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A plain-language summary of the cited sources below. Informational only — not medical advice.
Fentanyl is a powerful opioid painkiller that works very quickly and wears off relatively quickly compared to many other pain medicines. It attaches to specific sites in the brain and spinal cord to block pain signals and produce sedation. The body breaks fentanyl down mainly through a liver enzyme called CYP 3A4, which means other medications that affect this enzyme can change how fentanyl works or how long it stays in the system.
Doctors prescribe fentanyl for severe pain that other painkillers haven't controlled, including breakthrough pain in people already taking regular opioids, and chronic severe pain. It's also used during and after surgery—for example, as part of anaesthesia, before an operation to help someone relax, or in recovery rooms when pain relief is needed urgently. Sometimes it's given alongside other medications during anaesthesia.
Fentanyl is not prescribed for long-term non-cancer pain. It should not be used in children under two years old, in people with severe breathing problems or bronchial asthma, or in anyone who has taken a type of antidepressant called an MAO inhibitor in the past two weeks. People with myasthenia gravis, a condition that causes muscle weakness, should not take fentanyl because it can cause muscle rigidity that may need reversing with other drugs that worsen myasthenia gravis. Anyone with a known allergy to fentanyl or other opioids should not take it.
Common side effects include nausea, vomiting, and muscle stiffness (sometimes in the chest, which can affect breathing). Blood pressure may drop or, less commonly, rise. Serious risks include severe allergic reactions, breathing that becomes dangerously slow or stops, seizures, loss of consciousness, and cardiac arrest. Because fentanyl is very potent and can suppress breathing, it requires close medical supervision, especially when first started or when the dose is changed.
Breakthrough pain Clinical criteria: Treatment Phase: Initial treatment for dose titration Patient must have cancer, AND Patient must have pain directly attributable to cancer, AND Patient must be assessed as receiving adequate management of their persistent pain with opioids, AND Patient must have previously experienced inadequate pain relief following adequate doses of short acting opioids for the treatment of breakthrough pain; OR The treatment must be used as short acting opioids are considered clinically inappropriate; OR Patient must have previously experienced adverse effects following the use of short acting opioids for breakthrough pain. Treatment criteria: Patient must be undergoing palliative care.
“Fentanyl is a potent opioid analgesic with a rapid onset and short duration of action. The principal actions of therapeutic value are analgesia and sedation.”
“After intravenous injection, fentanyl plasma concentrations fall rapidly, with sequential distribution half-lives of 1 minute and 18 minutes and a terminal elimination half-life of 475 minutes.”
A plain-language summary of the cited sources below. Informational only — not medical advice.
Fentanyl is a potent phenylpiperidine opioid analgesic with rapid onset and short duration of action, exerting its principal therapeutic effects through analgesia and sedation. TGA-approved indications span perioperative contexts—analgesic supplement during general and regional anaesthesia, premedication, induction, maintenance, and immediate postoperative analgesia—as well as breakthrough pain, severe disabling pain, and chronic severe disabling pain. Administration with a neuroleptic such as droperidol for premedication and induction is also approved. Fentanyl is contraindicated for chronic non-cancer pain.
After intravenous administration, plasma concentrations decline rapidly with distribution half-lives of 1 minute and 18 minutes and a terminal elimination half-life of 475 minutes. Fentanyl undergoes oxidative N-dealkylation predominantly via CYP3A4 to the inactive metabolite norfentanyl; concurrent use of CYP3A4 inhibitors or inducers may alter fentanyl exposure. Contraindications include known intolerance to fentanyl or other opioids, bronchial asthma, severe or acute respiratory disease, children under two years, concurrent or recent MAO inhibitor use (within 14 days), and myasthenia gravis. Common adverse effects include nausea, vomiting, muscle rigidity (including thoracic musculature), and blood-pressure fluctuations; serious risks encompass respiratory depression, cardiac arrest, convulsions, loss of consciousness, and anaphylactic reactions.
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Severe disabling pain Clinical criteria: Patient must not be opioid naive, AND Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; OR Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance. Treatment criteria: Patient must be undergoing palliative care. Authority requests for treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia. Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).
Chronic severe disabling pain Clinical criteria: Treatment Phase: Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months The condition must require daily, continuous, long term opioid treatment, AND Patient must not be opioid naive, AND Patient must have cancer pain; OR Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; OR Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance. Treatment criteria: Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner. Authorities for increased maximum quantities and/or repeats under this restriction must only be considered for chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months. Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia. Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).
Curated subset. The full adverse-effect list is in the TGA Product Information; click any citation above to open it.
“In humans, in vitro experiments have demonstrated that fentanyl is metabolised mainly by cytochrome P450 3A4 (CYP 3A4) to norfentanyl via oxidative N-dealkylation.”