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U.S. Department of Health and Human Services

Safety

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Lyrica (pregabalin) capsules and oral solution

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

 

August 2011 

Summary View

 

ADVERSE REACTIONS

Postmarketing Experience
  • Gynecomastia and breast enlargement

 

June 2011

Summary View

 

MEDICATION GUIDE

What is the most important information I should know about Lyrica
  • section revised to furnish adequate information for the safe and effective use of the drug