Edoxaban
Edoxaban is a blood thinner (anticoagulant) used to lower the risk of stroke in people with nonvalvular atrial fibrillation and to treat deep vein thrombosis and pulmonary embolism.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Edoxaban (Savaysa) is a once-daily blood thinner that blocks factor Xa, a clotting protein, to lower stroke risk in atrial fibrillation not caused by a valve problem and to treat deep vein thrombosis and pulmonary embolism; a warfarin alternative since about 2015, it is prescribed less often than apixaban or rivaroxaban. Most people feel nothing from it; serious bleeding is the main risk, and easier bruising or nosebleeds are the common nuisance. Never stop it on your own, since its boxed warning flags stroke and clots after stopping early, plus weaker protection in atrial fibrillation with very high kidney function and spinal bleeding after an epidural or spinal tap.
Clinical pearls
- If swallowing is hard, tablets can be crushed and mixed into water or applesauce, but take the mixture right away.
- Tell surgeons and dentists you take it; its effect lasts about 24 hours, and no specific reversal agent exists.
- For everyday aches, acetaminophen is the safer choice; ibuprofen and naproxen add to edoxaban's bleeding risk.
- Your dose is set by kidney function, so expect periodic kidney blood tests, especially if you become sick or dehydrated.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Savaysa has three boxed warnings, the FDA's most serious type.
- Not for atrial fibrillation with very good kidney function: People with nonvalvular atrial fibrillation and creatinine clearance above 95 mL/min had more ischemic strokes (strokes caused by a blocked blood vessel) than those on warfarin. Another blood thinner should be used.
- Stopping early raises stroke and clot risk: Stopping any blood thinner too soon without a replacement increases the risk of clots and stroke. Don't stop unless your doctor says so. Your doctor may switch you to another anticoagulant.
- Spinal or epidural hematoma: If you have spinal or epidural anesthesia or a spinal puncture while on Savaysa, bleeding around the spine can occur. It may cause long-term or permanent paralysis. Risk is higher with epidural catheters, NSAIDs, platelet inhibitors or other blood thinners, repeated or traumatic punctures, or a history of spinal surgery or deformity. Watch for leg numbness or weakness, and bowel or bladder problems, and get urgent help if they appear.
Patient information guide A plain-language walkthrough of Edoxaban, written from its FDA label.
What Edoxaban is used for
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Edoxaban is a factor Xa inhibitor blood thinner with two approved uses.
- Savaysa lowers the risk of stroke and systemic embolism in people with nonvalvular atrial fibrillation.
- Savaysa treats deep vein thrombosis (DVT) and pulmonary embolism (PE) after 5 to 10 days of initial therapy with a parenteral (injected or infused) anticoagulant.
- Savaysa should not be used for nonvalvular atrial fibrillation if creatinine clearance is above 95 mL/min.
How Edoxaban works
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Edoxaban selectively blocks factor Xa, a key protein in the clotting process. This lowers thrombin production and reduces clot formation. It also reduces thrombin-induced platelet clumping. It works directly and does not need antithrombin III.
Edoxaban dosage
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Savaysa is a tablet taken by mouth once a day, with or without food. Your dose is set by your prescriber based on your condition, kidney function and, for DVT and PE, your body weight and certain other medicines.
- If you miss a dose, take it the same day as soon as possible, then resume the next day. Don't double up.
- If you can't swallow tablets, they can be crushed and mixed with water or applesauce and taken right away.
- Your doctor will tell you how to switch to or from other blood thinners such as warfarin.
- It is usually stopped at least 24 hours before surgery or invasive procedures.
Dosing details from the FDA-approved label
From the Edoxaban prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Nonvalvular Atrial Fibrillation (NVAF), CrCL >50 to ≤ 95 mL/min
- 60 mg taken orally once daily
- Assess CrCL (Cockcroft-Gault) before initiating therapy; do not use in patients with CrCL > 95 mL/min
- Nonvalvular Atrial Fibrillation (NVAF), CrCL 15 to 50 mL/min
- 30 mg once daily
- Dose reduced for CrCL 15 to 50 mL/min
- Treatment of Deep Vein Thrombosis and Pulmonary Embolism
- 60 mg taken orally once daily following 5 to 10 days of initial therapy with a parenteral anticoagulant
- Deep Vein Thrombosis and Pulmonary Embolism, patients with CrCL 15 to 50 mL/min, body weight less than or equal to 60 kg, or taking certain concomitant P-gp inhibitor medications
- 30 mg once daily
- Reduced dose for CrCL 15 to 50 mL/min, weight ≤ 60 kg, or certain P-gp inhibitors
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Treatment of NVAF: Assess CrCL before initiating therapy ( 2.1 ) The recommended dose is 60 mg once daily in patients with CrCL >50 to ≤ 95 mL/min. Do not use SAVAYSA in patients with CrCL > 95 mL/min ( 2.1 ) Reduce dose to 30 mg once daily in patients with creatinine clearance 15 to 50 mL/min ( 2.1 ) Treatment of DVT and PE: The recommended dose is 60 mg once daily ( 2.2 ) Reduce dose to 30 mg once daily for patients with CrCL 15 to 50 mL/min or body weight less than or equal to 60 kg or who use certain P-gp inhibitors ( 2.2 ) 2.1 Nonvalvular Atrial Fibrillation The recommended dose of SAVAYSA is 60 mg taken orally once daily [see Warnings and Precautions (5.1) and Clinical Studies (14.1) ] . Assess creatinine clearance, as calculated using the Cockcroft-Gault equation Cockcroft-Gault CrCL = (140-age) × (weight in kg) × (0.85 if female) / (72 × creatinine in mg/dL). , before initiating therapy with SAVAYSA. Do not use SAVAYSA in patients with CrCL > 95 mL/min. Reduce SAVAYSA dose to 30 mg once daily in patients with CrCL 15 to 50 mL/min [see Use in Specific Populations (8.6) , and Clinical Pharmacology (12.3) ] . 2.2 Treatment of Deep Vein Thrombosis and Pulmonary Embolism The recommended dose of SAVAYSA is 60 mg taken orally once daily following 5 to 10 days of initial therapy with a parenteral anticoagulant [see Clinical Studies (14.2) ] . Reduce SAVAYSA dose to 30 mg once daily in patients with CrCL 15 to 50 mL/min, patients who weigh less than or equal to 60 kg, or patients who are taking certain concomitant P-gp inhibitor medications [see Clinical Studies (14.2) ] . 2.3 Administration Information If a dose of SAVAYSA is missed, the dose should be taken as soon as possible on the same day. Dosing should resume the next day according to the normal dosing schedule. The dose should not be doubled to make up for a missed dose. SAVAYSA can be taken without regard to food [see Clinical Pharmacology (12.3) ] .
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Edoxaban side effects
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The most common side effects are related to bleeding and blood counts.
Common side effects
- Bleeding (the most common side effect)
- Anemia (low red blood cell count)
- Rash
- Abnormal liver function tests
When to get medical help
- Call your doctor or get emergency help for signs of serious bleeding, such as bleeding that won't stop, black or bloody stools, or vomiting blood.
- Get urgent help for new numbness or weakness in your legs, or bowel or bladder problems, especially after a spinal or epidural procedure.
- Tell your doctor right away if you think you've taken too much, since overdose raises the risk of bleeding.
- Don't stop Savaysa on your own. Stopping early can raise your risk of stroke or clots.
- Seek help for any unusual or unexplained signs of blood loss.
Serious bleeding can be fatal. Get medical help right away for signs of blood loss or serious bleeding.
Edoxaban warnings and precautions
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- Serious bleeding: The biggest risk. The stomach and intestines were the most common sites of major bleeding in studies.
- No reversal agent: There is no specific way to reverse Savaysa, and its effect lasts about 24 hours after the last dose.
- Spinal or epidural hematoma: Can cause permanent paralysis after spinal procedures. Catheters should not be removed earlier than 12 hours after the last dose.
- Stopping early: Raises the risk of stroke and clots.
- Not recommended: Mechanical heart valves, moderate to severe mitral stenosis, triple positive antiphospholipid syndrome.
Edoxaban interactions
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Several medicines can raise bleeding risk or affect Savaysa.
- Other anticoagulants: more bleeding, so avoid long-term combined use.
- Aspirin, antiplatelets and thrombolytics: raise bleeding risk.
- NSAIDs: increase bleeding time and bleeding risk.
- SSRIs and SNRIs: may raise bleeding risk through effects on platelets.
- Rifampin: avoid use together.
Interactions listed in the FDA-approved label
From the Edoxaban prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Anticoagulants: Co-administration may increase the risk of bleeding. Avoid concomitant use; long-term concomitant treatment is not recommended. Short term co-administration may be needed when transitioning to or from SAVAYSA. Promptly evaluate any signs or symptoms of blood loss.
- Antiplatelet drugs (including aspirin and thienopyridines): May increase the risk of bleeding; in clinical studies concomitant use of low dose aspirin (≤ 100 mg/day) or thienopyridines resulted in increased rates of Clinically Relevant Bleeding. Avoid concomitant use; carefully monitor for bleeding in patients who require chronic treatment with low dose aspirin.
- Thrombolytics: Co-administration may increase the risk of bleeding. Avoid concomitant use due to increased risk of bleeding.
- SSRIs/SNRIs: Patients may be at increased risk of bleeding with concomitant use due to their reported effect on platelets. Avoid concomitant use due to increased risk of bleeding.
- NSAIDs: Concomitant use in clinical studies resulted in increased rates of Clinically Relevant Bleeding. Carefully monitor for bleeding in patients who require chronic treatment with NSAIDs; promptly evaluate any signs or symptoms of blood loss.
- P-gp inhibitors (NVAF): Dose reduction in patients concomitantly receiving P-gp inhibitors resulted in edoxaban blood levels lower than in patients given the full dose. No dose reduction is recommended for concomitant P-gp inhibitor use in NVAF.
Read the label’s full interactions text
7 DRUG INTERACTIONS Anticoagulants, Antiplatelets, Thrombolytics, and Selective Serotonin Reuptake Inhibitors (SSRIs)/Serotonin Norepinephrine Reuptake Inhibitors (SNRIs): Avoid concomitant use due to increased risk of bleeding. ( 7.1 ) Rifampin: Avoid concomitant use ( 7.2 ) 7.1 Anticoagulants, Antiplatelets, Thrombolytics, and SSRIs/SNRIs Co-administration of anticoagulants, antiplatelet drugs, thrombolytics and SSRIs or SNRIs may increase the risk of bleeding. Promptly evaluate any signs or symptoms of blood loss if patients are treated concomitantly with anticoagulants, aspirin, other platelet aggregation inhibitors, and/or NSAIDs [see Warnings and Precautions (5.3) ] . Long-term concomitant treatment with SAVAYSA and other anticoagulants is not recommended because of increased risk of bleeding [see Warnings and Precautions (5.3) ] . Short term co-administration may be needed for patients transitioning to or from SAVAYSA [see Dosage and Administration (2.4) ] . In clinical studies with SAVAYSA concomitant use of aspirin (low dose ≤ 100 mg/day) or thienopyridines, and NSAIDs was permitted and resulted in increased rates of Clinically Relevant Bleeding. Carefully monitor for bleeding in patients who require chronic treatment with low dose aspirin and/or NSAIDs [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3) ] . As with other anticoagulants the possibility may exist that patients are at an increased risk of bleeding in case of concomitant use with SSRIs or SNRIs due to their reported effect on platelets [see Warnings and Precautions (5.3) ]. 7.2 P-gp Inducers Avoid the concomitant use of SAVAYSA with rifampin [see Clinical Pharmacology (12.3) ] . 7.3 P-gp Inhibitors Treatment of NVAF Based on clinical experience from the ENGAGE AF-TIMI 48 study, dose reduction in patients concomitantly receiving P-gp inhibitors resulted in edoxaban blood levels that were lower than in patients who were given the full dose.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Edoxaban
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- Do not use with active pathological (abnormal) bleeding.
- Kidney function matters: dose is lowered at moderately reduced function, and use is not recommended below 15 mL/min.
- Moderate or severe liver impairment: not recommended.
- Breastfeeding: not recommended.
- Pregnancy: data are insufficient. Talk with your doctor, and note anticoagulants may increase bleeding risk in the fetus and newborn.
- Women of reproductive potential: Savaysa can cause uterine bleeding. Discuss pregnancy planning with your doctor.
- Children: safety and effectiveness not established.
- Older adults: safety and effectiveness were similar to younger adults in studies, though bleeding rates appeared higher in those over 75.
Edoxaban overdose
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Too much Savaysa increases the risk of bleeding. There is no specific reversal agent. Protamine sulfate, vitamin K and tranexamic acid are not expected to reverse it, and hemodialysis does not clear it well. Get medical help right away.
What Edoxaban does in the body
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By blocking factor Xa, edoxaban lengthens clotting tests such as PT and aPTT. These changes are small and variable, so they aren't useful for monitoring its effect. Peak effects occur within 1 to 2 hours of a dose. Taking it with aspirin or naproxen increased bleeding time compared with either drug alone.
How your body processes Edoxaban
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Edoxaban reaches peak blood levels in 1 to 2 hours, and food does not change how much is absorbed. It is mostly cleared unchanged, with about half removed by the kidneys, so poor kidney function raises blood levels. Its half-life is 10 to 14 hours, and steady levels build up within 3 days of once-daily dosing.
How to store Edoxaban
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Store at 20-25°C (68-77°F); excursions permitted to 15°-30°C (59°-86°F) . Keep out of the reach of children.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Edoxaban
218 supplements and herbal products have documented interactions with Edoxaban in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 3
- Moderate · 190
- Minor · 25
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Edoxaban: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Edoxaban — the kind of thing our pharmacy team would talk through with you at the counter.
What is Savaysa (edoxaban) for?
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How do I take it, and what if I miss a dose?
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What side effects should I expect?
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Can I stop it if I feel fine?
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What should I avoid taking with it?
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Is it safe during pregnancy or breastfeeding?
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Is Edoxaban available over the counter?
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When was Edoxaban first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Edoxaban on HelloPharmacist
Edoxaban forms and strengths (how it comes)
Edoxaban is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Savaysa lowers the risk of stroke and systemic embolism in nonvalvular atrial fibrillation.
- Savaysa treats deep vein thrombosis and pulmonary embolism after 5 to 10 days of initial injected or infused anticoagulant therapy.
- Savaysa tablets are taken by mouth once daily, with or without food.
- Savaysa tablets may be crushed and mixed with water or applesauce and taken right away if swallowing whole tablets is hard.
- If a Savaysa dose is missed, take it the same day as soon as possible, then resume the normal schedule. Do not double up.
Edoxaban on the U.S. market: products, makers and brands
How Edoxaban appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 3 Edoxaban product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2015. Brand names on the directory include Savaysa; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (11) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
How widely Edoxaban is used (Medicaid data)
A general measure of how commonly Edoxaban is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Edoxaban is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Edoxaban prescribed? Of the 1,601 medications we measure, Edoxaban ranks #1,444 by Medicaid prescriptions — more than 10% of them.
Utilization by Edoxaban product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
edoxaban 60 MG Oral Tablet Most dispensed
Summed across the 1 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1599555
edoxaban 30 MG Oral Tablet
Summed across the 1 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1599551
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Edoxaban, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 16 listed Edoxaban NDCs with Medicaid activity.
Compare Edoxaban products
A representative set of FDA-listed product records for Edoxaban — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 15 mg | Oral | Daiichi Sankyo Inc. | NDA | View NDC → |
| 30 mg | Oral | Daiichi Sankyo Inc. | NDA | View NDC → |
| 60 mg | Oral | Daiichi Sankyo Inc. | NDA | View NDC → |
Showing 3 of 3 products — FDA National Drug Code Directory. See every product, package size and price: browse all 3 Edoxaban NDCs →
Edoxaban side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Edoxaban — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Edoxaban in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Edoxaban FDA approval history
How Edoxaban went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Edoxaban recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Edoxaban recalls since July 2021.
✅No Edoxaban recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1599538 1 dose form · 3 strengths
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Dose form (SCDF) Oral Tablet RxCUI 1599542In current FDA listings
Look up RxCUI 1599538 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Edoxaban supply and shortage status
Whether Edoxaban is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Edoxaban costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Tablet, Film Coated · Oral | 30 mg | $12.48–$15.48 per tablet | NDC details & price history |
| Tablet, Film Coated · Oral | 60 mg | $12.46–$15.51 per tablet | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Edoxaban brand names
Edoxaban is sold under one brand name in the FDA directory — Savaysa. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Edoxaban: manufacturers and labelers
One company lists Edoxaban products with the FDA. By number of product records, the largest are Daiichi Sankyo Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Edoxaban drug class (RxNorm)
Edoxaban belongs to the Factor Xa Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Edoxaban page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Daiichi Sankyo is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →