Spironolactone shortage — CA supply status & alternatives

Spironolactone

ATC C03DA01

🇦🇺 AUST R 338092 · Alphapharm Pty Ltd

In supply · Australia

WHO Essential Medicine

Espironolactona AccordALDACTONE spironolactone

In supply · 🇦🇺 Australia · short in🇨🇦 CA🇺🇸 US🇧🇪 BE🇮🇪 IE

In supply in Australia

Reading today’s signals…

🇦🇺 AUAEMPA$3.50DPMQ A$21.84details →

✓ Can I substitute?

Per normal rules

Confirm with prescriber

⇄ Best alternative

Same class · therapeutic class alternative

◷ Expected back

No estimate

No estimate provided

Product attributes reference data we hold

Active ingredient (INN)	Spironolactone
Brand names	Espironolactona Accord, ALDACTONE spironolactone
ATC level 5	C03DA01
ATC level 4	C03DA
Therapeutic category	Auto-created by Therapeutic Goods Administration — Medicine Shortages scraper
WHO Essential Medicine	Yes (2023)
Controlled substance	No
Marketing-authorisation holders	Alphapharm Pty Ltd, ACCORD-UK LIMITED, TEVA UK LIMITED, WAYMADE PLC +4 more
Registrations on file	19
Patient information leaflet (PIL)	Not on file
Summary of product characteristics (SPC)	Not on file

Trade price 🇦🇺 PBS · July 2026

🇦🇺 AU

● Official price on file

Ex-manufacturer

A$3.50

AEMP

Dispensed (DPMQ)

A$21.84

incl. fees

Pack

spironolactone 25 mg tablet, 100

Source: PBSEffective July 2026 · AUD

Other markets

🇬🇧 GB

£1.81

Drug Tariff

🇫🇷 FR

€2.96

Retail price

🇺🇸 US

US$0.09

Acquisition

Substitution pathways 🇦🇺 Australia · TGA

—

No substitution instrument in force

Dispense per normal rules, or refer to the prescriber. No active SSSI/S19A instrument detected for this medicine.

How long have past shortages lasted? from 1 resolved event

◷

~6 months

Historical pattern from resolved shortage records — not a prediction of this event.

Global API supply base 🇺🇸 FDA Drug Master Files · active Type II

9 API manufacturers

Manufacturers with an active Type II Drug Master File — i.e. cleared to supply this active ingredient into the US market. A proxy for how concentrated the global manufacturing base is.

Low concentration risk

Gedeon Richter PLCEuroapi FranceTianjin Tianyao Pharmaceuticals CO LTDZhejiang Shenzhou Pharmaceutical CO LTDZhejiang Langhua Pharmaceutical CO LTDTianjin Jinjin Pharmaceutical CO LTD+3 more

Manufacturing countries: Hungary, France, China, India, Brazil · Source: FDA List of Drug Master Files

FDA-approved products 🇺🇸 Drugs@FDA

Approved applications

Generic (ANDA)

Brand (NDA/BLA)

Feb 2025

Latest approval

Shortage status by regulator official notices

🇨🇦

Canada

HC · just now

Critical

🇺🇸

United States

FDA MedWatch · 1mo ago

Critical

🇧🇪

FAMHP · 10d ago

Medium

🇮🇪

Ireland

HPRA · 1mo ago

Medium

🇦🇺

Australia

TGA · 22d ago

Resolved

Recalls official enforcement reports

🇺🇸

SPIRONOLACTONE

SUN PHARMACEUTICAL INDUSTRIES INC · Aug 2025

Class IIdetails ↗

🇺🇸

Spironolactone

Health Innovations Pharmacy, Inc · Feb 2015

Class IIdetails ↗

🇺🇸

ALDACTONE

Pfizer Us Pharmaceutical Group · Sept 2013

Class IIdetails ↗

Verified timeline regulator events

🇧🇪 18 May 2026

medium reported

🇧🇪 18 Mar 2026

medium reported

🇮🇪 1 Mar 2026

medium reported

🇺🇸 10 Dec 2025

medium reported

🇺🇸 10 Dec 2025

medium reported

🇦🇺 2 Dec 2025

Shortage resolved

Sources official regulators

🇨🇦

verified just now

verify ↗

🇺🇸

FDA

verified just now

verify ↗

🇧🇪

FAMHP

verified 10d ago

verify ↗

🇦🇺

TGA

verified 22d ago

verify ↗

🇺🇸

FDA MedWatch

verified 1mo ago

verify ↗

🇮🇪

HPRA

verified 1mo ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders19 registrations · 8 MA holders

Product	Strength	Form	Market	MA holder	Status
Spironolactone Viatris	100 mg	—	🇦🇺 AU	Alphapharm Pty Ltd	Active
Spironolactone Tablets Bp	25MG	tablet	🇬🇧 GB	ACCORD-UK LIMITED	Active
Spironolactone Tablets Bp	50MG	tablet	🇬🇧 GB	ACCORD-UK LIMITED	Active
Spironolactone Tablets Bp	100MG	tablet	🇬🇧 GB	ACCORD-UK LIMITED	Active
SPIRONOLACTONE 25MG TABLETS	25MG	tablet	🇬🇧 GB	TEVA UK LIMITED	Active
SPIRONOLACTONE 100MG TABLETS	100MG	tablet	🇬🇧 GB	TEVA UK LIMITED	Active
SPIRONOLACTONE 50MG TABLETS	50MG	tablet	🇬🇧 GB	TEVA UK LIMITED	Active
Spironolactone Waymade	25 MG	solution	🇬🇧 GB	WAYMADE PLC	Active
SPIRONOLACTONE 12.5 MG FILM-COATED TABLETS	12.5 MG	tablet	🇬🇧 GB	MERCURY PHARMACEUTICALS LIMITED	Active
SPIRONOLACTONE 25 MG FILM-COATED TABLETS	25 MG	tablet	🇬🇧 GB	MERCURY PHARMACEUTICALS LIMITED	Active
SPIRONOLACTONE 50 MG FILM-COATED TABLETS	50 MG	tablet	🇬🇧 GB	MERCURY PHARMACEUTICALS LIMITED	Active
SPIRONOLACTONE 100 MG FILM-COATED TABLETS	100 MG	tablet	🇬🇧 GB	MERCURY PHARMACEUTICALS LIMITED	Active
SPIRONOLACTONE TABLETS 25MG	25MG	tablet	🇬🇧 GB	BRISTOL LABORATORIES LIMITED	Active
SPIRONOLACTONE TABLETS 100MG	100MG	tablet	🇬🇧 GB	BRISTOL LABORATORIES LIMITED	Active
SPIRONOLACTONE 25MG FILM-COATED TABLETS	25MG	tablet	🇬🇧 GB	KEY PHARMACEUTICALS LIMITED	Active

+4 more registrations on file

Mederti Drug Report

Generated 1 July 2026 · Australia market · 6 regulatory sources

For health-professional reference only. Mederti aggregates shortage and substitution information from official regulatory sources. It is not clinical advice and data may be incomplete or delayed. Confirm any substitution or supply decision against the primary regulator source, the prescriber, and current clinical references (e.g. AMH) before acting. Terms.