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Fentanyl

Actiq, Durogesic, Fentabucc Akut, Fentanyl · ATC code N02AB03

Also known as: Fentanil, Fentanilo, Fentanyl Citrate · Brand names: Abstral, Actiq, Durogesic Smat, Fenta Regiomedica Matrix, Fentamat, Fentamedica Matrix, Fentapatch Matrix, Fentapon, Fentaristo, Fentavera, Fentinal, Fenylat, Matrifen, Matrix, Tts …

Key facts
Active substance
Fentanyl
Drug class
Opioid
ATC code
N02AB03
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-11-06

Boxed warning

Addiction, Abuse, and Misuse

Because the use of Fentanyl Citrate Injection exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.1)].

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of Fentanyl Citrate Injection especially during initiation or following a dosage increase‎. To reduce the risk of respiratory depression, proper dosing and titration of Fentanyl Citrate Injection are essential [see Warnings and Precautions (5.2)].

Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of Fentanyl Citrate Injection and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see Warnings and Precautions (5.3), Drug Interactions (7)].

Cytochrome P450 3A4 Interaction

The concomitant use of Fentanyl Citrate Injection with all cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in fentanyl plasma concentration. Monitor patients receiving Fentanyl Citrate Injection and any CYP3A4 inhibitor or inducer [see Warnings and Precautions (5.4) , Drug Interactions (7), Clinical Pharmacology (12.3)].

Key facts

Fentanyl is a potent, short-acting opioid agonist. Per the US label the fentanyl citrate injection (50 mcg/mL) is used as an analgesic during and after anaesthesia and as an anaesthetic adjunct or agent.

What it is used for

  • Short-acting analgesia during anaesthetic premedication, induction, maintenance and in the immediate postoperative period
  • Opioid analgesic supplement in general or regional anaesthesia; with a neuroleptic as premedication and anaesthetic adjunct
  • Anaesthetic agent with oxygen in selected high-risk patients, such as open heart surgery

Dosing

  • Only by staff trained in intravenous anaesthetics; naloxone or nalmefene, intubation equipment and oxygen must be at hand
  • Premedication in adults: 50 to 100 mcg intramuscularly 30 to 60 minutes before surgery
  • Adjunct to general anaesthesia: low dose 2 mcg/kg; moderate 2–20 mcg/kg; high 20–50 mcg/kg (open heart and complex neurosurgical or orthopaedic surgery, postoperative ventilation expected)
  • Adjunct to regional anaesthesia or recovery room: 50 to 100 mcg intramuscularly or slowly intravenously; may be repeated in one to two hours
  • Children 2 to 12 years: a reduced dose as low as 2 to 3 mcg/kg
  • As a general anaesthetic with oxygen and a muscle relaxant: 50 to 100 mcg/kg, in some cases up to 150 mcg/kg

Contraindications

  • Hypersensitivity to fentanyl (e.g. anaphylaxis)

Important warnings

  • Boxed warning: addiction, abuse and misuse; life-threatening respiratory depression; profound sedation, coma and death with benzodiazepines or other CNS depressants; CYP3A4 inhibitors raise fentanyl levels
  • Respiratory depression can outlast the analgesic effect
  • Muscle rigidity, including of the respiratory muscles, related to dose and injection speed
  • Severe bradycardia and hypotension, especially with hypovolaemia or other CNS depressants
  • Serotonin syndrome with serotonergic drugs; adrenal insufficiency; opioid-induced hyperalgesia; caution with raised intracranial pressure

Side effects

  • Respiratory depression, apnoea, rigidity, bradycardia
  • Hypotension, nausea, vomiting
  • Dizziness, blurred vision, laryngospasm, pruritus

Interactions

  • CYP3A4 inhibitors increase, and stopping CYP3A4 inducers can increase, fentanyl concentrations
  • Benzodiazepines, other CNS depressants and alcohol: profound sedation, respiratory depression, coma, death
  • Serotonergic drugs (SSRIs, SNRIs, tricyclics, triptans, MAO inhibitors): serotonin syndrome
  • Phenothiazines and general anaesthetics: severe hypotension

Pregnancy and breastfeeding

  • Prolonged opioid use in pregnancy may cause neonatal opioid withdrawal syndrome; data on birth defects are insufficient
  • Present in breast milk; effects on the breastfed infant are not established

Summary of the official product information, written with AI on 2026-11-14. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Patient information (US)

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Germany

  • AbstralGrünenthal Gmbh, Pb Pharma Gmbh · 2 register entries
  • ActiqPhoenix Labs, Pb Pharma Gmbh · 3 register entries
  • Durogesic SmatJanssen-Cilag Gmbh, Pb Pharma Gmbh · 2 register entries
  • Fenta Regiomedica MatrixHexal Ag · 1 register entry
  • FentamatHexal Ag, Pb Pharma Gmbh · 2 register entries
  • Fentamedica MatrixHexal Ag · 1 register entry
  • Fentanyl1 A Pharma Gmbh, Hikma Pharma Gmbh, Lavipharm S.A, Teva Gmbh, Ratiopharm Gmbh, Hexal Ag, Aliud Pharma Gmbh, Panpharma Gmbh, B.Braun Melsungen Ag, Winthrop Arzneimittel Gmbh, Heumann Pharma Gmbh & Co. Generica Kg, Kalceks, Piramal Critical Care B.V., Aristo Pharma Gmbh (Art 57), Hameln Pharma Gmbh, Hennig Arzneimittel Gmbh & Co. Kg, Pb Pharma Gmbh, Viatris Germany Gmbh, Puren Pharma Gmbh & Co. Kg, Stadapharm Gmbh, Betapharm Arzneimittel Gmbh, Abz-Pharma Gmbh · 38 register entries
  • Fentapatch MatrixHexal Ag · 1 register entry
  • FentaponLavipharm S.A · 1 register entry
  • FentaristoViatris Healthcare Gmbh · 1 register entry
  • FentaveraAcino Ag · 1 register entry
  • FentinalAliud Pharma Gmbh · 1 register entry
Show all 16 brand names
  • FenylatLuye Pharma Ag · 1 register entry
  • MatrifenIstituto Gentili S.R.L, Pb Pharma Gmbh · 6 register entries
  • MatrixAliud Pharma Gmbh · 1 register entry
  • TtsAliud Pharma Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-11-06

Austria

  • ActiqPhoenix Labs · 1 register entry
  • DurogesicJanssen-Cilag Pharma Gmbh · 1 register entry
  • Fentabucc AkutGenericon Pharma Gesellschaft M.B.H. · 1 register entry
  • Fentanyl1a Pharma Gmbh, Stada Arzneimittel Ag, Genericon Pharma Gesellschaft M.B.H., Actavis Group Ptc Ehf., Kalceks, Piramal Critical Care B.V., Aristo Pharma Gmbh (Art 57), Hameln Pharma Gmbh, Hexal Pharma Gmbh, Stada Arzneimittel Gmbh · 12 register entries
  • FentoronTeva B.V · 1 register entry
  • MatrifenIstituto Gentili S.R.L · 1 register entry
  • SubmenaG.L. Pharma Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-11-06

Turkey

  • DurogesicJOHNSON AND JOHNSON SIHHİ MAL. SAN. VE TİC. LTD. ŞTİ. · 5 register entries
  • EffentoraTEVA İLAÇ SAN. VE TİC. A.Ş. · 4 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-11-06

Brand names in 28 more European countries
Belgium
Durogesic, Fentanyl Matrix Eg, Fentanyl Matrix Sandoz, Fentanyl-Piramal, Matrifen
Bulgaria
Fentadolor, Sublifen, Велофент, Виктанил, Фентадолор, Фентанил Калцекс
Croatia
Durogesic, Fentanil Kalceks, Fentanyl Piramal Critical Care
Cyprus
Abstral, Lavifent
Czechia
Adolor, Dolforin, Durogesic, Fenroo, Fentalis, Fentanyl Kalceks, Fentanyl Piramal, Fentanyl Ratiopharm, Fentanyl Torrex, Fentanyl Viatris, Lunaldin, Matrifen, Menasu
Denmark
Abstral, Actiq, Fentanyl "kalceks", Fentanyl B. Braun, Fentanyl Ethypharm, Fentanyl Hameln, Fentanyl Orion, Fentanyl Piramal, Fentanyl Sandoz, Fentanyl Viatris, Fentanyl ”hameln”, Lafene, Matrifen, Sublifen
Estonia
Fentanyl Basi, Fentanyl Kalceks, Lunaldin, Matrifen
Finland
Durogesic, Fentanyl Basi, Fentanyl Hameln, Fentanyl Kalceks, Fentanyl Piramal, Fentanyl Ratiopharm, Fentanyl Sandoz, Fentanyl Stada, Matrifen
France
Abstral, Actiq, Breakyl, Durogesic, Fentanyl Arrow, Fentanyl Bgr, Fentanyl Biogaran, Fentanyl Eg, Fentanyl Panpharma, Fentanyl Piramal, Fentanyl Renaudin, Fentanyl Sandoz, Fentanyl Teva Sante, Fentanyl Viatris, Fentanyl Zentiva, Matrifen, Recivit
Greece
Abstral, Actiq, Demogyl, Durogesic, Fentadur, Fentanyl Demo, Fentanyl Sandoz, Fentanyl/Kalceks, Matrifen, Vellofent
Hungary
Dolforin, Durogesic, Fentanyl Kalceks, Fentanyl Ratiopharm, Fentanyl Sandoz, Matrifen
Iceland
Durogesic, Fentanyl Actavis, Fentanyl Alvogen, Leptanal, Pecfent
Ireland
Abstral, Actiq, Durogesic Dtrans, Fentadur, Fental Matrix, Fentanyl As Kalceks, Fentanyl Mercury Pharmaceuticals (Ireland), Matrifen, Sublimaze
Italy
Abstral, Actiq, Alghedon, Dogetic, Durfenta, Durogesic, Fenpatch, Fenroo, Fentanest, Fentanil Aristo, Fentanil Ethypharm, Fentanil Helm, Fentanil Kalceks, Fentanil Zentiva, Fentanyl Hameln, Fenticer, Fenvel, Matrifen, Sublifen, Vellofent
Latvia
Dolforin, Fentanyl Citrate Kalceks, Lunaldin, Matrifen
Liechtenstein
Pecfent
Lithuania
Dolforin, Fentanyl Kalceks, Lunaldin, Matrifen
Luxembourg
Durogesic, Fentanyl Hameln, Fentanyl Matrix Eg, Fentanyl-Piramal, Matrifen, Recorfen
Malta
Fentadur, Fentanyl Kalceks, Fentanyl Mercury Pharmaceuticals (Ireland)
Netherlands
Abstral, Actiq, Durogesic, Fentanyl, Submena
Norway
Abstral, Durogesic, Fentanyl Basi, Fentanyl Ethypharm, Fentanyl Hameln, Fentanyl Kalceks, Fentanyl Piramal, Fentanyl Ratiopharm, Fentanyl Sandoz, Pecfent
Poland
Aurofena, Fentanyl Actavis, Fentanyl Kalceks, Fentanyl Wzf, Matrifen, Submena, Vellofent
Portugal
Abstral, Actiq, Breakyl, Durogesic, Fentanest, Fentanilo, Nilfene, Vellofent
Romania
Fentanil Kalceks, Fentanyl Lavipharm, Fentanyl Sandoz, Fentanyl Teva, Fentanyl Torrex, Lunaldin, Tabfyl
Slovakia
Breakyl, Fentanyl Kalceks, Fentanyl Ratiopharm, Fentanyl Sandoz, Lunaldin, Submena
Slovenia
Durogesic, Epufen, Fentanil Kalceks, Fentanil Torrex
Spain
Abattra, Abfentiq, Abstral, Actiq, Avaric, Breakyl, Doloxital, Durfenta, Durogesic Matrix, Fendivia, Fentanest, Fentanilo Aristo, Fentanilo Aurovitas Spain, Fentanilo Basi, Fentanilo Ethypharm, Fentanilo Kalceks, Fentanilo Matrix Cinfa, Fentanilo Matrix Kern Pharma, Fentanilo Matrix Normon, Fentanilo Matrix Ratiopharm, Fentanilo Matrix Stada, Fentanilo Matrix Viatris, Fentanilo Sandoz, Fenticerta, Kaptic, Matrifen
Sweden
Abstral, Actiq, Durogesic, Fentanyl, Leptanal, Matrifen, Matrimed, Quatrofen, Submena, Vellofent

EMA – Article 57 product data (EU/EEA), 2026-11-06

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Sources

  1. U.S. Food and Drug Administration. Fentanyl Citrate (Hospira, Inc.) – Prescribing Information, 2026-08-24. DailyMed (NLM), 2026-11-06. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=bfa8018a-4cbc-434b-e09e-782872b0340a
  2. EMA – Article 57 product data (EU/EEA), 2026-11-06. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-11-06. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-11-06. https://www.titck.gov.tr/dinamikmodul/85
  5. Wikidata (CC0): ATC N02AB.

Editorial: Medelix editorial team · last updated 2026-11-06 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.