Is Spironolactone registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 5 valid registrations of Spironolactone, including ALDACTONE TAB (100 mg, Tablet, SAR 25.05); ALDACTONE TAB (25 mg, Tablet, SAR 18.00); NORACTONE (25 mg, Tablet, SAR 9.05); Spironolactone Amarox (5 mg/ml, Oral suspension, SAR 605.00).

Is Spironolactone approved by the US FDA?

Drugs@FDA lists 29 application product lines for Spironolactone, including ALDACTONE (Prescription); SPIRONOLACTONE (Prescription); SPIRONOLACTONE (Prescription); SPIRONOLACTONE (Prescription); SPIRONOLACTONE (Prescription).

Is Spironolactone authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Spironolactone: Qaialdo.

Is Spironolactone on the WHO Model List of Essential Medicines?

Yes — 16. Diuretics (core (EML); complementary (EMLc) list): Oedema; Ascites.

Are there safety signals or safety updates for Spironolactone?

US FDA: 3 entries (latest 2025-11-14).

Active substance

Spironolactone

SFDA 9
US FDA 29
EMA 1
Health Canada 6
US price lines 6
NHS prices 4
WHO EML 2
Safety 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ALDACTONE TAB	100 mg	Tablet · Oral use	10 Blister	SAR 25.05	NCE · Prescription	Pfizer Limited	Valid
ALDACTONE TAB	25 mg	Tablet · Oral use	20 Blister	SAR 18.00	NCE · Prescription	Pfizer Limited	Valid
NORACTONE	25 mg	Tablet · Oral use	30 Blister	SAR 9.05	Generic · Prescription	The Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM)	Valid
NORACTONE	25 mg	Tablet · Oral use	1000 Blister	SAR 207.90	Generic · Prescription	The Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM)	Valid
Spironolactone Amarox	5 mg/ml	Oral suspension · Oral use	1 Bottle	SAR 605.00	Generic · Prescription	Saudi Amarox	Valid
ALDACTONE TAB	25 mg	Tablet · Oral use	20 Blister	SAR 18.00	NCE · Prescription	G.D.SEARLE	Withdrawn by MAH · Not Marketed
ALDACTONE TAB	100 mg	Tablet · Oral use	10 Blister	SAR 25.05	NCE · Prescription	G.D.SEARLE	Withdrawn by MAH · Not Marketed
SPIROCTAN TAB 25MG	25 mg	Tablet · Oral use	20 Blister	SAR 19.60	Generic · Prescription	ROCHE DIAGNOSTICS	Withdrawn by MAH · Not Marketed
SPIROCTAN TAB 50MG	50 mg	Tablet · Oral use	20 Blister	SAR 22.45	Generic · Prescription	ROCHE DIAGNOSTICS	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

CARDIOMYOPATHY; CHRONIC KIDNEY DISEASE; CONGESTIVE HEART FAILURE; HYPERTENSION; LIVER CIRRHOSIS; MENSTRUAL DISORDERS; PRIMARY ALDOSTERONISM; PULMONARY ARTERIAL HYPERTENSION

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

Product	Strength	Form · route	Applicant	Status	First approved
ALDACTONE	50MG; 25MG; 100MG	tablet · oral	PFIZER	Prescription	21 Jan 1960
SPIRONOLACTONE	25MG; 50MG; 100MG	tablet · oral	SUN PHARM INDUSTRIES	Prescription	23 Jul 1986
SPIRONOLACTONE	25MG; 50MG; 100MG	tablet · oral	MYLAN	Prescription	20 Aug 2001
SPIRONOLACTONE	25MG; 50MG; 100MG	tablet · oral	OXFORD PHARMS	Prescription	29 Aug 2006
SPIRONOLACTONE	25MG; 50MG; 100MG	tablet · oral	AMNEAL PHARMS	Prescription	2 Jul 2010
SPIRONOLACTONE	25MG; 50MG; 100MG	tablet · oral	AUROBINDO PHARMA	Prescription	6 Mar 2014
SPIRONOLACTONE	25MG; 50MG; 100MG	tablet · oral	JUBILANT GENERICS	Prescription	23 Apr 2014
SPIRONOLACTONE	25MG; 50MG; 100MG	tablet · oral	ACCORD HLTHCARE	Prescription	19 Sep 2016
CAROSPIR	25MG/5ML	suspension · oral	CMP DEV LLC	Prescription	4 Aug 2017
SPIRONOLACTONE	25MG; 50MG; 100MG	tablet · oral	ZYDUS PHARMS	Prescription	18 Jul 2018
SPIRONOLACTONE	25MG/5ML	suspension · oral	AMNEAL	Prescription	5 Sep 2023
SPIRONOLACTONE	25MG; 50MG; 100MG	tablet · oral	GRAVITI PHARMS	Prescription	23 Jan 2025
SPIRONOLACTONE	25MG/5ML	suspension · oral	HETERO LABS LTD III	Prescription	21 Feb 2025
SPIRONOLACTONE	25MG; 50MG; 100MG	tablet · oral	ANNORA PHARMA	Prescription	25 Jul 2025
SPIRONOLACTONE	25MG	tablet · oral	IVAX PHARMS	Discontinued	7 May 1980
SPIRONOLACTONE	25MG	tablet · oral	CHARTWELL RX	Discontinued	10 Jul 1980
SPIRONOLACTONE	25MG	tablet · oral	MUTUAL PHARM	Discontinued	28 Jan 1981
SPIRONOLACTONE	25MG	tablet · oral	PHARMOBEDIENT	Discontinued	3 Feb 1981
SPIRONOLACTONE	25MG	tablet · oral	WATSON LABS	Discontinued	23 Feb 1981
SPIRONOLACTONE	25MG	tablet · oral	VANGARD	Discontinued	1 Feb 1982
SPIRONOLACTONE	50MG; 100MG; 25MG	tablet · oral	ACTAVIS ELIZABETH	Discontinued	29 Jul 1999
SPIRONOLACTONE	25MG	tablet · oral	WATSON LABS	Discontinued
SPIRONOLACTONE	25MG	tablet · oral	UPSHER SMITH	Discontinued
SPIRONOLACTONE	25MG	tablet · oral	LEDERLE	Discontinued
SPIRONOLACTONE	25MG	tablet · oral	ASCOT	Discontinued

4 more — full table

EMA European Union — centrally authorised medicines

Qaialdo Lipomed GmbH · Authorised · authorised 26 May 2023 · ATC C03DA01

Therapeutic indication (EMA)

In the management of refractory oedema associated with congestive cardiac failure; hepatic cirrhosis with ascites and oedema, malignant ascites, nephrotic syndrome, diagnosis and treatment of primary aldosteronism, essential hypertension. Neonates, children and adolescents should only be treated under guidance of a paediatric specialist (see sections 5.1 and 5.2).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
JAMP SPIRONOLACTONE	02518821	25 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP SPIRONOLACTONE	02518848	100 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
MINT-SPIRONOLACTONE	02488140	25 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC
MINT-SPIRONOLACTONE	02488159	100 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC
TEVA-SPIRONOLACTONE	00613215	25 MG	TABLET · ORAL	TEVA CANADA LIMITED
TEVA-SPIRONOLACTONE	00613223	100 MG	TABLET · ORAL	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	CAROSPIR 25 MG/5 ML SUSPENSION	$3.45207	per ML	23 Sep 2026
US NADAC	SPIRONOLACTONE 100 MG TABLET	$0.16783	per EA	23 Sep 2026
US NADAC	SPIRONOLACTONE 25 MG TABLET	$0.04264	per EA	23 Sep 2026
US NADAC	SPIRONOLACTONE 25 MG/5 ML SUSP	$1.61922	per ML	23 Sep 2026
US NADAC	SPIRONOLACTONE 25 MG/5 ML SUSP	$1.81187	per ML	23 Sep 2026
US NADAC	SPIRONOLACTONE 50 MG TABLET	$0.08319	per EA	23 Sep 2026
NHS Drug Tariff	Spironolactone 100mg tablets	£1.86	28 tablet	1 Oct 2026
NHS Drug Tariff	Spironolactone 12.5mg tablets	£24.12	28 tablet	1 Oct 2026
NHS Drug Tariff	Spironolactone 25mg tablets	£1.09	28 tablet	1 Oct 2026
NHS Drug Tariff	Spironolactone 50mg tablets	£1.88	28 tablet	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 (EML); complementary (EMLc)
Oedema; Ascites
Oral > Liquid: 25 mg per 5 mL (EMLc) | Oral > Solid > tablet: 25 mg; 12.5 mg (EMLc)
12.4. Medicines used in heart failure · core
Heart failure
Oral > Solid > tablet: 25 mg

Safety signals and safety-related labeling changes

US FDA 14 Nov 2025 ALDACTAZIDE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions
US FDA 14 Nov 2025 ALDACTONE — safety-related labeling change
Labeling sections changed: Adverse Reactions; Drug Interactions; Use in Specific Populations
US FDA 24 Aug 2023 CAROSPIR — safety-related labeling change
Labeling sections changed: Drug Interactions; Use in Specific Populations

All safety entries for spironolactone →

Combinations containing Spironolactone

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.