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Direct Oral Anticoagulant (Direct Thrombin Inhibitor)

Dabigatran Etexilate

Brand names: Pradaxa

Dabigatran etexilate is an oral direct thrombin inhibitor (a direct oral anticoagulant) used for stroke prevention in atrial fibrillation and for treatment and prevention of venous thromboembolism.

Dosing — being independently re-sourced

ClinCalc Pro is rebuilding its dose data from primary open sources — the manufacturer SmPC (eMC), the WHO Model Formulary and other official references — under clinician review. This drug's structured dose is not yet published here. Confirm all doses against the product SmPC and your local formulary before prescribing.

Clinical monograph

How it works

The prodrug is converted to dabigatran, which directly and reversibly inhibits free and clot-bound thrombin (factor IIa), preventing conversion of fibrinogen to fibrin and thrombus formation.

Prescribing in practice

  • Bleeding is the principal hazard; assess renal function and bleeding risk before and during treatment, as clearance is substantially renal and it is contraindicated in severe renal impairment.
  • A specific reversal agent, idarucizumab, is available for life-threatening bleeding or urgent surgery.
  • Capsules must be swallowed whole and kept in the original packaging because of moisture sensitivity; absorption is reduced if the pellets are removed from the capsule.

Monitoring

Routine coagulation monitoring is not required, but assess renal function periodically and watch for bleeding.

Counselling the patient

  • Report unusual bruising or any bleeding that does not stop, and black or bloody stools.
  • Swallow the capsule whole with water and keep capsules in their original blister or bottle.
  • Tell any dentist, surgeon or pharmacist that you take an anticoagulant before procedures or new medicines.

Evidence & guidelines

The RE-LY trial established dabigatran for stroke prevention in atrial fibrillation, and it is recommended by NICE for this and for venous thromboembolism.

Reference: NICE TA249; RE-LY trial; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.