Bumetanide

Generic Name: Bumetanide

Brand Names: Bumex, Burinex

Drug Type: Small Molecule

Chemical Formula: C_₁₇H_₂₀N_₂O_₅S

CAS Number: 28395-03-1

Unique Ingredient Identifier: 0Y2S3XUQ5H

Overview

Bumetanide is a sulfamyl diuretic.

Indication

For the treatment of edema associated with congestive heart failure, hepatic and renal disease including the nephrotic syndrome.

Associated Conditions

Edema

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Efficacy of Bumetanide in Children With Autism Spectrum Disorder Guided by Peripheral Blood Biomarkers and Machine Learning Models	2025/06/05	NCT07005414	Phase 2	Recruiting	Fei Li
Bumetanide vs. Furosemide in Cirrhosis	2025/04/23	NCT06941415	Phase 3	Not yet recruiting	Stacy Johnson
Efficacy of Bumetanide to Improve Cognitive Functions in Down Syndrome	2024/06/20	NCT06465823	Phase 2	Recruiting	Stefano Vicari
Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts	2024/01/23	NCT06218199	Phase 4	Recruiting	Heart Center Research, LLC
Bumetanide in Patients With Alzheimer's Disease	2023/09/25	NCT06052163	Phase 2	Recruiting	Stanford University
A Study of Ultra High Dose Diuretics to Treat Heart Failure	2023/09/14	NCT06036914	Phase 2	Completed	Mayo Clinic
Diuretic Treatment in Acute Heart Failure With Volume Overload Guided by Serial Spot Urine Sodium Assessment	2022/06/09	NCT05411991	Phase 4	Completed	Vrije Universiteit Brussel
Mechanisms of Diuretic Resistance in Heart Failure, Aim 1	2022/04/12	NCT05323487	Phase 1	Recruiting	Yale University
Role of Bumetanide in Treatment of Autism	2021/02/23	NCT04766177	Phase 3	Recruiting	Sherief Abd-Elsalam
Polydiuretic Therapy for Heart Failure With Preserved Ejection Fraction and Diabetes Mellitus	2021/01/06	NCT04697485	Phase 4	Withdrawn	Northwestern University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
bumetanide	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	14539-702	ORAL	2 mg in 1 1	9/21/2020
Bumetanide	Major Pharmaceuticals	0904-7016	ORAL	1 mg in 1 1	6/4/2021
Bumetanide	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8393	ORAL	1 mg in 1 1	8/9/2023
Bumetanide	Upsher-Smith Laboratories, LLC	0832-0540	ORAL	0.5 mg in 1 1	10/12/2018
Bumetanide	A-S Medication Solutions	50090-6345	ORAL	1 mg in 1 1	9/5/2018
Bumetanide	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8394	ORAL	2 mg in 1 1	8/9/2023
Bumetanide	Amneal Pharmaceuticals NY LLC	69238-1489	ORAL	0.5 mg in 1 1	12/29/2023
Bumetanide	Athenex Pharmaceutical Division, LLC.	70860-405	INTRAVENOUS, INTRAMUSCULAR	0.25 mg in 1 mL	3/2/2024
Bumetanide	Cardinal Health 107, LLC	55154-3572	ORAL	1 mg in 1 1	3/21/2022
bumetanide	Zydus Lifesciences Limited	70771-1026	ORAL	2 mg in 1 1	12/5/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
BURINEX TABLET 1 mg	allphamed PHARBIL Arzneimittel GmbH	SIN00718P	TABLET	1 mg	5/3/1988
BURINEX INJECTION 0.5 mg/ml	CENEXI	SIN01421P	INJECTION	0.5 mg/ml	5/20/1988

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
Burinex 1mg tablet blister pack	51734	AFT Pharmaceuticals Pty Ltd	Medicine	A	3/17/1995
BUMETANIDE 5 mg tablet bulk (AF)	75390	Alphapharm Pty Ltd	Medicine	A	7/19/2000
BUMETANIDE 1mg tablet bulk (AF)	75391	Alphapharm Pty Ltd	Medicine	A	7/19/2000

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
BURINEX - TAB 2MG	LEO Pharma Inc	02176076	Tablet - Oral	2 MG	12/31/1996
BURINEX	karo pharma ab	00728276	Tablet - Oral	5 MG	12/31/1993
BURINEX	karo pharma ab	00728284	Tablet - Oral	1 MG	12/31/1993

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
FORDIURAN 1 mg COMPRIMIDOS	Karo Pharma Ab	52047	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

FDA Accepts Corstasis Therapeutics' Bumetanide Nasal Spray NDA for Review

7 months ago

The FDA has accepted Corstasis Therapeutics' New Drug Application (NDA) for Bumetanide Nasal Spray (RSQ-777) for treating edema in heart failure, liver, and kidney disease.

Lupin Receives FDA Approval for Generic Bumetanide Injection

a year ago

Lupin has secured FDA approval for its bumetanide injection, available in single and multiple-dose vials, offering a generic alternative to Validus Pharmaceuticals' Bumex.

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