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Direct thrombin (factor IIa) inhibitor (DOAC)

Dabigatran etexilate

Brand names: Pradaxa

Dabigatran etexilate is an oral prodrug of the direct thrombin inhibitor dabigatran (a direct oral anticoagulant) used to prevent stroke in non-valvular atrial fibrillation and to treat and prevent 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

After absorption it is converted to dabigatran, which directly and reversibly inhibits free and clot-bound thrombin, preventing conversion of fibrinogen to fibrin and thrombin-mediated platelet activation.

Prescribing in practice

  • Bleeding is the main risk and the drug is substantially renally cleared, so it is contraindicated in severe renal impairment and renal function must be assessed before and during use; idarucizumab is the specific reversal agent.
  • It is contraindicated with mechanical heart valves, and the capsules must not be removed from their blister or pill organiser as moisture degrades the product and reduces effectiveness.
  • P-glycoprotein inhibitors and inducers (e.g. certain antifungals, verapamil, rifampicin) significantly alter exposure and require avoidance or dose consideration.

Monitoring

Assess renal function before starting and at least annually (more often if impaired or in older patients), with full blood count and review of bleeding signs.

Counselling the patient

  • Keep capsules in the original blister or bottle and swallow whole — do not open, crush or decant them.
  • Report unusual bleeding, bruising, or black or bloody stools promptly, and avoid stopping suddenly.
  • Take with a full glass of water and carry an anticoagulant alert card.

Evidence & guidelines

Dabigatran is recommended by NICE for atrial fibrillation and venous thromboembolism, with pivotal evidence from the RE-LY trial.

Reference: NICE NG196; NICE NG158; BSH; ESC AF guidelines; 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.