Last reviewed 2026-05-23 · How we verify

DABIGATRAN ETEXILATE

DABIGATRAN ETEXILATE is a drug. It is currently FDA-approved (first approved 2008).

Dabigatran etexilate is a small molecule anticoagulant used to treat conditions such as atrial fibrillation, venous thromboembolism, and portal vein thrombosis, particularly in patients with cirrhosis. It is compared to other anticoagulants like enoxaparin in clinical trials for its efficacy and safety in these conditions.

At a glance

Approved indications

No approved indications tracked.

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

• Gastrointestinal adverse reactions
• Bleeding
• Dyspepsia
• Nausea
• Upper abdominal pain
• Diarrhea

Serious adverse events

• Major bleeding
• Intracranial hemorrhage
• Intracerebral hemorrhage (hemorrhagic stroke)
• Subarachnoid hemorrhage
• Subdural hemorrhage
• Gastrointestinal hemorrhage
• Thrombotic events
• Thromboembolic events
• Spinal/epidural hematoma
• Stroke

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)
• Anticoagulation in Patients With Venous Thromboembolism and Cancer
• High Gastrointestinal Bleed Risk Outcomes in Patients With Non-valvular Atrial Fibrillation (NVAF) in France
• 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)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

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

Frequently asked questions about DABIGATRAN ETEXILATE

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing