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Savaysa Side Effects

Generic Name: edoxaban

Note: This page contains side effects data for the generic drug edoxaban. It is possible that some of the dosage forms included below may not apply to the brand name Savaysa.

For the Consumer

Applies to edoxaban: oral tablet

As well as its needed effects, edoxaban (the active ingredient contained in Savaysa) may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking edoxaban, check with your doctor immediately:

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
Rare
  • Confusion
  • cough
  • difficulty with speaking
  • double vision
  • fever
  • headache, sudden, severe
  • inability to move the arms, legs, or facial muscles
  • inability to speak
  • nausea and vomiting
  • slow speech
Incidence not known:
  • Back pain
  • bowel or bladder dysfunction
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • leg weakness
  • paralysis

Minor Side Effects

Some edoxaban side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Less common:
  • Rash

For Healthcare Professionals

Applies to edoxaban: oral tablet

General

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]

Hematologic

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]

Gastrointestinal

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]

Dermatologic

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

Genitourinary

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

Hepatic

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

Other

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

Respiratory

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]

References

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

It is possible that some side effects of Savaysa may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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