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Edoxaban Side Effects

In Summary

More frequently reported side effects include: hemorrhage. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to edoxaban: oral tablet

Along with its needed effects, edoxaban may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking edoxaban:

More common
  • Bloody nose
  • heavy non-menstrual vaginal bleeding
  • pale skin
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
Less common
  • Bloody or black, tarry stools
  • vomiting of blood or material that looks like coffee grounds
  • Confusion
  • cough
  • difficulty with speaking
  • double vision
  • fever
  • headache, sudden, severe
  • inability to move the arms, legs, or facial muscles
  • inability to speak
  • nausea
  • slow speech
  • vomiting
Incidence not known
  • Back pain
  • bowel or bladder dysfunction
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • leg weakness
  • paralysis

Some side effects of edoxaban may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Rash

For Healthcare Professionals

Applies to edoxaban: oral tablet


During nonvalvular atrial fibrillation treatment, the most common adverse reactions were bleeding and anemia. During deep venous thromboembolism and pulmonary embolism treatment, the most common adverse reactions were bleeding, rash, abnormal liver function tests, and anemia.[Ref]


Very common (10% or more): Any bleeding (21.7%), clinically-relevant non-major bleeding (up to 18.1%)
Common (1% to 10%): Major bleeding, anemia-related adverse events, non-fatal non-critical organ bleeding, clinically relevant bleeding, anemia
Uncommon (0.1% to 1%): Fatal bleeding, non-fatal critical organ bleeding, a 2 g/dL or greater decrease in hemoglobin, blood loss requiring transfusion of 2 or more units of RBC
Rare (less than 0.1%): Fatal non-intracranial bleeding[Ref]

Major bleeding included intracranial hemorrhage (ICH), gastrointestinal hemorrhage, and fatal bleeds. A major bleeding event was defined as clinically overt bleeding that met one of the following criteria: fatal bleeding, symptomatic bleeding in a critical site (e.g. spine, eye), drop in hemoglobin of at least 2 g/dL, or a drop in hematocrit of at least 6%. A clinically relevant non-major bleed was defined as overt bleeding that required medical intervention.[Ref]


Major GI bleeds included both upper and lower GI bleeds. A GUSTO severe GI bleed is defined as a severe or life-threatening bleed that causes hemodynamic compromise and requires intervention.[Ref]

Common (1% to 10%): Major gastrointestinal (GI) bleeding, upper GI bleeding, lower GI bleeding (including anorectal bleeding), oral and pharyngeal bleeding
Uncommon (0.1% to 1%): GUSTO severe GI bleeding
Rare (less than 0.1%): Fatal GI bleed[Ref]

Nervous system

ICH included hemorrhagic stroke, subarachnoid hemorrhage, epidural/subdural hemorrhage, and ischemic stroke with major hemorrhage.[Ref]

Uncommon (0.1% to 1%): Any intracranial hemorrhage (ICH), hemorrhagic stroke, ICH other than hemorrhagic stroke, fatal ICH[Ref]


Common (1% to 10%): Cutaneous soft tissue bleeding, rash[Ref]


Common (1% to 10%): Vaginal bleeding, macroscopic hematuria, urethral bleeding[Ref]


Common (1% to 10%): Abnormal liver function tests[Ref]


Common (1% to 10%): Puncture site bleeding[Ref]


Common (1% to 10%): Epistaxis
Uncommon (0.1% to 1%): Interstitial lung disease (ILD)[Ref]

Most cases of ILD were confounded by concurrent amiodarone, which is known to cause ILD, or infectious pneumonia. Overall, 5 patients out of 5417 died of ILD during the course of the study.[Ref]


1. "Product Information. Savaysa (edoxaban)." Daiichi Sankyo, Inc., Parsippany, NJ.

Some side effects of edoxaban may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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