Prescription medicine
Edoxaban Brand names: Savaysa
Edoxaban (Savaysa) is a prescription medicine with an FDA approval on record since 2015. No generic is listed; pharmacies paid $15.51 per Savaysa 60 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the edoxaban FDA label on DailyMed (effective July 10, 2025, Daiichi Sankyo Inc.); the NDA 206316 record on Drugs@FDA; every edoxaban label on DailyMed.
Highlights of the record
FDA label of July 10, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
(A) REDUCED EFFICACY IN NONVALVULAR ATRIAL FIBRILLATION PATIENTS WITH CREATININE CLEARANCE (CRCL) > 95 ML/MIN; (B) PREMATURE DISCONTINUATION OF SAVAYSA INCREASES THE RISK OF ISCHEMIC EVENTS; (C) SPINAL/EPIDURAL HEMATOMA WARNING:; (C) SPINAL/EPIDURAL HEMATOMA.
See full prescribing information for complete boxed warning. (A) REDUCED EFFICACY IN NONVALVULAR ATRIAL FIBRILLATION PATIENTS WITH CRCL > 95 ML/MIN: SAVAYSA should not be used in patients with CrCL > 95 mL/min. In the ENGAGE AF-TIMI 48 study, nonvalvular atrial fibrillation patients with CrCL > 95 mL/min had an increased rate of ischemic stroke with SAVAYSA 60 mg once daily compared to patients treated with warfarin. In these patients another anticoagulant should be used ( 5.1 ). (B) PREMATURE DISCONTINUATION OF SAVAYSA INCREASES THE RISK OF ISCHEMIC EVENTS: Premature discontinuation of any oral anticoagulant in the absence of adequate alternative anticoagulation increases the risk of ischemic events. If SAVAYSA is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant as described in the transition guidance ( 2.4 , 5.2 , 14 ). […]
Used for
From the label: indications and usageSAVAYSA is a factor Xa inhibitor indicated: To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) ( 1.1 ) Limitation of Use for NVAF SAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) ( 1.1 ) SAVAYSA is indicated for the treatm
Forms and strengths
- 15 mg
- 30 mg
- 60 mg
Film-coated tablet.
On the market
- Earliest approval on file
- January 8, 2015 Savaysa, Daiichi Sankyo Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- March 28, 2028 Savaysa tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $15.51 per tablet Savaysa 60 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 6,591 through July 30, 2026
What is edoxaban used for?
From the label: indications and usageSAVAYSA is a factor Xa inhibitor indicated: To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) ( 1.1 ) Limitation of Use for NVAF SAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) ( 1.1 ) SAVAYSA is indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5 to 10 days of initial therapy with a parenteral anticoagulant ( 1.2 ) 1.1 Reduction in the Risk of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation SAVAYSA is indicated to reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF). […]
Conditions named in the indications of edoxaban's FDA labels, with every medicine labeled for each:
From other edoxaban labelsBlood clots (DVT and PE): Thrombosis and Pulmonary Embolism SAVAYSA is indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5 to 10 days of initial therapy with a parenteral anticoagulant.
FDA pharmacologic class: Factor Xa Inhibitor.
Source: FDA drug label (SAVAYSA), Daiichi Sankyo Inc., effective July 10, 2025 (SPL set e77d3400-56ad-11e3-949a-0800200c9a66), via openFDA; the full label on DailyMed
What does the patient leaflet for edoxaban say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about SAVAYSA?For people who take SAVAYSA for nonvalvular atrial fibrillation (a type of irregular heartbeat): People with nonvalvular atrial fibrillation are at an increased risk of forming a blood clot in the heart, which can travel to the brain, causing a stroke, or to other parts of the body. SAVAYSA reduces your risk of having a stroke by helping to prevent clots from forming. Your healthcare provider should check your kidney function before you start taking SAVAYSA. People whose kidneys work really well should not receive SAVAYSA because it may not work well to prevent stroke. Do not stop taking SAVAYSA without first talking to the healthcare provider who prescribed it for you. Stopping SAVAYSA increases your risk of having a stroke. SAVAYSA can cause bleeding which can be serious, and sometimes lead to death. This is because SAVAYSA is a blood thinner medicine that reduces blood clotting. During treatment with SAVAYSA, you may bleed more easily, bleed longer, or bruise more easily. Call your healthcare provider or get medical help right away if you experience bleeding that is severe (for example, coughing up or vomiting blood) or bleeding that cannot be controlled. You may have a higher risk of bleeding if you take SAVAYSA and take other medicines that increase your risk of bleeding, including: aspirin or aspirin-containing products long-term (chronic) use of nonsteroidal anti-inflammatory drugs (NSAIDs) long-term (chronic) use of blood thinner medicines, such as: warfarin sodium (Coumadin, Jantoven) any medicine that contains heparin selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) other medicines to prevent or treat blood clots Tell your healthcare provider if you take any of these medicines. […]
From the patient leaflet: How should I store SAVAYSA?Store SAVAYSA at room temperature between 68°F to 77°F (20°C to 25°C). Keep SAVAYSA and all medicines out of the reach of children.
Source: FDA drug label (SAVAYSA), Daiichi Sankyo Inc., effective July 10, 2025 (SPL set e77d3400-56ad-11e3-949a-0800200c9a66), via openFDA; the full label on DailyMed
Is there a generic for edoxaban (Savaysa)?
No generic edoxaban is approved (Drugs@FDA, October 8, 2026). Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 2 patents for Savaysa tablets: the compound patent runs to April 18, 2027, and the last listed entry to March 28, 2028. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2015 earliest approval on file
- 2028 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for edoxaban (Savaysa)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $15.51 per Savaysa 60 mg tablet, up 6% from $14.63 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Savaysa 30 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Savaysa 30 mg tablet | Brand | $15.48 per tablet | $464.44 | +5% |
| Savaysa 60 mg tablet | Brand | $15.51 per tablet | $465.35 | +6% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the edoxaban label say about other medicines?
The edoxaban label names 5 other medicines in its interaction, contraindication or warning sections. The labels of 13 other medicines name edoxaban. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aspirin | drug interactions | 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) ]. |
| Protamine | warnings and precautions | Protamine sulfate, vitamin K, and tranexamic acid are not expected to reverse the anticoagulant activity of SAVAYSA. |
| Rifampin | drug interactions | Avoid concomitant use due to increased risk of bleeding. ( 7.1 ) Rifampin: Avoid concomitant use |
| Tranexamic acid | warnings and precautions | Protamine sulfate, vitamin K, and tranexamic acid are not expected to reverse the anticoagulant activity of SAVAYSA. |
| Warfarin | boxed warning | In the ENGAGE AF-TIMI 48 study, nonvalvular atrial fibrillation patients with CrCL > 95 mL/min had an increased rate of ischemic stroke with SAVAYSA 60 mg once daily compared to patients treated with warfarin. |
Other labels that name edoxaban
Source: FDA drug label (SAVAYSA), Daiichi Sankyo Inc., effective July 10, 2025 (SPL set e77d3400-56ad-11e3-949a-0800200c9a66), via openFDA; the full label on DailyMed
What do FAERS reports show for edoxaban?
The FDA Adverse Event Reporting System holds 6,591 reports that list edoxaban among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 873 are coded as a death and 3,493 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2024 (1,188, against a median of 253 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as edoxaban?
4 other medicines are given the same way (oral) and in the same FDA class as edoxaban or labeled mainly for the same use (atrial fibrillation), the same class first. Atrial fibrillation lists all 17 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Rivaroxaban | Atrial fibrillation, Blood clots (DVT and PE), Stroke prevention | 20 labelers | $0.650 per tablet 2.5 mg tablet | A presentation being discontinued |
| Apixaban | Atrial fibrillation, Blood clots (DVT and PE), Stroke prevention | 2 labelers | $5.52 per tablet 5 mg tablet | No current entry |
| Warfarin | Atrial fibrillation, Blood clots (DVT and PE) | 19 labelers | $0.093 per tablet 2 mg tablet | No current entry |
| Dabigatran | Atrial fibrillation, Blood clots (DVT and PE), Stroke prevention | 16 labelers | $0.795 per capsule 150 mg capsule | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does edoxaban compare with medicines for the same use?
1 side-by-side page set edoxaban beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to edoxaban
- 4 medicines for the same use
- Other factor Xa inhibitors
- the pharmacologic class, with prices and generics
- Edoxaban side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other