FDA — authorised 21 January 1960
- Application: NDA012151
- Marketing authorisation holder: PFIZER
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Aldactone in United States
FDA authorised Aldactone on 21 January 1960 · 15,996 US adverse-event reports
Marketing authorisations
FDA — authorised 5 June 2002
- Application: ANDA089424
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 22 September 2014
- Application: ANDA040750
- Marketing authorisation holder: OXFORD PHARMS
- Indication: Labeling
- Status: approved
FDA — authorised 4 August 2017
- Application: NDA209478
- Marketing authorisation holder: CMP DEV LLC
- Indication: Type 3 - New Dosage Form
- Status: approved
FDA — authorised 21 February 2025
- Application: ANDA218085
- Marketing authorisation holder: HETERO LABS LTD III
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 15,996
Most-reported reactions
- Dyspnoea — 2,271 reports (14.2%)
- Hyperkalaemia — 1,730 reports (10.82%)
- Diarrhoea — 1,684 reports (10.53%)
- Nausea — 1,634 reports (10.22%)
- Acute Kidney Injury — 1,572 reports (9.83%)
- Fatigue — 1,558 reports (9.74%)
- Hypotension — 1,465 reports (9.16%)
- Drug Interaction — 1,377 reports (8.61%)
- Cardiac Failure — 1,362 reports (8.51%)
- Anaemia — 1,343 reports (8.4%)
Aldactone in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Aldactone approved in United States?
Yes. FDA authorised it on 21 January 1960; FDA authorised it on 5 June 2002; FDA authorised it on 22 September 2014.
Who is the marketing authorisation holder for Aldactone in United States?
PFIZER holds the US marketing authorisation.