Spironolactone for Acne in Geriatric Patients (65+): Transition to Adult Care

What the acne evidence covers

The main randomized acne evidence comes from adult women, including the SAFA trial, whose participants had a mean age of 29.2; these studies do not establish outcomes specifically in people over 65 [2][5]. SAFA, published in Health Technology Assessment in 2024, randomized 410 women aged 18 and older with facial acne persisting at least six months to 50 mg daily for six weeks then 100 mg daily to week 24, or placebo, with usual topical treatment continued [2]. On the Acne-Specific Quality of Life symptom subscale the difference favored spironolactone by 1.27 points at 12 weeks (95% CI 0.07 to 2.46) and 3.77 points at 24 weeks (2.50 to 5.03); Investigator's Global Assessment success at week 12 was 18.5% versus 5.6%, and 81.9% versus 63.3% rated themselves improved at 24 weeks [2]. Headache was more common with spironolactone (20.4% versus 12.0%); there were no serious adverse reactions and other adverse reactions were similar between groups [2].

The rest of the acne literature is weaker. A 2017 systematic review found 10 randomized trials and 21 case series, rated every trial at high risk of bias and the evidence low or very low quality; only a crossover trial of 200 mg daily beat placebo for inflamed lesions [5]. A retrospective case series of 403 adult women at one academic center reported reduction or clearance of facial acne in 75.5% of patients with data at first follow-up, with no control group [6].

What is different about spironolactone after 65

The label is direct about one gap: the effect of age, sex, race or ethnicity, and renal impairment on spironolactone pharmacokinetics has not been specifically studied [1]. One small study did address age. Ten older women with multiple medical conditions took 100 mg daily to steady state, and their serum concentrations of spironolactone metabolites were twice those of a younger healthy female control group, with a statistically significant positive correlation between the kinetic parameters and age [3]. Ten patients is a small sample, so this reads as a signal rather than a dosing rule.

The label says spironolactone is substantially excreted by the kidney, and that impaired renal function raises the risk of adverse reactions, particularly hyperkalemia, so potassium needs close monitoring [1]. Postmenopausal bleeding and breast and nipple pain are listed among reported adverse reactions [1], and gynecomastia is the most common adverse reaction overall, affecting about 9% of men in RALES at a mean dose of 26 mg daily [1].

Hyperkalemia: the label's rules, and what the young-women data do not cover

Hyperkalemia is the risk the label treats as central. It is increased by impaired renal function, potassium supplements, potassium-containing salt substitutes, ACE inhibitors and angiotensin receptor blockers; NSAIDs, heparin and low molecular weight heparin, and trimethoprim are also named as potassium-raising drugs [1]. Monitoring is within one week of initiation or titration and regularly thereafter, with more frequent checks when potassium-raising drugs are used or renal function is impaired; if hyperkalemia occurs the label says to decrease the dose or discontinue and treat it [1]. Contraindications are hyperkalemia, Addison's disease and concomitant eplerenone [1].

The reassuring potassium data come from healthy young women without heart or kidney disease and not on renin-angiotensin-aldosterone drugs, so they do not cover most people over 65. Among 974 healthy young women taking spironolactone for acne, none with cardiovascular disease or renal failure and none on drugs affecting the renin-angiotensin-aldosterone system, 13 of 1,802 potassium measurements were abnormal (0.72%), against a baseline rate of 0.76% in 1,165 comparison women [7]. The authors concluded that routine monitoring had low usefulness in that specific population; the label's monitoring instruction is unchanged [1][7].

Kidney function, dose and which label applies

Acne is not a labeled indication, so the label does not provide an acne dosing regimen. Its renal adjustment sits in the heart failure section, where the label says to consider 25 mg every other day for patients with an eGFR of 30 to 50 mL/min/1.73 m² because of the risk of hyperkalemia [1]. For older adults generally, a 2009 consensus statement from geriatric clinical pharmacists placed spironolactone among 10 medications for which the recommendation was not to use them in older adults below a specified level of renal function, giving creatinine clearance under 30 mL/min as an example threshold [4].

The contraindication list depends on which label you read. The current Aldactone label lists hyperkalemia, Addison's disease and concomitant eplerenone [1]. An older generic spironolactone tablets label also lists anuria, acute renal insufficiency and significant impairment of renal excretory function, and it still carries a boxed warning that spironolactone was a tumorigen in chronic rat toxicity studies and should be used only for labeled conditions [8]. The current Aldactone label has no boxed warning [1]. That older wording matters on an acne page, because acne is not a labeled condition [1][8].

Blood pressure, dizziness and what the label lists

Spironolactone lowers blood pressure in older adults. In a 45-person randomized trial of older adults with hypertension, with a mean age of 69, 24 participants received spironolactone and 21 received hydrochlorothiazide. After 6 months, both groups had significant reductions in 24-hour and nocturnal systolic and diastolic blood pressure [9]. The label warns that excessive diuresis can cause symptomatic dehydration, hypotension and worsening renal function, particularly in salt-depleted patients or those taking ACE inhibitors or ARBs, and that NSAIDs, aminoglycosides and cisplatin add renal risk [1]. Dizziness, lethargy, mental confusion, ataxia, headache, drowsiness and leg cramps are all listed as reported adverse reactions [1]. In patients with cirrhosis and ascites, the label warns that shifts in fluid and electrolytes can precipitate hepatic encephalopathy and coma, and says to start treatment in a hospital setting [1].

The handoff: what the next prescriber needs

When an over-65 patient moves to a new practice, the facts that matter are the ones the label ties to safe use. First, the exact product and formulation; the FDA record identifies Aldactone oral tablets in 25 mg, 50 mg, and 100 mg strengths [10]. Second, the most recent potassium and creatinine values with their dates, since the label's monitoring runs from one week after a start or dose change to regularly thereafter [1]. Third, a full list of potassium-raising drugs, including over-the-counter potassium supplements, potassium-containing salt substitutes and NSAIDs [1]. Fourth, why the drug was started: acne appears on none of the labeled indications, which are heart failure with reduced ejection fraction, add-on hypertension, edema in cirrhosis or nephrotic syndrome, and primary hyperaldosteronism [1].

One practical detail is easy to lose between practices: the label says to take spironolactone consistently with respect to food, and food increased its bioavailability by about 95% [1].

Polypharmacy is the norm in this age group. In a single-center study of 1,200 inpatients aged 65 and older, the median medication count was 9, 91.58% took five or more drugs, and spironolactone was one of the three most frequently encountered potentially inappropriate medications under the 2019 Beers criteria; 30.08% of patients had at least one such medication [11].