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Opioid Analgesic (Short-Acting) Pregnancy: There are no adequate data on use in pregnant women; fentanyl can cross the placenta in early pregnancy and animal studies have shown some reproductive toxicity. Regular use during pregnancy may cause drug dependence in the foetus, leading to neonatal withdrawal symptoms — if prolonged opioid use is required, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure appropriate treatment will be available. Administration during labour may depress respiration in the neonate and an antidote for the child should be readily available. Breast-feeding or use of expressed breast milk is not recommended within 24 hours of treatment.

Fentanyl (IV — Anaesthesia/ICU)

Brand names: Sublimaze

Fentanyl is a potent synthetic opioid used intravenously in anaesthesia and intensive care and, as transdermal patches, for stable chronic severe pain; it is a controlled drug.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Spontaneous respiration: initial 50-200 micrograms, supplemental 50 micrograms. Assisted ventilation: initial 300-3500 micrograms, supplemental 100-200 micrograms. (Doses in excess of 200 micrograms are for use in anaesthesia only.)
Route: Intravenous, either as a bolus or by infusion; intramuscular for premedication
Frequency: Initial dose then supplemental doses titrated to individual patient response
Source: Fentanyl 50 microgram/ml Injection SPC. The dose must be individualised according to age, body weight, physical status, underlying pathological condition, use of other drugs and the type of surgery and anaesthesia. Give only in an environment where the airway can be controlled and by personnel who can control the airway. To avoid bradycardia it is recommended to give a small intravenous dose of an anticholinergic just before anaesthetic induction. PREMEDICATION: 1-2 ml fentanyl (i.e. of the 50 microgram/ml injection) intramuscularly 45 minutes before induction of anaesthesia. In unpremedicated adults, 2 ml intravenously may be expected to provide sufficient analgesia for 10-20 minutes in surgical procedures involving low pain intensity; 10 ml injected as a bolus gives analgesia lasting about one hour, sufficient for moderately painful procedures. A dose of 50 micrograms/kg will provide intense analgesia for some four to six hours for intensely stimulating surgery. INFUSION (exact units as stated in the SPC): in ventilated patients a loading dose may be given as a fast infusion of approximately 1 microgram/kg/min for the first 10 minutes, followed by an infusion of approximately 0.1 micrograms/kg/min; alternatively the loading dose may be given as a bolus. Infusion rates should be titrated to individual patient response and lower infusion rates may be adequate. Unless post-operative ventilation is planned, the infusion should be terminated about 40 minutes before the end of surgery. Lower infusion rates, e.g. 0.05-0.08 micrograms/kg/minute, are necessary if spontaneous ventilation is to be maintained. Higher infusion rates (up to 3 micrograms/kg/minute) have been used in cardiac surgery. ELDERLY/DEBILITATED: the initial dose should be reduced in patients over 65 years and in debilitated patients; the effect of the initial dose should be taken into account when determining supplemental doses. OBESE PATIENTS: risk of overdosing if the dose is calculated on body weight — calculate dosage according to estimated lean body mass. Chemically incompatible with the induction agents pentobarbital sodium, thiopentone and methohexitone (wide pH differences). Before starting opioid treatment, discuss a strategy for ending treatment with the patient to minimise the risk of addiction and drug withdrawal syndrome.

Paediatric dose

Route: intravenous
Frequency: Initial dose, with supplemental doses as required
Max: Not stated in source
dosePerKg is left null because the SPC states a RANGE, not a single value. Children aged 2 to 11 years — spontaneous respiration: initial 1-3 micrograms/kg, supplemental 1-1.25 micrograms/kg; assisted ventilation: initial 1-3 micrograms/kg, supplemental 1-1.25 micrograms/kg. Children aged 12 to 17 years: follow adult dosage. Techniques involving analgesia in a spontaneously breathing child should only be used as part of an anaesthetic technique, or as part of a sedation/analgesia technique with experienced personnel, in an environment that can manage sudden chest wall rigidity requiring intubation or apnoea requiring airway support. US labelling adds that safety and efficacy in paediatric patients under two years of age has not been established.

Dose adjustments

Renal

In patients with renal impairment, reduced dosing of fentanyl should be considered and these patients should be observed carefully for signs of fentanyl toxicity.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

US labelling (FDA)

Reference — US labelling, may differ from UK

• Fentanyl Citrate Injection should be administered only by persons specifically trained in the use of intravenous anesthetics and management of the respiratory effects of potent opioids. • Ensure that an opioid antagonist, resuscitative and intubation equipment, and oxygen are readily available ( 2.1 ). • Individualize dosing based on the factors such as age, body weight, physical status, underlying pathological condition, use of other drugs, type of anesthesia to be used, and the surgical procedure involved. ( 2.1 ) • Initiate treatment in adults with 50 mcg to 100 mcg. ( 2.2 ) • Initiate treatment in children 2 to 12 years of age, with a reduced dose as low as 2 mcg/kg to 3 mcg/kg. ( 2.2 …

Source: US FDA prescribing information (openFDA / DailyMed), label dated 2025-09-24. Accessed 2026-06-12. US dosing and indications can differ from UK practice — use UK sources for prescribing decisions.

Contraindications

  • Hypersensitivity to the active substance, to any of the excipients, or to other opioids
  • Respiratory depression; obstructive airways disease
  • Concurrent administration with monoamine oxidase inhibitors, or within 2 weeks of their discontinuation

Side effects

  • Nausea (26.1%) and vomiting (18.6%)
  • Muscle rigidity, which may also involve the thoracic muscles (10.4%)
  • Hypotension (8.8%) and hypertension (8.8%)
  • Bradycardia (6.1%); also tachycardia and arrhythmia
  • Sedation (5.3%); dizziness, dyskinesia
  • Respiratory depression, apnoea, laryngospasm and bronchospasm; drug withdrawal syndrome and drug dependence

Interactions

  • Monoamine oxidase inhibitors — concurrent use, or use within 2 weeks of discontinuation, is contraindicated (UK SPC section 4.3; the eMC bundle did not include section 4.5)
  • CYP3A4 inhibitors (examples given: macrolide antibiotics such as erythromycin, azole antifungals such as ketoconazole, protease inhibitors) can increase fentanyl plasma concentration, causing increased or prolonged opioid effects — if concomitant use is necessary consider dosage reduction and monitor frequently for respiratory depression and sedation; on stopping the inhibitor, fentanyl concentrations fall, risking reduced efficacy or withdrawal in physically dependent patients (US label section 7)
  • Chemically incompatible in the same line with the induction agents pentobarbital sodium, thiopentone and methohexitone (UK SPC sections 4.2 and 6.2)
  • When a neuroleptic is used with fentanyl, chills and/or shivering, restlessness, postoperative hallucinatory episodes and extrapyramidal symptoms may be observed

Clinical monograph

How it works

It is a potent mu-opioid receptor agonist with rapid onset given intravenously.

Prescribing in practice

  • It is many times more potent than morphine, so dosing errors are dangerous; transdermal patches are only for opioid-tolerant patients with stable pain, not for acute or opioid-naive use.
  • Heat increases absorption from patches (fever or external heat) and can cause overdose.
  • Respiratory depression is the main risk; it causes less histamine release and is often preferred in haemodynamic instability or renal impairment.

Monitoring

Monitor respiratory rate, sedation and pain; with patches review at each change.

Counselling the patient

  • With a patch, avoid heat (hot baths, heat pads) over it and follow the change schedule.
  • Report excessive drowsiness or slow breathing.
  • Dispose of used patches safely — they still contain drug.

Evidence & guidelines

A potent opioid for anaesthesia and intensive care and, as patches, for stable chronic severe pain in opioid-tolerant patients.

Reference: FICM Guidelines on Analgesia/Sedation in ICU; Stoelting's Pharmacology; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.