Is Dexmedetomidine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 13 valid registrations of Dexmedetomidine, including Demexa (100 µ/ml, Solution for injection, SAR 498.40); Dexdor (100 µg/ml, Concentrate for solution for infusion, SAR 1922.40); Dexmedetomidine PSI (4 µ/ml, Solution for infusion, SAR 142.40); Dormidex (100 µg/ml, Concentrate for solution for infusion, SAR 302.05); Naplax (4 µl/ml, Solution for infusion, SAR 49.85).

Is Dexmedetomidine approved by the US FDA?

Drugs@FDA lists 38 application product lines for Dexmedetomidine, including PRECEDEX (Prescription); DEXMEDETOMIDINE HYDROCHLORIDE (Prescription); DEXMEDETOMIDINE HYDROCHLORIDE (Prescription); DEXMEDETOMIDINE HYDROCHLORIDE (Prescription); DEXMEDETOMIDINE HYDROCHLORIDE (Prescription).

Is Dexmedetomidine authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Dexmedetomidine: Dexdor.

Are there safety signals or safety updates for Dexmedetomidine?

EMA PRAC: 4 entries; US FDA: 3 entries (latest 2026-05-01).

Active substance

Dexmedetomidine

SFDA 13
US FDA 38
EMA 1
Health Canada 9
Safety 7

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Demexa	100 µ/ml	Solution for injection · Intravenous use	10 Vial	SAR 498.40	Generic · Prescription	Boston Oncology Arabia	Valid
Dexdor	100 µg/ml	Concentrate for solution for infusion · Intravenous use	25 Ampoule	SAR 1922.40	NCE · Prescription	Exeltis Healthcare S.L	Valid
Dexmedetomidine PSI	4 µ/ml	Solution for infusion · Intravenous use	1 Vial	SAR 142.40	Generic · Prescription	Pharmaceutical Solutions Industry Ltd	Valid
Dormidex	100 µg/ml	Concentrate for solution for infusion · Intravenous use	10 Ampoule	SAR 302.05	Generic · Prescription	B. BRAUN	Valid
Dormidex	100 µg/ml	Concentrate for solution for infusion · Intravenous use	10 Ampoule	SAR 605.85	Generic · Prescription	B. BRAUN	Valid
Dormidex	100 µg/ml	Concentrate for solution for infusion · Intravenous use	10 Ampoule	SAR 1514.60	Generic · Prescription	B. BRAUN	Valid
Naplax	4 µl/ml	Solution for infusion · Intravenous use	1 Vial	SAR 49.85	Generic · Prescription	Med City Pharma	Valid
Naplax	4 µg/ml	Solution for infusion · Intravenous use	10 Vial	SAR 854.50	Generic · Prescription	Med City Pharma	Valid
PRECEDEX 100 MCG -ML IV. VIAL	100 µ/ml	Injection · Intravenous use	1 Vial	SAR 102.50	NCE · Prescription	HOSPIRA INC	Valid
SEDALERT 100 MCG -ML IV. VIAL	100 µ/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 83.25	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
SOPORIDEX	100 µ/ml	Concentrate for solution for infusion · Intravenous use	5 Vial	SAR 680.55	Generic · Prescription	EVER Valinject GmbH	Valid
SOPORIDEX	100 µ/ml	Concentrate for solution for infusion · Intravenous use	5 Vial	SAR 395.70	Generic · Prescription	EVER Valinject GmbH	Valid
SOPORIDEX	100 µ/ml	Concentrate for solution for infusion · Intravenous use	5 Vial	SAR 1592.30	Generic · Prescription	EVER Valinject GmbH	Valid

Indications — CHI Daman Drug Formulary

BURN MANAGEMENT

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

Product	Strength	Form · route	Applicant	Status	First approved
PRECEDEX	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML); EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML); EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML); EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML); EQ 1MG BASE/250ML (EQ 4MCG BASE/ML)	injectable · injection	HOSPIRA	Prescription	17 Dec 1999
DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	injectable · injection	MYLAN INSTITUTIONAL	Prescription	18 Aug 2014
DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	injectable · injection	PH HEALTH	Prescription	18 Aug 2014
DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	injectable · injection	RISING	Prescription	24 Nov 2014
DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	injectable · injection	GLAND	Prescription	20 Aug 2015
DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	injectable · injection	FRESENIUS KABI USA	Prescription	18 Sep 2015
DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML); EQ 1MG BASE/10ML (EQ 100MCG BASE/ML); EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML); EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	solution · intravenous	HQ SPCLT PHARMA	Prescription	21 Oct 2015
DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	injectable · injection	ACCORD HLTHCARE	Prescription	9 Feb 2016
DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	injectable · injection	EUGIA PHARMA	Prescription	17 Mar 2016
DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	injectable · injection	ACTAVIS INC	Prescription	17 Oct 2016
DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	injectable · injection	HIKMA PHARMS	Prescription	26 Apr 2017
DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML); EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML); EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	injectable · injection	HENGRUI PHARMA	Prescription	19 Sep 2017
DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	injectable · injection	TEVA PHARMS USA	Prescription	28 Nov 2017
DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	injectable · injection	ZYDUS PHARMS	Prescription	27 Feb 2018
DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML); EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	injectable · injection	BAXTER HLTHCARE CORP	Prescription	21 Aug 2018
DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML); EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML); EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	injectable · injection	FRESENIUS KABI USA	Prescription	29 Nov 2018
DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	injectable · injection	MEITHEAL	Prescription	18 Jan 2019
DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML); EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	injectable · injection	WILSHIRE PHARMS INC	Prescription	4 Dec 2019
DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML); EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML); EQ 1MG BASE/250ML (EQ 4MCG BASE/ML)	injectable · injection	HIKMA PHARMS	Prescription	30 Jan 2020
DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML); EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	injectable · injection	AMNEAL PHARMS CO	Prescription	20 May 2020
DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML); EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	injectable · injection	GLAND	Prescription	3 Jun 2020
DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML); EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	injectable · injection	MYLAN LABS LTD	Prescription	27 Aug 2020
DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML); EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	injectable · injection	PH HEALTH	Prescription	15 Sep 2020
DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML); EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML); EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	injectable · injection	TAGI	Prescription	23 Nov 2020
DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML); EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	injectable · injection	EUGIA PHARMA	Prescription	7 Dec 2020

13 more — full table

EMA European Union — centrally authorised medicines

Dexdor Orion Corporation · Authorised · authorised 15 Sep 2011 · ATC N05CM18

Therapeutic indication (EMA)

For sedation of adult intensive care unit patients requiring a sedation level not deeper than arousal in response to verbal stimulation (corresponding to Richmond Agitation-Sedation Scale (RASS) 0 to -3).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION	02464381	100 MCG / ML	SOLUTION · INTRAVENOUS	AURO PHARMA INC
DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION	02477327	100 MCG / ML	SOLUTION · INTRAVENOUS	ACCORD HEALTHCARE INC
DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION	02528886	100 MCG / ML	SOLUTION · INTRAVENOUS	EUGIA PHARMA INC.
DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION, USP	02467976	100 MCG / ML	SOLUTION · INTRAVENOUS	JUNO PHARMA CANADA INC.
DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION, USP	02513978	100 MCG / ML	SOLUTION · INTRAVENOUS	BAXTER CORPORATION
DEXMEDETOMIDINE HYDROCHLORIDE INJECTION	02487365	200 MCG / 50 ML	SOLUTION · INTRAVENOUS	JUNO PHARMA CANADA INC.
DEXMEDETOMIDINE HYDROCHLORIDE INJECTION	02487373	400 MCG / 100 ML	SOLUTION · INTRAVENOUS	JUNO PHARMA CANADA INC.
DEXMEDETOMIDINE HYDROCHLORIDE INJECTION	02537109	4 MCG / ML	SOLUTION · INTRAVENOUS	HIKMA CANADA LIMITED
PRECEDEX	02437147	4 MCG / ML	SOLUTION · INTRAVENOUS	PFIZER CANADA ULC

Safety signals and safety-related labeling changes

US FDA 1 May 2026 DEXMEDETOMIDINE HYDROCHLORIDE — 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 1 May 2026 PRECEDEX — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 19 Nov 2025 IGALMI — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions
EMA PRAC 1 Sep 2017 PRAC signal: Polyuria
Action for MAH: update of the product information: No
EMA PRAC 13 Jun 2014 PRAC signal: Infantile apnoeic attack
Action for MAH: update of the product information: Yes
EMA PRAC 9 Jan 2014 PRAC signal: Infantile apnoeic attack
Action for MAH: update of the product information: No
EMA PRAC 5 Sep 2013 PRAC signal: Infantile apnoeic attack
Action for MAH: update of the product information: No

All safety entries for dexmedetomidine →

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.