Spironolactone

Treats NYHA Class III–IV heart failure and reduced ejection fraction. Sold as Aldactone, Carospir. Every FDA application for this active ingredient: 2 branded and 27 generic.

As of Nov 14, 2026, FDA lists 29 applications for Spironolactone (sold as Aldactone, Carospir), first approved Jan 21, 1960, with 1 new use approved and 0 published complete response letters.

First approved: Jan 21, 1960
Applications: 29
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $83.9M
First approved in the EU: May 26, 2023

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Spironolactone	Part D	$83.4M	+3%	2,639,115
Aldactone	Part D	$347K	-19%	247
Carospir	Part D	$115K	-38%	37

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

SPIRONOLACTONE 100 MG TABLET: $0.164 per unitGeneric · -13% in a year
SPIRONOLACTONE 25 MG TABLET: $0.043 per unitGeneric · -15% in a year
SPIRONOLACTONE 25 MG/5 ML SUSP: $1.85 per MLGeneric · -9% in a year
SPIRONOLACTONE 50 MG TABLET: $0.083 per unitGeneric · -14% in a year
CAROSPIR 25 MG/5 ML SUSPENSION: $3.45 per MLBrand · -2% in a year

Orphan Designations (FDA)

One designation, 0 approved for the designated use; see all orphan designations

Use in pediatric patients with primary hyperaldosteronismCMP Pharma, Inc. · designated May 22, 2014

Approvals in the EU (EMA)

First approved in the EU 760 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Qaialdo, new substanceLipomed GmbH · May 26, 2023

Shortages

FDA's drug shortage list, as of Nov 13, 2026

Shortage	Status	First posted	Updated
Spironolactone Tablet	To Be Discontinued	Dec 10, 2025	Dec 10, 2025

Clinical Trials

57 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Virtual Human Twins as Tools for Personalized Clinical Care in Heart Failure With Preserved Ejection Fraction: a Pilot StudyHeart Failure · Assistance Publique - Hôpitaux de Paris	Not applicable	Not yet recruiting	Oct 28, 2026
Comparing Inclisiran Versus Statin for Primary AldosteronismPrimary Aldosteronism · Third Military Medical University	Not applicable	Recruiting	Oct 21, 2026
This Will be a Randomized Comparison of the Proteomic Effects of Vicadrostat/Empagliflozin Versus Empagliflozin and Versus Empagliflozin/Spironolactone in Heart Failure Patients With Preserved Ejection FractionHeart Failure With Preserved Ejection Fraction (HFPEF) · Baim Institute for Clinical Research	Phase 2	Not yet recruiting	Oct 5, 2026
Efficacy and Safety of Spironolactone in Pediatric Hemodialysis Patients With Anemia.Anemia · Ain Shams University	Phase 2	Not yet recruiting	Jul 20, 2026
SPIRO-First: A Pragmatic Primary Care-Embedded Pilot Trial of Renin-Guided First-Line Antihypertensive TherapyHypertension · Ottawa Hospital Research Institute	Phase 4	Not yet recruiting	Jul 7, 2026
Efficacy and Safety of Finerenone Compared to Spironolactone in Treatment of Primary AldosteronismPrimary Aldosteronism, Endocrine Hypertension · Bangladesh Medical University	Not applicable	Recruiting	Jul 7, 2026
"Exploring the Potential Benefits of Using Dapagliflozin in Cirrhotic Chronic Liver Disease Patients- A Randomized Controlled Trial"Ascites Hepatic · Beni-Suef University	Phase 2 / Phase 3	Recruiting	Jul 6, 2026
LOw DosE Spironolactone, chlorThAlidone oR Combination in CKD TrialHypertension Treated With Antihypertensive Drugs, Chronic Kidney Disease, 3B and 4 · VA Office of Research and Development	Phase 2	Not yet recruiting	Jun 12, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Jan 21, 1960	AldactoneNDA 12151 · New molecular entity	Pfizer	41	Marketed
May 7, 1980	SpironolactoneANDA 87108	Ivax Pharms	0	Discontinued
Jul 10, 1980	SpironolactoneANDA 86809	Chartwell Rx	35	Discontinued
Jan 28, 1981	SpironolactoneANDA 87265	Mutual Pharm	17	Discontinued
Feb 3, 1981	SpironolactoneANDA 87086	Pharmobedient	16	Discontinued
Feb 23, 1981	SpironolactoneANDA 87078	Watson Labs	1	Discontinued
Feb 1, 1982	SpironolactoneANDA 87648	Vangard	2	Discontinued
Jul 23, 1986	SpironolactoneANDA 89424	Sun Pharm Industries	40	Marketed
Jul 29, 1999	SpironolactoneANDA 40353	Actavis Elizabeth	9	Discontinued
Aug 20, 2001	SpironolactoneANDA 40424	Mylan	10	Marketed
Aug 29, 2006	SpironolactoneANDA 40750	Oxford Pharms	8	Marketed
Jul 2, 2010	SpironolactoneANDA 91426	Amneal Pharms	10	Marketed
Mar 6, 2014	SpironolactoneANDA 202187	Aurobindo Pharma	5	Marketed
Apr 23, 2014	SpironolactoneANDA 203253	Jubilant Generics	3	Marketed
Sep 19, 2016	SpironolactoneANDA 203512	Accord Hlthcare	5	Marketed
Aug 4, 2017	CarospirNDA 209478 · New dosage form	Cmp Dev LLC	3	Marketed
Jul 18, 2018	SpironolactoneANDA 205936	Zydus Pharms	3	Marketed
Sep 5, 2023	SpironolactoneANDA 215572	Amneal	0	Marketed
Jan 23, 2025	SpironolactoneANDA 219494	Graviti Pharms	1	Marketed
Feb 21, 2025	SpironolactoneANDA 218085	Hetero Labs Ltd Iii	0	Marketed
Jul 25, 2025	SpironolactoneANDA 217761	Annora Pharma	1	Marketed
—	SpironolactoneANDA 86898	Watson Labs	0	Discontinued
—	SpironolactoneANDA 87554	Upsher Smith	0	Discontinued
—	SpironolactoneANDA 87634	Lederle	2	Discontinued
—	SpironolactoneANDA 87687	Ascot	1	Discontinued
—	SpironolactoneANDA 87952	Warner Chilcott	0	Discontinued
—	SpironolactoneANDA 87998	Purepac Pharm	0	Discontinued
—	SpironolactoneANDA 88053	Purepac Pharm	0	Discontinued
—	SpironolactoneANDA 89364	Superpharm	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA