Regulatory PathRegulatory requirements compared

Active substance

Cilostazol

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
FANCATA 100MG TABLET100 mgTablet · Oral use60 BlisterSAR 67.40Generic · PrescriptionSPIMACO ADDWAEIHValid
FANCATA 50MG TABLET50 mgTablet · Oral use60 BlisterSAR 52.95Generic · PrescriptionSPIMACO ADDWAEIHValid

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
CILOSTAZOL50MG; 100MGtablet · oralAUROBINDO PHARMA USAPrescription23 Nov 2004
CILOSTAZOL100MG; 50MGtablet · oralEPIC PHARMA LLCPrescription23 Nov 2004
CILOSTAZOL50MG; 100MGtablet · oralTEVAPrescription24 Nov 2004
CILOSTAZOL100MGtablet · oralACTAVIS ELIZABETHPrescription26 Nov 2004
CILOSTAZOL50MG; 100MGtablet · oralAPOTEXPrescription10 Dec 2004
CILOSTAZOL100MG; 50MGtablet · oralSLATE RUN PHARMAPrescription29 Mar 2006
CILOSTAZOL50MGtablet · oralCHARTWELL RXPrescription24 Sep 2012
CILOSTAZOL100MG; 50MGtablet · oralCHARTWELL RXPrescription24 Sep 2012
PLETAL50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralOTSUKADiscontinued15 Jan 1999
CILOSTAZOL100MGtablet · oralCHARTWELL RXDiscontinued23 Nov 2004
CILOSTAZOL100MGtablet · oralACTAVIS ELIZABETHDiscontinued26 Nov 2004
CILOSTAZOL100MGtablet · oralIVAX SUB TEVA PHARMSDiscontinued1 Mar 2005
CILOSTAZOL50MG; 100MGtablet · oralHIKMA PHARMSDiscontinued17 May 2005
CILOSTAZOL50MGtablet · oralCHARTWELL RXDiscontinued8 Nov 2005
CILOSTAZOL100MG; 50MGtablet · oralRISINGDiscontinued20 Apr 2006
CILOSTAZOL50MG; 100MGtablet · oralPLIVA HRVATSKA DOODiscontinued29 Oct 2007
CILOSTAZOL50MG; 100MGtablet · oralSANKALP LIFECAREDiscontinued28 Sep 2009

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACCILOSTAZOL 100 MG TABLET$0.13176per EA23 Sep 2026
US NADACCILOSTAZOL 50 MG TABLET$0.13039per EA23 Sep 2026
NHS Drug TariffCilostazol 100mg tablets£56.5756 tablet1 Oct 2026
NHS Drug TariffCilostazol 50mg tablets£35.3156 tablet1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

  • US FDA 17 May 2017 PLETAL — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions
  • MHRA 11 Dec 2014 Cilostazol (Pletal): risks of cardiovascular and bleeding events
    Indication restricted to second-line treatment and contraindicated with some cardiovascular conditions and medicines Furthermore, cilostazol is now contraindicated in patients with any of the following: Unstable angina, recent myocardial infarction or coronary intervention (within 6 months) a history of severe tachyarrhythmia those receiving two or more other antiplatelet or anticoagulant treatments For patients starting cilostazol, prescribers should assess benefit after 3 months of treatment, and should stop treatment if patients have not made clinically relevant improvements in walking distance. All patients who are currently receiving long-term treatment should be reassessed at a routine appointment, in light of the new advice.

All safety entries for cilostazol →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.