Aim: To evaluate the maternal, fetal and neonatal safety of eplerenone exposure during pregnancy and lactation.
Background: Eplerenone (selective mineralocorticoid receptor antagonist) is used to treat resistant hypertension, primary hyperaldosteronism and heart failure. Evidence regarding its safety during pregnancy and lactation remains limited.
Methods: A retrospective matched case-control study was conducted within South Western Sydney Local Health District. Women exposed to eplerenone before, during or after pregnancy between January 2015 – February 2026 were compared with matched controls receiving conventional antihypertensive therapy in pregnancy. Controls were matched for age, body mass index, parity, medical history and booking blood pressure. Data were from electronic medical records. Primary outcome was composite adverse neonatal outcomes comprising perinatal death and/or major congenital anomaly. Secondary outcomes included maternal, pregnancy, and neonatal outcomes.
Results: 72 women (36 eplerenone,36 controls) and 76 infants were included. Maternal characteristics were comparable between groups (p>0.05). The most common indication for eplerenone was suspected/confirmed primary hyperaldosteronism (69.4%). Median exposure duration was 348 days (IQR136–544), with median maximum dose of 50mg/day (IQR25–100). Eplerenone was most initiated preconception (36.1%), and 86.1% of women continued during breastfeeding. There was no difference in congenital anomalies, fetal death or oligohydramnios (p=1.00). Gestational age at delivery, birthweight percentile, Apgar scores, and maternal outcomes were comparable, although maternal length of stay was longer in the eplerenone group (median 7 [IQR 5–9] vs 5 [IQR 4–7]days, p=0.009).
Conclusion: Eplerenone exposure during pregnancy and lactation was not associated with increased adverse maternal, fetal, or neonatal outcomes compared with matched controls.