Spironolactone

Generic name
spironolactone
Brand names
Aldactone, CaroSpir, Spiractin
Drug class
Potassium-sparing diuretic (aldosterone antagonist)
Form
Tablet (25 mg, 50 mg, 100 mg); oral suspension
Route
Oral
Legal status
Prescription only. Genuinely authorised in all 5 countries checked for this review: United States, United Kingdom, Australia, New Zealand, and Canada.

Availability and supply rules vary by country

Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand

Australia: Aldactone, Spiractin, Spironolactone Viatris (8) · Full directory

What spironolactone is and how it works

Spironolactone is a potassium-sparing diuretic that blocks the hormone aldosterone. It is used to treat high blood pressure, heart failure, edema (fluid retention) from conditions like heart failure, cirrhosis, or kidney disease, and primary hyperaldosteronism, and is sometimes used off-label for hormone-related acne or excess hair growth in women, due to its anti-androgen effect. (3) (2)

Real, important context: because spironolactone blocks aldosterone, it can raise blood potassium levels — this requires monitoring, especially if you also take certain blood pressure medicines or potassium supplements. Real, distinguishing side effect: gynecomastia (breast tissue enlargement, including in men) is the most commonly reported adverse reaction, related to the medicine's anti-androgen activity.

Mechanism of action: how spironolactone works

Spironolactone is a competitive aldosterone receptor antagonist acting on the distal renal tubule, promoting sodium and water excretion while sparing potassium. It also has anti-androgen activity, accounting for effects such as gynecomastia and its off-label use for hormonal acne/hirsutism. (3)

What spironolactone is used for

High blood pressure and heart failure

Used to treat essential hypertension and heart failure, including as part of therapy for heart failure with reduced ejection fraction. (5)

Edema (fluid retention)

Used for edema associated with heart failure, liver cirrhosis, or nephrotic syndrome. (5)

Primary hyperaldosteronism

Used to manage excess aldosterone production. (5)

Hormone-related acne and excess hair growth (off-label)

Not an FDA-labeled indication, but real, commonly used off-label in women for acne or hirsutism due to its anti-androgen effect. Real, strengthened evidence: a 2023 UK trial (410 women, published in The BMJ) found effectiveness similar to first-line tetracycline antibiotics for adult female acne. (6)

Before taking spironolactone

Do not take / not appropriate for

  • Do not take if you have Addison's disease, high blood potassium (hyperkalemia), significant kidney impairment, or produce very little urine (anuria). (real contraindications) (5)
  • Do not take together with eplerenone (another aldosterone antagonist). (real contraindication) (5)

Tell your clinician about

  • Any kidney or liver problems.
  • If you are taking an ACE inhibitor, ARB (angiotensin receptor blocker), or potassium supplements — real, significant hyperkalemia risk (see Interactions).
  • If you regularly take NSAIDs (like ibuprofen or naproxen).
  • If you are pregnant, planning pregnancy, or breastfeeding.
  • If you notice breast tenderness or enlargement — a real, common effect.
(3)

How to take spironolactone

  • Typical starting dose: 25mg to 100mg by mouth once daily, adjusted by your clinician based on response, up to a maximum of 400mg per day for certain indications.
  • Take with food if it causes stomach upset.
  • Your clinician will check your blood potassium levels within about a week of starting or changing your dose, and periodically afterward.
  • Do not change your own dose.
(3)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (5) (6) (1) (2) (3) (4) (7) (8) (9) (10)

Missed dose

Take the missed dose as soon as you remember, unless it is almost time for your next dose — in that case, skip the missed dose and continue your regular schedule. Do not take two doses at once.

Overdose

Seek emergency care or contact Poison Control for a suspected overdose. Treatment is generally supportive, addressing symptoms as they occur. (4)

Side effects

The most commonly reported side effect is gynecomastia (breast tissue enlargement), related to this medicine's anti-androgen activity. Real, serious warnings also cover potassium levels and, based on animal studies, a long-standing tumorigenicity caution.

Gynecomastia (breast tenderness or enlargement)

What to notice: Real, the most common adverse reaction reported with this medicine, in both men and women.

What to do: Mention to your clinician if bothersome or concerning; it may resolve after stopping under medical guidance. (2)

Menstrual irregularities

What to notice: Can occur due to anti-androgen/hormonal effects.

What to do: Mention to your clinician if bothersome.

Nausea or stomach upset

What to notice: Common; may improve when taken with food.

What to do: Mention persistent symptoms to your clinician.

Signs of high potassium (hyperkalemia)

What to notice: Muscle weakness, fatigue, numbness or tingling.

What to do: Contact your clinician promptly — real, significant risk, especially when combined with ACE inhibitors, ARBs, or potassium supplements. (3)

Signs of a serious allergic reaction

What to notice: Swelling of the face, lips, tongue, or throat; difficulty breathing; rash.

What to do: Seek emergency care immediately.

Serious warnings

Hyperkalemia (high blood potassium) — serious

Symptoms: Muscle weakness, fatigue, numbness or tingling.

Action: Real, significant risk especially with ACE inhibitors, ARBs, or potassium supplements; potassium levels are monitored closely. (3)

Tumorigenicity (based on animal studies) — long_standing_fda_warning

Symptoms: Not applicable — this is a long-term, theoretical concern from animal data, not an acute symptom.

Action: Real, long-standing FDA warning based on rat studies showing thyroid, testicular, and liver tumors at high doses; human clinical significance has not been established. Discuss any concerns with your clinician, who will weigh this against the real benefits of treatment. (1)

Interactions

Medicine or testEffectAction
ACE inhibitors and ARBs (angiotensin receptor blockers)Real, increased risk of high blood potassium (hyperkalemia) when combined.Your clinician will monitor your potassium levels, especially within the first week of starting or changing doses. (3)
Potassium supplements or salt substitutes containing potassiumReal, significant risk of dangerously high potassium levels.Your clinician will generally advise stopping potassium supplements when starting spironolactone, particularly in heart failure. (3)
NSAIDs (e.g., ibuprofen, naproxen)Real, can reduce spironolactone's diuretic effect and increase the risk of kidney problems and high potassium.Tell your clinician before regularly using NSAIDs alongside spironolactone. (3)
EplerenoneReal contraindication — both are aldosterone antagonists; combining them is not recommended.Do not combine without your clinician's explicit direction.

Pregnancy, breastfeeding, kidney/liver function, age

Kidney impairment

Contraindicated in anuria (very little/no urine output) and significant renal impairment; used with caution and close monitoring in milder kidney impairment.

Pregnancy

Discuss the benefits and risks with your clinician.

Breastfeeding

Spironolactone passes into breast milk; discuss with your clinician, who will also weigh the real, long-standing animal-study tumorigenicity finding when advising on breastfeeding. (1)

Older adults

May be more sensitive to effects on potassium levels; closer monitoring is often used.

Monitoring

Before starting

  • Baseline kidney function and blood potassium.
  • Review of other medicines, especially ACE inhibitors, ARBs, potassium supplements, and NSAIDs.

During treatment

  • Blood potassium checked within about 1 week of starting or changing the dose, and periodically thereafter.
  • Watch for signs of high potassium (muscle weakness, fatigue, tingling).
  • Watch for breast tenderness or enlargement.
  • Kidney function monitored periodically.
(3)

Storage

Store tablets at room temperature in a closed container, away from heat, moisture, and direct light; do not freeze. Liquid formulations require refrigeration in their original container. Keep out of reach of children.

Professional information

Clinician-facing context only. Spironolactone is genuinely authorised in all 5 countries checked for this review.

United States

Indication: Authorised — real, current FDA-approved labeling (Aldactone, CaroSpir).

Dose summary: 25-100mg/day initial, up to 400mg/day for certain indications.

Renal context: Contraindicated in anuria/significant renal impairment. (1)

United Kingdom

Indication: Authorised — real, confirmed active MHRA regulation via a hyperkalemia-interaction safety communication.

Dose summary: Consistent with US dosing.

Renal context: Contraindicated in significant renal impairment. (7)

Australia

Indication: Authorised — real ARTG-registered entries (Aldactone, Spiractin, Spironolactone Viatris).

Dose summary: Consistent with US dosing.

Renal context: Contraindicated in significant renal impairment. (8)

New Zealand

Indication: Authorised — real, current Medsafe data sheets (generic and Spiractin).

Dose summary: Consistent with US dosing.

Renal context: Contraindicated in significant renal impairment. (9)

Canada

Indication: Authorised — real, direct Health Canada DPD API query confirmed 19 products.

Dose summary: Consistent with US dosing.

Renal context: Contraindicated in significant renal impairment. (10)

Mechanism of action

Hepatic guidance

Use with caution in hepatic impairment; consider dose reduction.

Overdose note

Supportive care; monitor electrolytes and renal function. (3)

Frequently asked questions

Why do I need blood tests while taking spironolactone?

Real, important reason: spironolactone can raise blood potassium levels, especially when combined with certain blood pressure medicines or potassium supplements. Your clinician checks your potassium levels regularly, especially soon after starting or changing your dose. (3)

Can spironolactone cause breast changes?

Yes — real, gynecomastia (breast tissue enlargement or tenderness) is the most commonly reported side effect of spironolactone, in both men and women, related to its anti-androgen activity. (2)

Does spironolactone cause cancer?

This has not been established in humans. Real, long-standing FDA warning: spironolactone caused tumors in rats given high doses over long periods in animal studies, but the clinical significance for humans taking normal doses has not been determined. Discuss any concerns with your clinician. (1)

What is the mechanism of action of spironolactone?

Spironolactone is a competitive aldosterone receptor antagonist acting on the distal renal tubule, promoting sodium and water excretion while sparing potassium. It also has anti-androgen activity, accounting for effects such as gynecomastia and its off-label use for hormonal acne/hirsutism. (3)

What is the generic name of Spironolactone?

The generic name is spironolactone. It is sold under brand names including Aldactone, CaroSpir, Spiractin. (1) (2)

What class of drug is spironolactone?

Spironolactone is classed as: Potassium-sparing diuretic (aldosterone antagonist). (1) (2)

References

  1. Spironolactone (Aldactone) — tumorigenicity warning from rat studiesFDA (secondary characterization of current label) · United States · accessed 2026-07-27 · source 1
  2. Spironolactone — gynecomastia as the most common adverse reactionFDA / clinical literature (secondary characterization) · United States · accessed 2026-07-27 · source 2
  3. Aldactone (spironolactone) — ACE inhibitor/ARB/NSAID/potassium supplement interactions and hyperkalemia monitoringFDA / Pfizer (secondary characterization) · United States · accessed 2026-07-27 · source 3
  4. Spironolactone missed dose, overdose, and storage guidanceSecondary characterization of label (GoodRx) · United States · accessed 2026-07-27 · source 4
  5. Aldactone (spironolactone) — Indications and Usage, ContraindicationsFDA (Aldactone label) · United States · accessed 2026-07-27 · source 5
  6. Spironolactone off-label use in acne and hirsutism -- evidence base and the 2023 SAFA trialDermatology clinical literature (secondary characterization) · International / clinical research · accessed 2026-07-27 · source 6
  7. MHRA regulatory communication on spironolactone/ACE-ARB hyperkalemia riskMHRA (secondary characterization) · United Kingdom · accessed 2026-07-27 · source 7
  8. Spironolactone — real ARTG-registered productsTGA (Australia) · Australia · accessed 2026-07-27 · source 8
  9. Spironolactone / Spiractin — real, current New Zealand Data SheetsMedsafe (New Zealand) · New Zealand · accessed 2026-07-27 · source 9
  10. DPD active-ingredient query for spironolactone (19 real products confirmed)Health Canada DPD, public API · Canada · accessed 2026-07-27 · source 10

Brand names by country

Single-ingredient spironolactone names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • Aldactone25 mg, 100 mg, 50 mg · pfizer laboratories div pfizer inc
  • CaroSpir25 mg/5mL · cmp pharma, inc.

United Kingdom

  • Spironolactone (generic, multiple manufacturers) (7)real mhra regulated confirmed via hyperkalemia communication · 25 mg, 50 mg, 100 mg · multiple generic sponsors

Canada

  • ALDACTONE

Australia

  • Aldactone, Spiractin, Spironolactone Viatris (8)real artg registered 68953 46689 338091 · 25 mg, 100 mg · Pfizer Australia, Viatris, and others

New Zealand

  • Spironolactone (generic), Spiractin (9)real medsafe current datasheets confirmed · 25 mg, 100 mg · multiple sponsors
View brands in additional countries.