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Label Changes for:

Lyrica (pregabalin) Capsules and Oral Solution

August 2011

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

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


August 2011 



Postmarketing Experience
  • Gynecomastia and breast enlargement


June 2011



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