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Label Changes for:

Zoloft (sertraline hydrochloride) Tablets and Oral Concentrate

February 2013

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) 


February 2013  



Other Events Observed During the Post marketing Evaluation
  • diabetes mellitus


December 2012

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