Regulatory PathRegulatory requirements compared

Active substance

Torasemide

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
EXAMIDE5 mgFilm-coated tablet · Oral use30 BlisterSAR 23.45Generic · PrescriptionApex PharmaValid
EXAMIDE10 mgFilm-coated tablet · Oral use30 BlisterSAR 39.75Generic · PrescriptionApex PharmaValid
EXAMIDE20 mgFilm-coated tablet · Oral use20 BlisterSAR 66.10Generic · PrescriptionApex PharmaValid
Exetora 20 mg/4 ml5 mg/mlSolution for injection · Intravenous use5 AmpouleSAR 84.00Generic · PrescriptionTabuk Pharmaceutical Manufacturing CompanyValid
UNAT 10MG TAB10 mgTablet · Oral use30 BlisterSAR 39.75NCE · PrescriptionROCHE DIAGNOSTICSWithdrawn by MAH · Not Marketed
UNAT 5MG TAB5 mgTablet · Oral use30 BlisterSAR 23.45NCE · PrescriptionROCHE DIAGNOSTICSWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

ACUTE KIDNEY INJURY (AKI); CARDIOMYOPATHY; CONGESTIVE HEART FAILURE; HYPERKALEMIA; PULMONARY ARTERIAL HYPERTENSION

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

ProductStrengthForm · routeApplicantStatusFirst approved
TORSEMIDE5MG; 10MG; 20MG; 100MGtablet · oralPLIVA PHARM INDPrescription30 May 2003
TORSEMIDE20MGtablet · oralHIKMA PHARMSPrescription1 Mar 2005
TORSEMIDE5MG; 10MG; 20MG; 100MGtablet · oralCOREPHARMAPrescription31 May 2005
TORSEMIDE5MG; 10MG; 20MG; 100MGtablet · oralAUROBINDO PHARMAPrescription17 Oct 2007
TORSEMIDE5MG; 10MG; 20MG; 100MGtablet · oralHETERO LABS LTD IIIPrescription27 Jan 2009
SOAANZ40MGtablet · oralSARFE PHARMSPrescription14 Jun 2021
TORSEMIDE5MG; 10MG; 20MGtablet · oralMICRO LABSPrescription1 May 2026
DEMADEX5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralPHARMOBEDIENTDiscontinued23 Aug 1993
DEMADEX20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**solution · intravenousROCHEDiscontinued23 Aug 1993
TORSEMIDE5MG; 10MG; 20MG; 100MGtablet · oralTEVADiscontinued14 May 2002
TORSEMIDE5MG; 10MG; 20MG; 100MGtablet · oralSTRIDES PHARMA INTLDiscontinued27 May 2003
TORSEMIDE5MG; 10MGtablet · oralHIKMA PHARMSDiscontinued1 Mar 2005
TORSEMIDE5MG; 10MG; 20MG; 100MGtablet · oralSUN PHARM INDSDiscontinued26 Feb 2008
TORSEMIDE20MG/2ML (10MG/ML); 50MG/5ML (10MG/ML)solution · intravenousHIKMADiscontinued11 Jun 2008
TORSEMIDE20MG/2ML (10MG/ML); 50MG/5ML (10MG/ML)solution · intravenousAM REGENTDiscontinued21 Apr 2010
TORSEMIDE5MG; 10MG; 20MG; 100MGtablet · oralSTRIDES PHARMA INTLDiscontinued22 Mar 2011
SOAANZ20MG; 60MGtablet · oralSARFE PHARMSDiscontinued14 Jun 2021

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACTORSEMIDE 10 MG TABLET$0.06594per EA23 Sep 2026
US NADACTORSEMIDE 100 MG TABLET$0.17384per EA23 Sep 2026
US NADACTORSEMIDE 20 MG TABLET$0.06361per EA23 Sep 2026
US NADACTORSEMIDE 5 MG TABLET$0.05726per EA23 Sep 2026
NHS Drug TariffTorasemide 10mg tablets£13.6928 tablet1 Oct 2026
NHS Drug TariffTorasemide 5mg tablets£16.5128 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

  • US FDA 3 Feb 2017 DEMADEX — safety-related labeling change
    Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for torasemide →

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.