Is Furosemide registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 14 valid registrations of Furosemide, including DIUSEMIDE 20MG-2ML AMP (10 mg/ml, Solution for injection, SAR 17.70); DIUSEMIDE 40 MG TAB (40 mg, Tablet, SAR 7.00); DROLINA (1 mg/ml, Oral solution, SAR 19.40); DROLINA (40 mg, Tablet, SAR 60.00); DROLINA (20 mg, Tablet, SAR 30.00).

Is Furosemide approved by the US FDA?

Drugs@FDA lists 74 application product lines for Furosemide, including FUROSEMIDE (Prescription); FUROSEMIDE (Prescription); FUROSEMIDE (Prescription); FUROSEMIDE (Prescription); FUROSEMIDE (Prescription).

Is Furosemide authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Furosemide: Bopediat.

Is Furosemide on the WHO Model List of Essential Medicines?

Yes — 16. Diuretics (core list): Anuria or oliguria; Oedema.

Are there safety signals or safety updates for Furosemide?

US FDA: 5 entries (latest 2026-07-23).

Active substance

Furosemide

SFDA 20
US FDA 74
EMA 1
Health Canada 21
US price lines 12
NHS prices 9
WHO EML 2
Safety 5

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
DIUSEMIDE 20MG-2ML AMP	10 mg/ml	Solution for injection · Intravenous use	5 Ampoule	SAR 17.70	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
DIUSEMIDE 40 MG TAB	40 mg	Tablet · Oral use	30 Blister	SAR 7.00	Generic · Prescription	APM	Valid
DROLINA	1 mg/ml	Oral solution · Oral use	1 Bottle	SAR 19.40	Generic · Prescription	ALPHA PHARMA INDUSTRY	Valid
DROLINA	40 mg	Tablet · Oral use	100 Blister	SAR 60.00	Generic · Prescription	ALPHA PHARMA INDUSTRY	Valid
DROLINA	20 mg	Tablet · Oral use	100 Blister	SAR 30.00	Generic · Prescription	ALPHA PHARMA INDUSTRY	Valid
FUSIX 40MG TABLET	40 mg	Tablet · Oral use	30 Blister	SAR 24.65	Generic · Prescription	KUWAIT SAUDI PHARMACEUTICAL INDUSTRIES	Valid
Furosemide PSI 250 mg per 25 ml	10 mg/ml	Solution for injection/infusion · Intramuscular and intravenous use	1 Vial	SAR 18.20	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
LASIX AMP 20MG-2ML	10 mg/ml	Solution for injection · Intravenous use	5 Ampoule	SAR 20.80	NCE · Prescription	sanofi-aventis	Valid
LASIX TAB 40 MG	40 mg	Tablet · Oral use	20 Blister	SAR 20.20	NCE · Prescription	sanofi-aventis	Valid
OEDEMAX	40 mg	Tablet · Oral use	10 Blister	SAR 5.85	Generic · Prescription	MERCKLE	Valid
OEDEMAX	40 mg	Tablet · Oral use	50 Blister	SAR 28.40	Generic · Prescription	MERCKLE	Valid
SALURIN 20MG-2ML AMPOULES	10 mg/ml	Solution for injection · Intravenous use	5 Ampoule	SAR 14.85	Generic · Prescription	Gulf Pharmaceutical Industries (Julphar)	Valid
SALURIN 40 MG TABLETS	40 mg	Tablet · Oral use	20 Blister	SAR 14.15	Generic · Prescription	Gulf Pharmaceutical Industries (Julphar)	Valid
SALURIN 5MG-5ML SYRUP	1 mg/ml	Syrup · Oral use	1 Bottle	SAR 15.25	Generic · Prescription	Gulf Pharmaceutical Industries (Julphar)	Valid
IMPUGAN 10MG-ML INJ 2ML AMP	10 mg/ml	Solution · Intravenous use	10 Ampoule	SAR 8.95	Generic · Prescription	ALPHARMA APS	Withdrawn by MAH · Not Marketed
IMPUGAN TABLETS 40 MG	40 mg	Tablet · Oral use	24 Blister	SAR 7.95	Generic · Prescription	ALPHARMA APS	Withdrawn by MAH · Not Marketed
LASIX AMP 20MG-2ML	10 mg/ml	Solution for injection · Intravenous use	5 Ampoule	SAR 12.95	NCE · Prescription	sanofi-aventis	Withdrawn by MAH · Not Marketed
LASIX INFUSION SOLN 250 MG.	250 mg	Solution for injection · Intravenous use	5 Ampoule	SAR 126.45	Generic · Prescription	sanofi-aventis	Withdrawn by MAH · Not Marketed
LASIX INFUSION SOLN 250 MG.	250 mg	Solution for injection · Intravenous use	5 Ampoule	SAR 91.45	Generic · Prescription	sanofi-aventis	Withdrawn by MAH · Not Marketed
LASIX PAED. LIQUID	1 mg/ml	Solution · Oral use	1 Bottle	SAR 22.85	NCE · Prescription	HOECHST	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ACUTE KIDNEY INJURY (AKI); ANESTHESIA-SUPPORTIVE AGENTS/ CARDIAC ARREST, CARDIOVASCULAR EMERGENCIES AND/OR DYSRHYTHMIAS; CONGESTIVE HEART FAILURE; HYPERKALEMIA; HYPERTENSION; LIVER CIRRHOSIS; PEDIATRIC ACUTE LYMPHOBLASTIC LEUKAEMIA (ALL)-ADVERSE REACTIONS MANAGEMENT; PRE-ECLAMPSIA; PULMONARY ARTERIAL HYPERTENSION

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

Product	Strength	Form · route	Applicant	Status	First approved
FUROSEMIDE	10MG/ML	injectable · injection	HIKMA PHARMS	Prescription	19 May 1981
FUROSEMIDE	40MG; 20MG; 80MG	tablet · oral	EPIC PHARMA LLC	Prescription	19 Oct 1981
FUROSEMIDE	10MG/ML	injectable · injection	HOSPIRA	Prescription	28 May 1982
FUROSEMIDE	20MG; 40MG; 80MG	tablet · oral	ESJAY PHARMA	Prescription	27 Jul 1982
FUROSEMIDE	20MG; 40MG	tablet · oral	HIKMA PHARMS	Prescription	10 Nov 1983
FUROSEMIDE	10MG/ML	injectable · injection	FRESENIUS KABI USA	Prescription	22 May 1984
FUROSEMIDE	80MG	tablet · oral	HIKMA PHARMS	Prescription	24 Jan 1986
FUROSEMIDE	10MG/ML	injectable · injection	ACCORD HLTHCARE	Prescription	15 Dec 1986
FUROSEMIDE	40MG/5ML	solution · oral	HIKMA PHARMS	Prescription	22 Apr 1987
FUROSEMIDE	10MG/ML	solution · oral	HIKMA PHARMS	Prescription	22 Apr 1987
FUROSEMIDE	10MG/ML	injectable · injection	HOSPIRA	Prescription	28 May 1999
FUROSEMIDE	20MG; 40MG; 80MG	tablet · oral	PRINSTON INC	Prescription	26 Mar 2004
FUROSEMIDE	20MG; 40MG; 80MG	tablet · oral	LEADING	Prescription	9 Nov 2005
FUROSEMIDE	20MG; 40MG; 80MG	tablet · oral	IPCA LABS LTD	Prescription	18 Sep 2006
FUROSEMIDE	10MG/ML	injectable · injection	APOTEX	Prescription	22 Mar 2007
FUROSEMIDE	10MG/ML	injectable · injection	BAXTER HLTHCARE CORP	Prescription	27 Jan 2014
FUROSEMIDE	10MG/ML	injectable · injection	AVET LIFESCIENCES	Prescription	26 Aug 2014
FUROSEMIDE	10MG/ML	injectable · injection	EUGIA PHARMA	Prescription	3 May 2019
FUROSEMIDE	10MG/ML	injectable · injection	GLAND	Prescription	1 Jul 2020
FUROSEMIDE	10MG/ML	injectable · injection	AREVA PHARMS	Prescription	18 Dec 2020
FUROSEMIDE	10MG/ML	injectable · injection	SAGENT	Prescription	27 Jan 2021
FUROSEMIDE	10MG/ML	injectable · injection	MEITHEAL	Prescription	27 Jan 2022
FUROSCIX	80MG/10ML (8MG/ML)	solution · subcutaneous	SCPHARMACEUTICALS	Prescription	7 Oct 2022
FUROSCIX READYFLOW (AUTOINJECTOR)	80MG/ML (80MG/ML)	solution · subcutaneous	SCPHARMACEUTICALS	Prescription	7 Oct 2022
FUROSEMIDE	20MG; 40MG; 80MG	tablet · oral	GRAVITI PHARMS	Prescription	17 Oct 2022

49 more — full table

EMA European Union — centrally authorised medicines

Bopediat Proveca Pharma Limited · Authorised · authorised 29 May 2026 · ATC C03CA01

Therapeutic indication (EMA)

Bopediat is indicated in children from birth to less than 18 years of age for the treatment of oedema of cardiac or renal origin, oedema of hepatic origin, and hypertension in patients with chronic kidney disease.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO-FUROSEMIDE	00362166	40 MG	TABLET · ORAL	APOTEX INC
APO-FUROSEMIDE	00396788	20 MG	TABLET · ORAL	APOTEX INC
APO-FUROSEMIDE	00707570	80 MG	TABLET · ORAL	APOTEX INC
FUROSEMIDE INJ USP	00527033	10 MG / ML	LIQUID · INTRAVENOUS; INTRAMUSCULAR	SANDOZ CANADA INCORPORATED
FUROSEMIDE INJECTION SDZ	02382539	10 MG / ML	SOLUTION · INTRAVENOUS; INTRAMUSCULAR	SANDOZ CANADA INCORPORATED
FUROSEMIDE INJECTION USP	02384094	20 MG / 2 ML	SOLUTION · INTRAVENOUS; INTRAMUSCULAR	HIKMA CANADA LIMITED
FUROSEMIDE INJECTION USP	02461404	10 MG / ML	SOLUTION · INTRAVENOUS; INTRAMUSCULAR	STERIMAX INC
FUROSEMIDE INJECTION USP	02480530	10 MG / ML	SOLUTION · INTRAVENOUS; INTRAMUSCULAR	MARCAN PHARMACEUTICALS INC
FUROSEMIDE INJECTION, USP	02535882	10 MG / ML	SOLUTION · INTRAMUSCULAR; INTRAVENOUS	EUGIA PHARMA INC.
FUROSEMIDE SPECIAL INJECTION	02527499	250 MG / 25 ML	SOLUTION · INTRAVENOUS	JAMP PHARMA CORPORATION
LASIX ORAL SOLUTION	02224720	10 MG / ML	SOLUTION · ORAL	SANOFI-AVENTIS CANADA INC
LASIX SPECIAL	02224755	500 MG	TABLET · ORAL	SANOFI-AVENTIS CANADA INC
MINT-FUROSEMIDE	02466759	20 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC
MINT-FUROSEMIDE	02466767	40 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC
MINT-FUROSEMIDE	02466775	80 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC
PRO-FUROSEMIDE	00397792	40 MG	TABLET · ORAL	PRO DOC LIMITEE
PRO-FUROSEMIDE	00496723	20 MG	TABLET · ORAL	PRO DOC LIMITEE
PRO-FUROSEMIDE	00667080	80 MG	TABLET · ORAL	PRO DOC LIMITEE
TEVA-FUROSEMIDE	00337730	20 MG	TABLET · ORAL	TEVA CANADA LIMITED
TEVA-FUROSEMIDE	00337749	40 MG	TABLET · ORAL	TEVA CANADA LIMITED
TEVA-FUROSEMIDE	00765953	80 MG	TABLET · ORAL	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	FUROSEMIDE 1,000 MG/100 ML VL	$0.25253	per ML	23 Sep 2026
US NADAC	FUROSEMIDE 10 MG/ML SOLUTION	$0.09203	per ML	23 Sep 2026
US NADAC	FUROSEMIDE 100 MG/10 ML VIAL	$0.25253	per ML	23 Sep 2026
US NADAC	FUROSEMIDE 20 MG TABLET	$0.02602	per EA	30 Sep 2026
US NADAC	FUROSEMIDE 20 MG/2 ML VIAL	$0.49014	per ML	23 Sep 2026
US NADAC	FUROSEMIDE 40 MG TABLET	$0.0291	per EA	30 Sep 2026
US NADAC	FUROSEMIDE 40 MG/4 ML ORAL SOLUTION CUP	$0.09203	per ML	23 Sep 2026
US NADAC	FUROSEMIDE 40 MG/4 ML VIAL	$0.25253	per ML	23 Sep 2026
US NADAC	FUROSEMIDE 500 MG/50 ML VIAL	$0.49014	per ML	23 Sep 2026
US NADAC	FUROSEMIDE 80 MG TABLET	$0.04982	per EA	30 Sep 2026
US NADAC	LASIX 20 MG TABLET	$0.74852	per EA	23 Sep 2026
US NADAC	LASIX 40 MG TABLET	$1.0493	per EA	23 Sep 2026
NHS Drug Tariff	Furosemide 20mg tablets	£0.64	28 tablet	1 Oct 2026
NHS Drug Tariff	Furosemide 20mg/2ml solution for injection ampoules	£13.20	10 ampoule	1 Oct 2026
NHS Drug Tariff	Furosemide 20mg/5ml oral solution sugar free	£13.53	150 ml	1 Oct 2026
NHS Drug Tariff	Furosemide 250mg/25ml solution for injection ampoules	£40.00	10 ampoule	1 Oct 2026
NHS Drug Tariff	Furosemide 40mg tablets	£0.84	28 tablet	1 Oct 2026
NHS Drug Tariff	Furosemide 40mg/5ml oral solution sugar free	£15.71	150 ml	1 Oct 2026
NHS Drug Tariff	Furosemide 500mg tablets	£18.08	28 tablet	1 Oct 2026
NHS Drug Tariff	Furosemide 50mg/5ml oral solution sugar free	£16.58	150 ml	1 Oct 2026
NHS Drug Tariff	Furosemide 50mg/5ml solution for injection ampoules	£15.40	10 ampoule	1 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
Anuria or oliguria; Oedema
Parenteral > General injections > IV: 10 mg per mL in 2 mL ampoule; 10 mg per mL in 5 mL ampoule | Oral > Liquid: 20 mg per 5 mL (EMLc); 50 mg per 5 mL (EMLc) | Oral > Solid > tablet: 40 mg; 20 mg
12.4. Medicines used in heart failure · core
Heart failure
Parenteral > General injections > IV: 10 mg per mL in 2 mL ampoule; 10 mg per mL in 5 mL ampoule | Oral > Liquid: 20 mg per 5 mL (EMLc); 50 mg per 5 mL (EMLc) | Oral > Solid > tablet: 40 mg; 20 mg

Safety signals and safety-related labeling changes

US FDA 23 Jul 2026 FUROSCIX — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 23 Feb 2023 FUROSEMIDE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 31 Aug 2022 FUROSEMIDE — 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
US FDA 14 Jul 2017 FUROSEMIDE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Drug Interactions
US FDA 8 Mar 2016 FUROSEMIDE — safety-related labeling change
Labeling sections changed: Drug Interactions

All safety entries for furosemide →

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.