What this pack is
PLETAL / Pletaal is the brand name in this record; cilostazol is the generic name. Read both together with the dosage form (oral tablet).
PACK CHECK · MARKET FIRST
PLETAL / PletaalGeneric namecilostazol
How this medicine works
Official labels describe cilostazol as inhibiting phosphodiesterase III, increasing intracellular cAMP and affecting platelet aggregation and vascular responses. This helps explain why bleeding, heart rate, heart failure and the complete medicine list need priority review. ‘Antiplatelet’ does not make it interchangeable or self-combinable with aspirin, clopidogrel or an anticoagulant.
Read source: United States ↗Historical public record · reviewed 2026-08-29More 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
- PLETAL / Pletaal
- Source-scoped market brand names
- Pletaal OD / プレタール OD · JapanCurrent regulator record ↗Current PMDA record: 50 mg and 100 mg orally disintegrating tablets, Otsuka.
- PLETAL · United StatesHistorical public record ↗FDA original 1999 approval and 2015/2017 historical labels; not a current-supply claim.
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
- cilostazol
- Dosage-form class
- Current Japanese Pletaal OD orally disintegrating tablets; historical U.S. conventional oral tablets. A shared ingredient and milligram number do not merge product form, packaging or market status.
- Route
- Oral
- Package-image status
- No exact original-brand package image is shown This is deliberate: do not use a retailer, repackager or another-market image to identify the pack in hand. See why and what to check instead →
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 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.
NEXT SAFE STEP
Choose the next safe check
A question about changing, combining or splitting?Put the exact packs on one list before a pharmacist or prescriber checks the full context.Open the family medicine list →A question about cost, reimbursement or availability?First lock the market, exact presentation and date. Use local official reimbursement, hospital or pharmacy channels for a current answer rather than a web estimate.Open regulator and market-record entry points →Unsure about a pack or a cross-border product?Photo reading can return possible record matches only. Check the actual product against the current regulator record for its market.Identify pack text locally →Saw a recall, approval or procurement headline?Open the original publisher, then match its product, market and date. Do not make a stop or switch decision from a headline.Read primary-source news →
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.
JP · Current PMDA electronic label (revised Feb 2023; verified 29 Aug 2026)
Cilostazol 50 mg per tablet; Japanese orally disintegrating tablet
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- 22100AMX02276
- Form and route
- Pletaal OD cilostazol orally disintegrating tablet · oral (product-identity field)
- Container
- pack count not established in this identity card
- Listing review
- Cited public label display reviewed 2026-08-29; actual marketing, stock and availability are not established.
- cilostazol
- 50 mgJapanese labelled amount per tablet; not an individual's tablet count, frequency, splitting or conversion instruction
- Labelled appearance
- white · round tabletUnscored in this labelled presentation
JP · Current PMDA electronic label (revised Feb 2023; verified 29 Aug 2026)
Cilostazol 100 mg per tablet; Japanese orally disintegrating tablet
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- 22100AMX02275
- Form and route
- Pletaal OD cilostazol orally disintegrating tablet · oral (product-identity field)
- Container
- pack count not established in this identity card
- Listing review
- Cited public label display reviewed 2026-08-29; actual marketing, stock and availability are not established.
- cilostazol
- 100 mgJapanese labelled amount per tablet; not an individual's tablet count, frequency, splitting or conversion instruction
- Labelled appearance
- white · round tablet · imprint OG18Scored appearance; this is not a self-splitting instruction
United States label · Historical 2015 U.S. FDA label (not a current label or supply claim)
Cilostazol 50 mg per tablet; 60-tablet bottle (historical U.S. label)
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDC 59148-003-16
- Form and route
- PLETAL cilostazol conventional oral tablet (historical U.S. record) · oral (historical product-identity field)
- Container
- bottle (historical)
- Listing review
- Cited product evidence reviewed 2026-08-29; actual marketing, stock and availability are not established.
- cilostazol
- 50 mgHistorical U.S. labelled amount per tablet; not current supply, an individual dose or cross-market conversion
- Package
- 60 tablets per bottle
- Labelled appearance
- white · triangular tablet · imprint PLETAL 50Unscored in this labelled presentation
United States label · Historical 2015 U.S. FDA label (not a current label or supply claim)
Cilostazol 100 mg per tablet; 60-tablet bottle (historical U.S. label)
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDC 59148-002-16
- Form and route
- PLETAL cilostazol conventional oral tablet (historical U.S. record) · oral (historical product-identity field)
- Container
- bottle (historical)
- Listing review
- Cited product evidence reviewed 2026-08-29; actual marketing, stock and availability are not established.
- cilostazol
- 100 mgHistorical U.S. labelled amount per tablet; not current supply, an individual dose or cross-market conversion
- Package
- 60 tablets per bottle
- Labelled appearance
- white · round tablet · imprint PLETAL 100Unscored in this labelled presentation
PACKAGE-VISUAL STATUS
Four traceable text identities are established; no retail or cross-market pack is presented as the exact product
The current PMDA document verifies shape, size and the 100 mg imprint for the two Japanese OD tablets, while historical FDA labels verify two U.S. conventional tablets and bottle information. No exact reusable public principal-display image is mapped one-to-one to all four identities, so the page discloses the image gap and does not substitute a generic cilostazol, retail or other-market pack.
LABEL READING · NOT A PRESCRIPTION
PLETAL / Pletaal label reading: check heart failure, bleeding, co-medications and exact dosage form first
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.
This module distinguishes current Japanese Pletaal OD tablets from historical U.S. PLETAL conventional tablets and brings higher-risk review cues forward. It does not decide individual suitability or generate tablet count, frequency, initiation, stopping, missed-use, switching, peri-procedure stopping or co-use plans.
- Japanese OD identifies an orally disintegrating product; it does not permit arbitrary crushing, dissolving into an arbitrary volume, sharing or conversion from historical U.S. conventional tablets. Check the current label for the exact product and professional instruction.
- The Japanese 100 mg tablet has a score and OG18 imprint. A score is first an appearance clue, not universal permission for everyone to split a tablet or assemble a strength from halves. Check 50 mg, 100 mg and other manufacturers' products separately.
- The current PMDA document and historical FDA label identify congestive/any-severity heart failure as a major contraindication boundary. With known heart failure, unexplained breathlessness, swelling, chest pain, marked palpitations or fainting, do not use a webpage to start, continue, increase or stop the medicine; contact the responsible team promptly. Severe chest pain, breathing difficulty or fainting requires local emergency care.
- Aspirin, clopidogrel, prasugrel, ticagrelor, warfarin, apixaban, rivaroxaban, dabigatran, edoxaban or NSAID pain medicines on the same list are priority bleeding-review cues. Do not self-combine, alternate, time-separate or stop one of them.
- Black stool, vomiting blood, uncontrolled bleeding, sudden weakness or speech trouble, severe headache, altered consciousness or severe allergy may be emergencies. Use local emergency services immediately; do not wait for a webpage or self-take, stop or switch medicine to observe.
- The historical FDA label indicates that several CYP3A4 or CYP2C19 inhibitors may affect cilostazol exposure, including some antifungals, antibacterials, verapamil/diltiazem, omeprazole and grapefruit-related products. This source cue must not become a web dose table; have a pharmacist review every prescription medicine, OTC product, supplement and relevant dietary product.
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
- Brand and generic nameBoth must match the medicine named by the record.
- Dosage form and strengthTablet, capsule, injection, inhaler, patch and eye drop are not interchangeable.
- Market and notice dateA record applies only to the country or region and date it names.
- Lot, pack and manufacturerRecord these only when the official notice specifically names them.
- 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 checkPMDA · Japan · Regulatory product record · 2026-08-29
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
- Japan · 2
- United States · 3
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 routeJapan PMDA: current electronic label for Pletaal OD 50 mg / 100 mg tablets (revised Feb 2023) ↗Current regulatory record · reviewed 2026-08-29
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.
- PMDA · Japan · Regulatory product record · 2026-08-29Japan PMDA: current professional product record for Pletaal OD 50 mg / 100 mg tablets ↗Current regulatory record · reviewed 2026-08-29
- FDA · United States · Regulatory product record or label archive · 2026-08-29U.S. FDA: original approval letter for PLETAL cilostazol NDA 020863 (15 Jan 1999) ↗Historical public record · reviewed 2026-08-29
- FDA · United States · Regulatory product record or label archive · 2026-08-29U.S. FDA: historical PLETAL cilostazol 50 mg / 100 mg label (2017; not a current label) ↗Historical public record · reviewed 2026-08-29
- FDA · United States · Regulatory product record or label archive · 2026-08-29U.S. FDA: historical PLETAL cilostazol 50 mg / 100 mg label and packaging information (2015; not a current label) ↗Historical public record · reviewed 2026-08-29
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 PLETAL / Pletaal (cilostazol). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
PLETAL / Pletaal is the brand in this record and cilostazol is the active-ingredient name. Check both with the dosage form (Current Japanese Pletaal OD orally disintegrating tablets; historical U.S. conventional oral tablets. A shared ingredient and milligram number do not merge product form, packaging or market status.) and the market on the actual pack.
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.
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.
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.
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.
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.
- Japan PMDA: current electronic label for Pletaal OD 50 mg / 100 mg tablets (revised Feb 2023) ↗Current regulatory record · reviewed 2026-08-29
- Japan PMDA: current professional product record for Pletaal OD 50 mg / 100 mg tablets ↗Current regulatory record · reviewed 2026-08-29
- U.S. FDA: original approval letter for PLETAL cilostazol NDA 020863 (15 Jan 1999) ↗Historical public record · reviewed 2026-08-29
- U.S. FDA: historical PLETAL cilostazol 50 mg / 100 mg label (2017; not a current label) ↗Historical public record · reviewed 2026-08-29
- U.S. FDA: historical PLETAL cilostazol 50 mg / 100 mg label and packaging information (2015; not a current label) ↗Historical public record · reviewed 2026-08-29
HOW IT WORKS · NOT A TREATMENT PLAN
How cilostazol works: PDE3 inhibition and platelet effects are not switching rules
- Mechanism cannot decide whether an individual should use cilostazol or generate tablet count, frequency or duration from walking distance, leg pain, blood pressure or heart rate.
- Medicines that are antiplatelet or affect clotting do not share the same pathway, approved use, bleeding risk or stopping/switching boundary. The responsible team must review the diagnosis, exact packs, full medicine list and any planned procedure or surgery.
- Do not use a mechanism explanation to self-take an extra tablet or stop after palpitations or heart-rate changes. Severe chest pain, breathing difficulty, fainting, stroke features or major bleeding require immediate local emergency care.
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.
- Japan PMDA: current professional product record for Pletaal OD 50 mg / 100 mg tablets ↗Current regulatory record · reviewed 2026-08-29
- Japan PMDA: current public product record for Pletaal OD 50 mg / 100 mg tablets ↗Current regulatory record · reviewed 2026-08-29
- Japan PMDA: current electronic label for Pletaal OD 50 mg / 100 mg tablets (revised Feb 2023) ↗Current regulatory record · reviewed 2026-08-29
- Japan PMDA: patient guide for Pletaal OD 50 mg / 100 mg tablets (updated Oct 2022) ↗Current regulatory record · reviewed 2026-08-29
- U.S. FDA: original approval letter for PLETAL cilostazol NDA 020863 (15 Jan 1999) ↗Historical public record · reviewed 2026-08-29
- U.S. FDA: historical PLETAL cilostazol 50 mg / 100 mg label (2017; not a current label) ↗Historical public record · reviewed 2026-08-29
- U.S. FDA: historical PLETAL cilostazol 50 mg / 100 mg label and packaging information (2015; not a current label) ↗Historical public record · reviewed 2026-08-29
SOURCE-TRACEABLE ARCHIVE
PLETAL / Pletaalcilostazol
This page links to public primary-source material for PLETAL / Pletaal. The archive is historical or documentary evidence only; it does not by itself establish originator status, product quality, current labelling, availability or sale eligibility.
DOCUMENT TIMELINE
Document timeline
Original U.S. FDA approval
The FDA letter connects Pletal 50 mg and 100 mg tablets, NDA 020863 and Otsuka. This historical node does not establish a current 2026 U.S. label or supply.
U.S. FDA: original approval letter for PLETAL cilostazol NDA 020863 (15 Jan 1999) ↗Japanese Pletaal OD sales-start node
The current PMDA electronic label lists Apr 2010 as the sales-start month for 50 mg and 100 mg OD tablets; this does not establish pharmacy stock.
Japan PMDA: current electronic label for Pletaal OD 50 mg / 100 mg tablets (revised Feb 2023) ↗Current Japanese electronic-label revision
The page uses this current PMDA document as the Japanese label entry point and separately links the Oct 2022 patient guide.
Japan PMDA: current electronic label for Pletaal OD 50 mg / 100 mg tablets (revised Feb 2023) ↗
MARKET SCOPE
Market-record boundary
Japan
Current PMDA records linked for Pletaal OD 50 mg / 100 mgA regulatory record does not establish stock, purchasing eligibility, individual suitability or self-switching.
United States
1999 approval and 2015/2017 historical archives linked; current status not establishedThe 60-tablet bottle NDCs in historical labels are archival identities only and do not claim current marketing or supply.
Mainland China, EU and other markets
Current market record not establishedNo local brand, approval, pack, supply, originator/generic relationship or interchangeability is inferred from Japanese or U.S. documents.
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.
RECORD FAQ
Record questions
Are Pletaal OD and conventional PLETAL the same pack?
No. The current Japanese record is an orally disintegrating tablet, while the U.S. sources describe historical conventional tablets. Similar names and milligram numbers do not merge dosage form, pack, market status or permit self-switching.
Can a scored 100 mg tablet be self-split into 50 mg?
A webpage cannot make that decision. A score is a product-appearance clue, not universal splitting or conversion permission; check the current label, prescription and professional instruction for the exact product.
Can cilostazol be added to aspirin or an anticoagulant?
A webpage cannot decide this. Do not self-add, stop or time-separate. Have the responsible team review every prescription medicine, OTC pain product, supplement and actual pack for bleeding risk, purpose and monitoring.
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.