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Note: This document contains side effect information about edoxaban. Some of the dosage forms listed on this page may not apply to the brand name Savaysa.
More frequent side effects include: hemorrhage. See below for a comprehensive list of adverse effects.
Applies to edoxaban: oral tablet
Oral route (Tablet)
Edoxaban should not be used in patients with nonvalvular arterial fibrillation who have a CrCl greater than 95 mL/min due to an increased risk of ischemic stroke. Premature discontinuation of oral anticoagulant therapy may increase the risk of ischemic events. If edoxaban is discontinued for reasons other than pathological bleeding or therapy completion, consider covering with an alternative anticoagulant. Epidural or spinal hematomas, possibly resulting in permanent paralysis, may occur with edoxaban use during neuraxial anesthesia or spinal puncture. Consider the risk of edoxaban use in patients undergoing spinal procedures.
Along with its needed effects, edoxaban (the active ingredient contained in Savaysa) 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:
Incidence not known
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:
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.
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
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.
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.
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
ICH included hemorrhagic stroke, subarachnoid hemorrhage, epidural/subdural hemorrhage, and ischemic stroke with major hemorrhage.
Uncommon (0.1% to 1%): Any intracranial hemorrhage (ICH), hemorrhagic stroke, ICH other than hemorrhagic stroke, fatal ICH
Common (1% to 10%): Cutaneous soft tissue bleeding, rash
Common (1% to 10%): Vaginal bleeding, macroscopic hematuria, urethral bleeding
Common (1% to 10%): Abnormal liver function tests
Common (1% to 10%): Puncture site bleeding
Common (1% to 10%): Epistaxis
Uncommon (0.1% to 1%): Interstitial lung disease (ILD)
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.
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