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Precautions and Warnings With Fentanyl Sublingual Spray

Before starting treatment with fentanyl sublingual spray, be aware that this medication can cause adverse effects, such as a slow heart rate or potentially life-threatening breathing problems. Other precautions and warnings with fentanyl sublingual spray involve the dangers of overdosing on this drug and the potential risks of using it while pregnant or breastfeeding.

What Should I Tell My Healthcare Provider?

Talk with your healthcare provider prior to using fentanyl sublingual spray (Subsys®) if you have:
  • A history of drug or alcohol dependence or abuse
  • Liver disease, such as cirrhosis, liver failure, or hepatitis
  • Kidney disease, such as kidney failure (renal failure)
  • A history of breathing problems, asthma, chronic obstructive lung disease (COPD), or other lung disease
  • A head injury, brain tumor, or increased pressure around the brain
  • Ever had a seizure
  • A slow heart rate or other heart problems
  • Low blood pressure (hypotension)
  • Any allergies, including to foods, dyes, or preservatives.
Also, let your healthcare provider know if you are:
  • Breastfeeding
  • Pregnant or thinking of becoming pregnant.
Make sure to tell your healthcare provider about any other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Specific Fentanyl Sublingual Spray Precautions and Warnings

Some warnings and precautions to be aware of prior to using 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 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.


  • Doses of fentanyl sublingual spray are not equivalent to doses of other fentanyl-containing medications. The initial dose of fentanyl sublingual spray should be 100 mcg, even in people who are already taking another fentanyl medication. Starting fentanyl sublingual spray at a higher dose could cause an overdose.
  • Fentanyl sublingual spray should not be substituted for any other medication that contains fentanyl. Substituting fentanyl sublingual spray for another fentanyl product could result in an overdose.
  • Fentanyl sublingual spray could cause serious problems, including death, if taken by a child or someone for whom the medication was not prescribed. Do not share this medication with anyone. Store it in a safe place to help prevent theft or accidental ingestion by someone else (see Subsys Storage and Disposal for more information).
  • Do not drink alcohol while using this medication. Consuming alcohol with fentanyl sublingual spray could be dangerous, potentially causing extreme drowsiness, confusion, memory loss, or difficulty breathing.
  • Fentanyl sublingual spray is a narcotic opioid medication with a significant potential for abuse (see Subsys Abuse). Do not use the drug more frequently or at a higher dose than prescribed. If you think you may be developing a problem with fentanyl sublingual spray abuse, please seek help from a healthcare provider.
  • Like all narcotics, fentanyl sublingual spray can cause physical dependence, which means you may experience uncomfortable withdrawal symptoms if you suddenly stop using it. If you no longer need this medication, talk to your healthcare provider about the best way to stop using it (see Subsys Withdrawal for more information).
  • Like all opioids, fentanyl sublingual spray 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 fentanyl sublingual spray, 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 these cases.
  • Fentanyl sublingual spray 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 fentanyl sublingual spray affects you. Fentanyl sublingual spray can make you extremely drowsy. Your reflexes and reaction times may be significantly altered, even if you feel fine.
  • Fentanyl sublingual spray comes 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 sublingual spray passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to using the drug (see Subsys and Breastfeeding).
  • Fentanyl sublingual spray 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 Subsys and Pregnancy).
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