What does the evidence show about Spironolactone's effects?

Read Off Label rates the evidence for Spironolactone as Strong and the benefit magnitude as strong, producing an overall grade of B (6.8/10). It is widely used for androgen-mediated conditions in women.

What safety findings are reported for Spironolactone?

Spironolactone has a med risk profile in the database. Med (menstrual irregularity, breast tenderness, hyperkalemia risk especially with ACEi/ARB/K-supplements, teratogenic — feminization of male fetus) Legal status: Rx.

Rankings / Hormones & Endocrine

Spironolactone

Hormones & Endocrine · Aldosterone / androgen receptor antagonist

Tier B

Reviewed by Read Off Label · Last reviewed Jul 23, 2026 · How we grade

prescription

6.8 / 10

Tier B

Ev 8 Bn 8 Sf 5

Bottom line

Read Off Label grades Spironolactone as B (6.8/10) based on strong evidence, strong benefit magnitude, and a med-risk safety profile.

It is widely used for androgen-mediated conditions in women.

Studied, labeled, or reported-use context: 50-200 mg/day PO (dermatology); 25-100 mg/day (cardiac/HTN) — Rx; not individualized guidance.

Citation correction in progress

1 PubMed link was found to be unrelated to this entry and removed from public output. The remaining sources are shown below, but this row's claims and score still need a full source-by-source revalidation.

What the evidence says

It is widely used for androgen-mediated conditions in women. FDA 2022 removed the long-standing but evidence-free breast cancer black box. Male use can produce antiandrogenic or feminizing effects; indications and risk contexts differ. Pregnancy exposure carries fetal-feminization concerns.

Mechanism

Potassium-sparing diuretic with antiandrogen activity (AR antagonism); reduces androgenic effects on skin and hair follicles; used for female-pattern AGA, female hormonal acne, and hirsutism

Studied, labeled, or reported dose & route

50-200 mg/day PO (dermatology); 25-100 mg/day (cardiac/HTN)

This records doses and routes described in studies, approved labeling, clinical practice, or documented use. It is not individualized guidance and does not establish safety; context changes with indication, formulation, health history, monitoring, and other medicines.

Citations

A link means the source informed this entry; it does not mean every claim on the page comes from that source. If a citation looks wrong or you want a claim re-checked, send a correction.

Common questions

What does the evidence show about Spironolactone's effects?: Read Off Label rates the evidence for Spironolactone as Strong and the benefit magnitude as strong, producing an overall grade of B (6.8/10). It is widely used for androgen-mediated conditions in women.
What safety findings are reported for Spironolactone?: Spironolactone has a med risk profile in the database. Med (menstrual irregularity, breast tenderness, hyperkalemia risk especially with ACEi/ARB/K-supplements, teratogenic — feminization of male fetus) Legal status: Rx.
What doses or routes are reported for Spironolactone?: 50-200 mg/day PO (dermatology); 25-100 mg/day (cardiac/HTN) This is context from studies, approved labeling, clinical practice, or documented use; it is not individualized guidance and does not establish safety.
How does Spironolactone work?: Potassium-sparing diuretic with antiandrogen activity (AR antagonism); reduces androgenic effects on skin and hair follicles; used for female-pattern AGA, female hormonal acne, and hirsutism

This is an independent synthesis of published research by a non-clinician. Scores are opinions supported by citations, not prescriptions. See the full disclaimer and methodology for how this score was produced and what it does and doesn't mean.