Note: This document contains side effect information about edoxaban. Some dosage forms listed on this page may not apply to the brand name Savaysa.

Summary

More frequent side effects include: hemorrhage. Continue reading for a comprehensive list of adverse effects.

Applies to edoxaban: oral tablet.

Serious side effects of Savaysa

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:

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
• slow speech
• vomiting

Incidence not known

• Back pain
• bleeding gums
• blood in urine
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• fast heartbeat
• hives, itching, rash, redness of the skin
• hoarseness
• irritation
• joint pain, stiffness or swelling
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs
• leg weakness
• loss of bladder or bowel control
• paralysis
• pinpoint red spots on the skin
• stomach pain
• swelling of the eyelids, face, lips, hands, or feet
• tightness in the chest
• troubled breathing or swallowing

Other side effects of Savaysa

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:

Incidence not known

• Dizziness

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, thrombocytopenia

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, abdominal pain, nausea

Uncommon (0.1% to 1%): GUSTO severe GI bleeding

Rare (less than 0.1%): Fatal GI bleed, retroperitoneal hemorrhage^[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache

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

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

Genitourinary

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

Dermatologic

Common (1% to 10%): Cutaneous soft tissue bleeding, rash, pruritus

Uncommon (0.1% to 1%): Urticaria^[Ref]

Hepatic

Common (1% to 10%): Abnormal liver function tests, blood bilirubin increased, gamma-glutamyltransferase increased

Uncommon (0.1% to 1%): Blood alkaline phosphatase increased, transaminases increased^[Ref]

Respiratory

Common (1% to 10%): Epistaxis

Uncommon (0.1% to 1%): Interstitial lung disease (ILD), hemoptysis^[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]

Other

Common (1% to 10%): Puncture site bleeding

Uncommon (0.1% to 1%): Surgical site hemorrhage

Rare (less than 0.1%): Procedural hemorrhage^[Ref]

Immunologic

Uncommon (0.1% to 1%): Hypersensitivity

Rare (less than 0.1%): Anaphylactic reaction, allergic edema^[Ref]

Ocular

Uncommon (0.1% to 1%): Conjunctival/scleral hemorrhage, intraocular hemorrhage^[Ref]

Musculoskeletal

Rare (less than 0.1%): Intramuscular hemorrhage (no compartment syndrome), intra-articular hemorrhage

Frequency not reported: Compartment syndrome^[Ref]

Cardiovascular

Rare (less than 0.1%): Pericardial hemorrhage

Frequency not reported: Hypoperfusion^[Ref]

Renal

Frequency not reported: Renal failure^[Ref]