TheraRadar
Data updated: Jun 17, 2026

FUROSEMIDE

Cardiovascular Approved 1979-01-10

Edema Furosemide tablets are indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide tablets are particularly useful when an agent with greater diuretic potential is desired. Hypertension Oral furosemide may be used in adults for the treatment of hypertension alone or in combination with other antihypertensive agents.

Source: FDA Label • Sun Pharma
Jump to: Indications Approvals Trials Competitors Safety Patents
49
Indications
--
Phase 3 Trials
47
Years on Market

Details

Status
Discontinued
First Approved
1979-01-10
Routes
ORAL, INJECTION
Dosage Forms
TABLET, INJECTABLE, SOLUTION

Companies

Sun Pharma GLAND EPIC PHARMA LLC Fresenius Kabi MICRO LABS ACCORD HLTHCARE WATSON LABS ANI PHARMS Pfizer Hikma AMNEAL PHARMS SABA ILAC SANAYIVE SMITH AND NEPHEW WATSON LABS TEVA MEITHEAL ASPIRO PHARMOBEDIENT CNSLTG PHARMOBEDIENT PRINSTON INC WARNER CHILCOTT LLC KALAPHARM Baxter MANKIND PHARMA Aurobindo Pharma LEADING INTL MEDICATION AM REGENT AVET LIFESCIENCES AstraZeneca MARSAM PHARMS LLC Apotex CHARTWELL RX ESJAY PHARMA ABRAXIS PHARM EUGIA PHARMA SAGENT GRAVITI PHARMS IPCA LABS LTD SUPERPHARM AREVA PHARMS IGI LABS INC
Active Ingredient: FUROSEMIDE

FUROSEMIDE Approval History

1980
1981
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1986
1987
1988
1989
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2026
Original
New Indication
New Form
Label Update
866 FDA actions from 1979 to 2026
Jun 2026 SUPPL
Label · Labeling
FDA Letter
Jan 2026 ORIGINAL
Update
Sep 2025 SUPPL
Label · Labeling

What FUROSEMIDE Treats

49 FDA approvals

Originally approved for its first indication in 1979 . Covers 49 distinct patient populations.

  • Other (49)

Sun Pharma's other novel FDA approvals

Other CDER-designated drugs from the same sponsor (2016–2025).

LEQSELVI
2024
DEURUXOLITINIB PHOSPHATE
1 designation
WINLEVI
2020
CLASCOTERONE
1 designation
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Clinical Trial Registry

72 trials
Trial Sponsor ID Phase Status Title
NCT05915286 DIURESED Pro00119451 Ph 4 terminated Diuretic Use in Hemodialysis Patients With Residual Renal Function
NCT06941415 BUFF IRB_00186841 Ph 3 recruiting Bumetanide vs. Furosemide in Cirrhosis
NCT05470283 2022-0356 NCI-2022-06873 Ph 1 active not recruiting Phase I, Open-Label, Study of Tumor Infiltrating Lymphocytes Engineered With Membrane Bound IL15 Plus Acetazolamide in Adult Patients With Metastatic Melanoma
NCT06899061 D9723C00002 2024-513692-41-00 Ph 1 active not recruiting Modular Clinical Pharmacology Study to Evaluate the Drug-drug Interaction Potential and Relative Bioavailability of Saruparib
NCT07431866 2828-005 Ph 1 active not recruiting A Clinical Study of the Effect of MK-2828 on Rosuvastatin or Furosemide in Healthy People (MK-2828-005)
NCT03892148 ProDUCT-HF CHU-428 2018-A02971-54 Ph 4 completed Protocol of Diuretics Use in Congestive Therapy in Heart Failure
NCT06036914 results posted 23-005262 Ph 2 completed A Study of Ultra High Dose Diuretics to Treat Heart Failure
NCT06504862 results posted 1479-0015 2024-510628-38-00, U1111-1302-1171 Ph 1 completed A Study in Healthy Men to Test Whether Zongertinib Influences the Amount of 4 Other Medicines (Dabigatran, Rosuvastatin, Metformin, and Furosemide) in the Blood
NCT04481789 results posted MT-1186-J02 Ph 1 completed Clinical Pharmacology Study of Oral Edaravone in Healthy Adult Males (Drug Interaction Study and Preliminary Regimen-Finding Study)
NCT05779943 results posted STUDY00004720 RAD5689-22-BED-IIT-439, STUDY00004720 Ph 2 active not recruiting Comparison of 18F-rhPSMA-7.3 PET/CT With and Without Furosemide in Biochemical Recurrence of Prostate Cancer
NCT03296813 TRANSFORM-HF results posted Pro00080595 U01HL125511-01A1 Ph 3 completed TRANSFORM-HF: ToRsemide compArisoN With furoSemide FORManagement of Heart Failure
NCT07173738 BIA-51058-111 2017-002807-93 Ph 1 completed Pharmacokinetics, Safety and Tolerability of Concurrent Doses of BIA 5-1058 and Furosemide
NCT05986773 P-Value-AHF P-Value-AHF Ph 4 terminated Diuretic Strategies in Acute Heart Failure Patients at High Risk for Diuretic Resistance
NCT04180397 GODIF GODIF 2024-512186-14-00, 2019-004292-40 Ph 4 recruiting Controlled Fluid Removal in Critical Ill Patients With Fluid Overload in the Intensive Care Unit.
NCT05079789 AMILOR results posted AmiloridNS-01 2019-002607-18 Ph 3 terminated Amiloride in Nephrotic Syndrome
NCT04752475 LAPP results posted AAAT2525 Ph 3 completed Lasix for the Prevention of De Novo Postpartum Hypertension
NCT05981365 results posted GBT440-0122 C5341029 Ph 1 completed Voxelotor CYP and Transporter Cocktail Interaction Study
NCT05093621 TFO results posted 2000029589 Ph 3 completed Torsemide Comparison With Furosemide for Management of Patients With Stable Heart Failure
NCT02163655 DIUPRE DIUPRE DIUPRE Ph 4 completed Diuretics for Postpartum High Blood Pressure in Preeclampsia
NCT04615624 results posted 2020-003 Ph 3 completed Furosemide vs. Placebo for Severe Antepartum Hypertension
NCT06218199 DART-HA Dart-HA Ph 4 recruiting Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts
NCT02574845 results posted 352.2094 2015-003052-46 Ph 1 completed DDI (Effect of Metformin and Furosemide on Rosuvastatin PK)
NCT02854527 results posted 352.2096 2016-001893-14 Ph 1 completed Transporter Cocktail Mutual Interaction
NCT03307252 results posted 0352-2100 2017-001549-29 Ph 1 completed This Study Tests the Effect of Certain Medicines on the Transport of Other Medicines in the Body of Healthy Men
NCT02231931 352.2082 2014-001940-40 Ph 1 completed Drug-drug Interaction Between Digoxin, Furosemide, Metformin, and Rosuvastatin
NCT04343235 results posted 06784 Ph 4 terminated Postpartum Management of Gestational Hypertensive Disorders Using Furosemide
NCT05620784 STU00217795 Ph 3 recruiting Intra-operative Loop Diuretics to Improve Same-day Discharge Rates After HoLEP
NCT03362515 results posted 17D.264 Ph 2 terminated Treatment of Post-Operative Sinonasal Polyposis With Topical Furosemide
NCT05768360 D5084C00014 2022-003785-21 Ph 1 completed A Study to Assess the Effects of Savolitinib on the Pharmacokinetics of Digoxin, Rosuvastatin, Metformin, and Furosemide in Healthy Male Subjects
NCT05158153 ORKID results posted 21-33602 Ph 4 terminated Outpatient Recovery From Acute Kidney Injury Requiring Dialysis
NCT02450773 201501157 Ph 2 withdrawn Prevention of Severe Postpartum Hypertension
NCT05840536 COMBIND-HF OchsnerHS Ph 4 withdrawn Combination Diuretic Therapy for Acute Decompensated Heart Failure
NCT01156220 IPT0901 Ph 4 withdrawn Investigation of Gender Specificity of the Effects of Furosemide in Healthy Female and Male Volunteers
NCT04763226 CV021-004 Ph 1 completed A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986308 in Healthy Participants
NCT03901729 AVANTI 17909 2018-004059-18 Ph 2 completed A Trial to Study BAY1753011 in Patients With Congestive Heart Failure
NCT02345681 IRIHS-REA RC14_0268 Ph 3 completed Impact of Rational Control of Fluid Balance in the Intensive Care Unit
NCT03730961 results posted CV013-034 2018-000970-31 Ph 2 completed An Investigational Study of Continuous 8-Hour Intravenous Administrations of BMS-986231 in Participants With Heart Failure and Reduced Heart Function Given a Standard Dose of Loop Diuretic
NCT04691687 OUTLAST 307139 307139 Ph 4 completed OUTpatient Intravenous LASix Trial in Reducing Hospitalization for Acute Decompensated Heart Failure
NCT03731117 FURTHER P170404J Ph 4 terminated FURosemide Stress Test to Predict Need of Renal Replacement THERapy in Ischemic Acute Tubular Necrosis in ICU
NCT04628325 UPalermo Ph 3 completed Effects of Furosemide Plus Small HSS in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF)
NCT02531581 14-AOI-11 Ph 4 completed Diuretic Vascular Filling in the Initial Management of Acute PE With Right Ventricular Dysfunction Normotensive
NCT02183792 AQUA-AHF results posted HS-13-00705 Ph 4 completed Aquaresis Utility for Hyponatremic Acute Heart Failure Study
NCT02960412 Pro00026976 Ph 4 completed Effect of Furosemide on Confirmation of Ureteral Patency During Routine Cystoscopy
NCT03801759 AKB-6548-CI-0031 Ph 1 completed Drug-Drug Interaction Study of Vadadustat With Digoxin, Adefovir and Furosemide
NCT02877095 SUBQ-Pilot results posted Pro00070399 Ph 1 completed Subcutaneous Furosemide in Acute Decompensated Heart Failure Pilot
NCT02767024 PRIORITY-ADHF 2014-3586 Ph 4 withdrawn Intravenous Vasodilator vs. Inotropic Therapy in Patients With Heart Failure
NCT01558674 results posted 7145-011 Ph 1 terminated A Study of MK-7145 in Participants With Renal Insufficiency (Part I) and Heart Failure With Renal Insufficiency (Part II) (MK-7145-011)
NCT01901809 ROPA-DOP results posted NA 00083629 Ph 4 completed Diuretics and Dopamine in Heart Failure With Preserved Ejection Fraction
NCT02351934 results posted 14-008292 UL1TR000135 Ph 4 completed Early Diuresis Following Colorectal Surgery
NCT02524054 results posted 2011P000027 R01NR012009 Ph 1, Ph 2 completed Aerosol Inhalation Treatment for Dyspnea - Patients

Showing 50 of 72 trials

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

FUROSEMIDE FDA Label Details

Indications & Usage

FDA Label (PDF)

Edema Furosemide tablets are indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide tablets are particularly useful when an agent with greater diuretic potential is desired. Hypertension Oral furosemide may be used in adults for the treatment of hypertension alone or in combination with other antihypertensive agents. Hypertensive patients who cannot be adequately controlled with thiazides will probably also not be adequately controlled with furosemide...

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Full clinical data, patents, trials, and competitive landscape for furosemide.

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Data Sources

FDA Approval: NDA018790 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.