Your safety is our first priority. Learn more about key medication details, possible side effects, warnings, and other important information about topical spironolactone 5% below.
Prescribing Information
Topical spironolactone 5% is a compounded anti-androgen formulation that may be prescribed for selected skin or hair concerns. It is not FDA-approved as a topical finished drug product. No FDA-approved label establishes its systemic absorption, dosing, safety, or effectiveness.
Black Box Warning
Topical spironolactone does not have an FDA-approved boxed warning because it is not an approved finished drug product. Oral spironolactone labeling includes serious potassium, kidney, blood-pressure, and pregnancy precautions that may be relevant if systemic absorption occurs.
Common Side Effects
Common or possible side effects may include:
- Skin dryness
- Redness
- Burning or stinging
- Itching
- Peeling
- Local swelling
- Dizziness
- Breast tenderness
- Menstrual changes
Important Safety Information
Do not use topical spironolactone if you are allergic to spironolactone or an ingredient in the formulation. Avoid use during pregnancy unless your clinician specifically determines otherwise because anti-androgen exposure may affect fetal development.
Tell your provider about kidney disease, high potassium, Addison’s disease, low blood pressure, heart disease, or use of potassium supplements, ACE inhibitors, ARBs, trimethoprim, oral spironolactone, or other medications that raise potassium.
Apply only to intact skin and avoid the eyes, lips, mucous membranes, and unintended transfer. Systemic side effects may be more likely with large application areas, damaged skin, high frequency, or occlusion.
Stop use and seek medical guidance for severe irritation, muscle weakness, irregular heartbeat, fainting, facial swelling, or trouble breathing.
To report suspected adverse reactions, contact the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
