clinical Action
Ketoconazole (systemic) Strong P-gp inhibitor Increases dabigatran AUC by 138–153% Contraindicated — do not co-administer
Dronedarone Strong P-gp inhibitor Increases dabigatran AUC by approximately 70–100% Contraindicated — do not co-administer
Cyclosporine Strong P-gp inhibitor Significant increase in dabigatran levels Contraindicated — do not co-administer
Itraconazole Strong P-gp inhibitor Significant increase in dabigatran levels Contraindicated — do not co-administer
Rifampicin Potent P-gp inducer Decreases dabigatran AUC by approximately 66% Avoid concomitant use — markedly reduced efficacy
St John's Wort P-gp inducer Decreased dabigatran exposure Avoid concomitant use
Carbamazepine P-gp inducer Decreased dabigatran exposure Avoid concomitant use

Interactions Requiring Caution

Drug Interactions Requiring Caution or Dose Adjustment
Interacting Drug Mechanism Effect Clinical Action
Amiodarone Moderate P-gp inhibitor Increases dabigatran AUC by approximately 50–60% No dose reduction in AF; reduce dose for VTE prophylaxis post-surgery
Verapamil Moderate P-gp inhibitor Increases dabigatran Cmax by 90–180% if taken simultaneously Consider dose reduction; take dabigatran at least 2 hours before verapamil
Aspirin Additive antihaemostatic effect Increased bleeding risk by approximately 12–18% Use only when clinically necessary; monitor for bleeding
Clopidogrel Additive antiplatelet effect Increased bleeding risk Use with caution; evaluate risk-benefit carefully
NSAIDs Impaired platelet function + GI mucosal injury Increased bleeding risk, particularly GI bleeding Avoid long-term NSAIDs; use short courses if needed
SSRIs/SNRIs Impaired platelet serotonin uptake Slightly increased bleeding risk Monitor for signs of bleeding
Proton pump inhibitors (PPIs) Increased gastric pH may reduce absorption May decrease dabigatran AUC by approximately 20–30% No dose adjustment recommended; clinical significance likely minor

It is important to inform your healthcare provider about all medications you are taking, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements. This includes any anticoagulants or antiplatelet agents, as the combination with dabigatran significantly increases the risk of bleeding. Switching between dabigatran and other anticoagulants requires careful timing to maintain adequate anticoagulation while minimising bleeding risk.

What Is the Correct Dosage of Dabigatran Etexilate Viatris?

Quick Answer: The standard dose for stroke prevention in atrial fibrillation is 150 mg twice daily. A reduced dose of 110 mg twice daily is recommended for patients aged 80 years or older, those taking verapamil, and may be considered for patients aged 75–80 or with moderate renal impairment. For VTE prophylaxis after surgery, the dose is 220 mg once daily (or 150 mg once daily in selected patients).

The dosage of dabigatran varies depending on the indication, patient age, kidney function, and concomitant medications. It is essential that the dose prescribed by your healthcare provider is followed precisely. The capsules must always be swallowed whole with a full glass of water and should never be opened, crushed, or chewed.

Adults

Dosage Recommendations by Indication
Indication Standard Dose Reduced Dose Duration
Stroke prevention in AF 150 mg twice daily 110 mg twice daily (age ≥80, verapamil use, or high bleeding risk) Long-term (as long as benefit outweighs risk)
DVT/PE treatment 150 mg twice daily (after ≥5 days parenteral anticoagulant) 110 mg twice daily for age ≥80 years Minimum 3 months; duration based on individual risk assessment
DVT/PE prevention (recurrence) 150 mg twice daily 110 mg twice daily for age ≥80 years Based on individual risk-benefit assessment
VTE prophylaxis — hip replacement 220 mg once daily (110 mg on day of surgery, 1–4 hours post-op) 150 mg once daily (75 mg on day of surgery) 28–35 days
VTE prophylaxis — knee replacement 220 mg once daily (110 mg on day of surgery, 1–4 hours post-op) 150 mg once daily (75 mg on day of surgery) 10 days

Children and Adolescents

Dabigatran Etexilate Viatris is not recommended for use in children and adolescents below 18 years of age. The safety and efficacy of dabigatran in the paediatric population have not been established in all indications. A specific paediatric formulation (oral pellets) of the originator product has been developed for some indications, but this is separate from the Viatris hard capsule formulation.

Elderly Patients

For patients aged 75 to 80 years with atrial fibrillation, the prescriber may consider either 150 mg or 110 mg twice daily based on individual assessment of thromboembolic risk versus bleeding risk. The ESC guidelines note that the 110 mg dose may be preferred in this age group, particularly if additional risk factors for bleeding are present.

For patients aged 80 years or older, the recommended dose for stroke prevention in atrial fibrillation is 110 mg twice daily. This reduced dose is based on pharmacokinetic data showing higher dabigatran exposure in elderly patients and the increased bleeding risk associated with advanced age.

For VTE prophylaxis after orthopaedic surgery in patients aged 75 years or older, the total daily dose should be reduced to 150 mg (administered as 75 mg on the day of surgery, followed by 150 mg once daily).

Renal Impairment Dosing

Moderate Renal Impairment (CrCl 30–50 mL/min)

Consider dose reduction to 110 mg twice daily for atrial fibrillation and DVT/PE. For VTE prophylaxis, the dose should be reduced to 150 mg once daily (75 mg on day of surgery). Close clinical monitoring is recommended, particularly for signs of bleeding.

Severe Renal Impairment (CrCl <30 mL/min)

Contraindicated. Dabigatran must not be used in patients with a creatinine clearance below 30 mL/min due to the high risk of drug accumulation and consequent bleeding events.

Missed Dose

If you forget to take a dose of dabigatran, take it as soon as you remember on the same day. If fewer than 6 hours remain before the next scheduled dose, skip the missed dose entirely and take the next dose at the normal time. Never take a double dose to compensate for a forgotten dose, as this substantially increases the risk of bleeding. If you are concerned about missed doses, speak to your pharmacist or prescriber.

Overdose

There is no general antidote for dabigatran in the usual sense, but a specific reversal agent — idarucizumab (Praxbind) — is available. Idarucizumab is a humanised monoclonal antibody fragment that binds specifically to dabigatran and neutralises its anticoagulant effect within minutes. It is indicated for use when rapid reversal is required, such as in emergency surgery or life-threatening or uncontrolled bleeding.

In the absence of idarucizumab, overdose management includes discontinuation of the drug, adequate diuresis, surgical haemostasis if needed, and consideration of fresh frozen plasma, activated prothrombin complex concentrates, or recombinant Factor VIIa in severe cases. Haemodialysis can remove approximately 60% of dabigatran from the blood over 2–3 hours, although clinical experience is limited. Activated charcoal may be considered if ingestion occurred within the previous 2 hours.

What Are the Side Effects of Dabigatran Etexilate Viatris?

Quick Answer: The most common side effects are gastrointestinal symptoms (dyspepsia, nausea, abdominal pain) and bleeding events. Serious but less common effects include major gastrointestinal haemorrhage and, rarely, intracranial bleeding. Any unexplained bleeding, dark stools, or blood in urine should be reported to a healthcare provider immediately.

Like all medicines, dabigatran can cause side effects, although not everybody gets them. The most clinically significant adverse effect is bleeding, which can range from minor (bruising, nosebleeds) to serious and potentially life-threatening (intracranial haemorrhage, major gastrointestinal bleeding). The frequency of bleeding events depends on the dose used and the patient population studied.

The following side effects have been reported in clinical trials and post-marketing surveillance. They are organised by frequency according to MedDRA (Medical Dictionary for Regulatory Activities) conventions:

Common

Affects 1 to 10 in every 100 patients

  • Gastrointestinal haemorrhage (stomach or intestinal bleeding)
  • Abdominal pain
  • Diarrhoea
  • Dyspepsia (indigestion, heartburn)
  • Nausea
  • Epistaxis (nosebleeds)
  • Urogenital haemorrhage (including blood in urine)
  • Skin and subcutaneous haemorrhage (bruising)
  • Decreased haemoglobin (anaemia)

Uncommon

Affects 1 to 10 in every 1,000 patients

  • Intracranial haemorrhage (bleeding in the brain)
  • Haemorrhage at surgical wound site
  • Haematoma (collection of blood outside vessels)
  • Rectal haemorrhage
  • Haemorrhoidal haemorrhage
  • Gastric ulcer (including oesophageal ulcer)
  • Gastro-oesophagitis
  • Gastro-oesophageal reflux disease
  • Vomiting
  • Dysphagia (difficulty swallowing)
  • Thrombocytopenia (low platelet count)
  • Hypersensitivity reactions (rash, pruritus)
  • Abnormal liver function tests
  • Elevated hepatic transaminases

Rare

Affects 1 to 10 in every 10,000 patients

  • Anaphylactic reaction
  • Angioedema
  • Urticaria (hives)
  • Bronchospasm
  • Hepatic injury (liver damage)
  • Alopecia (hair loss)

In the RE-LY trial, gastrointestinal symptoms including dyspepsia were more common with dabigatran than with warfarin. This is thought to be related to the tartaric acid core of the dabigatran capsule, which creates an acidic microenvironment to enhance drug absorption. Taking the capsules with food or a full glass of water may help reduce gastrointestinal discomfort. The rate of major gastrointestinal bleeding was higher with dabigatran 150 mg twice daily compared to warfarin, while the rate of intracranial haemorrhage was significantly lower — a critical finding that underpins its favourable benefit-risk profile for most patients.

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed above. You can also report side effects directly to your national pharmacovigilance authority (for example, the Yellow Card Scheme in the UK, MedWatch in the US, or the EMA's EudraVigilance system in Europe).

How Should You Store Dabigatran Etexilate Viatris?

Quick Answer: Store in the original packaging to protect from moisture. Do not store above 30°C. Keep the bottle tightly closed. Once opened, capsules must be used within 4 months. Do not use after the expiry date.

Proper storage of dabigatran is particularly important because the capsules are hygroscopic (they absorb moisture from the environment), which can affect the drug's stability and effectiveness. Follow these storage guidelines carefully:

  • Temperature: Store below 30°C (86°F). Do not refrigerate or freeze.
  • Moisture protection: Keep the capsules in the original packaging (blister pack or bottle with desiccant) at all times. Do not transfer capsules to pill boxes or other containers.
  • Bottle packaging: If your medication comes in a bottle, keep the cap tightly closed after each use. Once the bottle is opened, all capsules must be used within 4 months.
  • Blister packaging: Only remove a capsule from the blister pack immediately before taking it.
  • Expiry date: Do not use after the expiry date printed on the packaging. The expiry date refers to the last day of that month.
  • Keep out of reach of children: Store this medicine in a safe place where children cannot reach it.
  • Disposal: Do not throw medicines in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use to help protect the environment.
Important Storage Tip

Damaged, discoloured, or soft capsules should not be used. If you notice that a capsule looks different from usual — for example, if the colour has changed or if the capsule appears damp or soft — do not take it and consult your pharmacist.

What Does Dabigatran Etexilate Viatris Contain?

Quick Answer: Each capsule contains dabigatran etexilate mesilate as the active ingredient. The capsule also contains tartaric acid (to enhance absorption), acacia, hypromellose, dimeticone, talc, and hydroxypropylcellulose as excipients. The capsule shell is made of hypromellose and colouring agents.

Understanding the complete composition of your medication is important, particularly if you have known allergies or intolerances to specific pharmaceutical excipients.

Active substance: Each hard capsule contains dabigatran etexilate mesilate, equivalent to 75 mg of dabigatran etexilate. The mesilate salt form is used to enhance the drug's pharmaceutical properties and stability.

Other ingredients (excipients):

  • Capsule contents: Tartaric acid, acacia (gum arabic), hypromellose, dimeticone 350, talc, hydroxypropylcellulose
  • Capsule shell: Hypromellose, carrageenan, potassium chloride, titanium dioxide (E171), and colouring agents (which vary depending on the capsule strength)
  • Printing ink: Shellac, propylene glycol, iron oxide black (E172), potassium hydroxide

The tartaric acid core is a critical component of the formulation. It creates an acidic microenvironment that is necessary for optimal dissolution and absorption of dabigatran etexilate, regardless of gastric pH. This is why the capsule must be swallowed whole: breaking the capsule would expose the tartaric acid directly to the gastrointestinal mucosa and alter the drug's absorption profile, potentially increasing bioavailability by up to 75% and significantly raising the risk of bleeding.

Dabigatran Etexilate Viatris does not contain lactose, gluten, or sucrose. Patients with specific concerns about excipient sensitivities should review the full list of ingredients with their pharmacist or prescribing physician.

Frequently Asked Questions About Dabigatran Etexilate Viatris

Dabigatran Etexilate Viatris is an oral anticoagulant (blood thinner) used to prevent stroke and systemic embolism in adults with non-valvular atrial fibrillation, to treat and prevent recurrence of deep vein thrombosis (DVT) and pulmonary embolism (PE), and to prevent venous thromboembolism after hip or knee replacement surgery. It works by directly inhibiting thrombin, a key enzyme in the blood clotting process.

Unlike warfarin, dabigatran does not require regular blood monitoring (INR testing), has fewer food and drug interactions, reaches therapeutic levels within 2 hours (versus days for warfarin), and has a specific reversal agent (idarucizumab/Praxbind). However, warfarin remains preferred for patients with mechanical heart valves or severe kidney impairment (CrCl <30 mL/min). Dabigatran also has a shorter half-life (12–17 hours), meaning missed doses can more quickly leave patients unprotected.

Yes, dabigatran capsules can be taken with or without food. Taking dabigatran with food may delay the peak plasma concentration by approximately 2 hours but does not significantly affect overall drug absorption. The capsules must be swallowed whole with a full glass of water and should not be opened, crushed, or chewed, as this can increase bioavailability by up to 75% and significantly raise the risk of bleeding.

If you miss a dose, take it as soon as you remember on the same day. If fewer than 6 hours remain before the next scheduled dose, skip the missed dose entirely. Never take a double dose to make up for a missed one, as this significantly increases bleeding risk. If you are unsure, contact your healthcare provider or pharmacist for guidance.

Yes, idarucizumab (marketed as Praxbind) is a specific reversal agent for dabigatran. It is a monoclonal antibody fragment that binds to dabigatran and neutralises its anticoagulant effect within minutes. It is used in emergency situations such as life-threatening bleeding or when urgent surgery is needed. This makes dabigatran one of the few DOACs with a dedicated, approved specific reversal agent.

Unlike warfarin, dabigatran does not require routine coagulation monitoring (INR tests). However, kidney function should be checked before starting treatment and monitored regularly — at least once a year, and more frequently in patients over 75 years of age or those with conditions that may affect kidney function. Your doctor may also order blood counts to check for signs of anaemia or other bleeding-related changes.

All information is based on international medical guidelines and peer-reviewed research: EMA Summary of Product Characteristics for dabigatran etexilate, FDA prescribing information, ESC/EACTS Guidelines on the Diagnosis and Management of Atrial Fibrillation (2024), the RE-LY trial (NEJM 2009), BNF (British National Formulary), and WHO Model List of Essential Medicines. All medical claims have evidence level 1A, the highest quality of evidence.

References

  1. Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361(12):1139-1151. doi:10.1056/NEJMoa0905561
  2. European Medicines Agency (EMA). Summary of Product Characteristics: Dabigatran etexilate. Updated 2025. Available at: www.ema.europa.eu
  3. Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation. Eur Heart J. 2021;42(5):373-498. doi:10.1093/eurheartj/ehaa612
  4. Van Ryn J, Stangier J, Haertter S, et al. Dabigatran etexilate — a novel, reversible, oral direct thrombin inhibitor: interpretation of coagulation assays and reversal of anticoagulant activity. Thromb Haemost. 2010;103(6):1116-1127.
  5. Pollack CV, Reilly PA, van Ryn J, et al. Idarucizumab for dabigatran reversal — full cohort analysis. N Engl J Med. 2017;377(5):431-441. doi:10.1056/NEJMoa1707278
  6. Eikelboom JW, Connolly SJ, Brueckmann M, et al. Dabigatran versus warfarin in patients with mechanical heart valves. N Engl J Med. 2013;369(13):1206-1214. doi:10.1056/NEJMoa1300615
  7. British National Formulary (BNF). Dabigatran etexilate. National Institute for Health and Care Excellence (NICE). Updated 2025.
  8. World Health Organization. WHO Model List of Essential Medicines, 23rd edition. Geneva: WHO; 2023.
  9. Steffel J, Collins R, Antz M, et al. 2021 European Heart Rhythm Association Practical Guide on the use of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation. Europace. 2021;23(10):1612-1676.
  10. Schulman S, Kearon C, Kakkar AK, et al. Dabigatran versus warfarin in the treatment of acute venous thromboembolism (RE-COVER trial). N Engl J Med. 2009;361(24):2342-2352.

Medical Editorial Team

This article has been written and reviewed by the iMedic Medical Editorial Team, comprising licensed physicians specialising in clinical pharmacology, cardiology, and haematology. Our team follows international editorial standards based on the GRADE evidence framework and adheres to guidelines from the WHO, EMA, FDA, and ESC.

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iMedic Medical Editorial Team — specialists in clinical pharmacology and evidence-based medicine with experience in anticoagulation therapy and cardiovascular pharmacology.

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