Spironolactone and Sexual Function: What the Evidence Actually Shows

What the label lists

The current Aldactone label, effective 28 November 2025, lists decreased libido and inability to achieve or maintain erection under reproductive adverse reactions. Irregular menses or amenorrhea, postmenopausal bleeding, and breast and nipple pain appear in the same group [1]. The label says these reactions were reported voluntarily from a population of uncertain size, so it is not always possible to estimate their frequency reliably or to establish a causal relationship to the drug [1].

What the label says about androgen-receptor binding

Spironolactone and its active metabolites are aldosterone antagonists at the aldosterone-dependent sodium-potassium exchange site in the distal convoluted renal tubule, which is how the drug works as a diuretic and antihypertensive [1]. The label also states that spironolactone binds the androgen receptor, and describes its known endocrine effects in animals as progestational and antiandrogenic [1]. The label does not describe a mechanism by which this binding would change libido.

Acne is not a labeled indication. Approved uses are NYHA Class III-IV heart failure with reduced ejection fraction, add-on therapy for hypertension, edema in cirrhosis or nephrotic syndrome, and primary hyperaldosteronism [1].

What the acne studies reported

The SAFA trial, published in Health Technology Assessment in 2024, randomized 410 women aged 18 or older with facial acne persisting at least 6 months. They received spironolactone 50 mg/day to week 6 then 100 mg/day to week 24 (201 women) or placebo (209), with usual topical treatment continued [2]. Investigator's Global Assessment success at week 12 was 18.5% versus 5.6% (adjusted OR 5.18, 2.18 to 12.28) [2]. Headache was more frequent with spironolactone (20.4% versus 12.0%). There were no serious adverse reactions, and other adverse reactions were similar between groups [2].

A hybrid systematic review of oral spironolactone for adult female acne retrieved 10 randomized trials and 21 case series. It rated every trial at high risk of bias and graded the quality of evidence low or very low [3]. One crossover trial showed superiority of 200 mg daily over placebo for inflamed lesions. The remaining trials could not establish the efficacy of lower doses [3].

Menstrual changes

In the 2017 systematic review, menstrual side effects were significantly more common with the 200 mg daily dose, and their frequency was significantly reduced by concomitant use of a combined oral contraceptive [3]. A single-center series of 403 adult women treated for acne found the same direction: menstrual adverse effects were less common among women using combined oral contraception (odds ratio 0.23, 95% CI 0.11 to 0.50) [4]. That series was uncontrolled [4].

Combined oral contraceptives and sex hormone-binding globulin

A retrospective study of 124 premenopausal women with sexual health complaints lasting more than 6 months found that sex hormone-binding globulin averaged 157 nmol/L in women currently using oral contraceptives versus 41 nmol/L in never-users. That is roughly four times higher, and levels stayed above never-user values more than 120 days after the contraceptive was stopped [5]. That study did not involve spironolactone, so it shows what a combined oral contraceptive does to sex hormone-binding globulin, not what happens when the two drugs are used together [5].

Gynecomastia: the label's most common adverse reaction

The label calls gynecomastia the most common adverse reaction with Aldactone. In RALES, about 9% of male participants developed it at a mean dose of 26 mg/day. The risk increases with dose, onset varies from 1 to 2 months to over a year, and it is usually reversible [1]. The published RALES results, which counted gynecomastia or breast pain together, reported 10% of men on spironolactone versus 1% on placebo (P<0.001) [6]. A 2014 review of gynaecomastia names spironolactone among the medications that can cause it, and notes that medication-related breast enlargement may resolve when the drug is stopped [7].

What is not known

The acne figures above cover headache and menstrual effects. They do not give how often libido or erectile changes occur in women taking spironolactone for acne, whether spironolactone with a combined oral contraceptive differs from spironolactone alone for sexual function, or how long any change lasts [2][3][4].