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U.S. Department of Health and Human Services


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Sarafem (fluoxetine hydrochloride) Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- April 2009


The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.

Summary View


Sections Modified

Summary of Changes to Contraindications and Warnings


Risk of neuroleptic malignant syndrome associated with use of selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs)



  • Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-Like Reactions
    • The development of a potentially life-threatening serotonin syndrome, or Neuroleptic Malignant Syndrome (NMS)-like reactions, has been reported with SNRIs and SSRIs alone, including Sarafem treatment, but particularly with concomitant use of serotonergic drugs (including triptans)...



  • Other Events Observed in US Clinical Trials/ Body as a Whole
    • Rare: neuroleptic malignant syndrome