The Basics
What is Spironolactone?
Used to treat certain patients with hyperaldosteronism; low potassium levels; heart failure; and used in patients with fluid retention caused by various conditions, including liver, or kidney disease. It is also used alone or with other medications to treat high blood pressure.
Brand names for Spironolactone
Aldactone
How Spironolactone is classified
Antihypertensive Agents, Diuretics
Spironolactone During Pregnancy
Spironolactone pregnancy category
Category Not AssignedNote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.
What we know about taking Spironolactone while pregnant
Teratogenic Effects Teratology studies with ALDACTONE have been carried out in mice and rabbits at doses of up to 20 mg/kg/day. On a body surface area basis, this dose in the mouse is substantially below the maximum recommended human dose and, in the rabbit, approximates the maximum recommended human dose. No teratogenic or other embryotoxic effects were observed in mice, but the 20 mg/kg dose caused an increased rate of resorption and a lower number of live fetuses in rabbits. Because of its antiandrogenic activity and the requirement of testosterone for male morphogenesis, ALDACTONE may have the potential for adversely affecting sex differentiation of the male during embryogenesis. When administered to rats at 200 mg/kg/day between gestation days 13 and 21 (late embryogenesis and fetal development), feminization of male fetuses was observed. Offspring exposed during late pregnancy to 50 and 100 mg/kg/day doses of ALDACTONE exhibited changes in the reproductive tract including dose-dependent decreases in weights of the ventral prostate and seminal vesicle in males, ovaries and uteri that were enlarged in females, and other indications of endocrine dysfunction, that persisted into adulthood. There are no adequate and well-controlled studies with ALDACTONE in pregnant women. ALDACTONE has known endocrine effects in animals including progestational and antiandrogenic effects. The antiandrogenic effects can result in apparent estrogenic side effects in humans, such as gynecomastia. Therefore, the use of ALDACTONE in pregnant women requires that the anticipated benefit be weighed against the possible hazards to the fetus.
Taking Spironolactone While Breastfeeding
What are recommendations for lactation if you're taking Spironolactone?
Spironolactone appears acceptable to use during breastfeeding.
Maternal / infant drug levels
Spironolactone appears acceptable to use during breastfeeding.
Possible effects of Spironolactone on milk supply
Intense diuresis can suppress lactation;[4][5] however, it is unlikely that spironolactone alone is sufficiently potent to cause this effect. Spironolactone can also cause gynecomastia.[6]
Possible alternatives to Spironolactone
List of References
Lactation sources: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/1. Phelps DL, Karim A. Spironolactone: relationship between concentrations of dethioacetylated metabolite in human serum and milk. J Pharm Sci. 1977;66:1203. PMID: 894512
2. Gutgesell M, Overholt E, Boyle R. Oral bretylium tosylate use during pregnancy and subsequent breastfeeding: a case report. Am J Perinatol. 1990;7:144-5. PMID: 2331276
3. Reisman T, Goldstein Z. Case report: Induced lactation in a transgender woman. Transgend Health. 2018;3:24-6. PMID: 29372185
4. Healy M. Suppressing lactation with oral diuretics. Lancet. 1961;1:1353-4.
5. Cominos DC, Van Der Walt A, Van Rooyen AJ. Suppression of postpartum lactation with furosemide. S Afr Med J. 1976;50:251-2. PMID: 3858
6. Bowman JD, Kim H, Bustamante JJ. Drug-induced gynecomastia. Pharmacotherapy. 2012;32:1123-40. PMID: 23165798
Disclaimer: This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Consult your healthcare provider with any questions.
