Fentanyl
Fentanyl is a highly potent synthetic opioid analgesic used primarily for the management of severe pain, particularly breakthrough cancer pain and perioperative analgesia. It acts as a full opioid agonist, binding primarily to mu receptors in the brain and spinal cord to produce profound analgesia and sedation. Due to its high potency (50-100 times stronger than morphine), it is classified as a Schedule II controlled substance and is typically administered only in supervised clinical settings.
Fentanyl is an extremely potent opioid analgesic used for severe pain management, operating as an opioid agonist with significant risks requiring clinical supervision.
This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.
Key facts at a glance
- ATC
- N01AH01
- RxNorm
- 4337
- Generic
- Fentanyl
- Class
- atc-n01
- Brands
- Abstral, Subsys, Ionsys, Actiq, Fentora
- Availability
- rx
- Lactation
- unknown
- Routes
- sublingual, oral
- Forms
- prefilled syringe, injection, tablet, spray
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 25-100 mcg/hour
- Maximum
- consult physician
- Frequency
- every 72 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 200-800 mcg
- Maximum
- consult physician
- Frequency
- as needed, every 4 hours maximum
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 25 mcg/hour
- Maximum
- consult physician
- Frequency
- every 72 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
9 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks to the mother
regular fetal monitoring, assess uterine activity
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
third trimesteravoid if possible
avoid use near delivery due to risk of neonatal respiratory depression
continuous fetal monitoring, assess for neonatal withdrawal
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
breastfeedingavoid or discontinue breastfeeding
avoid breastfeeding during fentanyl treatment and for at least 4 days (96 hours) after last dose due to excretion in breast milk
monitor infant for excessive sedation, respiratory depression, feeding difficulties
Use with caution and monitor for adverse effects.
geriatric
elderly 65plusreduce initial dose by 25-50%
start with lowest effective dose, titrate slowly, use caution with repeated dosing due to increased sensitivity and reduced clearance
close monitoring of respiratory and cardiac function, assess for sedation and confusion
Use with caution and monitor for adverse effects.
pediatric_age
children 2 12 yearsweight-based dosing only for opioid-tolerant patients
use only in opioid-tolerant children for breakthrough pain, contraindicated for opioid-naive pediatric patients
continuous respiratory monitoring required, observe for signs of respiratory depression
Use with caution and monitor for adverse effects.
pediatric_age
adolescents 12 17 yearsuse adult dosing with caution, weight-based for opioid-tolerant
reserve for opioid-tolerant adolescents, avoid in opioid-naive patients
monitor respiratory status closely, assess for misuse potential
Use with caution and monitor for adverse effects.
renal_impairment
severe creatinine clearance below 30reduce dose by 25-50%, extend dosing interval
use with caution in severe renal impairment; consider dose reduction and extended intervals
monitor for accumulation of metabolites and signs of toxicity, check renal function regularly
Use with caution and monitor for adverse effects.
hepatic_impairment
moderatereduce dose by 50%
use with caution in moderate hepatic impairment, start with reduced dose
monitor for prolonged sedation and respiratory depression, assess liver function
Use with caution and monitor for adverse effects.
hepatic_impairment
severeavoid or use with extreme caution at very low doses
use only if benefits clearly outweigh risks; avoid in severe hepatic impairment due to significantly reduced metabolism
intensive monitoring for respiratory depression, sedation, and drug accumulation
Use of this medication in this population requires careful consideration of risks and benefits.
Statistics and clinical data
Commonly prescribed since
General prescribing information
Drug class
Drug class information
Common uses
Common therapeutic uses
Management of severe pain including breakthrough cancer pain, perioperative analgesia, induction and maintenance of general anesthesia, and sedation during medical procedures. Also used for chronic pain management in opioid-tolerant patients via transdermal patches.
Fentanyl binds to and activates mu-opioid receptors throughout the central nervous system, particularly in brain regions involved in pain perception. This activation inhibits pain transmission pathways and produces analgesia, sedation, and euphoria. Its high lipid solubility allows for rapid onset of action.
Carries black box warnings for addiction, abuse, misuse, life-threatening respiratory depression, and accidental exposure. Contraindicated in opioid-naive patients for non-intravenous routes. Should not be discontinued abruptly after prolonged use. Requires careful dose titration and monitoring, particularly during initiation and dose adjustments. Keep out of reach of children; even single doses can be fatal.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy