Spironolactone for Acne in Adults 65 and Older: School, Work, and Activity Considerations

At a glance

  • Acne indication / off-label; labeled uses are heart failure, add-on hypertension, edema and primary hyperaldosteronism [1]
  • Acne trial / SAFA: 410 women aged 18 and older, mean age 29.2, 50 mg then 100 mg daily [3]
  • Age and drug levels / label says the effect of age on pharmacokinetics has not been specifically studied [1]
  • Dizziness and drowsiness / listed adverse reactions reported voluntarily, so no frequency can be estimated [1]
  • Potassium timing / label says within 1 week of starting or titrating, then regularly [1]
  • Competitive sport / prohibited at all times by WADA, S5 diuretics and masking agents [2]
  • Potassium-raising drugs / ACE inhibitors, ARBs, NSAIDs, heparin, trimethoprim, potassium supplements, salt substitutes [1]

What is known about spironolactone for acne at 65 and older?

Acne is not a labeled use at any age. The current Aldactone label covers NYHA Class III to IV heart failure with reduced ejection fraction, add-on therapy for hypertension, edema in cirrhosis or nephrotic syndrome, and primary hyperaldosteronism [1]. Acne treatment is off-label and rests mainly on SAFA, a randomized trial of 410 women aged 18 and older with a mean age of 29.2 [3]. That trial used 50 mg daily to week 6 then 100 mg daily to week 24, and at 24 weeks the acne-specific quality-of-life symptom score difference favoring spironolactone was 3.77 points [3].

The evidence that speaks to older adults comes from elsewhere. The label says the impact of age on spironolactone pharmacokinetics has not been specifically studied [1]. A 1984 study of 10 older women with multiple medical conditions, taking 100 mg daily at steady state, found serum concentrations of spironolactone metabolites (canrenone and fluorigenic metabolites) about twice as high as in younger healthy women [4]. The label also notes that spironolactone is substantially excreted by the kidney and that the risk of adverse reactions may be greater with impaired renal function, where potassium needs close monitoring [1]. A geriatric pharmacist consensus statement recommended not using spironolactone in older adults below a specified level of renal function [5].

Separately, in a 2021 single-center study of 1,200 inpatients aged 65 and older in China, spironolactone was one of the three most frequently encountered potentially inappropriate medications under the 2019 Beers criteria [6].

What does the label say about dizziness, alertness and the working day?

The label lists dizziness, ataxia, lethargy, mental confusion, drowsiness and headache among adverse reactions collected from voluntary reports, so it gives no frequency for them [1]. Separately, it warns that excessive diuresis may cause symptomatic dehydration, hypotension and worsening renal function, particularly in salt-depleted patients or those taking ACE inhibitors or ARBs, and it says to monitor volume status and renal function periodically [1]. Hyponatremia and hypovolemia also appear in its list of metabolic reactions [1].

For a 65-year-old whose week includes driving, ladders, machinery or long shifts on their feet, those label entries are the relevant ones. The label gives no activity-level hydration target [1].

Potassium, hydration and physically demanding days

The label says to check serum potassium within one week of starting spironolactone or changing the dose, and regularly thereafter, with more frequent monitoring when kidney function is impaired or other potassium-raising drugs are used. If hyperkalemia occurs, the label says to decrease the dose or discontinue the drug and treat the hyperkalemia [1].

The label names potassium-containing salt substitutes as a hyperkalemia risk alongside potassium supplements, ACE inhibitors, ARBs, NSAIDs, heparin, low molecular weight heparin and trimethoprim [1]. In an ordinary week that could include a potassium-based salt substitute in the kitchen or an NSAID for arthritic knees [1]. NSAIDs may also reduce the diuretic, natriuretic and antihypertensive effect of spironolactone [1].

On food, the label says spironolactone can be taken with or without food but should be taken consistently with respect to food; food increased its bioavailability by about 95% [1].

Does the WADA rule apply to a 65-year-old competitor?

The 2026 WADA Prohibited List places spironolactone and its metabolite canrenone in class S5, diuretics and masking agents, prohibited at all times, in and out of competition [2]. Every substance in that class is a Specified Substance, and a Therapeutic Use Exemption is needed for permitted use [2]. For competitions governed by WADA rules, the prohibition applies regardless of the competitor's age [2].

Which interactions turn up in an ordinary week?

ACE inhibitors and ARBs sit at the top. The label states that concomitant use with drugs that raise potassium can lead to severe hyperkalemia, and says to check serum potassium when ACE inhibitor or ARB therapy is altered [1]. NSAIDs are on the same potassium-raising list, as are trimethoprim, heparin and low molecular weight heparin [1].

Other interactions the label names:

  • Lithium: spironolactone reduces lithium renal clearance and raises the risk of lithium toxicity, and the label says to monitor lithium levels periodically [1].
  • Digoxin: spironolactone and its metabolites interfere with digoxin radioimmunoassays and raise the apparent exposure, and the label says to use an assay that does not interact [1].
  • Cholestyramine: hyperkalemic metabolic acidosis has been reported [1].
  • Abiraterone: the label says concomitant use is not recommended [1].
  • Mitotane: the label says to avoid concomitant use [1].

Gynecomastia and other effects an older adult may notice

Gynecomastia is the label's most common adverse reaction: in RALES, about 9% of men taking a mean of 26 mg daily developed it, the risk rises with dose, onset ranged from 1 to 2 months to over a year, and it is usually reversible [1]. A review of gynecomastia names spironolactone among the medications that can cause it and notes that it can resolve when the drug is stopped [7]. Postmenopausal bleeding is listed among reproductive adverse reactions [1].

What do the acne studies show about side effects and potassium?

In SAFA, headache occurred in 20.4% of participants receiving spironolactone and 12.0% receiving placebo; no serious adverse reactions occurred [3].

The reassuring potassium numbers come from young, healthy women. A retrospective study of 974 healthy young women on spironolactone for acne found 13 abnormal potassium values in 1,802 measurements, 0.72%, about equal to the 0.76% baseline rate in 1,165 comparison women. The authors concluded routine monitoring had low usefulness in that group, and the study excluded women with cardiovascular disease, renal failure, or drugs acting on the renin-angiotensin system [8]. A 65-year-old with reduced kidney function or on an ACE inhibitor falls outside that study, and the Aldactone label's potassium instruction still stands [1][8].

Frequently asked questions

Has spironolactone for acne been studied in people over 65?
SAFA enrolled women aged 18 and older with a mean age of 29.2 and does not establish an acne result specifically for people over 65 [3]. A separate 1984 study of 10 older women examined serum levels of spironolactone metabolites, not acne outcomes [4]. The label says the effect of age on spironolactone pharmacokinetics has not been specifically studied [1].
Does spironolactone affect driving or work that needs concentration?
The label lists dizziness, ataxia, drowsiness, lethargy and mental confusion among adverse reactions reported voluntarily, so it gives no frequency for them [1]. It also warns that excessive diuresis can cause symptomatic dehydration, hypotension and worsening renal function [1].
Is spironolactone allowed in competitive sport?
Not in competitions governed by WADA rules. The 2026 WADA Prohibited List names spironolactone and canrenone in class S5, diuretics and masking agents, prohibited at all times in and out of competition, and a Therapeutic Use Exemption is needed for permitted use [2].
Can I use a potassium-based salt substitute?
The label names potassium-containing salt substitutes as a hyperkalemia risk, along with potassium supplements, ACE inhibitors, ARBs, NSAIDs, heparin, low molecular weight heparin and trimethoprim [1].
Does spironolactone interact with blood pressure pills?
ACE inhibitors and ARBs are on the label's potassium-raising list, and concomitant use with drugs that increase potassium can lead to severe hyperkalemia [1]. The label says to check serum potassium when ACE inhibitor or ARB therapy is altered [1].

References

  1. U.S. National Library of Medicine, DailyMed. Aldactone (spironolactone) tablets, Pfizer prescribing information. Aldactone (spironolactone) tablets, Pfizer label
  2. World Anti-Doping Agency. World Anti-Doping Agency
  3. Santer M, Lawrence M, Pyne S, Renz S, Stuart BL, Sach T, et al. Clinical and cost-effectiveness of spironolactone in treating persistent facial acne in women: SAFA double-blinded RCT. Health Technol Assess. 2024;28(56):1-86. Clinical and cost-effectiveness of spironolactone in treating persistent facial acne in women: SAFA double-blinded RCT
  4. Platt D, Abshagen U, Mühlberg W, Horn HJ, Schmitt-Rüth R, Vollmar J. The influence of age and multimorbidity on the pharmacokinetics and metabolism of spironolactone. Arch Gerontol Geriatr. 1984;3(2):147-59. The influence of age and multimorbidity on the pharmacokinetics and metabolism of spironolactone
  5. Hanlon JT, Aspinall SL, Semla TP, Weisbord SD, Fried LF, Good CB, et al. Consensus guidelines for oral dosing of primarily renally cleared medications in older adults. J Am Geriatr Soc. 2009;57(2):335-40. Consensus guidelines for oral dosing of primarily renally cleared medications in older adults
  6. Tao L, Qu X, Gao H, Zhai J, Zhang Y, Song Y. Polypharmacy and potentially inappropriate medications among elderly patients in the geriatric department at a single-center in China: A retrospective cross-sectional study. Medicine (Baltimore). 2021;100(42):e27494. Polypharmacy and potentially inappropriate medications among elderly patients in the geriatric department at a single-center in China: A retrospective cross-sectional study
  7. Narula HS, Carlson HE. Gynaecomastia--pathophysiology, diagnosis and treatment. Nat Rev Endocrinol. 2014;10(11):684-98. Gynaecomastia--pathophysiology, diagnosis and treatment
  8. Plovanich M, Weng QY, Mostaghimi A. Low Usefulness of Potassium Monitoring Among Healthy Young Women Taking Spironolactone for Acne. JAMA Dermatol. 2015;151(9):941-4. Low Usefulness of Potassium Monitoring Among Healthy Young Women Taking Spironolactone for Acne
Evidence overview for age v2 spironolactone acne: Spironolactone for Acne in Adults 65 and Older: School, Work, and Activity Considerations