Remeron and Remeron SolTab (mirtazapine) tablets and orally disintegrating tablets

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

December 2015

Summary View


Other Adverse Events Observed During Postmarketing Evaluation of REMERON section:
  • Increased creatine kinase blood levels and rhabdomyolysis have also been reported 


October 2012

Summary View 


  • Starting Remeron 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 


  • There may be circumstances when it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking Remeron. Remeron should be discontinued before initiating treatment with the MAOI. 


Who should not take Remeron?
Do not take Remeron
  • Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid. 


Page Last Updated: 01/13/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English