Spironolactone and persistent hoarseness – a hormonally induced side effect

Spironolactone and persistent hoarseness – a hormonally induced side effect

The antiandrogenic properties of the potassium-sparing diuretic spironolactone can cause side effects that affect the vocal cords, such as hoarseness and potentially persistent changes to voice pitch.

Before starting treatment with spironolactone, the benefits and risks should be carefully weighed up and alternative therapies considered, particularly in people whose voice is particularly important for their work.


Voice changes, hoarseness, hormonally induced side effect, mineralocorticoid receptor antagonist aldosterone receptor antagonist, steroid receptorandrogen receptor, progesterone receptor, potassium-sparing diuretic, antiandrogen, spironolactone, Aldactone, off-label use, androgenetic alopecia, alopecia, gynaecomastia, mastodynia, altered libido, menstrual disorders, erectile dysfunction

Incident data

Description

Year: 2024

Age group: Adult

Gender: Female

Medicinal products: Aldactone®

Active substance(s): spironolactone

Indication: None (off-label use in alopecia)

ADRs: Hoarseness

Outcome: not recovered

A middle-aged female patient received off-label oral spironolactone for diffuse alopecia. A few months after the initial dosage had been increased from 50 mg to 100 mg daily, she developed hoarseness that occurred frequently and primarily when her voice was tired. The patient was not taking other medicines with a temporal relationship to the hoarseness or regular concomitant medication. The hoarseness persisted despite the spironolactone being subsequently and temporarily discontinued.

Summary and recommendation

Spironolactone is authorised for the treatment of arterial hypertension, idiopathic oedema, oedema in heart failure, ascites in liver cirrhosis and primary hyperaldosteronism. Spironolactone is a mineralocorticoid receptor antagonist (aldosterone receptor antagonist), but also has an antagonist effect on other steroid receptors, particularly progesterone and androgen receptors. Thus it has antiandrogenic properties and is used off-label to treat hormonally induced (androgenetic) alopecia, particularly in women.

The medicinal product information for spironolactone lists potentially persistent voice changes, for example in the form of hoarseness – and also deepening of voice pitch in women – as adverse drug reactions (frequency unknown). The pathophysiological cause of this hormonally induced ADR is spironolactone's non-selective, dose-dependent effect on several steroid receptors. Other hormonally induced adverse reactions of spironolactone include gynaecomastia, mastodynia, altered libido, menstrual disorders and erectile dysfunction.

If patients taking spironolactone experience hoarseness or voice changes that persist, as in the case above, other causes apart from a possible side effect should be considered and investigated more closely if necessary.

Statutory duty of healthcare professionals to report adverse drug reactions (ADRs)

In Switzerland, healthcare professionals who are authorised to dispense or administer medicinal products are obligated to report severe and/or previously unknown side effects. Reports to Swissmedic can be entered and sent in the Electronic Vigilance Reporting Portal “ElViS” (ElViS login).

Supplementary information

Medicinal product information (spironolactone)