Section 13 · Monograph
Dabigatran
Reviewed Nov 2026FDA label
PradaxaDirect thrombin inhibitor (DOAC)
- Forms
- Cap: 75, 150mg | Pellets
- Dose
- AF stroke prevention: 150mg BID (75mg BID if CrCl 15-30)
- MOA
- Direct thrombin inhibition
Black Box Warning
- Premature discontinuation increases the risk of thrombotic events including stroke
- Spinal/epidural hematoma risk with neuraxial anesthesia or puncture
Indications
- Reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillationFDA-labeled
- Treatment and secondary prevention of DVT/PEFDA-labeled
Mechanism of Action
- Direct thrombin inhibitor (prodrug dabigatran etexilate)
Full Dosing
Adult / usual
- Capsules must be swallowed whole and kept in the original bottle or blister
Renal
- AF: 150mg twice daily; 75mg twice daily if CrCl 15-30mL/min
- Avoid P-gp inhibitors if CrCl below 30mL/min
Contraindications
- Active pathological bleeding
- Mechanical prosthetic heart valve
- Hypersensitivity to dabigatran
Drug Interactions
- P-gp inducers (rifampin) reduce levels — avoid
- P-gp inhibitors (dronedarone, ketoconazole) raise levels
- Specific reversal agent available: idarucizumab
Adverse Effects
- Dyspepsia and GI bleeding
- Intracranial hemorrhage
- Hypersensitivity reactions
Monitoring Parameters
- Renal function before and during therapy
- CBC
- Bleeding signs
Pregnancy & Lactation
- Limited data; avoid in pregnancy
- Avoid during breastfeeding