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U.S. Department of Health and Human Services

Safety

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Aldactone (spironolactone)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – September 2011

 

Summary View

ADVERSE REACTIONS

  • Skin: Stevens-Johnson Syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS).