What are the contraindications of fentanyl (opioid analgesic)?

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Last updated: March 28, 2025View editorial policy

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From the Guidelines

Fentanyl is contraindicated in patients with known hypersensitivity to fentanyl or other opioids, significant respiratory depression, severe asthma in unmonitored settings, paralytic ileus, and concurrent use with monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping MAOIs, as well as in patients with severe hepatic or renal impairment, elderly, debilitated patients, and those with adrenal insufficiency or myxedema, due to increased risk of adverse effects and potential for life-threatening complications 1.

Contraindications of Fentanyl

The use of fentanyl is associated with several contraindications that are crucial to consider in order to minimize the risk of adverse effects and ensure patient safety.

  • Patients with known hypersensitivity to fentanyl or other opioids should avoid fentanyl due to the risk of severe allergic reactions 1.
  • Fentanyl should not be used in patients with significant respiratory depression or severe asthma in unmonitored settings, as it can exacerbate respiratory problems and lead to life-threatening complications 1.
  • Patients with paralytic ileus should avoid fentanyl, as it can worsen gastrointestinal motility issues and lead to further complications 1.
  • Concurrent use with monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping MAOIs is contraindicated due to the risk of serotonin syndrome and unpredictable, potentially fatal reactions 1.
  • Fentanyl should be used with extreme caution in patients with head injuries, increased intracranial pressure, or impaired consciousness, as it can further increase intracranial pressure and mask neurological symptoms 1.
  • Patients with severe hepatic or renal impairment require dose adjustments due to altered drug metabolism, and elderly, debilitated patients, and those with adrenal insufficiency or myxedema are at higher risk for adverse effects 1.
  • Fentanyl should be avoided during pregnancy unless clearly needed, as it can cause neonatal withdrawal syndrome and respiratory depression in newborns if used near delivery 1.

Additional Considerations

When prescribing fentanyl, clinicians should consider the potential risks and benefits, as well as alternative treatment options.

  • Fentanyl patches should not be placed under forced air warmers, as this can increase the risk of toxicity 1.
  • Patients with renal insufficiency (GFR <30 mL/min/1.73 m2) and end-stage renal disease (ESRD) should avoid fentanyl, as it can accumulate to toxic levels and persist in the body for longer durations 1.
  • Clinicians should use additional caution when prescribing fentanyl to patients with renal or hepatic dysfunction, and consider a longer dosing interval to minimize the risk of adverse effects 1.

From the FDA Drug Label

Because serious or life-threatening hypoventilation could occur, fentanyl transdermal system is contraindicated: in patients who are not opioid-tolerant in the management of acute pain or in patients who require opioid analgesia for a short period of time in the management of post-operative pain, including use after out-patient or day surgeries, (e.g., tonsillectomies) in the management of mild pain in the management of intermittent pain (e.g., use on an as needed basis [prn]) in situations of significant respiratory depression, especially in unmonitored settings where there is a lack of resuscitative equipment in patients who have acute or severe bronchial asthma Fentanyl transdermal system is contraindicated in patients who have or are suspected of having paralytic ileus Fentanyl transdermal system is contraindicated in patients with known hypersensitivity to fentanyl or any components of this product.

The contraindications of fentanyl (opioid analgesic) are:

  • Non-opioid tolerant patients
  • Management of acute pain
  • Management of post-operative pain
  • Management of mild pain
  • Management of intermittent pain
  • Significant respiratory depression
  • Acute or severe bronchial asthma
  • Paralytic ileus
  • Known hypersensitivity to fentanyl or any components of the product 2 2

From the Research

Contraindications of Fentanyl

The contraindications of fentanyl, an opioid analgesic, include:

  • Respiratory depression, which can be fatal 3, 4, 5
  • Reduced cerebral circulation 3
  • Combination with illicit opioids such as diamorphine (also known as heroin), which can increase the risk of respiratory depression 3
  • Use as a frontline potent opioid due to its significant risks 3
  • Use in patients who are opioid-naive or have not been titrated to a safe dose 6
  • Presence of certain single-nucleotide polymorphisms (SNPs) that may increase the risk of fentanyl-induced respiratory depression 7

Special Considerations

  • Fentanyl should be used with caution in patients who are chronically consuming opioids, as the dose-response relationship for analgesia and respiratory depression may be altered 6
  • A preoperative fentanyl challenge may be useful in individualizing postoperative pain treatment in chronically opioid-consuming patients 6
  • The development of tolerance in the respiratory system can affect the degree of respiratory depression caused by fentanyl 4
  • The effectiveness of naloxone in reversing fentanyl-induced respiratory depression is not well understood 5

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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