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dabigatran etexilate

Oral direct thrombin inhibitor · Anticoagulant

Oral direct thrombin inhibitorAnticoagulant
CDSCO approved
EXCRETION
not curated
INTERACTIONS
2 major
incl. contraindicated
PREGNANCY
not curated
Top interactionssee all 12
  • DronedaroneContraindicatedDatabase
  • RifampicinSevereDatabase

Mechanism

Dabigatran etexilate is a prodrug rapidly hydrolyzed to dabigatran, a direct thrombin inhibitor that reversibly blocks the catalytic site of thrombin.

Indications

Prevention of venous thromboembolism (following hip/knee joint replacement surgery)Prevention of embolism and stroke in patients with atrial fibrillation

Dosing

Adult
110 mg once daily (75 mg for elderly > 75 years) for prevention of venous thromboembolism; 150 mg twice daily for prevention of embolism and stroke in atrial fibrillation.

Pharmacokinetics

Onset
Rapid (within 2 hours)
Duration
24 hours
Half-life
12–14 hours
Bioavailability
Low oral bioavailability, but consistent anticoagulant effect

Side effects

Common
Bleeding
Serious
  • Hepatobiliary disorders (less common)

Drug interactions

Dronedarone
Contraindicated
Database

Significantly increased dabigatran plasma concentrations, leading to a substantially increased risk of bleeding.

Concomitant use is CONTRAINDICATED due to a significant increase in dabigatran exposure and bleeding risk.

Rifampicin
Severe
Database

Decreased dabigatran plasma concentrations, leading to reduced anticoagulant effect and increased risk of thrombotic events.

Concomitant use is CONTRAINDICATED. If co-administration cannot be avoided, consider alternative anticoagulants.

Amiodarone
Moderate
Database

Increased dabigatran plasma concentrations, leading to increased risk of bleeding.

Monitor for signs of bleeding. Consider a reduced dose of dabigatran (75 mg twice daily) in patients with moderate renal impairment (CrCl 30-50 mL/min) when co-administered with amiodarone. Avoid co-administration in patients with severe renal impairment.

Aspirin
Moderate
Database

Increased risk of bleeding (gastrointestinal, intracranial).

Concomitant use should be carefully weighed against the benefits. Monitor closely for signs of bleeding, especially gastrointestinal bleeding. Consider a proton pump inhibitor for gastroprotection.

Carbamazepine
Moderate
Database

Decreased dabigatran plasma concentrations, leading to reduced anticoagulant effect and increased risk of thrombotic events.

Avoid co-administration. If co-administration is necessary, monitor for signs of reduced efficacy and consider alternative anticoagulants.

Clarithromycin
Moderate
Database

Increased dabigatran plasma concentrations, leading to increased risk of bleeding.

Monitor for signs of bleeding. Consider a reduced dose of dabigatran (75 mg twice daily) in patients with moderate renal impairment (CrCl 30-50 mL/min) when co-administered with clarithromycin. Avoid co-administration in patients with severe renal impairment.

Clopidogrel
Moderate
Database

Increased risk of bleeding (gastrointestinal, intracranial).

Concomitant use should be carefully weighed against the benefits. Monitor closely for signs of bleeding, especially gastrointestinal bleeding. Consider a proton pump inhibitor for gastroprotection.

Itraconazole
Moderate
Database

Increased dabigatran plasma concentrations, leading to increased risk of bleeding.

Monitor for signs of bleeding. Consider a reduced dose of dabigatran (75 mg twice daily) in patients with moderate renal impairment (CrCl 30-50 mL/min) when co-administered with itraconazole. Avoid co-administration in patients with severe renal impairment.

Ketoconazole
Moderate
Database

Increased dabigatran plasma concentrations, leading to increased risk of bleeding.

Monitor for signs of bleeding. Consider a reduced dose of dabigatran (75 mg twice daily) in patients with moderate renal impairment (CrCl 30-50 mL/min) when co-administered with ketoconazole. Avoid co-administration in patients with severe renal impairment.

Naproxen
Moderate
Database

Increased risk of bleeding (gastrointestinal, intracranial).

Avoid concomitant use if possible. If co-administration is necessary, monitor closely for signs of bleeding, especially gastrointestinal bleeding. Consider a proton pump inhibitor for gastroprotection.

Phenytoin
Moderate
Database

Decreased dabigatran plasma concentrations, leading to reduced anticoagulant effect and increased risk of thrombotic events.

Avoid co-administration. If co-administration is necessary, monitor for signs of reduced efficacy and consider alternative anticoagulants.

Quinidine
Moderate
Database

Increased dabigatran plasma concentrations, leading to increased risk of bleeding.

Monitor for signs of bleeding. Consider a reduced dose of dabigatran (75 mg twice daily) in patients with moderate renal impairment (CrCl 30-50 mL/min) when co-administered with quinidine. Avoid co-administration in patients with severe renal impairment.

Related guidelines

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Sources: KD Tripathi 7e·Verified: 2026-05-10 · House clinical team