Dabigatran

PRADAXA

Open Dabigatran in the interactive console ↗

What it isDirect thrombin inhibitor; atrial fibrillation and VTE.

Why this oneIt has a specific reversal agent, idarucizumab, which acts within minutes.

What limits itDyspepsia is common, and the capsules must not be opened. Renally cleared, so it is the DOAC least suited to CKD; P-gp interactions matter.

FDA-approved for

stroke prevention in AF (2010)

FDA label

Read the full label on DailyMed ↗

BOXED WARNING (A) Premature discontinuation of any oral anticoagulant increases risk of thrombotic events — consider bridging coverage. (B) Spinal/epidural hematoma may occur with neuraxial anesthesia or spinal puncture and can cause long-term or permanent paralysis.

FDA dosing	Population	Start	Target
Nonvalvular AF — reduce stroke/systemic embolism risk	Adults, CrCl >30 mL/min	150 mg BID	150 mg BID
Nonvalvular AF — reduce stroke/systemic embolism risk	Adults, CrCl 15–30 mL/min	75 mg BID	75 mg BID
Treatment of DVT/PE	Adults, CrCl >30 (after 5–10 d parenteral anticoagulant)	150 mg BID	150 mg BID
Reduce risk of recurrence of DVT/PE	Adults, CrCl >30	150 mg BID	150 mg BID
DVT/PE prophylaxis after hip replacement surgery	Adults, CrCl >30	110 mg day 1, then 220 mg QD	220 mg QD
Treatment / recurrence reduction of VTE	Pediatrics 8–<18 yr (after ≥5 d parenteral)	Weight-based BID (75–260 mg per Table 1)

Renal Severe (CrCl 15–30): 75 mg BID for AF; CrCl ≤30 or dialysis: no dosing recommendation for DVT/PE/hip; reduce or avoid with concomitant P-gp inhibitors per renal function

Hepatic Undefined

Do not substitute dosage forms mg-to-mg and do not combine more than one dosage form to reach the total dose

Instructions

Swallow capsules whole with a full glass of water; do not break, chew, or empty contents
Take with food if GI distress occurs
Missed dose: take same day if ≥6 h before next dose; do not double
If discontinued for a reason other than bleeding or completed therapy, consider alternative anticoagulant

Contraindications

Active pathological bleeding
Mechanical prosthetic heart valve

Cautions

Serious/fatal bleeding — risk increased with renal impairment and concomitant antithrombotics
Spinal/epidural hematoma with neuraxial procedures
Not recommended with bioprosthetic heart valves
Not recommended in triple-positive antiphospholipid syndrome
P-gp inducers reduce and inhibitors increase dabigatran exposure

Adverse reactions

Bleeding
Gastrointestinal reactions (dyspepsia, gastritis-like symptoms)

Pregnancy Insufficient data; anticoagulant use carries risk of maternal/fetal hemorrhage

Lactation Breastfeeding not recommended

⚠ BOXED WARNINGS

Premature discontinuation increases thrombotic risk
Spinal or epidural hematoma

Cost, est. cash$500–$750/month

Generic entry2022

Classes and tags

Clinical profile

Therapeutic safety burden3 / 4

Overdose danger3 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk2 / 4

Legacy pregnancy categoryC

Defining liabilityMajor bleeding; renal function, age and interacting drugs materially influence risk.

Mechanism of action: Dabigatran ballicule

Dabigatran ballicule: receptor binding, kinetics and half-life diagram

Open Dabigatran in the interactive console ↗

Memory aids: mascots and interaction avatars

Dabigatran PRADAXA mascot mnemonic cartoon — **“The Big-a-Tron’s Prada”**

P-gp substrate (sensitive)

Open Dabigatran in the interactive console ↗