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U.S. Department of Health and Human Services


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Tramadol hydrochloride tablets

  • Ultracet (tramadol HCl/acetaminophen) tablets
  • Ultram (tramadol hydrochloride) tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- September 2009


Summary View



Serotonin Syndrome Risk
  • The development of a potentially life-threatening serotonin syndrome may occur with the use of tramadol products...


Information for Patients
  • Patients should be informed that tramadol may cause seizures and/or serotonin syndrome with concomitant use of serotonergic agents (including SSRIs, SNRIs, and triptans) or drugs that significantly reduce the metabolic clearance of tramadol.