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U.S. Department of Health and Human Services

Safety

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Flexeril (Cyclobenzaprine Hydrochloride) Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2013

Summary View

 

WARNINGS

  • Serotonin Syndrome - The development of a potentially life-threatening serotonin syndrome has been reported with Flexeril when used in combination with other drugs, such as selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), Tramadol, Bupropion, Meperidine, Verapamil, or MAO inhibitors…
 

PRECAUTIONS

Information for Patients
  • Patients should be cautioned about the risk of serotonin syndrome with the concomitant use of Flexeril and other drugs, such as SSRIs, SNRIs, TCAs, Tramadol, Bupropion, Meperidine, Verapamil, or MAO inhibitors. Patients should be advised of the signs and symptoms of serotonin syndrome, and be instructed to seek medical care immediately if they experience these symptoms.
Drug Interactions
  • Flexeril may have life-threatening interactions with MAO inhibitors…
 

ADVERSE REACTIONS

Nervous System and Psychiatric
  • ...serotonin syndrome.