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U.S. Department of Health and Human Services


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Fentora (fentanyl buccal tablets)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – July 2011


Summary View

MEDICATION GUIDE (new, as part of approved REMS)

  • We have also determined that FENTORA (fentanyl buccal tablets) can remain on the market only if elements necessary to assure safe use are required as part of a REMS to mitigate the risks of overdose, abuse, addiction, and serious complications due to medication errors that are listed in the labeling. The elements to assure safe use will provide for the education of prescribers and patients so that they are aware of the risks associated with the use of FENTORA and about important information regarding how to use the product safely to help prevent the serious adverse effects noted above. The elements will also assure proper patient selection and dispensing of FENTORA (fentanyl buccal tablets).