Is Fentanyl registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 21 valid registrations of Fentanyl, including ABSTRAL 100MCG SUBLINGUAL TABLET (100 µg, Sublingual tablet, SAR 271.10); ABSTRAL 200MCG SUBLINGUAL TABLET (200 µg, Sublingual tablet, SAR 271.10); DUROGESIC 12MCG-H TRASDERMAL PATCHES (12 µg, Transdermal patch, SAR 79.75); DUROGESIC TTS 100 Ug-HOUR (100 µg, Transdermal patch, SAR 339.95); DUROGESIC TTS 25 Ug-HOUR (25 µg, Transdermal patch, SAR 110.50).

Is Fentanyl approved by the US FDA?

Drugs@FDA lists 82 application product lines for Fentanyl, including SUBLIMAZE PRESERVATIVE FREE (Prescription); FENTANYL CITRATE (Prescription); FENTANYL CITRATE (Prescription); FENTANYL-25 (Prescription); FENTANYL-50 (Prescription).

Is Fentanyl authorised in the European Union?

EMA lists 3 centrally authorised medicines containing Fentanyl: Effentora, Instanyl, PecFent.

Is Fentanyl on the WHO Model List of Essential Medicines?

Yes — 2.2. Opioid analgesics (core list): Chronic cancer pain.

Are there safety signals or safety updates for Fentanyl?

US FDA: 16 entries (latest 2025-12-22).

Active substance

Fentanyl

SFDA 30
US FDA 82
EMA 5
Health Canada 24
US price lines 10
NHS prices 34
WHO EML 1
Safety 16

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ABSTRAL 100MCG SUBLINGUAL TABLET	100 µg	Sublingual tablet · Sublingual use	10 Blister	SAR 271.10	NCE · Prescription	KYOWA KIRIN LIMITED	Valid
ABSTRAL 200MCG SUBLINGUAL TABLET	200 µg	Sublingual tablet · Sublingual use	10 Blister	SAR 271.10	NCE · Prescription	KYOWA KIRIN LIMITED	Valid
DUROGESIC 12MCG-H TRASDERMAL PATCHES	12 µg	Transdermal patch · Transdermal use	5 Box	SAR 79.75	Generic · Prescription	JANSSEN PHARMACEUTICA N.V	Valid
DUROGESIC TTS 100 Ug-HOUR	100 µg	Transdermal patch · Transdermal use	5 Box	SAR 339.95	NCE · Prescription	JANSSEN PHARMACEUTICA N.V	Valid
DUROGESIC TTS 25 Ug-HOUR	25 µg	Transdermal patch · Transdermal use	5 Box	SAR 110.50	NCE · Prescription	JANSSEN PHARMACEUTICA N.V	Valid
DUROGESIC TTS 50 Ug-HOUR	50 µg	Transdermal patch · Transdermal use	5 Box	SAR 206.75	NCE · Prescription	JANSSEN PHARMACEUTICA N.V	Valid
DUROGESIC TTS 75 Ug-HOUR	75 µg	Transdermal patch · Transdermal use	5 Box	SAR 276.05	NCE · Prescription	JANSSEN PHARMACEUTICA N.V	Valid
FENTANYL 50 mcg/ml solution for injection	50 µ/ml	Solution for injection · Intravenous use	10 Ampoule	SAR 63.15	Generic · Prescription	MACARTHYS LABORATORIES Ltd T/A MARTINDALE PHARMACEUTICALS	Valid
FENTANYL 50 mg mcg/ml solution for injection	50 µ/ml	Solution for injection · Intravenous use	10 Ampoule	SAR 23.60	Generic · Prescription	MACARTHYS LABORATORIES Ltd T/A MARTINDALE PHARMACEUTICALS	Valid
FENTANYL MEDIS 10 ml Ampoule	50 µ/ml	Solution for injection · Intravenous use	10 Ampoule	SAR 63.80	Generic · Prescription	LES LABORATOIRES MEDIS	Valid
FENTANYL MEDIS 2 ml Ampoule	50 µ/ml	Solution for injection · Intravenous use	10 Ampoule	SAR 25.85	Generic · Prescription	LES LABORATOIRES MEDIS	Valid
Fentanyl Kalceks	0.05 mg/ml	Solution for injection · Intramuscular and intravenous use	10 Ampoule	SAR 23.60	Generic · Prescription	AS Kalceks	Valid
Fentanyl Kalceks	0.05 mg/ml	Solution for injection · Intramuscular and intravenous use	10 Ampoule	SAR 63.15	Generic · Prescription	AS Kalceks	Valid
Fentanyl Piramal 0.05MG-ML AMPOULES	0.05 mg/ml	Solution for injection · Intravenous use	5 Ampoule	SAR 49.65	NCE · Prescription	Piramal Critical Care B.V	Valid
Fentanyl Piramal 0.05MG-ML AMPOULES	0.05 mg/ml	Solution for injection · Intravenous use	5 Ampoule	SAR 10.60	NCE · Prescription	Piramal Critical Care B.V	Valid
Fentanyl Piramal 0.05MG-ML AMPOULES	0.05 mg/ml	Solution for injection · Intravenous use	50 Ampoule	SAR 192.25	NCE · Prescription	Piramal Critical Care B.V	Valid
Fentanyl Piramal 0.05MG-ML AMPOULES	0.05 mg/ml	Solution for injection · Intravenous use	50 Ampoule	SAR 93.75	NCE · Prescription	Piramal Critical Care B.V	Valid
PecFent 100 MCG NASAL SPRAY	100 µg	Nasal spray, solution · Nasal use	1 Bottle	SAR 201.85	NCE · Prescription	Kyowa Kirin Holdings B.V.	Valid
PecFent 100 MCG NASAL SPRAY	100 µg	Nasal spray, solution · Nasal use	4 Bottle	SAR 772.40	NCE · Prescription	Kyowa Kirin Holdings B.V.	Valid
PecFent 400 MCG NASAL SPRAY	400 µg	Nasal spray, solution · Nasal use	1 Bottle	SAR 201.85	NCE · Prescription	Kyowa Kirin Holdings B.V.	Valid
PecFent 400 MCG NASAL SPRAY	400 µg	Nasal spray, solution · Nasal use	4 Bottle	SAR 772.40	NCE · Prescription	Kyowa Kirin Holdings B.V.	Valid
FENTANYL CITRATE 50MCG-ML VIAL	50 µ/ml	Solution for injection · Intravenous use	10 Ampoule	SAR 67.05	NCE · Prescription	ANTIGEN	Withdrawn by MAH · Not Marketed
FENTANYL Transdermal System 100 mcg/h	100 µg	Transdermal patch · Transdermal use	5 Box	SAR 287.80	Generic · Prescription	APOTEX	Withdrawn by MAH · Not Marketed
FENTANYL Transdermal System 25 mcg/h	25 µg	Transdermal patch · Transdermal use	5 Box	SAR 94.85	Generic · Prescription	APOTEX	Withdrawn by MAH · Not Marketed
FENTANYL Transdermal System 50 mcg/h	50 µg	Transdermal patch · Transdermal use	5 Box	SAR 166.60	Generic · Prescription	APOTEX	Withdrawn by MAH · Not Marketed

5 more — full table

Indications — CHI Daman Drug Formulary

ACUTE PANCREATITIS-PAIN MANAGEMENT; BURN MANAGEMENT; CHRONIC PANCREATITIS; DIABETIC NEUROPATHY; ENDOMETRIOSIS; ENTEROPATHIC ARTHROPATHIES, UNSPECIFIED SITE REACTIVE ARTHROPATHY, UNSPECIFIED; LOW BACK PAIN; NEUROPATHIC PAIN; PAIN MANAGEMENT IN CANCER PATIENTS; POST-HERPETIC NEURALGIA; POSTOPERATIVE PAIN; RENAL AND URETERIC STONES; SICKLE CELL DISEASE - PAIN MANAGEMENT

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
SUBLIMAZE PRESERVATIVE FREE	EQ 0.05MG BASE/ML	injectable · injection	RISING	Prescription	19 Feb 1968
FENTANYL CITRATE	EQ 0.05MG BASE/ML; EQ 0.025MG BASE/0.5ML	injectable · injection	HIKMA PHARMS	Prescription	11 Jul 1984
FENTANYL CITRATE	EQ 0.05MG BASE/ML	injectable · injection	HOSPIRA	Prescription	12 Jan 1985
FENTANYL-25	25MCG/HR	film, extended release · transdermal	MYLAN TECHNOLOGIES	Prescription	28 Jan 2005
FENTANYL-50	50MCG/HR	film, extended release · transdermal	MYLAN TECHNOLOGIES	Prescription	28 Jan 2005
FENTANYL-75	75MCG/HR	film, extended release · transdermal	MYLAN TECHNOLOGIES	Prescription	28 Jan 2005
FENTANYL-100	100MCG/HR	film, extended release · transdermal	MYLAN TECHNOLOGIES	Prescription	28 Jan 2005
FENTANYL-12	12.5MCG/HR	film, extended release · transdermal	MYLAN TECHNOLOGIES	Prescription	28 Jan 2005
FENTANYL-37	37.5MCG/HR	film, extended release · transdermal	MYLAN TECHNOLOGIES	Prescription	28 Jan 2005
FENTANYL-62	62.5MCG/HR	film, extended release · transdermal	MYLAN TECHNOLOGIES	Prescription	28 Jan 2005
FENTANYL-87	87.5MCG/HR	film, extended release · transdermal	MYLAN TECHNOLOGIES	Prescription	28 Jan 2005
FENTANYL-25	25MCG/HR	film, extended release · transdermal	DIFGEN PHARMS	Prescription	20 Oct 2008
FENTANYL-50	50MCG/HR	film, extended release · transdermal	DIFGEN PHARMS	Prescription	20 Oct 2008
FENTANYL-75	75MCG/HR	film, extended release · transdermal	DIFGEN PHARMS	Prescription	20 Oct 2008
FENTANYL-100	100MCG/HR	film, extended release · transdermal	DIFGEN PHARMS	Prescription	20 Oct 2008
FENTANYL-12	12.5MCG/HR	film, extended release · transdermal	DIFGEN PHARMS	Prescription	20 Oct 2008
FENTANYL-37	37.5MCG/HR	film, extended release · transdermal	DIFGEN PHARMS	Prescription	20 Oct 2008
FENTANYL-62	62.5MCG/HR	film, extended release · transdermal	DIFGEN PHARMS	Prescription	20 Oct 2008
FENTANYL-87	87.5MCG/HR	film, extended release · transdermal	DIFGEN PHARMS	Prescription	20 Oct 2008
FENTANYL-25	25MCG/HR	film, extended release · transdermal	SPECGX LLC	Prescription	9 Feb 2011
FENTANYL-50	50MCG/HR	film, extended release · transdermal	SPECGX LLC	Prescription	9 Feb 2011
FENTANYL-75	75MCG/HR	film, extended release · transdermal	SPECGX LLC	Prescription	9 Feb 2011
FENTANYL-100	100MCG/HR	film, extended release · transdermal	SPECGX LLC	Prescription	9 Feb 2011
FENTANYL-12	12.5MCG/HR	film, extended release · transdermal	SPECGX LLC	Prescription	9 Feb 2011
FENTANYL-37	37.5MCG/HR	film, extended release · transdermal	SPECGX LLC	Prescription	9 Feb 2011

57 more — full table

EMA European Union — centrally authorised medicines

Effentora Phoenix Labs Unlimited Company · Authorised · authorised 4 Apr 2008 · ATC N02AB03

Therapeutic indication (EMA)

Effentora is indicated for the treatment of breakthrough pain (BTP) in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain. BTP is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.

Instanyl Istituto Gentili S.r.l. · Authorised · authorised 20 Jul 2009 · ATC N02AB03

Therapeutic indication (EMA)

Instanyl is indicated for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.

PecFent Gruenenthal GmbH · Authorised · authorised 31 Aug 2010 · ATC N02AB03

Therapeutic indication (EMA)

PecFent is indicated for the management of breakthrough pain in adults who are already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equi-analgesic dose of another opioid for a week or longer.

Ionsys Janssen-Cilag International NV · Withdrawn · authorised 24 Jan 2006 · ATC N02AB03

Therapeutic indication (EMA)

Management of acute moderate to severe post-operative pain for use in a hospital setting only

Ionsys Incline Therapeutics Europe Ltd · Withdrawn · authorised 18 Nov 2015 · ATC N02AB03

Therapeutic indication (EMA)

Ionsys is indicated for the management of acute moderate to severe post-operative pain in adult patients.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
FENTANYL CITRATE INJECTION	02506963	50 MCG / ML	SOLUTION · INTRAVENOUS; INTRAMUSCULAR; EPIDURAL	JAMP PHARMA CORPORATION
FENTANYL CITRATE INJECTION SDZ	02384124	50 MCG / ML	SOLUTION · INTRAMUSCULAR; INTRAVENOUS; EPIDURAL	SANDOZ CANADA INCORPORATED
FENTANYL CITRATE INJECTION USP	02240434	50 MCG / ML	SOLUTION · EPIDURAL; INTRAMUSCULAR; INTRAVENOUS	SANDOZ CANADA INCORPORATED
FENTANYL CITRATE INJECTION, USP	02501554	50 MCG / ML	SOLUTION · INTRAVENOUS; INTRAMUSCULAR; EPIDURAL	FRESENIUS KABI CANADA LTD
FENTANYL INJECTION BP	02496143	100 MCG / 2 ML	SOLUTION · INTRAVENOUS; EPIDURAL; INTRAMUSCULAR	STERIMAX INC
FENTANYL INJECTION BP	02496151	250 MCG / 5 ML	SOLUTION · INTRAMUSCULAR; EPIDURAL; INTRAVENOUS	STERIMAX INC
FENTANYL INJECTION BP	02496178	1000 MCG / 20 ML	SOLUTION · INTRAVENOUS; EPIDURAL; INTRAMUSCULAR	STERIMAX INC
FENTANYL INJECTION BP	02496186	2500 MCG / 50 ML	SOLUTION · INTRAMUSCULAR; EPIDURAL; INTRAVENOUS	STERIMAX INC
FENTORA	02408007	100 MCG	TABLET (EFFERVESCENT) · BUCCAL; SUBLINGUAL	PHOENIX LABS UNLIMITED COMPANY
FENTORA	02408015	200 MCG	TABLET (EFFERVESCENT) · SUBLINGUAL; BUCCAL	PHOENIX LABS UNLIMITED COMPANY
FENTORA	02408023	400 MCG	TABLET (EFFERVESCENT) · SUBLINGUAL; BUCCAL	PHOENIX LABS UNLIMITED COMPANY
FENTORA	02408031	600 MCG	TABLET (EFFERVESCENT) · SUBLINGUAL; BUCCAL	PHOENIX LABS UNLIMITED COMPANY
FENTORA	02408058	800 MCG	TABLET (EFFERVESCENT) · BUCCAL; SUBLINGUAL	PHOENIX LABS UNLIMITED COMPANY
SANDOZ FENTANYL PATCH	02327112	12 MCG / HOUR	PATCH · TRANSDERMAL	SANDOZ CANADA INCORPORATED
SANDOZ FENTANYL PATCH	02327120	25 MCG / HOUR	PATCH · TRANSDERMAL	SANDOZ CANADA INCORPORATED
SANDOZ FENTANYL PATCH	02327139	37 MCG / HOUR	PATCH · TRANSDERMAL	SANDOZ CANADA INCORPORATED
SANDOZ FENTANYL PATCH	02327147	50 MCG / HOUR	PATCH · TRANSDERMAL	SANDOZ CANADA INCORPORATED
SANDOZ FENTANYL PATCH	02327155	75 MCG / HOUR	PATCH · TRANSDERMAL	SANDOZ CANADA INCORPORATED
SANDOZ FENTANYL PATCH	02327163	100 MCG / HOUR	PATCH · TRANSDERMAL	SANDOZ CANADA INCORPORATED
TEVA-FENTANYL	02282941	25 MCG / HOUR	PATCH · TRANSDERMAL	TEVA CANADA LIMITED
TEVA-FENTANYL	02282968	50 MCG / HOUR	PATCH · TRANSDERMAL	TEVA CANADA LIMITED
TEVA-FENTANYL	02282976	75 MCG / HOUR	PATCH · TRANSDERMAL	TEVA CANADA LIMITED
TEVA-FENTANYL	02282984	100 MCG / HOUR	PATCH · TRANSDERMAL	TEVA CANADA LIMITED
TEVA-FENTANYL	02311925	12 MCG / HOUR	PATCH · TRANSDERMAL	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	FENTANYL 100 MCG/2 ML VIAL	$1.78639	per ML	23 Sep 2026
US NADAC	FENTANYL 100 MCG/HR PATCH	$18.35787	per EA	23 Sep 2026
US NADAC	FENTANYL 12 MCG/HR PATCH	$8.98903	per EA	23 Sep 2026
US NADAC	FENTANYL 2,500 MCG/50 ML VIAL	$1.78639	per ML	7 Oct 2026
US NADAC	FENTANYL 25 MCG/HR PATCH	$6.01448	per EA	23 Sep 2026
US NADAC	FENTANYL 250 MCG/5 ML VIAL	$1.78639	per ML	23 Sep 2026
US NADAC	FENTANYL 37.5 MCG/HR PATCH	$35.02694	per EA	23 Sep 2026
US NADAC	FENTANYL 50 MCG/HR PATCH	$9.07	per EA	23 Sep 2026
US NADAC	FENTANYL 62.5 MCG/HR PATCH	$57.686	per EA	23 Sep 2026
US NADAC	FENTANYL 75 MCG/HR PATCH	$15.87124	per EA	23 Sep 2026
NHS Drug Tariff	Fentanyl 1.2mg lozenges	£17.75	3 lozenge	1 Oct 2026
NHS Drug Tariff	Fentanyl 1.2mg lozenges	£210.41	30 lozenge	1 Oct 2026
NHS Drug Tariff	Fentanyl 1.6mg lozenges	£17.75	3 lozenge	1 Oct 2026
NHS Drug Tariff	Fentanyl 1.6mg lozenges	£210.41	30 lozenge	1 Oct 2026
NHS Drug Tariff	Fentanyl 100microgram buccal tablets sugar free	£139.72	28 tablet	1 Oct 2026
NHS Drug Tariff	Fentanyl 100microgram sublingual tablets sugar free	£49.99	10 tablet	1 Oct 2026
NHS Drug Tariff	Fentanyl 100micrograms/2ml solution for injection ampoules	£16.24	10 ampoule	1 Oct 2026
NHS Drug Tariff	Fentanyl 100micrograms/dose nasal spray	£36.48	8 dose	1 Oct 2026
NHS Drug Tariff	Fentanyl 100micrograms/dose nasal spray	£145.92	32 dose	1 Oct 2026
NHS Drug Tariff	Fentanyl 100micrograms/hour transdermal patches	£34.60	5 patch	1 Oct 2026
NHS Drug Tariff	Fentanyl 12micrograms/hour transdermal patches	£7.53	5 patch	1 Oct 2026
NHS Drug Tariff	Fentanyl 200microgram buccal tablets sugar free	£139.72	28 tablet	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

WHO WHO Model List of Essential Medicines (2025)

2.2. Opioid analgesics · core
Chronic cancer pain
Local > Topical > Transdermal patch: 12 µg/hour; 25 µg/hour; 50 µg/hour; 75 µg/hour; 100 µg/hour

Safety signals and safety-related labeling changes

US FDA 22 Dec 2025 ACTIQ — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 22 Dec 2025 FENTANYL CITRATE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 22 Dec 2025 FENTANYL CITRATE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 22 Dec 2025 FENTORA — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 22 Dec 2025 SUBLIMAZE PRESERVATIVE FREE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 22 Dec 2025 FENTANYL CITRATE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 4 Mar 2021 DURAGESIC-100 — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 4 Mar 2021 DURAGESIC-12 — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 4 Mar 2021 DURAGESIC-25 — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 4 Mar 2021 DURAGESIC-50 — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 4 Mar 2021 DURAGESIC-75 — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 4 Mar 2021 LAZANDA — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 4 Mar 2021 ONSOLIS — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 4 Mar 2021 SUBSYS — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 7 Oct 2019 ABSTRAL — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for fentanyl →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.