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SkinTwo labels compared

Winlevi vs Spironolactone

Winlevi and spironolactone are discussed together constantly because both touch androgen signaling, and the comparison has an asymmetry that this page exists to state plainly: Winlevi is approved for acne, spironolactone is not. Its label covers heart failure, hypertension, edema and primary hyperaldosteronism, and acne appears nowhere in it. This page reads both documents.

Winlevi

Ingredient
Clascoterone
Approved for
Acne in patients 12 and oldercovers skin
Supply
Prescription
Boxed warning
None
Pharmacy cost
$9.99 per gram, brandwhat pharmacies pay to buy it, not the price at the counter
Sun Pharmaceutical Industries, Inc.. Label version 8, effective 2 January 2025.

Aldactone

Ingredient
Spironolactone
Approved for
Heart failure, hypertension, edema, hyperaldosteronismnot skin
Supply
Prescription
Boxed warning
None
Pharmacy cost
$0.087 per tablet, capsule or pen, genericwhat pharmacies pay to buy it, not the price at the counter
Pfizer Laboratories Div Pfizer Inc. Label version 25, effective 28 November 2025.
01From the FDA label

Side by side, straight from the labels

Generated from the two source labels, not typed out by hand, so it cannot drift from what the regulator approved. Rows where both labels say exactly the same thing are marked.

Active ingredientWinleviClascoteroneAndrogen receptor inhibitorAldactoneSpironolactoneAldosterone antagonist and potassium-sparing diuretic
Approved forWinleviAcne in patients 12 and olderAldactoneHeart failure, hypertension, edema, hyperaldosteronism
Supplysame in bothWinleviPrescriptionAldactonePrescription
What pharmacies payAcquisition cost, not retailWinlevi$9.99 per gram, brandAldactone$0.087 per tablet, capsule or pen, generic
Boxed warningsame in bothWinleviNoneAldactoneNone
What the FDA approved it forWinlevi
  • WINLEVI (clascoterone) cream is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
Aldactone
  • The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure.
  • Use as an add-on therapy for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
  • The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response.
  • Treatment of primary hyperaldosternism for: Short-term preoperative treatment; Long-term maintenance for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery and patients with bilateral micro or macronodular adrenal hyperplasia Heart Failure ALDACTONE is indicated for treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase...
Forms and strengthsWinlevi
  • 3 DOSAGE FORM AND STRENGTHS Cream 1%.
  • Each gram of WINLEVI cream contains 10 mg of clascoterone in a white to almost white cream.
Aldactone
  • Tablets: 25 mg round, light yellow, film-coated, with SEARLE and 1001 debossed on one side and ALDACTONE and 25 on the other side.
  • Tablets: 50 mg oval, light orange, scored, film-coated, with SEARLE and 1041 debossed on the scored side and ALDACTONE and 50 on the other side.
  • Tablets: 100 mg round, peach-colored, scored, film-coated, with SEARLE and 1031 debossed on the scored side and ALDACTONE and 100 on the other side.
  • Tablets: 25 mg, 50 mg, and 100 mg
How the label says it is takenWinlevi
  • Cleanse the affected area gently.
  • After the skin is dry, apply a thin uniform layer of WINLEVI cream twice per day, in the morning and the evening, to the affected area.
  • Avoid accidental transfer of WINLEVI cream into eyes, mouth or other mucous membranes.
  • If contact with mucous membranes occurs, rinse thoroughly with water.
  • WINLEVI cream is for topical use only.
  • WINLEVI cream is not for ophthalmic, oral or vaginal use.
Aldactone
  • Heart Failure: Initiate treatment at 25 mg once daily.
  • Hypertension: Initiate treatment at 25 to 100 mg daily in either single or divided doses.
  • Edema: Initiate therapy in a hospital setting and titrate slowly. The recommended initial daily dose is 100 mg in single or divided doses.
  • Primary hyperaldosteronism: Initiate treatment at 100 to 400 mg in preparation for surgery. In patients unsuitable for surgery use the lowest effective dosage determined for the individual patient. General Considerations ALDACTONE can be taken with or without food, but should be taken consistently with respect to food.
Most common adverse reactionsWinlevi
  • Most common adverse reactions occurring in 7 to 12% of patients are erythema/reddening, pruritus and scaling/dryness.
Aldactone
  • most common adverse reaction with ALDACTONE treatment is gynecomastia.
Warnings and precautionsWinlevi
  • Local Irritation: Pruritus, burning, skin redness or peeling may be experienced with WINLEVI cream. If these effects occur, discontinue or reduce the frequency of application of WINLEVI cream.
  • Hypothalamic-pituitary-adrenal (HPA) axis suppression may occur during or after treatment with clascoterone.
  • Attempt to withdraw use if HPA axis suppression develops.
  • Pediatric patients may be more susceptible to systemic toxicity.
  • Hyperkalemia: Elevated potassium levels were observed in some subjects during the clinical trials.
Aldactone
  • Hyperkalemia: Monitor serum potassium within one week of initiation and regularly thereafter.
  • Hypotension and Worsening Renal Function: Monitor volume status and renal function periodically.
  • Electrolyte and Metabolic Abnormalities: Monitor serum electrolytes, uric acid and blood glucose periodically.
  • Gynecomastia: ALDACTONE can cause gynecomastia. Hyperkalemia ALDACTONE can cause hyperkalemia. This risk is increased by impaired renal function or concomitant potassium supplementation, potassium-containing salt substitutes or drugs that increase potassium, such as angiotensin converting enzyme inhibitors and angiotensin receptor blockers.
ContraindicationsWinlevi
  • None. The label states that there are no contraindications.
Aldactone
  • Concomitant use of eplerenone ALDACTONE is contraindicated in patients with: ▪ Hyperkalemia ▪ Addison's disease ▪ Concomitant use of eplerenone
Drug interactionsWinlevi-Aldactone
  • Agents increasing serum potassium: Concomitant administration can lead to hyperkalemia.
  • Lithium: Increased risk of lithium toxicity.
  • NSAIDs: May reduce the diuretic, natriuretic and antihypertensive effect of ALDACTONE.
  • Digoxin: ALDACTONE can interfere with radioimmunologic assays of digoxin exposure.
  • Cholestyramine: Hyperkalemic metabolic acidosis has been reported with concomitant use.
  • Acetylsalicylic Acid (ASA): ASA may reduce the efficacy of ALDACTONE.
Label versionWinlevi2 January 2025Aldactone28 November 2025
02Written by us

One approval on point, one label about something else

The Winlevi label is short and specific: topical treatment of acne vulgaris in patients 12 years of age and older, applied twice daily as a cream. The Aldactone label is a cardiovascular document: NYHA Class III-IV heart failure, add-on therapy for hypertension, edema, primary hyperaldosteronism. The word acne does not occur in it.

Spironolactone's use for acne is prescribing outside the label - a clinical decision this catalog reports as a fact of the document, not as an option to weigh.

03Written by us

Cream against tablet, and two different sets of cautions

Winlevi is topical; its warnings concern local irritation and the possibility of hypothalamic-pituitary-adrenal axis suppression during or after treatment. Aldactone is an oral tablet whose label warns about hyperkalemia among other systemic effects, and its dosing is written for the heart and blood pressure, starting at 25 mg daily in heart failure.

04Written by us

What this page does not tell you

It does not evaluate spironolactone's use for acne or compare effectiveness: the documents give no basis for either. What can be honestly compared is what each label covers, and that comparison is one-sided by design.

05Written by us

Common questions

Is spironolactone FDA-approved for acne?
No. The Aldactone label covers heart failure, hypertension, edema and primary hyperaldosteronism. Prescribing it for acne is a decision outside the label, made by a clinician.
Do both act on androgens?
The Winlevi label calls clascoterone an androgen receptor inhibitor. The Aldactone label describes spironolactone as an aldosterone antagonist; androgen-related effects appear in its adverse reactions rather than its indications. The two documents describe different medicines for different purposes.
From what age is Winlevi approved?
From 12 years of age, per its label.
06

Sources

Every fact above comes from one of these documents. The date is the effective date of the label version this page was built from.

Each stripe is one section of the label, each division in a stripe one entry in that section.

07

Other comparisons in this category

Page last updated 29 August 2026

Compiled by the HealthyStudy editorial team from FDA source documents. No medical reviewer is credited on this page, because none reviewed it.