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U.S. Department of Health and Human Services

Safety

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Zoloft (sertraline hydrochloride) Tablets and Oral Concentrate

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

 

February 2013  

Summary View

 

ADVERSE REACTIONS

Other Events Observed During the Post marketing Evaluation
  • diabetes mellitus

 

December 2012

Summary View

(Serotonin Toxicity associated with co-administration with Linezolid and Methylene Blue)
 

CONTRAINDICATIONS

  • Starting Zoloft in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome…
 

WARNINGS

Serotonin Syndrome:
  • The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including Zoloft, alone but particularly with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, Fentanyl, Lithium, Tramadol, Tryptophan, Buspirone, and St. John’s Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue)…
 
 
March 2008
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.


 

Summary View

Sections Modified

PRECAUTIONS

  • Abnormal Bleeding
  • Information for Patients
  • Drug Interactions
    • Drugs That Interfere With Hemostasis (Non-selective NSAIDs, Aspirin, Warfarin, etc.)