Regulatory PathRegulatory requirements compared

Active substance

Bumetanide

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
BURINEX TABLETS 1 MG1 mgTablet · Oral use20 BlisterSAR 10.60NCE · PrescriptionLeo PharmaWithdrawn by MAH · Not Marketed

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

ProductStrengthForm · routeApplicantStatusFirst approved
BUMEX1MG; 0.5MG; 2MGtablet · oralVALIDUS PHARMSPrescription28 Feb 1983
BUMETANIDE0.25MG/MLinjectable · injectionSAGENTPrescription27 Jan 1995
BUMETANIDE0.5MG; 1MG; 2MGtablet · oralHERITAGE PHARMAPrescription24 Apr 1995
BUMETANIDE0.5MG; 1MG; 2MGtablet · oralSANDOZPrescription21 Nov 1996
BUMETANIDE0.25MG/MLinjectable · injectionWEST-WARD PHARMS INTPrescription30 Apr 2008
BUMETANIDE0.5MG; 1MG; 2MGtablet · oralAMNEAL PHARMS COPrescription18 Oct 2017
BUMETANIDE0.5MG; 1MG; 2MGtablet · oralUPSHER SMITH LABSPrescription23 Jan 2018
BUMETANIDE0.5MG; 1MG; 2MGtablet · oralZYDUS PHARMSPrescription30 Apr 2018
BUMETANIDE0.5MG; 1MG; 2MGtablet · oralRISINGPrescription12 Dec 2019
BUMETANIDE0.25MG/MLinjectable · injectionGLANDPrescription26 May 2022
BUMETANIDE0.25MG/MLinjectable · injectionMSNPrescription4 Aug 2022
BUMETANIDE0.5MG; 1MG; 2MGtablet · oralTAROPrescription24 Jul 2023
BUMETANIDE0.25MG/MLinjectable · injectionLUPINPrescription17 Sep 2024
BUMETANIDE0.5MG; 1MG; 2MGtablet · oralAPPCOPrescription18 Sep 2024
BUMETANIDE0.25MG/MLinjectable · injectionQILU PHARM HAINANPrescription19 Sep 2024
BUMETANIDE0.5MG; 1MG; 2MGtablet · oralRUBICON RESEARCHPrescription27 Dec 2024
BUMETANIDE0.25MG/MLinjectable · injectionASPIROPrescription27 Feb 2025
BUMETANIDE0.5MG; 1MG; 2MGtablet · oralMANKIND PHARMAPrescription3 Apr 2025
BUMETANIDE0.5MG; 1MG; 2MGtablet · oralJUBILANT GENERICSPrescription5 Aug 2025
ENBUMYST0.5MG/SPRAYspray · nasalCORSTASIS THERAPPrescription12 Sep 2025
BUMETANIDE0.5MG; 1MG; 2MGtablet · oralMSNPrescription5 Feb 2026
BUMETANIDE0.25MG/MLinjectable · injectionADAPTISPrescription26 Feb 2026
BUMEX0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**injectable · injectionVALIDUS PHARMSDiscontinued28 Feb 1983
BUMETANIDE0.25MG/MLinjectable · injectionHOSPIRADiscontinued31 Oct 1994
BUMETANIDE0.25MG/MLinjectable · injectionHOSPIRADiscontinued30 Oct 1997

1 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
BURINEX007282765 MGTABLET · ORALKARO PHARMA AB
BURINEX007282841 MGTABLET · ORALKARO PHARMA AB

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACBUMETANIDE 0.5 MG TABLET$0.12883per EA23 Sep 2026
US NADACBUMETANIDE 1 MG TABLET$0.10789per EA23 Sep 2026
US NADACBUMETANIDE 2 MG TABLET$0.1819per EA23 Sep 2026
NHS Drug TariffBumetanide 1mg tablets£5.7528 tablet1 Oct 2026
NHS Drug TariffBumetanide 1mg/5ml oral solution sugar free£289.35150 ml1 Oct 2026
NHS Drug TariffBumetanide 5mg tablets£62.7328 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.

WHO WHO Model List of Essential Medicines (2025)

  • 16. Diuretics · core
    Therapeutic equivalent to furosemide for Anuria or oliguria; Therapeutic equivalent to furosemide for Oedema
  • 12.4. Medicines used in heart failure · core
    Therapeutic equivalent to furosemide for Heart failure

Safety signals and safety-related labeling changes

All safety entries for bumetanide →

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.