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Onsolis Warnings and Precautions

Specific Precautions and Warnings With Onsolis

Some warnings and precautions to be aware of prior to using this pain medicine include the following:
  • Onsolis should only be used in people who are already taking other opioid narcotics 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 even death, from using this medication.
  • 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.


  • Do not substitute Onsolis for other medications that contain fentanyl. Doing this 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:
  • Onsolis can be dangerous, and may even cause death, if taken by a child. Keep this medication out of the reach of children at all times (see Onsolis Storage and Disposal for more information).
  • Do not share this medication with anyone, even if they seem to have the same symptoms as you. Sharing this medication is against the law and may cause serious problems, including death, in people for whom the medication was not prescribed.
  • Do not drink alcohol while using this medication. Consuming alcohol with Onsolis could increase your risk for serious side effects, including extreme drowsiness, confusion, memory loss, or difficulty breathing.
  • Onsolis is a narcotic opioid medication with a high abuse potential (see Onsolis Abuse). Do not use the drug more frequently or at a higher dose, than prescribed. Store it 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, Onsolis can cause physical dependence. This means you might experience uncomfortable withdrawal symptoms if you suddenly stop using it. If you no longer need to use Onsolis, ask your healthcare provider how to slowly stop using it to reduce your chance of experiencing withdrawal symptoms (see Onsolis Withdrawal for more information).
  • Like all opioids, Onsolis can cause life-threatening breathing problems (called "respiratory depression"). People who have respiratory depression may take slow and shallow breaths, or deep breaths separated by long pauses. Certain people may have an increased risk for respiratory depression with Onsolis, 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 (pressure around the brain). It should only be used with extreme caution in these people.
  • Onsolis 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 Onsolis will affect you. This medication can make you extremely drowsy. Your reflexes and reaction times may be significantly altered, even if you feel fine.
  • This medication comes with a guide that explains in detail the correct way to use it. Make sure to read this guide each time you get your prescription filled, as new information may be available.
  • This medicine passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to beginning treatment (see Onsolis and Breastfeeding).
  • Onsolis is a pregnancy Category C medication. This means that it may not be safe for use during pregnancy, although the full risks are currently unknown (see Onsolis and Pregnancy).
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