Label Changes for:

Flexeril (Cyclobenzaprine Hydrochloride) Tablets

April 2013

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

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

 

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…
 
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