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U.S. Department of Health and Human Services


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Lexapro (escitalopram oxalate) tablets and oral solution

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


December 2012

Summary View


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



Monoamine Oxidase Inhibitors (MAOIs)
  • The use of MAOIs intended to treat psychiatric disorders with Lexapro or within 14 days of stopping treatment with Lexapro is contraindicated because of an increased risk of serotonin syndrome. The use of Lexapro within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated…


Serotonin Syndrome
  • The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including Lexapro, 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 2011 

Summary View



ECG Changes
  • new QTc language