Overview
Fentanyl, a potent opioid agonist, was developed in the 1950s to fill a need for strong and rapid analgesia. Because of these characteristics, fentanyl is commonly used to treat chronic cancer pain or in anesthesia. Fentanyl is related to other opioids like morphine and oxycodone. Fentanyl's high potency has also made it a common adulterant in illicit drugs, especially heroin. In 2017, 47600 overdose deaths in the United States involved some opioid (over 2/3 of all overdose deaths). Opioid overdoses kill an average of 11 Canadians daily. Fentanyl was FDA approved in 1968.
Indication
Fentanyl intravenous or intramuscular injections are indicated for short term analgesia during induction, maintenance, and recovery from general or regional anesthesia. These injections are also used with a neuroleptic for premedication, induction, and as an adjunct to maintenance of anesthesia. Finally, fentanyl intravenous or intramuscular injections are used with oxygen for anesthesia in high risk patients. Fentanyl sublingual tablets, transmucosal lozenges, buccal tablets, sublingual sprays, transdermal systems, and nasal sprays are indicated for the management of breakthrough pain in opioid tolerant cancer patients who require around the clock pain management.
Associated Conditions
- Cancer Related Pain (Breakthrough Pain)
- Severe, Chronic Pain
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/08/29 | Not Applicable | Completed | |||
2025/08/27 | N/A | Active, not recruiting | University of Oradea | ||
2025/08/13 | Not Applicable | Not yet recruiting | |||
2025/08/06 | Not Applicable | Not yet recruiting | |||
2025/07/29 | Not Applicable | Active, not recruiting | |||
2025/07/22 | Not Applicable | Recruiting | Nashwa Ahmed | ||
2025/06/27 | Not Applicable | Recruiting | CAMC Health System | ||
2025/06/25 | Phase 4 | Completed | Nashwa Ahmed | ||
2025/05/29 | Not Applicable | Completed | |||
2025/05/13 | N/A | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Cephalon, LLC | 63459-546 | BUCCAL, SUBLINGUAL | 600 ug in 1 1 | 12/17/2023 | |
| Mylan Pharmaceuticals Inc. | 0378-9127 | TRANSDERMAL | 87.5 ug in 1 h | 4/13/2023 | |
| Cantrell Drug Company | 52533-174 | EPIDURAL | 1 ug in 1 mL | 1/13/2015 | |
| SpecGx LLC | 0406-9204 | TRANSMUCOSAL | 400 ug in 1 1 | 10/19/2023 | |
| ProStrakan, Inc. | 42747-228 | SUBLINGUAL | 800 ug in 1 1 | 1/21/2011 | |
| Hikma Pharmaceuticals USA Inc. | 0641-6249 | INTRAMUSCULAR, INTRAVENOUS | 50 ug in 1 mL | 3/5/2024 | |
| Quality Care Products, LLC | 55700-749 | TRANSDERMAL | 12 ug in 1 h | 7/13/2023 | |
| Fresenius Kabi USA, LLC | 63323-810 | INTRAVENOUS, INTRAMUSCULAR | 100 ug in 2 mL | 1/31/2023 | |
| Mayne Pharma | 51862-637 | BUCCAL, SUBLINGUAL | 600 ug in 1 1 | 1/31/2024 | |
| Exela Pharma Sciences, LLC | 51754-2150 | INTRAVENOUS | 50 ug in 1 mL | 12/18/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 7/20/2009 | ||
Authorised | 7/20/2009 | ||
Authorised | 4/4/2008 | ||
Authorised | 8/31/2010 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| DUROGESIC TRANSDERMAL SYSTEM 50 mcg/hr | SIN08335P | PATCH | 8.4 mg | 7/29/1995 | |
| ABSTRAL SUBLINGUAL TABLET 200 mcg | SIN15148P | TABLET | 200 µg | 1/6/2017 | |
| Fentanyl-hameln Injection 50 mcg/ml | SIN13542P | INJECTION, SOLUTION | 0.05mg/ml | 8/28/2008 | |
| PECFENT NASAL SPRAY SOLUTION 100 MCG/SPRAY | SIN16026P | SPRAY, METERED | 100 μg/spray | 10/12/2020 | |
| Durogesic Transdermal System 12mcg/hr | SIN13153P | PATCH | 2.1 mg | 11/2/2005 | |
| ABSTRAL SUBLINGUAL TABLET 800 mcg | SIN15152P | TABLET | 800 µg | 1/6/2017 | |
| FANTAMAX TTS MATRIX 12μg/h | SIN13949P | PATCH | 2.89 mg | 4/19/2011 | |
| FANTAMAX TTS MATRIX 25μg/h | SIN13620P | PATCH | 5.78 mg/10.5 sq cm | 3/19/2009 | |
| ABSTRAL SUBLINGUAL TABLET 300 mcg | SIN15149P | TABLET | 300 µg | 1/6/2017 | |
| PECFENT NASAL SPRAY SOLUTION 400 MCG/SPRAY | SIN16027P | SPRAY, METERED | 400 μg/spray | 10/12/2020 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| PMS-FENTANYL MTX | 02341395 | Patch - Transdermal | 50 MCG / HOUR | 3/18/2010 | |
| FENTANYL TRANSDERMAL SYSTEM 100 | 02304155 | Patch (Extended Release) - Transdermal | 100 MCG / HOUR | N/A | |
| DURAGESIC | 02334186 | Patch - Transdermal | 12 MCG / HOUR | 3/16/2010 | |
| DURAGESIC 100 | 01937413 | Patch - Transdermal | 100 MCG / HOUR | 12/31/1992 | |
| MYLAN-FENTANYL MATRIX PATCH | Mylan Pharmaceuticals ULC | 02396696 | Patch - Transdermal | 12 MCG / HOUR | 11/20/2012 |
| PAT-FENTANYL MAT | 02376776 | Patch - Transdermal | 25 MCG / HOUR | N/A | |
| SANDOZ FENTANYL PATCH | 02327120 | Patch - Transdermal | 25 MCG / HOUR | 11/1/2010 | |
| DURAGESIC | 02275813 | Patch - Transdermal | 25 MCG / HOUR | 5/11/2009 | |
| APO-FENTANYL MATRIX | 02314665 | Patch - Transdermal | 100 MCG / HOUR | 5/13/2009 | |
| INNOVAR INJ | janssen pharmaceutica, division of janssen-ortho inc. | 00554243 | Liquid - Intramuscular
,
Intravenous | .05 MG / ML | 12/31/1982 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| FENTANILO MATRIX VIATRIS 50 mcg/H PARCHES TRANSDERMICOS EFG | 75953 | PARCHE TRANSDÉRMICO | Medicamento Sujeto A Prescripción Médica. Estupefacientes | Commercialized | |
| ACTIQ 1200 microgramos, COMPRIMIDOS PARA CHUPAR CON APLICADOR BUCAL INTEGRADO | 64060 | COMPRIMIDO PARA CHUPAR | Medicamento Sujeto A Prescripción Médica. Estupefacientes | Commercialized | |
| DURFENTA 25 microgramos/HORA PARCHES TRANSDERMICOS EFG | Lavipharm S.A. | 72971 | PARCHE TRANSDÉRMICO | Medicamento Sujeto A Prescripción Médica. Estupefacientes | Commercialized |
| FENTANILO MATRIX KERN PHARMA 50 microgramos/H PARCHES TRANSDERMICOS EFG | 71896 | PARCHE TRANSDÉRMICO | Medicamento Sujeto A Prescripción Médica. Estupefacientes | Commercialized | |
| FENTANILO MATRIX STADA 25 microgramos /H PARCHE TRANSDERMICOS EFG | Laboratorio Stada S.L. | 71763 | PARCHE TRANSDÉRMICO | Medicamento Sujeto A Prescripción Médica. Estupefacientes | Commercialized |
| DUROGESIC MATRIX 100 microgramos/H PARCHES TRANSDERMICOS | Janssen Cilag S.A. | 61961 | PARCHE TRANSDÉRMICO | Medicamento Sujeto A Prescripción Médica. Estupefacientes | Commercialized |
| DURFENTA 100 microgramos/HORA PARCHES TRANSDERMICOS EFG | Lavipharm S.A. | 72974 | PARCHE TRANSDÉRMICO | Medicamento Sujeto A Prescripción Médica. Estupefacientes | Commercialized |
| MATRIFEN 25 microgramos/HORA PARCHE TRANSDERMICO | 68364 | PARCHE TRANSDÉRMICO | Medicamento Sujeto A Prescripción Médica. Estupefacientes | Commercialized | |
| DOLOXITAL 12 MICROGRAMOS/HORA PARCHES TRANSDERMICOS EFG | Aristo Pharma Iberia S.L. | 73928 | PARCHE TRANSDÉRMICO | Medicamento Sujeto A Prescripción Médica. Estupefacientes | Commercialized |
| DUROGESIC MATRIX 25 microgramos/H PARCHES TRANSDERMICOS | Janssen Cilag S.A. | 61959 | PARCHE TRANSDÉRMICO | Medicamento Sujeto A Prescripción Médica. Estupefacientes | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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