Last reviewed 2026-04-20 · How we verify

Dabigatran Etexilate (DABIGATRAN)

Dabigatran works by directly inhibiting the activity of thrombin, a key enzyme in the blood clotting process.

Dabigatran Etexilate, also known as dabigatran, is a small molecule anticoagulant medication. It is used to treat various conditions, including non-valvular atrial fibrillation, deep venous thrombosis, pulmonary embolism, and venous thromboembolic events following hip replacement surgery. Dabigatran is currently owned by Boehringer Ingelheim and has been FDA-approved since 2025. The medication is available from multiple generic manufacturers, indicating it is off-patent. Key safety considerations include bleeding risks, which can be managed with dose adjustments and monitoring.

At a glance

Mechanism of action

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. Both free and clot-bound thrombin, and thrombin-induced platelet aggregation are inhibited by the active moieties.

Approved indications

• Reduction of stroke and systemic embolism risk in non-valvular AF
• Treatment of DVT and PE in adults
• Reduction of DVT and PE recurrence in adults
• Prophylaxis of DVT and PE after hip replacement surgery
• Treatment of VTE in pediatric patients
• Reduction of VTE recurrence in pediatric patients

Boxed warnings

• WARNING: (A) PREMATURE DISCONTINUATION OF DABIGATRAN ETEXILATE CAPSULES INCREASES THE RISK OF THROMBOTIC EVENTS, and (B) SPINAL/EPIDURAL HEMATOMA (A) PREMATURE DISCONTINUATION OF DABIGATRAN ETEXILATE CAPSULES INCREASES THE RISK OF THROMBOTIC EVENTS Premature discontinuation of any oral anticoagulant, including dabigatran etexilate capsules , increases the risk of thrombotic events. If anticoagulation with dabigatran etexilate capsules a re discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant [see Dosage and Administration (2.6, 2.7, 2.8) and Warnings and Precautions (5.1)]. (B) SPINAL/EPIDURAL HEMATOMA Epidural or spinal hematomas may occur in patients treated with dabigatran etexilate capsules who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: • use of indwelling epidural catheters • concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants • a history of traumatic or repeated epidural or spinal punctures • a history of spinal deformity or spinal surgery • optimal timing between the administration of dabigatran etexilate capsules and neuraxial procedures is not known [see Warnings and Precautions (5.3)]. Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary [see Warnings and Precautions (5.3)]. Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated [see Warnings and Precautions (5.3)]. WARNING: (A) PREMATURE DISCONTINUATION OF DABIGATRAN ETEXILATE CAPSULES INCREASES THE RISK OF THROMBOTIC EVENTS, and (B) SPINAL/EPIDURAL HEMATOMA See full prescribing information for complete boxed warning (A) PREMATURE DISCONTINUATION OF DABIGATRAN ETEXILATE CAPSULES INCREASES THE RISK OF THROMBOTIC EVENTS: Premature discontinuation of any oral anticoagulant, including dabigatran etexilate capsules, increases the risk of thrombotic events. To reduce this risk, consider coverage with another anticoagulant if dabigatran etexilate capsules are discontinued for a reason other than pathological bleeding or completion of a course of therapy ( 2.6 , 2.7 , 2.8 , 5.1 ). (B) SPINAL/EPIDURAL HEMATOMA: Epidural or spinal hematomas may occur in patients treated with dabigatran etexilate capsules who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis ( 5.3 ). Monitor patients frequently for signs and symptoms of neurological impairment and if observed, treat urgently. Consider the benefits and risks before neuraxial intervention in patients who are or who need to be anticoagulated ( 5.3 ).

Common side effects

• Bleeding
• Gastrointestinal
• Intracranial Hemorrhage (ICH)
• Hemorrhagic Stroke
• Other ICH
• Diarrhea
• Dyspepsia
• Nausea
• Upper abdominal pain
• GERD
• Esophagitis
• Erosive gastritis

Drug interactions

• P-gp inducers (e.g., rifampin)
• P-gp inhibitors in adult patients with CrCl 30 to 50 mL/min
• P-gp inhibitors in adult patients with CrCl <30 mL/min
• P-gp inhibitors in patients with CrCl <50 mL/min (for treatment and reduction in the risk of recurrence of deep venous thrombosis and pulmonary embolism)
• P-gp inhibitors in patients with CrCl <50 mL/min (for prophylaxis of deep vein thrombosis and pulmonary embolism following hip replacement surgery)
• P-gp inhibitors in pediatric patients

Key clinical trials

• Short-Term Anticoagulation Versus Antiplatelet Therapy for Preventing Device Thrombosis Following Left Atrial Appendage Closure (PHASE4)
• FENOX Trial (Comparative Effectiveness of Fexuprazan Co-therapy in Patients Receiving Non-Vitamin K Antagonist Oral Anticoagulants) (NA)
• PFO Closure, Oral Anticoagulants or Antiplatelet Therapy After PFO-associated Stroke in Patients Aged 60 to 80 Years (PHASE3)
• Dabigatran vs. Oral Anti-Xa Inhibitors in S. Aureus Bacteremia (PHASE4)
• High Gastrointestinal Bleed Risk Outcomes in Patients With Non-valvular Atrial Fibrillation (NVAF) in France
• Anticoagulation in Patients With Venous Thromboembolism and Cancer
• A Study to Evaluate Safety and PK of Multiple Doses of LT3001 Drug Product and Drug-drug Interaction in Healthy Subjects (PHASE1)
• SNAP AF-52: Dose Appropriateness and Adherence to Oral Anticoagulation in Adults ≥65 With Atrial Fibrillation in Primary Care (Ordu, Türkiye)

Patents

Primary sources

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Dabigatran Etexilate CI brief — competitive landscape report
• Dabigatran Etexilate updates RSS · CI watch RSS
• Boehringer Ingelheim portfolio CI