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U.S. Department of Health and Human Services

Safety

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Prozac (fluoxetine hydrochloride)

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

Summary View

 

6 ADVERSE REACTIONS

6.2 Other Reactions
  • added balance disorder, bruxism, gynecological bleeding, hypotension
  • added alopecia, dysuria, micturition disorder
  • added depersonalization

 

8 USE IN SPECIAL POPULATIONS

8.1 Pregnancy

Treatment of Pregnant Women during the First Trimester

  • added information about the potential risk of cardiovascular defects in infants exposed during first trimester

 

MEDICATION GUIDE (new)