Overview

Spironolactone is a potassium-sparing diuretic. It binds to mineralocorticoid receptors and functions as aldosterone antagonists. It promotes sodium and water excretion and potassium retention. Spironolactone was originally developed purely for this ability before other pharmacodynamic properties of the drug were discovered. It is indicated to treat several conditions, including heart failure, edema, hyperaldosteronism, and hypertension. Off-label uses of spironolactone include hirsutism, female pattern hair loss, and adult acne vulgaris. Spironolactone was developed in 1957, marketed in 1959, and approved by the FDA on January 21, 1960.

Indication

Spironolactone is indicated for the treatment of the following conditions: As spironolactone has antiandrogenic activity, its off-label uses include the treatment of hirsutism, female pattern hair loss, and adult acne vulgaris.

Associated Conditions

Edema
Hypertension
Primary Aldosteronism
Primary Hyperaldosteronism
Secondary hyperaldosteronism
Chronic heart failure with reduced ejection fraction (NYHA Class III)
Chronic heart failure with reduced ejection fraction (NYHA Class IV)
Idiopathic hyperaldosteronism
Refractory Edema

Research Report

Published: Jul 23, 2025

A Comprehensive Monograph on Spironolactone (DB00421): From Aldosterone Antagonism to Anti-androgen Therapy

1.0 Introduction and Drug Profile

1.1 Overview of Spironolactone

Spironolactone is a synthetic 17-spironolactone corticosteroid that has occupied a unique and expanding role in therapeutics for over six decades.[1] Developed in 1957 and receiving its initial approval from the U.S. Food and Drug Administration (FDA) in 1960, its clinical journey began as a potassium-sparing diuretic for the management of hypertension and edematous states.[2] However, its multifaceted pharmacological profile has since established it as a cornerstone therapy in a diverse range of medical specialties. The drug is fundamentally characterized by a dual identity: it functions as a potent, competitive antagonist of the mineralocorticoid receptor (MR), thereby blocking the effects of aldosterone, and as a nonselective hormonal agent with clinically significant anti-androgenic properties.[5]

Continue reading the full research report

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Efficacy of Spironolactone Combined With Antihypertensive Drugs in Patients With Primary Aldosteronism	2025/08/22	NCT07137364	N/A	Recruiting	Third Military Medical University
Spironolactone to Improve Pregnancy-Associated Hypertension Trajectories	2025/06/27	NCT07041281	Not Applicable	Not yet recruiting	Massachusetts General Hospital
The Role of Skin Sodium Accumulation in Chronic Kidney Disease	2025/06/13	NCT07020104	Not Applicable	Recruiting	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Gender-Based Differences in Heart Failure Hospitalizations Among Patients With Heart Failure Treated With Spironolactone	2024/10/15	NCT06641284	N/A	Completed	Ahmad Abdullah Salawi
Bioequivalence Study of Spironolactone Tablets in Healthy Subjects	2024/08/30	NCT06579053	Phase 1	Completed	SPH Sine Pharmaceutical Laboratories Co., Ltd.
Finerenone for Patients With Primary Aldosteronism (FAIRY)	2024/06/13	NCT06457074	Phase 4	Recruiting	Qifu Li
Pharmacogenetics of Torasemide and Spironolactone in Hypertension Treatment	2024/05/14	NCT06413082	Phase 3	Completed	Ospedale San Raffaele
Optimal Medical Treatment of Difficult-to-treat Hypertension	2024/02/23	NCT06275763	Phase 4	Recruiting	National Institute of Cardiology, Warsaw, Poland
SPironolactONe for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation	2024/01/12	NCT06204640	Phase 3	Not yet recruiting	University Hospital, Caen
Efficacy and Safety of Finerenone vs. Spironolactone in Patients With Primary Aldosteronism	2023/12/11	NCT06164379	Phase 4	Not yet recruiting	Shanghai Jiao Tong University School of Medicine

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
SPIRONOLACTONE	NuCare Pharmaceuticals,Inc.	68071-2977	ORAL	100 mg in 1 1	4/17/2023
Spironolactone	Direct_Rx	72189-497	ORAL	25 mg in 1 1	7/6/2023
Spironolactone	Aidarex Pharmaceuticals LLC	33261-895	ORAL	50 mg in 1 1	2/2/2014
Spironolactone	Preferred Pharmaceuticals Inc.	68788-8452	ORAL	50 mg in 1 1	5/30/2023
Spironolactone	REMEDYREPACK INC.	70518-3625	ORAL	25 mg in 1 1	3/26/2024
SPIRONOLACTONE	NorthStar Rx LLC	72603-136	ORAL	100 mg in 1 1	9/27/2023
Spironolactone	NorthStar RxLLC	16714-639	ORAL	100 mg in 1 1	11/25/2022
Spironolactone	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	70934-368	ORAL	50 mg in 1 1	6/3/2020
SPIRONOLACTONE	Padagis US LLC	0574-1133	ORAL	25 mg in 5 mL	8/31/2023
Spironolactone	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8178	ORAL	25 mg in 1 1	1/25/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Qaialdo	Nova Laboratories Ireland Limited,3rd Floor, Ulysses House,Foley Street,Dublin 1, D01 W2T2,Ireland	Authorised	5/26/2023
Qaialdo	Nova Laboratories Ireland Limited,3rd Floor, Ulysses House,Foley Street,Dublin 1, D01 W2T2,Ireland	Authorised	5/26/2023

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
SPIRIDON TABLETS 50MG	Orion Corporation, Orion Pharma (primary and secondary packager), Orion Corporation, Orion Pharma	SIN16710P	TABLET	50.0mg	2/23/2023
URACTONUM TABLET 25 mg	MEDOCHEMIE LTD	SIN00664P	TABLET	25 mg	5/3/1988
SPIRIDON TABLETS 25MG	Orion Corporation, Orion Pharma (primary and secondary packager), Orion Corporation, Orion Pharma	SIN16711P	TABLET	25.0mg	2/23/2023
SPIROLON 100 TABLET 100 mg	REMEDICA LTD	SIN02168P	TABLET, FILM COATED	100 mg	6/27/1988
SPIRIDON TABLETS 100MG	Orion Corporation, Orion Pharma (primary and secondary packager), Orion Corporation, Orion Pharma	SIN16709P	TABLET	100.0mg	2/23/2023
SPIROLON 25 TABLET 25 mg	REMEDICA LTD	SIN02153P	TABLET, FILM COATED	25 mg	6/27/1988
ALDACTONE TABLET 25 mg	Piramal Healthcare UK Limited	SIN02222P	TABLET	25 mg	6/29/1988

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
Aldactone 25mg tablet blister pack	68953	Pfizer Australia Pty Ltd	Medicine	A	5/28/1999
Spironolactone and Hydrochlorothiazide Tablets USP 25 mg / 25 mg Bottle	401190	Alphapharm Pty Ltd	Medicine	A	12/18/2022
Spironolactone Tablets USP 25mg	400797	Alphapharm Pty Ltd	Medicine	A	12/8/2022
Aldazide tablets	33606	Proqualix Pty Ltd - in Administration	Medicine	A	11/7/1991
SPIRONOLACTONE VIATRIS 25 spironolactone 25 mg tablet bottle	338091	Alphapharm Pty Ltd	Medicine	A	8/19/2020
ALDACTONE TABLETS	24273	Proqualix Pty Ltd - in Administration	Medicine	A	10/9/1991
SPIRONOLACTONE VIATRIS 100 spironolactone100 mg tablet bottle	338092	Alphapharm Pty Ltd	Medicine	A	8/19/2020
Aldactone 100mg tablet blister pack	68954	Pfizer Australia Pty Ltd	Medicine	A	5/28/1999
SPIRACTIN 100 spironolactone 100mg tablets	46691	Alphapharm Pty Ltd	Medicine	A	10/14/1993
SPIRACTIN 25 spironolactone 25mg tablets	46689	Alphapharm Pty Ltd	Medicine	A	10/14/1993

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
ALDACTONE 25 MG	Pfizer Canada Ulc	00028606	Tablet - Oral	25 MG	12/31/1959
ALDACTAZIDE 50	Pfizer Canada Ulc	00594377	Tablet - Oral	50 MG	12/31/1983
ALDACTAZIDE 25	Pfizer Canada Ulc	00180408	Tablet - Oral	25 MG	12/31/1960
MINT-SPIRONOLACTONE	mint pharmaceuticals inc	02488159	Tablet - Oral	100 MG	2/6/2020
TEVA-SPIRONOLACTONE/HCTZ	teva canada limited	00657182	Tablet - Oral	50 MG	12/31/1986
MINT-SPIRONOLACTONE	mint pharmaceuticals inc	02488140	Tablet - Oral	25 MG	2/6/2020
JAMP SPIRONOLACTONE	Jamp Pharma Corporation	02518848	Tablet - Oral	100 MG	7/14/2022
ALDACTONE 100 MG	Pfizer Canada Ulc	00285455	Tablet - Oral	100 MG	12/31/1975
TEVA-SPIRONOLACTONE	teva canada limited	00613215	Tablet - Oral	25 MG	12/31/1984
TEVA-SPIRONOLACTONE/HCTZ	teva canada limited	00613231	Tablet - Oral	25 MG	12/31/1984

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
ESPIRONOLACTONA ORION 50 MG COMPRIMIDOS EFG	Orion Corporation	88190	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Not Commercialized
ESPIRONOLACTONA ACCORD 100 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Accord Healthcare S.L.U.	81033	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Commercialized
ESPIRONOLACTONA ORION 100 MG COMPRIMIDOS EFG	Orion Corporation	88191	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Commercialized
ALDOLEO 50 MG/50 MG COMPRIMIDOS	Teofarma S.R.L.	40215	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Commercialized
ESPIRONOLACTONA ALTER 100 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Laboratorios Alter S.A.	63833	COMPRIMIDO RECUBIERTO	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Commercialized
ALDACTONE 100 mg COMPRIMIDOS RECUBIERTOS CON PELICULA	Pfizer S.L.	54900	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Commercialized
ALDACTONE 25 mg COMPRIMIDOS RECUBIERTOS CON PELICULA	Pfizer S.L.	39059	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Commercialized
ESPIRONOLACTONA ORION 25 MG COMPRIMIDOS EFG	Orion Corporation	88189	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Commercialized
ESPIRONOLACTONA ALTER 25 mg COMPRIMIDOS RECUBIERTOS EFG	Laboratorios Alter S.A.	63835	COMPRIMIDO RECUBIERTO	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Commercialized
ALDACTACINE 25 mg/15 mg COMPRIMIDOS	Pfizer S.L.	53308	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	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.

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