Is spironolactone FDA-approved?

Yes, as specific products: Aldactone tablets, CaroSpir oral suspension and generic spironolactone are FDA-approved for the uses in their labels, and they're prescription only.

Checked 1 Nov 2026. The sources are below.

Spironolactone

Also: Aldactone, CaroSpir

Status label in the Peptimes Library
FDA Approved
Routes in Peptimes
Oral
Updated
1 Nov 2026

US regulatory status

FDA approval belongs to each product below, for its route and the uses in its label. Label uses are shortened unless quoted.

  • Aldactone (spironolactone) tablets

    Oral

    Heart failure (NYHA Class III to IV, with reduced ejection fraction); add-on treatment of high blood pressure; edema in adults with cirrhosis or nephrotic syndrome; and primary hyperaldosteronism, in the ways the label defines.

    Source: DailyMed label, checked 1 Nov 2026

  • CaroSpir (spironolactone) oral suspension

    Oral

    Heart failure (NYHA Class III to IV, with reduced ejection fraction); add-on treatment of high blood pressure; and edema in adults with cirrhosis, in the ways the label defines.

    Source: DailyMed label, checked 1 Nov 2026

  • Generic spironolactone tablets and oral suspension, from several manufacturers

    Oral

    As stated on each product's label (approved through abbreviated new drug applications, ANDAs).

    Source: Drugs@FDA, checked 1 Nov 2026

  • Prescription

    Prescription only. Drugs@FDA lists each product above as "Prescription".

    Source: Drugs@FDA, checked 1 Nov 2026

  • Investigational

    No, for the products and uses above.

    Source: Drugs@FDA, checked 1 Nov 2026

How to track it in Peptimes

Add spironolactone in My Protocols and set the schedule you already follow: days of the week, times of day and a start date. Peptimes never suggests an amount when you log or schedule a dose. Its Library entry shows the status label “FDA Approved”; the list above gives the detail by product.

  • Logging: the amount you took and how you feel. It’s logged as oral, so there’s no injection site to record.
  • Reminders and history: reminders at your times, Dose History, the Calendar and CSV or JSON export work as described on the peptide tracker app page.

Peptimes is a tracking app, not medical advice. Talk to a licensed clinician about your treatment. Peptimes doesn’t sell spironolactone or any other compound.

More sources

Brand names on this page are trademarks of their owners. Peptimes isn't affiliated with or endorsed by them.

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