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U.S. Department of Health and Human Services

Safety

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Prozac Pulvules (fluoxetine hydrochloride) capsules for oral use and Prozac Weekly (fluoxetine hydrochloride) delayed-release capsules

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

Summary View

 

WARNINGS AND PRECAUTIONS

Use in Patients with
  • Concomitant Illness: added text related to cautious use in patients with Acute Narrow-Angle Glaucoma.

ADVERSE REACTIONS

Clinical Trials Experience
  • Added text related to occasional persistence of sexual dysfunction following discontinuation of fluoxetine treatment.
Postmarketing Experience
  • Added the term "memory impairment."