Fentanyl

ATC code

N02AB03

Therapeutic class

Opioid · Phenylpiperidine derivative

Forms

transdermal patch

Brand names

Durogesic Matrix (ES) · Duragesic (US) · Durogesic DTrans (FR)

Overall confidence

high

Regulatory sources consulted

AEMPS CIMA FT 61961
https://cima.aemps.es/cima/dochtml/ft/61961/FT_61961.html
CredibleMeds.org
Flockhart Table
PMID:39961534
PMID:38431253
AEMPS CIMA · nº registro 61961 ↗
EMA EPAR · EMEA/H/C/000833 ↗
PubMed PMID:38431253 ↗
PubMed PMID:39832319 ↗
PubMed PMID:39961534 ↗

Approved indications

Management of severe chronic pain in adults that requires continuous, long-term opioid administration.
Management of severe chronic pain in children from 2 years of age who are already receiving opioid therapy.

Contraindications

Absolute

Hypersensitivity to fentanyl or any of the excipients.
Acute or postoperative pain, because dose titration is not possible in short-term use and it could cause severe or life-threatening hypoventilation.
Severe respiratory depression.
Opioid-naïve patients.

Clinical warnings

Boxed warning · Addiction, Abuse, and Misuse: Risk of overdose and death. Assess each patient's risk prior to prescribing and monitor regularly. — FDA
Boxed warning · Life-Threatening Respiratory Depression: Monitor, especially during initiation or following a dose increase. Overdose can occur from accidental exposure. — FDA
Major warning · Concomitant use with CYP3A4 inhibitors: May result in increased fentanyl concentration, which could increase or prolong adverse effects, including fatal respiratory depression. — AEMPS CIMA

Drug interactions

HighRitonavirJ05AE03
Mechanism: Potent inhibition of CYP3A4, the main metabolizing enzyme for fentanyl. This leads to decreased fentanyl clearance and increased plasma concentrations.
Recommendation: Concomitant use is not recommended. If unavoidable, it requires intensive patient monitoring for signs of prolonged or delayed respiratory depression, and a fentanyl dose adjustment may be necessary.
AEMPS CIMA
ModerateSertralineN06AB06
Mechanism: Additive serotonergic effect. Concomitant use of fentanyl with serotonergic agents (SSRIs, SNRIs, MAOIs) may increase the risk of serotonin syndrome.
Recommendation: Monitor the patient for signs and symptoms of serotonin syndrome, especially during treatment initiation and dose adjustments. Discontinue if suspected.
AEMPS CIMA

Adverse events

Common (≥1%)

nausea · vomiting · constipation · somnolence · dizziness · headache · application site reactions

Rare but serious

respiratory depression · serotonin syndrome · paralytic ileus · anaphylaxis · adrenal insufficiency · severe bradycardia

Pregnancy and lactation

FDA category: N/A

Not recommended during pregnancy unless clearly necessary. Prolonged use during pregnancy can cause neonatal withdrawal syndrome. Do not use during labor and delivery. Fentanyl is excreted in human milk; breastfeeding should be discontinued during treatment.

Recent literature (PubMed)

Neuroanesthesiological management of carotid rupture in the endoscopic endonasal approach to the skull base.
Iturri Clavero F, et al. · Rev Esp Anestesiol Reanim (Engl Ed) · 2025 · Relevance 2/5
Presenta recomendaciones clínicas para el manejo neuroanestesiológico de la rotura de la arteria carótida durante la cirugía endoscópica. El fentanilo es un componente clave en la neuroanestesia, por lo que el contexto es relevante para su uso en el ámbito perioperatorio, aunque no se centra en el fármaco en sí.
Diagnosis and treatment of disorders of intracranial pressure: consensus statement of the Spanish Society of Neurology's Headache Study Group.
García-Ull J, et al. · Neurologia (Engl Ed) · 2025 · Relevance 1/5
Documento de consenso sobre el diagnóstico y tratamiento de los trastornos de la presión intracraneal. La relevancia para el fentanilo es indirecta, a través de su posible uso en procedimientos de neurocirugía o manejo del dolor en estos pacientes, pero no es el tema principal.