Label Changes for:

Aldactone (spironolactone) Tablets

June 2013

Changes have been made to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – June 2013



  • Addison’s disease or other conditions associated with hyperkalemia, and with concomitant use of eplerenone.