ArticleCureus2026
Sex-Specific Safety Signals of Finerenone Versus Spironolactone: Insights From the FDA Adverse Event Reporting System.
Article in Cureus, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSpironolactone, a non-selective mineralocorticoid receptor antagonist (MRA), frequently causes off-target hormonal effects in women. Finerenone, a selective non-steroidal MRA, may mitigate these effects, but real-world comparative data remain scarce.
objectiveThis study aimed to compare adverse event reporting profiles of finerenone and spironolactone in female patients using the FDA Adverse Event Reporting System (FAERS).
methodsWe conducted a retrospective disproportionality analysis using FAERS data (January 2022-March 2026), identifying female primary suspect reports for finerenone (N = 715) and spironolactone (N = 4,651). Reporting odds ratios (ROR) with 95% confidence intervals were calculated across reproductive, endocrine, skin, and psychiatric domains. Hyperkalemia served as a positive control.
resultsFinerenone reporters were significantly older than spironolactone reporters (350 (75.9%) vs. 2,329 (59.9%) aged 65 years and older; p < 0.0001). Spironolactone demonstrated disproportionately higher reporting across all assessed domains compared to finerenone: reproductive (ROR 0.15, 95% CI 0.06-0.39), endocrine (ROR 0.20, 95% CI 0.07-0.58), psychiatric (ROR 0.26, 95% CI 0.16-0.43), and skin disorders (ROR 0.45, 95% CI 0.32-0.65). Hyperkalemia showed no directional signal (ROR 1.12, 95% CI 0.87-1.45). Notable individual spironolactone signals included polycystic ovaries, hypothyroidism, depression, and confusion.
conclusionsSpironolactone generates substantially more spontaneous reports of hormonal, dermatological, and psychiatric adverse events in women than finerenone. While indication confounding and age differences limit direct causal inference, these reporting patterns align with finerenone's enhanced receptor selectivity. The persistent psychiatric signal for spironolactone warrants further investigation.
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