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U.S. Department of Health and Human Services

Safety

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Lupron Depot (leuprolide acetate for depot suspension), 11.25 mg, Lupron Depot (leuprolide acetate for depot suspension), 3.75 mg

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

 

July 2012

Summary View

ADVERSE REACTIONS

Postmarketing
  • Respiratory, thoracic and mediastinal disorder – Interstitial lung disease

 

 

January 2012 

Summary View

ADVERSE REACTIONS

Postmarketing

Hepato-biliary disorder

  • rarely reported serious liver injury
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