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Label Changes for:

Zoloft (sertraline hydrochloride) Tablets and Oral Concentrate

August 2011

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.

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




  • Co-administration of Zoloft with other drugs which enhance the effects of serotonergic neurotransmission, such as tryptophan, fenfluramine, fentanyl, 5-HT agonists, or the herbal medicine St. John’s Wort (hypericum perforatum) should be undertaken with caution and avoided whenever possible due to the potential for pharmacodynamic interaction.



Laboratory Tests
  • False-positive urine immunoassay screening tests for benzodiazepines have been reported in patients taking sertraline. This is due to lack of specificity of the screening tests. False positive test results may be expected for several days following discontinuation of sertraline therapy. Confirmatory tests, such as gas chromatography/mass spectrometry, will distinguish sertraline from benzodiazepines.