Fentanyl

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

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Title	Posted	Study ID	Phase	Status	Sponsor
Comparison Between Effect of Systemic Fentanyl Infusion and Fentanyl Added as An Adjuvant to Lidocaine in Bier Block For Controlling Pain in Patients Undergoing Hand Surgeries	2024/11/20	NCT06696586	Phase 4	Not yet recruiting	Assiut University
A Randomized Study Comparing of Three Doses Nebulized Fentanyl in Older Adults	2024/11/14	NCT06689124	Not Applicable	Active, not recruiting	Bangkok Metropolitan Administration Medical College and Vajira Hospital
Comparative Study Between Intrathecal Magnesium Sulfate, Neostigmine and Fentanyl As Adjuvant for Bubivacaine in Postoperative Analgesia in Lower Abdominal Surgeries	2024/11/12	NCT06685705	Phase 4	Not yet recruiting	Assiut University
Perioperative Pain Management for Lumbar Spine Surgery	2024/10/28	NCT06662318	Not Applicable	Recruiting	Benha University
Opioid Free Anesthesia Versus Opioid Based Anesthesia	2024/10/21	NCT06650371	Not Applicable	Not yet recruiting	Ain Shams University
Dexmedetomidine Ropivacaine Versus Plain Ropivacaine in Bilateral Pectoralis Nerve (PECS) Block	2024/10/10	NCT06636578	Phase 4	Recruiting	Fayoum University
Comparing Ketamine and Fentanyl in Pediatric Tonsillectomy: Pain Control and Emergence Delirium Outcomes (KVFPT)	2024/10/08	NCT06630364	Phase 4	Completed	Medipol University
Intranasal Fentanyl in Preterm Infants Undergoing Peripherally Inserted Central Catheter Placement	2024/09/19	NCT06590870	Phase 3	Completed	Mount Sinai Hospital, Canada
Paracetamol Plus Tramadol Versus Fentanyl As Preemptive Analgesia For Enhanced Recovery After Day Case Surgeries	2024/08/20	NCT06561672	Early Phase 1	ENROLLING_BY_INVITATION	Zagazig University
Comparison of the Analgesic Efficacy of Dexketoprofen Trometamol, Meperidine, and Paracetamol in Renal Colic	2024/08/19	NCT06558916	Phase 4	Completed	Ismail Tekin

FDA Drug Approvals

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Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
FENTANYL	Apotex Corp.	60505-7017	TRANSDERMAL	87.5 ug in 1 h	7/13/2023
Fentanyl Citrate	Hikma Pharmaceuticals USA Inc.	0641-6028	INTRAMUSCULAR, INTRAVENOUS	50 ug in 1 mL	3/5/2024
FENTANYL	Bryant Ranch Prepack	63629-4976	TRANSDERMAL	75 ug in 1 h	7/13/2023
FENTANYL CITRATE	SpecGx LLC	0406-9202	TRANSMUCOSAL	200 ug in 1 1	10/19/2023
LAZANDA	West Therapeutic Development LLC	71500-110	NASAL	100 ug in 1 1	3/31/2021
SUBSYS	Insys Therapeutics, Inc.	20482-004	SUBLINGUAL	0.4 mg in 1 1	5/4/2021
FENTORA	Cephalon, LLC	63459-544	BUCCAL, SUBLINGUAL	400 ug in 1 1	12/17/2023
Transmucosal Fentanyl Citrate	H.J. Harkins Company, Inc.	52959-566	ORAL, TRANSMUCOSAL	1200 1 in 1 1	9/6/2011
Fentanyl Buccal	Mayne Pharma	51862-635	BUCCAL, SUBLINGUAL	200 ug in 1 1	1/31/2024
Fentanyl Citrate	Exela Pharma Sciences, LLC	51754-2160	INTRAVENOUS	50 ug in 1 mL	12/18/2023

EMA Drug Approvals

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Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

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Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

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Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

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Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
DENPAX fentanyl 12 micrograms/hour transdermal patch	163066	Alphapharm Pty Ltd	Medicine	A	12/7/2010
MARCAIN 0.125% WITH FENTANYL 1000 microgram/200mL	72870	Aspen Pharmacare Australia Pty Ltd	Medicine	A	5/3/2000
SUBLIMAZE fentanyl 500 microgram/10mL (as citrate) injection ampoule	48264	Piramal Critical Care Pty Ltd	Medicine	A	3/7/1994
ASPEN FENTANYL fentanyl (as citrate) 500 microgram/10 mL solution for injection	170931	Aspen Pharmacare Australia Pty Ltd	Medicine	A	8/3/2011
DUROGESIC fentanyl 25 micrograms/h transdermal patch sachet	112368	Janssen-Cilag Pty Ltd	Medicine	A	11/23/2005
ASPEN FENTANYL fentanyl (as citrate) 250 microgram/5 mL solution for injection	170930	Aspen Pharmacare Australia Pty Ltd	Medicine	A	8/3/2011
DENPAX fentanyl 100 micrograms/hour transdermal patch	163067	Alphapharm Pty Ltd	Medicine	A	12/7/2010
FENTANYL SANDOZ fentanyl 12 micrograms/hour transdermal drug delivery system sachet	152572	Sandoz Pty Ltd	Medicine	A	12/22/2009
FENTANYL JUNO fentanyl (as citrate) 100 microgram/2 mL injection ampoule	384587	Juno Pharmaceuticals Pty Ltd	Medicine	A	10/11/2022
FENTANYL MEDICIANZ fentanyl (as citrate) 500 microgram/10 mL injection ampoule	401505	Medsurge Pharma Pty Ltd	Medicine	A	11/10/2023

Health Canada Drug Approvals

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Approved Product	Company	DIN	Dosage Form	Strength	Market Date
DURAGESIC 75	Janssen Inc	01937405	Patch - Transdermal	75 MCG / HOUR	12/31/1992
SANDOZ FENTANYL PATCH	Sandoz Canada, Inc.	02327163	Patch - Transdermal	100 MCG / HOUR	11/1/2010
PMS-FENTANYL MTX	Pharmascience Inc	02341409	Patch - Transdermal	75 MCG / HOUR	3/18/2010
MYLAN-FENTANYL MATRIX PATCH	Mylan Pharmaceuticals ULC	02396726	Patch - Transdermal	50 MCG / HOUR	11/20/2012
PMS-FENTANYL MTX	Pharmascience Inc	02341379	Patch - Transdermal	12 MCG / HOUR	3/18/2010
RAN-FENTANYL TRANSDERMAL SYSTEM	ranbaxy pharmaceuticals canada inc.	02249448	Patch - Transdermal	10 MG	7/11/2006
MYLAN-FENTANYL MATRIX PATCH	Mylan Pharmaceuticals ULC	02396718	Patch - Transdermal	25 MCG / HOUR	11/20/2012
FENTANYL TRANSDERMAL SYSTEM 50	Actavis Group Ptc Ehf.	02304139	Patch (Extended Release) - Transdermal	50 MCG / HOUR	N/A
PAT-FENTANYL MAT	Janssen Inc	02376792	Patch - Transdermal	75 MCG / HOUR	N/A
PAT-FENTANYL MAT	Janssen Inc	02376784	Patch - Transdermal	50 MCG / HOUR	N/A

CIMA AEMPS Drug Approvals

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Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
FENTANILO MATRIX STADA 100 microgramos/H PARCHES TRANSDERMICOS EFG	Laboratorio Stada S.L.	71766	PARCHE TRANSDÉRMICO	Medicamento Sujeto A Prescripción Médica. Estupefacientes	Commercialized
FENDIVIA 25 microgramos/HORA PARCHE TRANSDERMICO	Istituto Gentili S.R.L.	68493	PARCHE TRANSDÉRMICO	Medicamento Sujeto A Prescripción Médica. Estupefacientes	Commercialized
FENTANILO MATRIX SANDOZ 100 microgramos/HORA PARCHES TRANSDERMICOS EFG	Sandoz Farmaceutica S.A.	69733	PARCHE TRANSDÉRMICO	Medicamento Sujeto A Prescripción Médica. Estupefacientes	Commercialized
FENTANILO MATRIX ZENTIVA 100 microgramos/H PARCHES TRANSDERMICOS EFG	Zentiva K.S.	68565	PARCHE TRANSDÉRMICO	Medicamento Sujeto A Prescripción Médica. Estupefacientes	Not Commercialized
FENTANILO MATRIX NORMON 25 microgramos/H PARCHES TRANSDERMICOS EFG	Laboratorios Normon S.A.	72738	PARCHE TRANSDÉRMICO	Medicamento Sujeto A Prescripción Médica. Estupefacientes	Commercialized
FENTANILO MATRIX NORMON 75 microgramos/H PARCHES TRANSDERMICOS EFG	Laboratorios Normon S.A.	72737	PARCHE TRANSDÉRMICO	Medicamento Sujeto A Prescripción Médica. Estupefacientes	Commercialized
FENTANILO MATRIX SANDOZ 25 microgramos/HORA PARCHES TRANSDERMICOS EFG	Sandoz Farmaceutica S.A.	69730	PARCHE TRANSDÉRMICO	Medicamento Sujeto A Prescripción Médica. Estupefacientes	Commercialized
DOLOXITAL 100 MICROGRAMOS/HORA PARCHES TRANSDERMICOS EFG	Aristo Pharma Iberia S.L.	73930	PARCHE TRANSDÉRMICO	Medicamento Sujeto A Prescripción Médica. Estupefacientes	Not Commercialized
ABATTRA 75 MICROGRAMOS/HORA PARCHES TRANSDERMICOS EFG	Aristo Pharma Iberia S.L.	74123	PARCHE TRANSDÉRMICO	Medicamento Sujeto A Prescripción Médica. Estupefacientes	Commercialized
MATRIFEN 100 microgramos/HORA PARCHE TRANSDERMICO	Istituto Gentili S.R.L.	68367	PARCHE TRANSDÉRMICO	Medicamento Sujeto A Prescripción Médica. Estupefacientes	Commercialized

Philippines FDA Drug Approvals

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Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

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Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

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Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

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Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
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