Is Epinephrine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 11 valid registrations of Epinephrine, including ADRENALINE 0.1MG/ML INJECTION (0.1 mg/ml, Solution for injection, SAR 50.45); ADRENALINE 0.1mg/mL (1 µ/ml, Solution for injection in pre-filled syringe, SAR 504.50); ADRENALINE 1:1000 INJ (1 mg/ml, Solution for injection, SAR 12.45); ADRENALINE/EPINEPHRINE INJ 1:1000 INJECTION (1 mg/ml, Solution for injection, SAR 19.15); Adijet (1 mg/ml, Solution for injection, SAR 80.00).

Is Epinephrine approved by the US FDA?

Drugs@FDA lists 42 application product lines for Epinephrine, including EPIPEN (Prescription); EPIPEN JR. (Prescription); ADRENACLICK (Prescription); AUVI-Q (Prescription); ADRENALIN (Prescription).

Is Epinephrine authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Epinephrine: Eurneffy.

Is Epinephrine on the WHO Model List of Essential Medicines?

Yes — 25.1. Antiasthmatic and medicines for chronic obstructive pulmonary disease (core list): Chronic obstructive pulmonary disease; Asthma.

Are there safety signals or safety updates for Epinephrine?

US FDA: 17 entries (latest 2026-03-26).

Active substance

Epinephrine

SFDA 14
US FDA 42
EMA 2
Health Canada 9
US price lines 13
NHS prices 11
WHO EML 4
Safety 17

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ADRENALINE 0.1MG/ML INJECTION	0.1 mg/ml	Solution for injection · Intrathecal, Intravenous, Intramuscular	1 Pre-filled syringe	SAR 50.45	Generic · Prescription	Aurum Pharmaceuticals Limited	Valid
ADRENALINE 0.1mg/mL	1 µ/ml	Solution for injection in pre-filled syringe · Intravenous use	10 Pre-filled syringe	SAR 504.50	Generic · Prescription	AGUETTANT LABORATORIES	Valid
ADRENALINE 1:1000 INJ	1 mg/ml	Solution for injection · Intravenous use	10 Ampoule	SAR 12.45	NCE · Prescription	ANTIGEN	Valid
ADRENALINE/EPINEPHRINE INJ 1:1000 INJECTION	1 mg/ml	Solution for injection · Intramuscular use	10 Ampoule	SAR 19.15	Generic · Prescription	MARTINDALE PHARMACEUTICALS LTD TRADING AS MARTINDALE PHARMA	Valid
Adijet	1 mg/ml	Solution for injection · Intramuscular and intravenous use	10 Ampoule	SAR 80.00	Generic · Prescription	SAUDI PHARMACEUTICAL INDUSTRIES	Valid
Aronep	1 mg/ml	Solution for injection · Intramuscular use	10 Ampoule	SAR 80.00	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
DILUTE ADRENALINE (Epinephrine) 1:10,000 solution for injection	100 µ/ml	Solution for injection · Parenteral use	10 Ampoule	SAR 243.00	Generic · Prescription	MACARTHYS LABORATORIES Ltd T/A MARTINDALE PHARMACEUTICALS	Valid
EpiPen 150 mcg per 0.3 ml	150 µg	Solution for injection · Intramuscular use	1 Injection Syringe	SAR 363.00	NCE · Prescription	Alphapharm Pty Ltd Mylan Australia	Valid
EpiPen 300 mcg per 0.3 ml	300 µg	Solution for injection · Intramuscular use	1 Injection Syringe	SAR 363.00	NCE · Prescription	Alphapharm Pty Ltd Mylan Australia	Valid
JEXT	150 µg	Solution for injection · Intramuscular use	1 Pre-filled pen	SAR 363.00	NCE · Prescription	ALK-Abello A/S	Valid
JEXT	300 µg	Solution for injection · Intramuscular use	1 Pre-filled pen	SAR 363.00	NCE · Prescription	ALK-Abello A/S	Valid
ADRENALINE HCL 1MG-ML AMP	1 mg/ml	Solution · Intravenous use	100 Ampoule	SAR 22.65	NCE · Prescription	AGUETTANT LABORATORIES	Withdrawn by MAH · Not Marketed
EPINEPHRINE INJ	100 µ/ml	Solution for injection · Intravenous use	1 Pre-filled syringe	SAR 32.60	NCE · Prescription	HOSPIRA INC	Withdrawn by MAH · Not Marketed
EPINEPHRINE INJ 1:10000 ABBOJECT GLASS SYRINGE (18 G x 3 1/2")	100 µ/ml	Solution for injection · Intravenous use	1 Pre-filled syringe	SAR 28.10	NCE · Prescription	HOSPIRA INC	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ANAPHYLACTIC SHOCK; BRADYCARDIA; BURN MANAGEMENT; HYPOTENSION; Septic Shock; URTICARIA

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

Product	Strength	Form · route	Applicant	Status	First approved
EPIPEN	0.3MG/DELIVERY	injectable · intramuscular, subcutaneous	VIATRIS	Prescription	22 Dec 1987
EPIPEN JR.	0.15MG/DELIVERY	injectable · intramuscular, subcutaneous	VIATRIS	Prescription	22 Dec 1987
ADRENACLICK	EQ 0.15MG/DELIVERY; EQ 0.3MG/DELIVERY	injectable · intramuscular, subcutaneous	IMPAX	Prescription	30 May 2003
AUVI-Q	EQ 0.3MG/DELIVERY; EQ 0.15MG/DELIVERY; EQ 0.1MG/DELIVERY	solution · intramuscular, subcutaneous	KALEO INC	Prescription	10 Aug 2012
ADRENALIN	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	solution · intramuscular, intravenous, subcutaneous	PH HEALTH	Prescription	7 Dec 2012
ADRENALIN	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	solution · intramuscular, intravenous, subcutaneous	PH HEALTH	Prescription	18 Dec 2013
EPINEPHRINE	1MG/ML (1MG/ML)	solution · intravenous, intraocular, intramuscular, subcutaneous	BPI LABS	Prescription	29 Jul 2014
EPINEPHRINE	10MG/10ML (1MG/ML); 30MG/30ML (1MG/ML); 1MG/ML (1MG/ML)	solution · intramuscular, intravenous, subcutaneous	BPI LABS	Prescription	29 Jul 2014
SYMJEPI	0.3MG/0.3ML (0.3MG/0.3ML)	solution · intramuscular, subcutaneous	ADAMIS PHARMS CORP	Prescription	15 Jun 2017
EPINEPHRINE (AUTOINJECTOR)	0.3MG/DELIVERY; 0.15MG/DELIVERY	injectable · intramuscular, subcutaneous	TEVA PHARMS USA	Prescription	16 Aug 2018
PRIMATENE MIST	0.125MG/INH	aerosol, metered · inhalation	ARMSTRONG PHARMS	Over-the-counter	7 Nov 2018
EPINEPHRINE	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	solution · intramuscular, intravenous, subcutaneous	INTL MEDICATION SYS	Prescription	24 Apr 2020
EPINEPHRINE	1MG/10ML (0.1MG/ML)	solution · intravenous	INTL MEDICATION SYS	Prescription	15 Aug 2022
ADRENALIN	2MG/250ML (8MCG/ML); 4MG/250ML (16MCG/ML); 5MG/250ML (20MCG/ML); 8MG/250ML (32MCG/ML); 10MG/250ML (40MCG/ML)	solution · intravenous	PH HEALTH	Prescription	21 Apr 2023
NEFFY	2MG/SPRAY; 1MG/SPRAY	spray · nasal	ARS PHARMS OPERATION	Prescription	9 Aug 2024
EPINEPHRINE	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	solution · intramuscular, intravenous, subcutaneous	AM REGENT	Prescription	6 Sep 2024
EPINEPHRINE	1MG/ML (1MG/ML)	solution · intravenous, intraocular, intramuscular, subcutaneous	FRESENIUS KABI USA	Prescription	20 Nov 2024
EPINEPHRINE	10MG/10ML (1MG/ML); 30MG/30ML (1MG/ML); 1MG/ML (1MG/ML)	solution · intramuscular, intravenous, subcutaneous	GLAND	Prescription	6 Feb 2025
EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)	solution · intravenous	BAXTER HLTHCARE CORP	Prescription	28 Feb 2025
EPINEPHRINE	30MG/30ML (1MG/ML)	solution · intramuscular, intravenous, subcutaneous	FRESENIUS KABI USA	Prescription	13 Mar 2025
EPINEPHRINE	1MG/ML (1MG/ML)	solution · intravenous, intraocular, intramuscular, subcutaneous	GLAND	Prescription	3 Jun 2025
EPINEPHRINE	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	solution · intramuscular, intravenous, subcutaneous	AMNEAL	Prescription	14 Oct 2025
EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	solution · intramuscular, intravenous, subcutaneous	AMNEAL	Prescription	8 Dec 2025
EPINEPHRINE	1MG/ML (1MG/ML); 30MG/30ML (1MG/ML)	solution · intramuscular, intravenous, subcutaneous	BAXTER HLTHCARE CORP	Prescription	30 Mar 2026
EPINEPHRINE	1MG/ML (1MG/ML)	solution · intramuscular, intravenous, subcutaneous	HIKMA PHARMS	Prescription	29 May 2026

17 more — full table

EMA European Union — centrally authorised medicines

Eurneffy ALK-Abelló A/S · Authorised · authorised 22 Aug 2024 · ATC C01CA24

Therapeutic indication (EMA)

Eurneffy is indicated in the emergency treatment of allergic reactions (anaphylaxis) due to insect stings or bites, foods, medicinal products and other allergens as well as idiopathic or exercise induced anaphylaxis. Treatment is indicated for adults and children aged 4 years and over with a body weight of 15 kg or more.

Neffy Ars Pharmaceuticals Irl Limited · Application withdrawn · ATC C01CA24

Therapeutic indication (EMA)

Emergency treatment of allergic reactions, including anaphylaxis.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ADRENALIN	00155357	1 MG / ML	SOLUTION · SUBCUTANEOUS; INTRASPINAL; INTRAVENOUS; OPHTHALMIC; INTRAMUSCULAR; INTRACARDIAC	SEARCHLIGHT PHARMA INC
ADRENALIN TOPICAL SOLUTION	00155365	1 MG / ML	SOLUTION · TOPICAL	SEARCHLIGHT PHARMA INC
EPINEPHRINE INJECTION	02521148	1 MG / 10 ML	SOLUTION · INTRAVENOUS	LABORATOIRE AGUETTANT
EPINEPHRINE INJECTION USP	00710814	1 MG / 10 ML	SOLUTION · INTRACARDIAC; INTRAVENOUS	PFIZER CANADA ULC
EPINEPHRINE INJECTION USP	00721891	1 MG / 1 ML	SOLUTION · INTRAMUSCULAR; INTRATRACHEAL; INTRAVENOUS; INTRACARDIAC; SUBCUTANEOUS	PFIZER CANADA ULC
EPINEPHRINE INJECTION USP	02435810	1 MG / 1 ML	SOLUTION · INTRATRACHEAL; INTRAMUSCULAR; SUBCUTANEOUS; INTRAVENOUS	HIKMA CANADA LIMITED
EPIPEN	00509558	0.3 MG / 0.3 ML	SOLUTION · INTRAMUSCULAR	VIATRIS SPECIALTY LLC
EPIPEN JR	00578657	0.15 MG / 0.3 ML	SOLUTION · INTRAMUSCULAR	VIATRIS SPECIALTY LLC
NEFFY	02567121	2 MG / 0.1 ML	SOLUTION · NASAL	ALK-ABELLÓ A/S

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	ADRENALIN 1 MG/ML VIAL	$7.79554	per ML	28 Oct 2025
US NADAC	AUVI-Q 0.1 MG AUTO-INJECTOR	$309.55227	per EA	1 Jul 2026
US NADAC	AUVI-Q 0.15 MG AUTO-INJECTOR	$309.85103	per EA	1 Jul 2026
US NADAC	AUVI-Q 0.3 MG AUTO-INJECTOR	$309.37573	per EA	1 Jul 2026
US NADAC	EPINEPHRINE 0.15 MG AUTO-INJCT	$129.05328	per EA	23 Sep 2026
US NADAC	EPINEPHRINE 0.15 MG AUTO-INJCT	$117.96603	per EA	23 Sep 2026
US NADAC	EPINEPHRINE 0.15 MG AUTO-INJCT	$141.88177	per EA	23 Sep 2026
US NADAC	EPINEPHRINE 0.3 MG AUTO-INJECT	$133.59659	per EA	23 Sep 2026
US NADAC	EPINEPHRINE 0.3 MG AUTO-INJECT	$111.99764	per EA	23 Sep 2026
US NADAC	EPINEPHRINE 0.3 MG AUTO-INJECT	$141.27567	per EA	23 Sep 2026
US NADAC	EPINEPHRINE 1 MG/10 ML LUERJET	$1.23804	per ML	23 Sep 2026
US NADAC	NEFFY 1 MG/0.1 ML NASAL SPRAY	$360.13761	per EA	23 Sep 2026
NHS Drug Tariff	Adrenaline (base) 100micrograms/1ml (1 in 10,000) dilute solution for injection ampoules	£166.53	10 ampoule	1 Oct 2026
NHS Drug Tariff	Adrenaline (base) 10mg/10ml (1 in 1,000) solution for injection ampoules	£172.76	10 ampoule	1 Oct 2026
NHS Drug Tariff	Adrenaline (base) 150micrograms/0.15ml (1 in 1,000) solution for injection pre-filled disposable devices	£60.69	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Adrenaline (base) 150micrograms/0.3ml (1 in 2,000) solution for injection pre-filled disposable devices	£60.69	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Adrenaline (base) 150micrograms/0.3ml (1 in 2,000) solution for injection pre-filled disposable devices	£121.38	2 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Adrenaline (base) 1mg/10ml (1 in 10,000) dilute solution for injection ampoules	£189.07	10 ampoule	1 Oct 2026
NHS Drug Tariff	Adrenaline (base) 1mg/1ml (1 in 1,000) solution for injection ampoules	£11.81	10 ampoule	1 Oct 2026
NHS Drug Tariff	Adrenaline (base) 1mg/1ml (1 in 1,000) solution for injection pre-filled syringes	£15.77	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Adrenaline (base) 300micrograms/0.3ml (1 in 1,000) solution for injection pre-filled disposable devices	£60.69	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Adrenaline (base) 500micrograms/0.5ml (1 in 1,000) solution for injection ampoules	£364.07	10 ampoule	1 Oct 2026
NHS Drug Tariff	Adrenaline (base) 5mg/5ml (1 in 1,000) solution for injection ampoules	£211.89	10 ampoule	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)

25.1. Antiasthmatic and medicines for chronic obstructive pulmonary disease · core
Chronic obstructive pulmonary disease; Asthma
Parenteral > General injections > unspecified: 1 mg per mL in ampoule (as hydrochloride or hydrogen tartrate)
3. Antiallergics and medicines used in anaphylaxis · core
Anaphylaxis
Parenteral > General injections > unspecified: 1 mg in 1 mL ampoule (as hydrochloride or hydrogen tartrate)
12.2. Antiarrhythmic medicines · core
Cardiac arrest
Parenteral > General injections > IV: 100 µg per mL in 10 mL ampoule (as acid tartrate or hydrochloride)
21.5. Ophthalmological preparations > Mydriatics · complementary
Primary open-angle glaucoma
Local > Ophthalmological > Solution (eye drops): 2% (as hydrochloride)

Safety signals and safety-related labeling changes

US FDA 26 Mar 2026 NEFFY — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 19 Mar 2026 ADRENACLICK — 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 2 Jul 2025 ORABLOC — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 13 May 2025 EPINEPHRINE — safety-related labeling change
Labeling sections changed: Adverse Reactions
US FDA 30 Apr 2025 AUVI-Q — 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 30 Oct 2024 XYLOCAINE W/ EPINEPHRINE — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 10 Feb 2023 EPIPEN — 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 3 Nov 2021 CITANEST FORTE DENTAL — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 10 Sep 2021 EPINEPHRINE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations
US FDA 29 Jun 2021 SYMJEPI — safety-related labeling change
Labeling sections changed: Adverse Reactions; Drug Interactions
US FDA 21 Aug 2020 MARCAINE HYDROCHLORIDE W/ EPINEPHRINE — 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 29 Jan 2019 ADRENALIN — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations
US FDA 29 Jan 2019 ADRENALIN — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations
US FDA 2 Nov 2018 BUPIVACAINE HYDROCHLORIDE W/EPINEPHRINE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 2 Nov 2018 SEPTOCAINE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for epinephrine →

Combinations containing Epinephrine

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.