• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail

Paxil (Paroxetine Hydrochloride) Tablets and Oral Suspension

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)



  • Starting Paxil 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


Serotonin Syndrome
  • The development of a potentially life-threatening serotonin syndrome 469 has been reported with SNRIs and SSRIs, including Paxil, 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)…


Serotonin Drugs
  • The concomitant use of Paxil with MAOIs (including Linezolid and intravenous Methylene Blue) is contraindicated…


April 2012

Summary View



Postmarketing Reports
Voluntary reports of adverse events in patients taking Paxil that have been received since market introduction…
  • Stevens-Johnson syndrome (added)