What it isDirect factor Xa inhibitor; atrial-fibrillation stroke prevention and venous thromboembolism treatment.
Why this oneUnlike other DOACs, it loses efficacy in atrial fibrillation above CrCl 95 mL/min and should not be used there.
What limits it⚑ Bleeding remains central; interruption raises thrombosis risk, and P-glycoprotein inhibitors increase exposure.
FDA-approved for
- stroke prevention in AF/VTE (2015)
FDA label
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BOXED WARNING (A) Reduced efficacy in NVAF with CrCL >95 mL/min; (B) premature discontinuation increases ischemic events; (C) spinal/epidural hematoma with neuraxial anesthesia/puncture.
| FDA dosing | Population | Start | Target | Max |
| Nonvalvular atrial fibrillation | Adults (CrCL >50 to ≤95) | 60 mg QD | 60 mg QD | 60 mg QD |
| DVT/PE treatment | Adults | 60 mg QD after 5-10 days parenteral anticoagulant | 60 mg QD | 60 mg QD |
Renal CrCL 15-50 mL/min: 30 mg QD; NVAF with CrCL >95: do not use; CrCL <15: not recommended
Hepatic Moderate-severe (Child-Pugh B/C): not recommended; mild (A): no adjustment
DVT/PE: reduce to 30 mg QD if CrCL 15-50, body weight ≤60 kg, or certain P-gp inhibitors
Instructions
- Take without regard to food
- May crush and mix with water or applesauce and give immediately
- If a dose is missed, take it the same day; do not double the dose
Contraindications
- Active pathological bleeding
Cautions
- Serious/fatal bleeding; no established reversal agent
- Reduced efficacy at CrCL >95 mL/min (NVAF)
- Increased stroke risk on premature discontinuation
- Spinal/epidural hematoma
- Not recommended with mechanical heart valves or moderate-severe mitral stenosis
- Not recommended in triple-positive antiphospholipid syndrome
Adverse reactions
- Bleeding
- Anemia
- Rash
- Abnormal liver function tests
Pregnancy Insufficient data; may increase fetal/neonatal bleeding risk.
Lactation Breastfeeding not recommended.
⚠ BOXED WARNINGS
- Reduced efficacy in nonvalvular AF with CrCl >95 mL/min
- Premature discontinuation increases thrombotic risk
- Spinal or epidural hematoma
Cost, est. cash$500–$750/month
Generic entry2028 est.
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 categoryUnknown / historical label unavailable
Defining liabilityMajor bleeding; renal function, age and interacting drugs materially influence risk.
Mechanism of action: Edoxaban ballicule
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P-gp substrate (sensitive)
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