PACK CHECK · MARKET FIRST

SAVAYSAGeneric nameedoxaban

Reading size

How this medicine works

The U.S. label describes edoxaban as a selective factor Xa inhibitor that does not require antithrombin III. Factor Xa inhibition reduces thrombin generation and thrombus formation. This explains why anticoagulation and bleeding must be considered together, but it cannot determine anyone's strength, frequency, duration, interruption or switch.

Read source: United States ↗Current regulatory record · reviewed 2026-08-28More about its action and precautions →

Check the market, names, dosage form and route together

A medicine may use different brand names across markets. Keep the market, brand, generic name, dosage form and route together; one matching field does not prove that two packs are the same or interchangeable.

Open the complete product-identity record

Use these fields when the pack, market name or package image needs closer checking. They are evidence boundaries, not substitution instructions.

International brand name
SAVAYSA
Source-scoped market brand names
  • LIXIANA · European UnionCurrent regulator record ↗
    EMA central-authorisation product name; exact national packs and supply require current local review.
  • リクシアナ · JapanCurrent regulator record ↗
    Japanese trade name in the current PMDA product page; not merged with U.S. NDCs or EU packs.

The evidence status and note below apply only to the stated market and source. They do not prove that packs in different markets can be substituted.

Generic name
edoxaban
Dosage-form class
Edoxaban film-coated oral tablets: U.S. SAVAYSA 15 mg, 30 mg and 60 mg. This dossier separately establishes a 15 mg 30-tablet bottle, a 30 mg 30-tablet bottle, a 30 mg 50-tablet hospital blister carton and a 60 mg 50-tablet hospital blister carton. EU LIXIANA and Japanese リクシアナ strengths and packs require their own documents and are not merged with U.S. NDCs.
Route
Oral (higher-risk cross-market anticoagulant exact-product identity field)
Package-image status
A source-linked public label image is available below

No source-verifiable mainland-China trade-name cue has been established for this record. This does not establish whether the medicine exists, is approved or is available in mainland China. Check pack text and current CDE/NMPA records item by item.

FOR EVERYDAY QUESTIONS

After the leaflet, continue with the question you still need to check

What this pack is

SAVAYSA is the brand name in this record; edoxaban is the generic name. Read both together with the dosage form (oral tablet).

What this page can show

This is a source-traceable public record. It helps you read the product identity and its listed source documents; each market still needs its own current record check.

What to bring to the next conversation

Bring the actual pack, the label or prescription, and a complete medicine list when you speak with a pharmacist or clinician.

PRODUCT PRESENTATION IDENTITY

Strength, pack and device identity

Package strength is not an individual dose. These fields help identify the exact labelled product; they do not calculate how much, how often, a missed-use action, splitting, switching or conversion.

How to read a score line: ‘scored’ or ‘unscored’ first identifies this labelled presentation. A score line by itself does not permit self-splitting, reducing or changing the product. Only an explicit statement in the current label for this exact presentation, checked with a pharmacist against the prescription, can support any further handling.

4 source-backed strength, pack or device records — open the full list

First match the market, dosage form and labelled amount on the pack in hand. The number of tablets, sachets or devices in a pack is not a personal dose or schedule.

United States label · U.S. DailyMed public label (page updated 10 Jul 2025; prescribing information revised Oct 2023)

Edoxaban 15 mg per tablet; 30-tablet bottle

Exact display panel in the cited public label · select to enlarge
Product code
NDC 65597-201-30
Form and route
SAVAYSA edoxaban film-coated oral tablet · oral (higher-risk anticoagulant exact-product identity field)
Container
bottle
Listing review
Current label display and NDC Directory listing reviewed 2026-08-28; actual marketing, stock and availability are not established.
edoxaban (supplied as edoxaban tosylate)
15 mglabelled amount per tablet; not an individual's tablet count, frequency, missed-use, stopping or switching instruction
Package
30 tablets per pack
Labelled appearance
orange · round, unscored film-coated tablet · imprint DSC L15Unscored in this labelled presentation
Open the presentation source ↗Current regulatory record · reviewed 2026-08-28

United States label · U.S. DailyMed public label (page updated 10 Jul 2025; prescribing information revised Oct 2023)

Edoxaban 30 mg per tablet; 30-tablet bottle

Exact display panel in the cited public label · select to enlarge
Product code
NDC 65597-202-30
Form and route
SAVAYSA edoxaban film-coated oral tablet · oral (higher-risk anticoagulant exact-product identity field)
Container
bottle
Listing review
Current label display and NDC Directory listing reviewed 2026-08-28; actual marketing, stock and availability are not established.
edoxaban (supplied as edoxaban tosylate)
30 mglabelled amount per tablet; not an individual's tablet count, frequency, missed-use, stopping or switching instruction
Package
30 tablets per pack
Labelled appearance
pink · round, unscored film-coated tablet · imprint DSC L30Unscored in this labelled presentation
Open the presentation source ↗Current regulatory record · reviewed 2026-08-28

United States label · U.S. DailyMed public label (page updated 10 Jul 2025; prescribing information revised Oct 2023)

Edoxaban 30 mg per tablet; five 10-tablet blister cards, 50 tablets total, hospital-use carton

Exact display panel in the cited public label · select to enlarge
Product code
NDC 65597-202-05
Form and route
SAVAYSA edoxaban film-coated oral tablet · oral (higher-risk anticoagulant exact-product identity field)
Container
hospital-use blister-card carton
Listing review
Current label display and NDC Directory listing reviewed 2026-08-28; actual marketing, stock and availability are not established.
edoxaban (supplied as edoxaban tosylate)
30 mglabelled amount per tablet; not an individual's tablet count, frequency, missed-use, stopping or switching instruction
Package
50 tablets per pack
Labelled appearance
pink · round, unscored film-coated tablet · imprint DSC L30Unscored in this labelled presentation
Open the presentation source ↗Current regulatory record · reviewed 2026-08-28

United States label · U.S. DailyMed public label (page updated 10 Jul 2025; prescribing information revised Oct 2023)

Edoxaban 60 mg per tablet; five 10-tablet blister cards, 50 tablets total, hospital-use carton

Exact display panel in the cited public label · select to enlarge
Product code
NDC 65597-203-05
Form and route
SAVAYSA edoxaban film-coated oral tablet · oral (higher-risk anticoagulant exact-product identity field)
Container
hospital-use blister-card carton
Listing review
Current label display and NDC Directory listing reviewed 2026-08-28; actual marketing, stock and availability are not established.
edoxaban (supplied as edoxaban tosylate)
60 mglabelled amount per tablet; not an individual's tablet count, frequency, missed-use, stopping or switching instruction
Package
50 tablets per pack
Labelled appearance
yellow · round, unscored film-coated tablet · imprint DSC L60Unscored in this labelled presentation
Open the presentation source ↗Current regulatory record · reviewed 2026-08-28

PUBLIC LABEL IMAGE

Appearance and package-text clues

United States · current public-label panel · exact package/label image · DailyMed page updated 10 Jul 2025; prescribing information revised Oct 2023Select the image to enlarge; press Escape to close

This current public-label package panel helps check the brand, generic name, strength and dosage-form clues only. It does not authenticate a product in hand or establish originator status, availability, sale eligibility, another package or another market.

Open the public label source ↗

LABEL READING · NOT A PRESCRIPTION

SAVAYSA/LIXIANA label reading: identify the anticoagulant, then review bleeding, interruption and procedure risks

Reading level: drug-specific label reading. This record has been expanded around its dosage form or a higher-risk reading question; the current target-market label and professional review still apply.

Edoxaban is a higher-risk oral anticoagulant. The U.S. label carries boxed warnings about reduced efficacy in a renal-function subgroup with nonvalvular atrial fibrillation, ischaemic risk after premature discontinuation, and spinal or epidural haematoma around neuraxial procedures. The site does not calculate creatinine clearance, select a strength, or plan interruption, bridging, missed use or switching.

  • Check the brand, edoxaban, target market, 15/30/60 mg strength per tablet, pack, NDC or local authorisation record together. A shared ingredient name does not make U.S. SAVAYSA, EU LIXIANA, Japanese リクシアナ or another market pack interchangeable.
  • Have the prescriber or pharmacist review renal function, body weight, age, liver status, planned surgery/dental work/lumbar puncture, falls, and a complete medicine list containing every prescription, non-prescription product and supplement. Other anticoagulants, antiplatelets, thrombolytics, some pain medicines and some antidepressants may increase bleeding risk; do not self-combine, alternate or space them.
  • Do not self-stop, double, make up or switch because of one missed use, bleeding concern, a planned test or another anticoagulant. Exact rules can differ across U.S., EU and Japanese labels; return to the individual's prescription, current target-market label and treating team.
  • Persistent or severe bleeding, black stools, vomiting or coughing blood, blood in urine, sudden severe headache, one-sided weakness, slurred speech, marked dizziness/fainting, a fall with head impact or altered consciousness requires local emergency help immediately. Bring every medicine pack and the medicine list; do not wait for a web response.
Open this record's official electronic leaflet ↗

PHARMACOVIGILANCE · OFFICIAL ROUTES

Check safety information in the right market

Start with the public label or product record linked to this dossier, then use the official safety routes below for the market that applies to the medicine in hand.

Match five details before using a safety record

  1. Brand and generic nameBoth must match the medicine named by the record.
  2. Dosage form and strengthTablet, capsule, injection, inhaler, patch and eye drop are not interchangeable.
  3. Market and notice dateA record applies only to the country or region and date it names.
  4. Lot, pack and manufacturerRecord these only when the official notice specifically names them.
  5. Current product informationA historical record may have been superseded by the current label.

This checklist only helps organise the right question. It does not create a personal conclusion about stopping, switching, dose, combination or suitability.

This dossier’s product-level source checkU.S. National Library of Medicine DailyMed · United States · Public medicine label · 2026-08-28

This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk.

Markets actually represented by the reviewed product documents
  • United States · 2
  • European Union / European Economic Area · 2
  • Japan · 2

This is a document-coverage summary, not a claim that the medicine is authorised, supplied, interchangeable or actively monitored in every listed market today.

This record’s label or product-record routeDailyMed (NLM): current U.S. SAVAYSA edoxaban public label (Daiichi Sankyo; page updated 10 Jul 2025) ↗Current regulatory record · reviewed 2026-08-28

Other official market or version documents for this record

These are separately reviewed product documents for the same dossier. Their market, date, dosage form and document status must stay attached to each link; they do not establish interchangeability between products, strengths, packs, indications or countries.

No dated, product-scoped official safety record is currently listed in this directory

This is not a conclusion that the medicine has no risk, warning, recall or newer notice in another market. Start with the checked product-level label above, then use the official market gateways below for the product in hand.

See the reviewed safety-record directory →

Global official safety gateways

  • NMPA Centre for Drug Reevaluation · Mainland ChinaPrimary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item.Drug-vigilance bulletins and safety notices ↗reviewed 2026-08-22
  • FDA · United StatesPrimary FDA pages for important new safety issues, labelling changes and risk communications.Drug Safety Communications ↗reviewed 2026-08-22
  • FDA MedWatch · United StatesU.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality.Safety information and serious-problem reporting ↗reviewed 2026-08-22
  • EMA · European Union / European Economic AreaOfficial EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment.Pharmacovigilance overview and EudraVigilance ↗reviewed 2026-08-22
  • MHRA · United KingdomPrimary UK MHRA medicine-safety updates for professionals and the public.Drug Safety Update ↗reviewed 2026-08-22
  • PMDA · JapanPMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents.Medicine safety information ↗reviewed 2026-08-22
  • MFDS · Republic of KoreaMFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case.Medicine safety letters ↗reviewed 2026-08-22
  • HSA · SingaporeHSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information.Adverse-event reporting and medicine-safety information ↗reviewed 2026-08-22
  • Health Canada · CanadaHealth Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item.MedEffect Canada: advisories, warnings and recalls ↗reviewed 2026-08-22
  • TGA · AustraliaPrimary Australian TGA safety alerts, advisories and monitoring information for therapeutic products.Medicine safety alerts ↗reviewed 2026-08-22
  • Swissmedic · SwitzerlandOfficial Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality.Pharmacovigilance and suspected adverse-reaction reporting ↗reviewed 2026-08-22
  • Medsafe · New ZealandNew Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information.Medicine safety communications ↗reviewed 2026-08-22
  • SAHPRA · South AfricaSAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information.Medicine safety information, alerts and pharmacovigilance ↗reviewed 2026-08-22
  • WHO · GlobalWHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market.Medicine and vaccine safety-alert archive ↗reviewed 2026-08-22
  • Anvisa · BrazilAnvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item.Pharmacovigilance, alerts and VigiMed ↗reviewed 2026-08-22

This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline.

For severe or rapidly worsening symptoms, suspected overdose, a severe allergic reaction, loss of consciousness or another emergency, use local emergency services. Do not wait for an online alert search or change a medicine from this page.

PRIVATE FAMILY LIST

Bring this record into a local medicine list

Only the brand, generic name, dosage form and route are added, and they stay in this browser. Copy strength, label directions, start/stop history and any concern from the actual pack; this tool does not calculate a dose or decide combination, switching or stopping.

Add to the family medicine list →

PACK · LABEL · MEDICINE LIST

Six checks for this medicine pack

Use this card to organise questions about SAVAYSA (edoxaban). Keep the exact pack, its current label and the full medicine list together.

  1. Identify the exact product

    SAVAYSA is the brand in this record and edoxaban is the active-ingredient name. Check both with the dosage form (Edoxaban film-coated oral tablets: U.S. SAVAYSA 15 mg, 30 mg and 60 mg. This dossier separately establishes a 15 mg 30-tablet bottle, a 30 mg 30-tablet bottle, a 30 mg 50-tablet hospital blister carton and a 60 mg 50-tablet hospital blister carton. EU LIXIANA and Japanese リクシアナ strengths and packs require their own documents and are not merged with U.S. NDCs.) and the market on the actual pack.

  2. Read the labelled strength in context

    mg, mcg, mg/mL or a percentage describes the labelled amount in one tablet, capsule, measured volume, spray or other unit. It is not an answer to how many units a person should take.

  3. Check before splitting or opening

    Before splitting, crushing, chewing or opening anything, find an explicit instruction for this exact product in its current label and ask a pharmacist. A score line or a previous pack is not enough by itself.

  4. Put every product on one list

    Include prescriptions, over-the-counter products, eye drops, creams, vitamins, minerals, herbs and supplements. A pharmacist or prescriber needs the whole list before any combination, alternation, switch or stop is considered.

  5. Ask a specific pharmacogenetics question

    Ask which medicine, which gene and what clinical decision a result could change. A gene–drug association does not mean broad genetic testing is needed for everyone and must not be used to change treatment without professional review.

  6. Know when to seek urgent help

    For a suspected overdose, a severe allergic reaction, fainting or difficulty breathing, use the local emergency or poison-information service now. Do not wait for a website reply or alter several medicines to test what caused it.

This card does not calculate a dose, decide whether medicines can be combined, or replace a clinician or pharmacist. Market-specific current labels and the person's full context still need review.

MARKET DOCUMENTS · READ SEPARATELY

Enlarged market leaflets and regulator documents

Each link retains its own market, date, dosage form and document status. These documents support larger-print reading and item-by-item checking; they do not make products, strengths, packs, indications or use between countries or regions interchangeable.

HOW IT WORKS · NOT A TREATMENT PLAN

How edoxaban works: direct factor Xa inhibition reduces thrombin generation

  • “Factor Xa inhibition” does not make all oral anticoagulants the same. Edoxaban, apixaban, rivaroxaban, dabigatran, warfarin and injectable anticoagulants differ in ingredient, mechanism, monitoring, labelled uses and transition rules.
  • A mechanism cannot decide whether an individual's renal-function range, body weight or other medicines require a change. A professional must review those facts against the target-market label and prescription. The site does not provide a creatinine-clearance calculator or dose selector.
  • Anticoagulation reduces clotting risk and also creates bleeding risk. Useful actions are to carry the exact drug name and strength, tell surgical, dental and emergency teams, record unusual bleeding, and seek immediate help for serious symptoms.
Open the primary pharmacology source ↗

SOURCE EVIDENCE REGISTER

Source evidence map

Every public link is labelled with its market, document status and document type. A historical public record is not a current label, and an official lookup entry is not a product-specific record.

SOURCE-TRACEABLE ARCHIVE

SAVAYSAedoxaban

This page includes an exact current U.S. public-label package panel for SAVAYSA, alongside documentary primary-source material. It helps check product identity, but does not itself establish originator status, product quality, availability or sale eligibility.

DOCUMENT TIMELINE

Document timeline

  1. FDA approved SAVAYSA NDA 206316

    The FDA approval letter and Drug Trials Snapshot link SAVAYSA, edoxaban, 15/30/60 mg oral tablets, NDA 206316 and the approval date 8 Jan 2015. This establishes U.S. product history only; it does not automatically establish packaging, supply or interchangeability in the EU, Japan, Mainland China or another market.

    FDA: SAVAYSA NDA 206316 approval letter (8 Jan 2015; 15/30/60 mg) ↗
  2. LIXIANA received central EU marketing authorisation

    EMA lists 19 Jun 2015 as the date of LIXIANA's central EU marketing authorisation and provides product information, labelling and patient leaflets in official EU languages. This node does not merge EU packs with U.S. NDCs or Japanese products.

    EMA: LIXIANA central EU authorisation page (authorisation valid since 19 Jun 2015) ↗
  3. Current U.S., EU and Japanese public routes reviewed together

    This review separately checked the current U.S. DailyMed label, EMA LIXIANA page/product information, and PMDA LIXIANA public page/electronic-label route. Market boundaries remain explicit; the review date is not a stock, purchase or individual-use conclusion.

    PMDA: current LIXIANA 15/30/60 mg tablet page and patient-information routes ↗

MARKET SCOPE

Market-record boundary

United States

Current label, NDA history and four exact pack identities linked

Separately records NDC, colour, imprint and source for SAVAYSA 15 mg/30-tablet bottle, 30 mg/30-tablet bottle, 30 mg/50-tablet hospital blister carton and 60 mg/50-tablet hospital blister carton. It does not establish stock, purchase, authenticity, individual tablet count, missed-use, interruption, transition or peri-procedure plans.

European Union

EMA LIXIANA central authorisation and multilingual product information linked

EMA provides professional information, labelling and the patient leaflet in official EU languages. Exact national packs and supply still require local review and are not merged with U.S. SAVAYSA NDCs.

Japan

PMDA LIXIANA 15/30/60 mg product, safety and patient-information routes linked

The current PMDA public page lists LIXIANA 15/30/60 mg tablets and edoxaban tosilate hydrate and provides patient-guide and bleeding-risk information routes. Japanese product numbers, packs and use rules are not merged with U.S./EU records.

Mainland China and other markets

Current regulatory product record not established

No local approval, trade name, packaging, supply, originator/reference relationship or interchangeability is inferred from SAVAYSA, LIXIANA, リクシアナ, a shared ingredient or the three reviewed market records; each product requires current local regulatory review.

How to read this record

Read each document in its stated market, date and dosage-form context. A historical record is not a current label and does not support individual medical, substitution or purchasing conclusions.

Keep international and mainland China records separate

This page has a U.S. public history/regulatory archive but no mainland China record for this specific product. That does not establish whether the medicine exists, is approved or is available in mainland China. Verify product identity, dosage form, strength, holder and the current label item by item.

CDE listed-drug directory ↗ NMPA public query ↗

RECORD FAQ

Record questions

Are SAVAYSA, LIXIANA and リクシアナ the same medicine and directly interchangeable?

They can all identify edoxaban products, but they belong to different regulatory markets. A shared ingredient does not prove identical strength, excipients, packaging, authorised uses, restrictions, supply or prescription rules and cannot establish self-substitution. Have a pharmacist or prescriber review the actual pack, target-market label and prescription.

Can 15, 30 and 60 mg be converted into a tablet count, or can two tablets be taken after a missed use?

No. mg is the labelled amount per exact tablet; individual strength and rules also depend on the indication, renal function, body weight, co-medications and target-market label. The site provides no tablet-count conversion, missed-use make-up, interruption or transition instruction; follow the individual's prescription and contact the prescriber or pharmacist.

Can it be self-stopped before surgery, dental work or lumbar puncture?

A webpage cannot decide this. Anticoagulant interruption and procedure timing involve both bleeding and clotting risks. Tell the procedural and prescribing teams the exact drug, strength, last use, renal function and complete medicine list early, so they can plan from the current label and clinical context; do not self-stop or substitute another anticoagulant.

READ NEXT

Related reading

Evidence status

The listed links are public sources selected for traceability. They must be rechecked against the current target-market record before any use beyond reading and research.

EDITORIAL RECORD

Who prepared and checked this page

Byline
OriginDrug Content Editorial
Review role
Public primary-source verification
Last reviewed
2026-08-28
Source record
6 clickable primary-source entry points are listed with this dossier.

The review role checks source traceability, stated market, document version and product-identity fields. It is not a claim of clinical licensure, prescribing authority or individual pharmacy service. Read the editorial policy.

Search records
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