Dabigatran Etexilate

Dabigatran and its acyl glucuronides are competitive, direct thrombin inhibitors. Because thrombin (serine protease) enables the conversion of fibrinogen into fibrin during the coagulation cascade, its inhibition prevents the development of a thrombus.

• Dabigatran etexilate capsules are a direct thrombin inhibitor indicated: • To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation ( 1.1 ) • For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days ( 1.2 ) • To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated ( 1.3 ) • For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery ( 1.4 ) • For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days ( 1.5 ) • To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated ( 1.6 ) 1.1 Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation in Adult Patients Dabigatran etexilate capsules are indicated to reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation.ICD-10: I26.99, I48.91, I63.9

• Dabigatran etexilate capsules are contraindicated in patients with: • Active pathological bleeding [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)] • History of a serious hypersensitivity reaction to dabigatran, dabigatran etexilate, or to one of the excipients of the product (e.g., anaphylactic reaction or anaphylactic shock) [see Adverse Reactions (6.1)] • Mechanical prosthetic heart valve [see Warnings and Precautions (5.4)] • Active pathological bleeding ( 4 ) • History of serious hypersensitivity reaction to dabigatran etexilate capsules ( 4 ) • Mechanical prosthetic heart valve ( 4 )contraindicated

• Non-valvular Atrial Fibrillation in Adult Patients: o For patients with CrCl >30 mL/min: 150 mg orally, twice daily ( 2.2 ) o For patients with CrCl 15 to 30 mL/min: 75 mg orally, twice daily ( 2.2 ) • Treatment of DVT and PE in Adult Patients : o For patients with CrCl >30 mL/min: 150 mg orally, twice daily after 5 to 10 days of parenteral anticoagulation ( 2.2 ) • Reduction in the Risk of Recurrence of DVT and PE in Adult Patients : o For patients with CrCl >30 mL/min: 150 mg orally, twice daily after previous treatment ( 2.2 ) • Prophylaxis of DVT and PE Following Hip Replacement Surgery in Adult Patients : o For patients with CrCl >30 mL/min: 110 mg orally first day, then 220 mg once daily ( 2.2 ) • Treatment of Pediatric VTE: o For pediatric patients: weight-based dosage, twice daily after at least 5 days of parenteral anticoagulant ( 2.3 ) • Reduction in the Risk of Recurrence of Pediatric VTE: o For pediatric patients: weight-based dosage, twice daily after previous treatment ( 2.3 ) • Dabigatran etexilate capsules are NOT substitutable on a milligram-to-milligram basis with other dabigatran etexilate dosage forms • Review recommendations for converting to or from other oral or parenteral anticoagulants ( 2.6 , 2.7 ) • Temporarily discontinue dabigatran etexilate capsules before invasive or surgical procedures when possible, then restart promptly ( 2.8 ) 2.1 Important Dosage Information Dabigatran etexilate is available in different dosage forms and not all dosage forms are approved for the same indications and age groups.

Bleeding: Dabigatran etexilate can cause serious and fatal bleeding ( 5.2 ) Bioprosthetic heart valves: Dabigatran etexilate use not recommended ( 5.4 ) Increased Risk of Thrombosis in Patients with Triple-Positive Antiphospholipid Syndrome: Dabigatran etexilate use not recommended ( 5.6 ) 5.1 Increased Risk of Thrombotic Events after Premature Discontinuation Premature discontinuation of any oral anticoagulant, including dabigatran etexilate, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. If dabigatran etexilate capsules are discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant and restart dabigatran etexilate capsules as soon as medically appropriate [see Dosage and Administration (2.6, 2.7, 2.8)]. 5.2 Risk of Bleeding Dabigatran etexilate increases the risk of bleeding and can cause significant and, sometimes, fatal bleeding. Promptly evaluate any signs or symptoms of blood loss (e.g., a drop in hemoglobin and/or hematocrit or hypotension). Discontinue dabigatran etexilate capsules in patients with active pathological bleeding [see Dosage and Administration (2.4)]. Risk factors for bleeding include the concomitant use of other drugs that increase the risk of bleeding (e.g., anti-platelet agents, heparin, fibrinolytic therapy, and chronic use of NSAIDs). Dabigatran etexilate’s anticoagulant activity and half-life are increased in patients with renal impairment [see Clinical Pharmacology (12.2)].

The following clinically significant adverse reactions are described elsewhere in the labeling: Increased Risk of Thrombotic Events after Premature Discontinuation [see Warnings and Precautions (5.1)] Risk of Bleeding [see Warnings and Precautions (5.2)] Spinal/Epidural Anesthesia or Puncture [see Warnings and Precautions (5.3)] Thromboembolic and Bleeding Events in Patients with Prosthetic Heart Valves [see Warnings and Precautions (5.4)] Increased Risk of Thrombosis in Patients with Triple-Positive Antiphospholipid Syndrome [see Warnings and Precautions (5.6)] The most serious adverse reactions reported with dabigatran etexilate were related to bleeding [see Warnings and Precautions (5.2)]. Most common adverse reactions (>15%) are gastrointestinal adverse reactions and bleeding ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adult Trials Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation The RE-LY (Randomized Evaluation of Long-term Anticoagulant Therapy) study provided safety information on the use of two doses of dabigatran etexilate capsules and warfarin [see Clinical Studies (14.1)] . The numbers of patients and their exposures are described in Table 2.

Lactation: Breastfeeding not recommended ( 8.2 ) Geriatric Use: Risk of bleeding increases with age ( 8.5 ) 8.1 Pregnancy Risk Summary The limited available data on dabigatran etexilate use in pregnant women are insufficient to determine drug-associated risks for adverse developmental outcomes. There are risks to the mother associated with untreated venous thromboembolism in pregnancy and a risk of hemorrhage in the mother and fetus associated with the use of anticoagulants (see Clinical Considerations) . In pregnant rats treated from implantation until weaning, dabigatran increased the number of dead offspring and caused excess vaginal/uterine bleeding close to parturition at an exposure 2.6 times the human exposure. At a similar exposure, dabigatran decreased the number of implantations when rats were treated prior to mating and up to implantation (gestation Day 6). Dabigatran administered to pregnant rats and rabbits during organogenesis up to exposures 8 and 13 times the human exposure, respectively, did not induce major malformations. However, the incidence of delayed or irregular ossification of fetal skull bones and vertebrae was increased in the rat (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.

Metabolism

Dabigatran etexilate mesylate is absorbed as the dabigatran etexilate ester. The ester is then hydrolyzed, forming dabigatran, the active moiety.

Accidental overdose may lead to hemorrhagic complications. In the event of hemorrhagic complications, initiate appropriate clinical support, discontinue treatment with dabigatran etexilate, and investigate the source of bleeding. A specific reversal agent (idarucizumab) is available for adult patients. Dabigatran is primarily eliminated by the kidneys with a low plasma protein binding of approximately 35%. Hemodialysis can remove dabigatran; however, data supporting this approach are limited. Using a high-flux dialyzer, blood flow rate of 200 mL/min, and dialysate flow rate of 700 mL/min, approximately 49% of total dabigatran can be cleared from plasma over 4 hours. At the same dialysate flow rate, approximately 57% can be cleared using a dialyzer blood flow rate of 300 mL/min, with no appreciable increase in clearance observed at higher blood flow rates. Upon cessation of hemodialysis, a redistribution effect of approximately 7% to 15% is seen. The effect of dialysis on dabigatran’s plasma concentration would be expected to vary based on patient specific characteristics.

• Oct 19, 2010NDANDA022512Boehringer Ingelheim
• Mar 11, 2020ANDAANDA208040Alkem Labs Ltd
• May 6, 2020ANDAANDA207961Hetero Labs Ltd Iii
• Jun 21, 2021NDANDA214358Boehringer Ingelheim
• Dec 15, 2023ANDAANDA208070Apotex
• May 22, 2024ANDAANDA213879Msn
• Jun 14, 2024ANDAANDA215233Alembic
• Jan 28, 2025ANDAANDA208048Dr Reddys

1. 1Gastrointestinal Haemorrhage8,32411%
2. 2Cerebrovascular Accident4,0755.2%
3. 3Fall3,2984.2%
4. 4Haemorrhage3,2714.2%
5. 5Anaemia2,8703.7%
6. 6Dyspnoea2,3163.0%
7. 7Ischaemic Stroke2,2972.9%
8. 8Dizziness2,2342.9%
9. 9Death2,2202.8%
10. 10Rectal Haemorrhage2,1352.7%
11. 11Atrial Fibrillation2,0442.6%
12. 12Diarrhoea1,8062.3%
13. 13Asthenia1,7982.3%
14. 14Nausea1,6902.2%
15. 15Fatigue1,6482.1%

Recent PubMed references pinned to Dabigatran Etexilate as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Safety and Outcomes of Dabigatran Reversal With Idarucizumab Before IV Thrombolysis in Patients With Acute Ischemic Stroke.
  Neurology · 2026 · Säflund M, Matusevicius M, Tsivgoulis G, et al.
  PMID 42133915DOI 10.1212/WNL.0000000000218012
• Modulatory Effects of Dabigatran on PAR-1 Activity and Viability in Adipose-Derived Mesenchymal Stem Cells.
  International journal of molecular sciences · 2026 · Kubat E, Gürpınar ÖA, Özdem T, et al.
  PMID 42123368DOI 10.3390/ijms27093783
• Assessment of the Drug-Drug Interaction Potential of Lotiglipron (PF-07081532) with Midazolam, Omeprazole, Dabigatran, Rosuvastatin, and the Oral Contraceptives Levonorgestrel and Ethinyl Estradiol.
  Journal of clinical pharmacology · 2026 · Cronenberger C, Amin NB, Le VH, et al.
  PMID 42053447DOI 10.1002/jcph.70158
• Is dabigatran a good alternative to warfarin in patients with atrial fibrillation accompanied by valvular and non-valvular heart diseases? A systematic review and meta-analysis.
  La Tunisie medicale · 2025 · Youssef E, Daher M, Milad A, et al.
  PMID 41879686DOI 10.62438/tunismed.v103i10.6102
• Dabigatran-induced Gastrointestinal Bleed Treated by 4-factor Prothrombin Complex Concentrate in a Tertiary Care Hospital in Sikkim.
  The Journal of the Association of Physicians of India · 2026 · Dhakal M, Dhakal OP, Dhakal N, et al.
  PMID 41818114DOI 10.59556/japi.74.1324
• Proposal for a tooth extraction protocol for patients taking direct oral anticoagulants: a clinical trial.
  Oral surgery, oral medicine, oral pathology and oral radiology · 2026 · Higashi EM, Neves ILI, Darrieux FCDC, et al.
  PMID 41444034DOI 10.1016/j.oooo.2025.10.021
• Is there a role for anticoagulation with dabigatran in S. aureus bacteremia? Protocol for the adjunctive treatment domain of the Staphylococcus aureus Network Adaptive Platform (SNAP) randomised controlled trial.
  BMJ open · 2025 · McDonald EG, Cheng MP, Davis JS, et al.
  PMID 41387009DOI 10.1136/bmjopen-2025-107493
• Translation of a physiologically-based pharmacokinetic model for dabigatran etexilate to the design of a safety and efficacy study in post-partum women.
  British journal of clinical pharmacology · 2026 · Ogungbenro K, Aucott L, Kamali F, et al.
  PMID 41273069DOI 10.1002/bcp.70344

The 10 most recently updated of 409 ClinicalTrials.gov registrations naming Dabigatran Etexilate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Antithrombotic Treatment Strategies in Cervical Artery Dissection
  Not yet recruiting · Interventional · 1,100 enrolled · University Department of Geriatric Medicine FELIX PLATTER
  NCT07639892updated 2026-06-10
• Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions
  Recruiting · Phase 1 · Phase 2 · Interventional · 336 enrolled · IDEAYA Biosciences
  NCT03947385updated 2026-06-08
• Single and Multiple Dose Study to Evaluate Safety and Pharmacokinetics of BMS-986533 in Healthy Participants and Assessments of Food and pH Effects on Relative Bioavailability, and Drug-Drug Interaction Potential in Healthy Participants
  Not yet recruiting · Phase 1 · Interventional · 118 enrolled · Bristol-Myers Squibb
  NCT07629999updated 2026-06-05
• Stroke Prevention In Ischemic Stroke With Covert Atrial Fibrillation
  Recruiting · Phase 4 · Interventional · 1,148 enrolled · Assistance Publique - Hôpitaux de Paris
  NCT06486792updated 2026-06-05
• THRomboprophylaxis in Individuals Undergoing Superficial endoVEnous Treatment (THRIVE)
  Recruiting · Phase 4 · Interventional · 3,175 enrolled · Imperial College London
  NCT05735639updated 2026-06-04
• Discontinuation of Anticoagulations After Successful Catheter Ablation of Atrial Fibrillation
  Recruiting · Early phase 1 · Interventional · 3,160 enrolled · China National Center for Cardiovascular Diseases
  NCT06615596updated 2026-06-04
• Oral Anticoagulation After Stroke With Prior ICH in Subjects With AF
  Not yet recruiting · Phase 4 · Interventional · 852 enrolled · Second Affiliated Hospital, School of Medicine, Zhejiang University
  NCT07609654updated 2026-05-27
• Anticoagulation in Patients With Venous Thromboembolism and Cancer
  Active not recruiting · Observational · 1 enrolled · Pfizer
  NCT04618913updated 2026-05-26
• High Gastrointestinal Bleed Risk Outcomes in Patients With Non-valvular Atrial Fibrillation (NVAF) in France
  Active not recruiting · Observational · 1 enrolled · Pfizer
  NCT05038228updated 2026-05-26
• STRATEGY-PE: Real-World Treatment Strategies for Intermediate-High Risk Pulmonary Embolism
  Not yet recruiting · Observational · 1,300 enrolled · Nanjing First Hospital, Nanjing Medical University
  NCT07603700updated 2026-05-22

Frequently asked questions

How does Dabigatran Etexilate work?

Dabigatran and its acyl glucuronides are competitive, direct thrombin inhibitors. Because thrombin (serine protease) enables the conversion of fibrinogen into fibrin during the coagulation cascade, its inhibition prevents the development of a thrombus.

What is Dabigatran Etexilate used for?

According to FDA labeling, Dabigatran Etexilate carries indications including: Dabigatran etexilate capsules are a direct thrombin inhibitor indicated: • To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation ( 1.1 ) • For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days ( 1.2 ) • To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated ( 1.3 ) • For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery ( 1.4 ) • For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days ( 1.5 ) • To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated ( 1.6 ) 1.1 Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation in Adult Patients Dabigatran etexilate capsules are indicated to reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Dabigatran Etexilate?

Dabigatran Etexilate is classified as Direct thrombin inhibitors, Thrombin Inhibitors, Decreased Coagulation Activity.

What are the brand names for Dabigatran Etexilate?

Dabigatran Etexilate is marketed under brand names including Pradaxa.

What are the contraindications for Dabigatran Etexilate?

Dabigatran Etexilate labeling lists contraindications including: Dabigatran etexilate capsules are contraindicated in patients with: • Active pathological bleeding [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)] • History of a serious hypersensitivity reaction to dabigatran, dabigatran etexilate, or to one of the excipients of the product (e.g., anaphylactic reaction or anaphylactic shock) [see Adverse Reactions (6.1)] • Mechanical prosthetic heart valve [see Warnings and Precautions (5.4)] • Active pathological bleeding ( 4 ) • History of serious hypersensitivity reaction to dabigatran etexilate capsules ( 4 ) • Mechanical prosthetic heart valve ( 4 ). Always consult the full prescribing information and a clinician.