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Precautions and Warnings With Fentanyl Buccal Tablets

Specific Fentanyl Buccal Tablets Precautions and Warnings

Some warnings and precautions to be aware of prior to taking this pain medicine include the following:
  • This medication should only be used in people who are already taking scheduled, around-the-clock opioids and are tolerant to their effects (which means the body has gotten used to the opioid). People who are not opioid tolerant may experience life-threatening breathing problems, or death, from even small doses of fentanyl buccal tablets.
  • Do not substitute fentanyl buccal tablets for other medications that contain fentanyl. Substituting these tablets for another fentanyl product could result in an overdose, as the doses used in these medications are not the same. Other products that contain fentanyl include but are not limited to:


  • Because it has a high risk for abuse and overdose, this medication is only available through a special program called the Transmucosal Immediate-Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) program. You, your healthcare provider, and your pharmacy must be enrolled in the program before you can receive this medication. Your healthcare provider and pharmacy will help you enroll in the program. For inpatient use (such as within a hospital), only the pharmacy (not the prescriber or the patient) needs to be enrolled. 
  • The amount of fentanyl in one tablet is enough to cause serious problems, including death, if taken by a child. Store this medication in a safe place, away from children (see Fentora Storage and Disposal for more information).
  • Some people may experience mouth pain, irritation, or sores at the application site (the area of the mouth where the tablet is placed). These problems are more likely to occur when the medication is first started. Talk to your healthcare provider if you get any mouth irritation or sores while using this medication.
  • Normally, you should not place more than one fentanyl buccal tablet in your mouth at a time, unless your healthcare provider is trying to find the best dose to treat your pain. Once an effective dose is established, use only one tablet at a time, and no more than two (30 minutes apart) for each breakthrough pain episode.
  • Do not drink alcohol while using this medication. Consuming alcohol with fentanyl buccal tablets could increase your risk for serious side effects, including extreme drowsiness, confusion, memory loss, or difficulty breathing.
  • Fentanyl buccal tablets may cause serious problems, including death, if used in people for whom the medication was not prescribed. Do not share this medication with someone else, even if they seem to have the same symptoms as you.
  • Fentanyl buccal tablets are a narcotic opioid medication with a significant potential for abuse (see Fentora Abuse). Do not take the drug more frequently, or at a higher dose, than prescribed. Store the tablets in a safe place to prevent theft. If you think you may be developing a problem with abusing this drug, please seek help from a healthcare provider.
  • Like other narcotics, fentanyl buccal tablets can cause physical dependence. This means that you might experience uncomfortable withdrawal symptoms if you suddenly stop taking the medication. If you no longer need to use the tablets, ask your healthcare provider how to slowly stop taking them, to reduce your chance of experiencing withdrawal symptoms (see Fentora Withdrawal for more information).
  • Fentanyl buccal tablets can cause potentially life-threatening slow and irregular breathing (known medically as respiratory depression). Certain people have an increased risk for respiratory depression with fentanyl buccal tablets, including:
    • Older adults
    • People who already have breathing difficulties
    • People who are not tolerant to opioids
    • People who are taking certain other medications.
  • This medication may be particularly dangerous for people with head injuries or high intracranial pressure. It should only be used with extreme caution in such circumstances.
  • Fentanyl buccal tablets can cause a slow heart rate (bradycardia) and should be used with caution in people who already have a very slow heart rate.
  • Do not drive or operate heavy machinery until you know how this pain medicine affects you. Fentanyl buccal tablets can make you extremely drowsy. Your reflexes and reaction times may be significantly altered, even if you feel fine.
  • Fentanyl buccal tablets come with a medication guide that describes the correct way to use it. Make sure to read this medication guide each time you get your prescription filled, as new information may be available.
  • Fentanyl buccal tablets pass through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see Fentora and Breastfeeding).
  • Fentanyl buccal tablets are a pregnancy Category C medication. This means that they may not be safe for use during pregnancy, although the full risks are currently unknown (see Fentora and Pregnancy).
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Fentanyl Buccal Tablet Information

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