Is Esomeprazole registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 39 valid registrations of Esomeprazole, including EMANERA 20mg Gastro-Resistant Capsule (20 mg, Gastro-resistant capsule, SAR 46.05); EMANERA 40mg Gastro-Resistant Capsule (40 mg, Gastro-resistant capsule, SAR 61.70); ESOMEP 20 mg gastro-resistant tablet (20 mg, Gastro-resistant tablet, SAR 28.45); ESOMEP 40 mg gastro-resistant tablet (40 mg, Gastro-resistant tablet, SAR 38.80); ESOPOLE (40 mg, Lyophilisate for solution for injection, SAR 13.55).

Is Esomeprazole approved by the US FDA?

Drugs@FDA lists 66 application product lines for Esomeprazole, including NEXIUM (Prescription); NEXIUM (Prescription); NEXIUM (Prescription); NEXIUM 24HR (Over-the-counter); ESOMEPRAZOLE MAGNESIUM (Prescription).

Is Esomeprazole authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Esomeprazole: Nexium Control.

Are there safety signals or safety updates for Esomeprazole?

EMA PRAC: 8 entries; US FDA: 8 entries (latest 2024-11-21).

Active substance

Esomeprazole

SFDA 48
US FDA 66
EMA 1
Health Canada 26
US price lines 17
NHS prices 5
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
EMANERA 20mg Gastro-Resistant Capsule	20 mg	Gastro-resistant capsule · Oral use	28 Blister	SAR 46.05	Generic · Prescription	KRKA D D NOVO MESTO	Valid
EMANERA 40mg Gastro-Resistant Capsule	40 mg	Gastro-resistant capsule · Oral use	28 Blister	SAR 61.70	Generic · Prescription	KRKA D D NOVO MESTO	Valid
ESOMEP 20 mg gastro-resistant tablet	20 mg	Gastro-resistant tablet · Oral use	14 Tablet Container	SAR 28.45	Generic · OTC	SANDOZ	Valid
ESOMEP 20 mg gastro-resistant tablet	20 mg	Gastro-resistant tablet · Oral use	28 Tablet Container	SAR 55.45	Generic · Prescription	SANDOZ	Valid
ESOMEP 40 mg gastro-resistant tablet	40 mg	Gastro-resistant tablet · Oral use	14 Tablet Container	SAR 38.80	Generic · Prescription	SANDOZ	Valid
ESOMEP 40 mg gastro-resistant tablet	40 mg	Gastro-resistant tablet · Oral use	28 Tablet Container	SAR 63.50	Generic · Prescription	SANDOZ	Valid
ESOPOLE	40 mg	Lyophilisate for solution for injection · Oral use	1 Vial	SAR 13.55	Generic · Prescription	Saudi Amarox	Valid
ESOPOLE	40 mg	Lyophilisate for solution for injection · Oral use	10 Vial	SAR 135.65	Generic · Prescription	Saudi Amarox	Valid
ESOPOLE	40 mg	Modified-release capsule · Oral use	14 Bottle	SAR 36.75	Generic · Prescription	Saudi Amarox	Valid
ESOPOLE	40 mg	Modified-release capsule · Oral use	56 Bottle	SAR 131.30	Generic · Prescription	Saudi Amarox	Valid
ESOPOLE	40 mg	Modified-release capsule · Oral use	28 Bottle	SAR 65.65	Generic · Prescription	Saudi Amarox	Valid
ESOPOLE	20 mg	Modified-release capsule · Oral use	28 Bottle	SAR 52.55	Generic · Prescription	Saudi Amarox	Valid
ESOPOLE	20 mg	Modified-release capsule · Oral use	56 Bottle	SAR 105.10	Generic · Prescription	Saudi Amarox	Valid
ESOPOLE	20 mg	Modified-release capsule · Oral use	14 Bottle	SAR 26.95	Generic · OTC	Saudi Amarox	Valid
EZIUM	40 mg	Gastro-resistant capsule, hard · Oral use	28 Blister	SAR 65.65	Generic · Prescription	DAMMAM PHARMA	Valid
EZIUM	20 mg	Gastro-resistant capsule, hard · Oral use	28 Blister	SAR 52.55	Generic · Prescription	DAMMAM PHARMA	Valid
EZIUM	40 mg	Gastro-resistant capsule, hard · Oral use	14 Blister	SAR 36.75	Generic · Prescription	DAMMAM PHARMA	Valid
EZIUM	20 mg	Gastro-resistant capsule, hard · Oral use	14 Blister	SAR 26.95	Generic · OTC	DAMMAM PHARMA	Valid
EZORA 20 MG GASTRO-RESISTANT HARD CAPSULES (14S)	20 mg	Gastro-resistant capsule · Oral use	14 Blister	SAR 26.95	Generic · OTC	SPIMACO ADDWAEIH	Valid
EZORA 20 MG GASTRO-RESISTANT HARD CAPSULES (28S)	20 mg	Gastro-resistant capsule · Oral use	28 Blister	SAR 52.55	Generic · Prescription	SPIMACO ADDWAEIH	Valid
EZORA 40 MG GASTRO-RESISTANT HARD CAPSULES (14S)	40 mg	Gastro-resistant capsule · Oral use	14 Blister	SAR 36.75	Generic · Prescription	SPIMACO ADDWAEIH	Valid
EZORA 40 MG GASTRO-RESISTANT HARD CAPSULES (28S)	40 mg	Gastro-resistant capsule · Oral use	28 Blister	SAR 65.65	Generic · Prescription	SPIMACO ADDWAEIH	Valid
Esoxo	40 mg	Gastro-resistant tablet · Oral use	28 Blister	SAR 65.65	Generic · Prescription	SAUDI PHARMACEUTICAL INDUSTRIES	Valid
Esoxo	20 mg	Gastro-resistant tablet · Oral use	28 Blister	SAR 52.55	Generic · Prescription	SAUDI PHARMACEUTICAL INDUSTRIES	Valid
NEXIUM 20MG TAB	20 mg	Gastro-resistant tablet · Oral use	14 Blister	SAR 35.25	NCE · OTC	AstraZeneca UK Limited	Valid

23 more — full table

Indications — CHI Daman Drug Formulary

ANESTHESIA-SUPPORTIVE AGENTS/ ASPIRATION PNEUMONIA PROPHYLAXIS; BACTRIAL INFECTIONS OF THE GASTROINTESTINAL TRACT- H-PYLORI ERADICATION-EVIDENCE BASED FIRST LINE TREATMENT STRATEGY; BACTRIAL INFECTIONS OF THE GASTROINTESTINAL TRACT- H-PYLORI ERADICATION-SALVAGE THERAPIES; BARIATRIC SURGERY; CORONARY ARTERY DISEASE; DENTAL ABSCESS-DENTAL PAIN; DYSPEPSIA; ENTEROPATHIC ARTHROPATHIES, UNSPECIFIED SITE REACTIVE ARTHROPATHY, UNSPECIFIED; GASTROESOPHAGEAL REFLUX DISEASE (GERD); HIP AND KNEE REPLACEMENT SURGERY; LOW BACK PAIN; MIGRAINE/ HEADACHE; MYASTHENIA GRAVIS; NON-ST WAVE ELEVATED MYOCARDIAL INFARCTION (NSTEMI); PAIN MANAGEMENT IN CANCER PATIENTS; PEPTIC ULCER; POSTOPERATIVE PAIN; PSORIATIC ARTHRITIS; RENAL TRANSPLANT; RHEUMATOID ARITHRITIS-SUPPORTIVE CARE AND ADRS MANAGEMENT; ST-WAVE ELEVATED MYOCARDIAL INFARCTION (STEMI); THROMBOTIC THROMBOCYTOPENIC PURPURA; TUBERCULOSIS-SUPPORTIVE CARE

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

Product	Strength	Form · route	Applicant	Status	First approved
NEXIUM	EQ 20MG BASE; EQ 40MG BASE	capsule, delayed rel pellets · oral	ASTRAZENECA	Prescription	20 Feb 2001
NEXIUM	EQ 20MG BASE/PACKET; EQ 40MG BASE/PACKET; EQ 2.5MG BASE/PACKET; EQ 5MG BASE/PACKET	for suspension, delayed release · oral	ASTRAZENECA	Prescription	20 Oct 2006
NEXIUM	EQ 10MG BASE/PACKET	for suspension, delayed release · oral	ASTRAZENECA	Prescription	27 Feb 2008
NEXIUM 24HR	EQ 20MG BASE	capsule, delayed release · oral	ASTRAZENECA LP	Over-the-counter	28 Mar 2014
ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE; EQ 40MG BASE	capsule, delayed rel pellets · oral	MYLAN	Prescription	3 Aug 2015
ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE; EQ 40MG BASE	capsule, delayed rel pellets · oral	DR REDDYS	Prescription	25 Sep 2015
NEXIUM 24HR	EQ 20MG BASE	tablet, delayed release · oral	ASTRAZENECA LP	Over-the-counter	23 Nov 2015
ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE; EQ 40MG BASE	capsule, delayed rel pellets · oral	AUROBINDO PHARMA LTD	Prescription	21 Apr 2016
ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	injectable · intravenous	REGCON HOLDINGS	Prescription	6 Mar 2017
ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	capsule, delayed release · oral	PERRIGO R AND D	Over-the-counter	18 Aug 2017
ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE; EQ 40MG BASE	capsule, delayed rel pellets · oral	LANNETT CO INC	Prescription	1 Sep 2017
ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	capsule, delayed release · oral	AUROBINDO PHARMA	Over-the-counter	16 Oct 2017
ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE; EQ 40MG BASE	capsule, delayed rel pellets · oral	ALKEM LABS LTD	Prescription	20 Oct 2017
ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE; EQ 40MG BASE	capsule, delayed rel pellets · oral	SUN PHARM	Prescription	30 Apr 2018
ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	capsule, delayed release · oral	DR REDDYS	Over-the-counter	15 May 2018
ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE; EQ 40MG BASE	capsule, delayed rel pellets · oral	ZYDUS PHARMS	Prescription	22 May 2019
ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE/PACKET; EQ 40MG BASE/PACKET	for suspension, delayed release · oral	CIPLA	Prescription	23 Mar 2020
ESOMEPRAZOLE MAGNESIUM	EQ 10MG BASE/PACKET	for suspension, delayed release · oral	CIPLA	Prescription	23 Mar 2020
ESOMEPRAZOLE SODIUM	EQ 20MG BASE/VIAL; EQ 40MG BASE/VIAL	injectable · intravenous	GLAND	Prescription	1 Apr 2020
ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	capsule, delayed release · oral	SUN PHARM	Over-the-counter	4 May 2020
ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	tablet, delayed release · oral	DR REDDYS	Over-the-counter	14 May 2020
ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE; EQ 40MG BASE	capsule, delayed rel pellets · oral	HETERO LABS LTD III	Prescription	2 Jun 2020
ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	capsule, delayed release · oral	HETERO LABS LTD III	Over-the-counter	2 Jun 2020
ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE; EQ 40MG BASE	capsule, delayed rel pellets · oral	CSPC OUYI	Prescription	2 Oct 2020
ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE; EQ 40MG BASE	capsule, delayed rel pellets · oral	GUANGZHOU NOVAKEN	Prescription	18 Nov 2020

41 more — full table

EMA European Union — centrally authorised medicines

Nexium Control Haleon Ireland Dungarvan Limited · Authorised · authorised 26 Aug 2013 · ATC A02BC05

Therapeutic indication (EMA)

Nexium Control is indicated for the short-term treatment of reflux symptoms (e.g. heartburn and acid regurgitation) in adults.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO-ESOMEPRAZOLE	02339099	20 MG	TABLET (DELAYED-RELEASE) · ORAL	APOTEX INC
APO-ESOMEPRAZOLE	02339102	40 MG	TABLET (DELAYED-RELEASE) · ORAL	APOTEX INC
ESOMEPRAZOLE	02394839	20 MG	TABLET (DELAYED-RELEASE) · ORAL	PRO DOC LIMITEE
ESOMEPRAZOLE	02394847	40 MG	TABLET (DELAYED-RELEASE) · ORAL	PRO DOC LIMITEE
ESOMEPRAZOLE	02442493	20 MG	TABLET (DELAYED-RELEASE) · ORAL	SIVEM PHARMACEUTICALS ULC
ESOMEPRAZOLE	02442507	40 MG	TABLET (DELAYED-RELEASE) · ORAL	SIVEM PHARMACEUTICALS ULC
ESOMEPRAZOLE	02520699	20 MG	TABLET (DELAYED-RELEASE) · ORAL	JAMP PHARMA CORPORATION
ESOMEPRAZOLE	02520702	40 MG	TABLET (DELAYED-RELEASE) · ORAL	JAMP PHARMA CORPORATION
M-ESOMEPRAZOLE	02520109	20 MG	TABLET (DELAYED-RELEASE) · ORAL	MANTRA PHARMA INC
M-ESOMEPRAZOLE	02520117	40 MG	TABLET (DELAYED-RELEASE) · ORAL	MANTRA PHARMA INC
MYL-ESOMEPRAZOLE	02479419	20 MG	TABLET (DELAYED-RELEASE) · ORAL	MYLAN PHARMACEUTICALS ULC
MYL-ESOMEPRAZOLE	02479427	40 MG	TABLET (DELAYED-RELEASE) · ORAL	MYLAN PHARMACEUTICALS ULC
NEXIUM	02300524	10 MG / SACHET	GRANULES FOR SUSPENSION (DELAYED-RELEASE · ORAL	ASTRAZENECA CANADA INC
NEXIUM - 20MG	02244521	20 MG	TABLET (DELAYED-RELEASE) · ORAL	ASTRAZENECA CANADA INC
NEXIUM - 40MG	02244522	40 MG	TABLET (DELAYED-RELEASE) · ORAL	ASTRAZENECA CANADA INC
NEXIUM 24HR	02444712	20 MG	CAPSULE (DELAYED-RELEASE) · ORAL	HALEON CANADA ULC
PMSC-ESOMEPRAZOLE DR	02528479	20 MG	TABLET (DELAYED-RELEASE) · ORAL	PHARMASCIENCE INC
PMSC-ESOMEPRAZOLE DR	02528487	40 MG	TABLET (DELAYED-RELEASE) · ORAL	PHARMASCIENCE INC
RIVA-ESOMEPRAZOLE	02557673	20 MG	TABLET (DELAYED-RELEASE) · ORAL	LABORATOIRE RIVA INC.
RIVA-ESOMEPRAZOLE	02557681	40 MG	TABLET (DELAYED-RELEASE) · ORAL	LABORATOIRE RIVA INC.
SANDOZ ESOMEPRAZOLE	02460920	20 MG	TABLET (DELAYED-RELEASE) · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ ESOMEPRAZOLE	02460939	40 MG	TABLET (DELAYED-RELEASE) · ORAL	SANDOZ CANADA INCORPORATED
TARO-ESOMEPRAZOLE	02423979	20 MG	TABLET (DELAYED-RELEASE) · ORAL	SUN PHARMA CANADA INC
TARO-ESOMEPRAZOLE	02423987	40 MG	TABLET (DELAYED-RELEASE) · ORAL	SUN PHARMA CANADA INC
TEVA-ESOMEPRAZOLE	02423855	20 MG	TABLET (DELAYED-RELEASE) · ORAL	TEVA CANADA LIMITED

1 more — full table

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	ESOMEPRAZOLE DR 10 MG PACKET	$4.96363	per EA	23 Sep 2026
US NADAC	ESOMEPRAZOLE DR 2.5 MG PACKET	$5.49156	per EA	23 Sep 2026
US NADAC	ESOMEPRAZOLE DR 20 MG PACKET	$4.00136	per EA	23 Sep 2026
US NADAC	ESOMEPRAZOLE DR 40 MG PACKET	$4.17167	per EA	23 Sep 2026
US NADAC	ESOMEPRAZOLE DR 5 MG PACKET	$5.00536	per EA	23 Sep 2026
US NADAC	ESOMEPRAZOLE MAG DR 20 MG CAP	$0.14458	per EA	30 Sep 2026
US NADAC	ESOMEPRAZOLE MAG DR 20 MG CAP	$0.34596	per EA	23 Sep 2026
US NADAC	ESOMEPRAZOLE MAG DR 40 MG CAP	$0.12181	per EA	23 Sep 2026
US NADAC	GNP ESOMEPRAZOLE MAG DR 20 MG	$0.34596	per EA	23 Sep 2026
US NADAC	GS ESOMEPRAZOLE MAG DR 20 MG	$0.34596	per EA	23 Sep 2026
US NADAC	NEXIUM DR 10 MG PACKET	$9.14112	per EA	23 Sep 2026
US NADAC	NEXIUM DR 2.5 MG PACKET	$9.16605	per EA	23 Sep 2026
NHS Drug Tariff	Esomeprazole 10mg gastro-resistant granules sachets	£47.84	28 sachet	1 Oct 2026
NHS Drug Tariff	Esomeprazole 20mg gastro-resistant capsules	£1.99	28 capsule	1 Oct 2026
NHS Drug Tariff	Esomeprazole 20mg gastro-resistant tablets	£1.95	28 tablet	1 Oct 2026
NHS Drug Tariff	Esomeprazole 40mg gastro-resistant capsules	£2.06	28 capsule	1 Oct 2026
NHS Drug Tariff	Esomeprazole 40mg gastro-resistant tablets	£2.56	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.

Safety signals and safety-related labeling changes

US FDA 21 Nov 2024 VIMOVO — 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
EMA PRAC 26 Oct 2023 PRAC signal: Erectile dysfunction
Action for MAH: update of the product information: No
US FDA 18 Jul 2023 NEXIUM — 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 18 Jul 2023 NEXIUM — 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 18 Jul 2023 NEXIUM — 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 18 Jul 2023 NEXIUM IV — 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 6 Sep 2022 NEXIUM 24HR — safety-related labeling change
Labeling sections changed: Warnings and Precautions
US FDA 6 Sep 2022 NEXIUM 24HR — safety-related labeling change
Labeling sections changed: Warnings and Precautions
US FDA 4 Mar 2022 ESOMEPRAZOLE STRONTIUM — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 12 Jan 2017 PRAC signal: Incident chronic kidney disease (CKD) and progression to end stage renal disease (ESRD)
Action for MAH: update of the product information: No
EMA PRAC 1 Dec 2016 PRAC signal: Gastric polyps
Action for MAH: update of the product information: Yes
EMA PRAC 2 Sep 2016 PRAC signal: Gastric polyps
Action for MAH: update of the product information: No
EMA PRAC 2 Sep 2016 PRAC signal: Incident chronic kidney disease (CKD) and progression to end stage renal disease (ESRD)
Action for MAH: update of the product information: No
EMA PRAC 8 Jul 2016 PRAC signal: Elevated circulating levels of chromogranin A
Action for MAH: update of the product information: Yes
EMA PRAC 17 Mar 2016 PRAC signal: Elevated circulating levels of chromogranin A
Action for MAH: update of the product information: No

All safety entries for esomeprazole →

Combinations containing Esomeprazole

Esomeprazole + naproxen

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.