Is Esmolol registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 3 valid registrations of Esmolol, including BREVIBLOC Premixed 10 mg/ml solution for infusion (10 mg/ml, Solution, SAR 387.00); ESOBLOC 10 mg/ml solution for infusion (10 mg/ml, Solution for infusion, SAR 13.20); Takidet (10 mg/ml, Solution for injection, SAR 125.75).

Is Esmolol approved by the US FDA?

Drugs@FDA lists 17 application product lines for Esmolol, including BREVIBLOC IN PLASTIC CONTAINER (Prescription); BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER (Prescription); BREVIBLOC (Prescription); ESMOLOL HYDROCHLORIDE (Prescription); ESMOLOL HYDROCHLORIDE (Prescription).

Are there safety signals or safety updates for Esmolol?

US FDA: 2 entries (latest 2024-05-02).

Active substance

Esmolol

SFDA 3
US FDA 17
Health Canada 2
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
BREVIBLOC Premixed 10 mg/ml solution for infusion	10 mg/ml	Solution · Intravenous use	1 Bag	SAR 387.00	NCE · Prescription	BAXTER HEALTHCARE	Valid
ESOBLOC 10 mg/ml solution for infusion	10 mg/ml	Solution for infusion · Intravenous use	1 Vial	SAR 13.20	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Takidet	10 mg/ml	Solution for injection · Intravenous use	10 Vial	SAR 125.75	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid

Indications — CHI Daman Drug Formulary

ANESTHESIA-SUPPORTIVE AGENTS/ CARDIAC ARREST, CARDIOVASCULAR EMERGENCIES AND/OR DYSRHYTHMIAS; ARRHYTHMIA; ATRIAL FIBRILLATION; HYPERTENSION; HYPERTHYROIDISM; SUPRAVENTRICULAR TACHYCARDIA; VENTRICULAR TACHYCARDIA

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

Product	Strength	Form · route	Applicant	Status	First approved
BREVIBLOC IN PLASTIC CONTAINER	1GM/100ML	injectable · injection	BAXTER HLTHCARE	Prescription	31 Dec 1986
BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER	2GM/100ML	injectable · injection	BAXTER HLTHCARE	Prescription	31 Dec 1986
BREVIBLOC	10MG/ML	injectable · injection	BAXTER HLTHCARE	Prescription	31 Dec 1986
ESMOLOL HYDROCHLORIDE	10MG/ML	injectable · injection	HIKMA PHARMS	Prescription	10 Aug 2004
ESMOLOL HYDROCHLORIDE	10MG/ML	injectable · injection	MYLAN INSTITUTIONAL	Prescription	2 May 2005
ESMOLOL HYDROCHLORIDE	10MG/ML	injectable · injection	EUGIA PHARMA	Prescription	23 Jul 2015
ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER	2.5GM/250ML (10MG/ML)	solution · intravenous	HQ SPCLT PHARMA	Prescription	7 Apr 2016
ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER	2GM/100ML (20MG/ML)	solution · intravenous	HQ SPCLT PHARMA	Prescription	7 Apr 2016
ESMOLOL HYDROCHLORIDE	1GM/100ML; 2GM/100ML	injectable · injection	MYLAN LABS LTD	Prescription	8 Jun 2018
ESMOLOL HYDROCHLORIDE	1GM/100ML; 2GM/100ML	injectable · injection	SAGENT PHARMS INC	Prescription	8 Jun 2018
ESMOLOL HYDROCHLORIDE	10MG/ML	injectable · injection	GLAND	Prescription	14 Aug 2019
ESMOLOL HYDROCHLORIDE	1GM/100ML; 2GM/100ML	injectable · injection	EUGIA PHARMA	Prescription	21 Mar 2022
ESMOLOL HYDROCHLORIDE	1GM/100ML; 2GM/100ML	injectable · injection	HQ SPCLT PHARMA	Prescription	2 Dec 2022
ESMOLOL HYDROCHLORIDE	1GM/100ML; 2GM/100ML	injectable · injection	AMNEAL	Prescription	13 Dec 2022
BREVIBLOC	250MG/ML; 10MG/ML; 20MG/ML	injectable · injection	BAXTER HLTHCARE	Discontinued	31 Dec 1986
ESMOLOL HYDROCHLORIDE	10MG/ML; 20MG/ML	injectable · injection	FRESENIUS KABI USA	Discontinued	2 May 2005
ESMOLOL HYDROCHLORIDE	10MG/ML	injectable · injection	AM REGENT	Discontinued	20 Feb 2015

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
BREVIBLOC INJECTION 10MG/ML	02188880	10 MG / ML	SOLUTION · INTRAVENOUS	BAXTER CORPORATION
BREVIBLOC PREMIXED INJECTION	02309238	10 MG / ML	SOLUTION · INTRAVENOUS	BAXTER CORPORATION

Safety signals and safety-related labeling changes

US FDA 2 May 2024 ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 15 Jun 2023 BREVIBLOC — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for esmolol →

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.