Is Dextrose registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 49 valid registrations of Dextrose, including 10% DEXTROSE W/V intravenous infusion (10 %, Intravenous infusion, SAR 6.50); 10% Dextrose intravenous infusion (10 %, Solution for injection, SAR 6.50); 20%W/V DEXTROSE injection, USP (20 %, Solution for injection, SAR 0.80); 40% w/v DEXTROSE Injection USP (40 %, Solution for injection, SAR 2.00); 5 % w/v DEXTROSE Injection 500 ml (5 %, Solution for infusion, SAR 162.00).

Is Dextrose approved by the US FDA?

Drugs@FDA lists 44 application product lines for Dextrose, including DEXTROSE 10% IN PLASTIC CONTAINER (Prescription); DEXTROSE 5% IN PLASTIC CONTAINER (Prescription); DEXTROSE 5% IN PLASTIC CONTAINER (Prescription); DEXTROSE 5% IN PLASTIC CONTAINER (Prescription); DEXTROSE 10% IN PLASTIC CONTAINER (Prescription).

Are there safety signals or safety updates for Dextrose?

US FDA: 3 entries (latest 2025-07-24).

Active substance

Dextrose

SFDA 137
US FDA 44
Health Canada 9
Safety 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
10% DEXTROSE W/V intravenous infusion	10 %	Intravenous infusion · Intravenous use	1 Bag	SAR 6.50	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
10% Dextrose intravenous infusion	10 %	Solution for injection · Intravenous use	1 Bottle	SAR 6.50	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
20%W/V DEXTROSE injection, USP	20 %	Solution for injection · Intravenous use	1 Bottle	SAR 0.80	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
40% w/v DEXTROSE Injection USP	40 %	Solution for injection · Intravenous use	1 Ampoule	SAR 2.00	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
5 % w/v DEXTROSE Injection 500 ml	5 %	Solution for infusion · Intravenous use	20 Bottle	SAR 162.00	Generic · Prescription	AL RAZI PHARMA INDUSTRIES	Valid
5%W/V DEXTROSE INJECTION 250ML	5 %	Solution for injection · Intravenous use	40 Bottle	SAR 232.00	Generic · Prescription	AL RAZI PHARMA INDUSTRIES	Valid
50% w/v DEXTROSE intravenous infusion	50 %	Intravenous infusion · Intravenous use	1 Bottle	SAR 5.50	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
50%W/V DESTROSE intravenous infusion	50 %	Intravenous infusion · Intravenous use	1 Bag	SAR 12.70	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
DEXTROSE 10% I.V.INFUSION	10 %	Solution for injection · Intravenous use	1 Bottle	SAR 3.40	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
DEXTROSE 10% I.V.INFUSION	10 %	Solution for injection · Intravenous use	1 Bag	SAR 5.40	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
DEXTROSE 10% I.V.INFUSION	10 %	Solution for injection · Intravenous use	1 Bag	SAR 9.25	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
DEXTROSE 10% SOLUTION FOR INJ	10 %	Solution for injection · Intravenous use	1 Bag	SAR 4.30	Generic · Prescription	KUWAIT SAUDI PHARMACEUTICAL INDUSTRIES	Valid
DEXTROSE 20% INJ	20 %	Solution for injection · Intravenous use	1 Bottle	SAR 0.80	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
DEXTROSE 20% INJ	20 %	Solution for injection · Intravenous use	1 Bottle	SAR 1.35	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
DEXTROSE 20% W-V INFUSION	20 %	Solution for injection · Intravenous use	1 Bottle	SAR 8.30	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
DEXTROSE 20% W-V INFUSION	20 %	Solution for injection · Intravenous use	1 Bag	SAR 9.95	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
DEXTROSE 25% INJ	25 %	Solution for injection · Intravenous use	1 Bottle	SAR 0.85	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
DEXTROSE 25% INJ	25 %	Solution for injection · Intravenous use	1 Bottle	SAR 2.10	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
DEXTROSE 25% INJ	25 %	Solution for injection · Intravenous use	1 Bottle	SAR 8.05	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
DEXTROSE 25% INJ	25 %	Solution for injection · Intravenous use	1 Bottle	SAR 0.95	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
DEXTROSE 25% INJ	25 %	Solution for injection · Intravenous use	1 Bag	SAR 11.50	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
DEXTROSE 40% INFUSION	40 %	Solution for injection · Intravenous use	1 Bag	SAR 9.00	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
DEXTROSE 40% INFUSION	40 %	Solution for injection · Intravenous use	1 Bottle	SAR 1.05	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
DEXTROSE 40% INFUSION	40 %	Solution for injection · Intravenous use	1 Bottle	SAR 1.10	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
DEXTROSE 40% INFUSION	40 %	Solution for injection · Intravenous use	1 Bottle	SAR 10.20	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid

112 more — full table

Indications — CHI Daman Drug Formulary

ANESTHESIA-SUPPORTIVE AGENTS/ FLUID RESUSCITATION (UNCONTROLLED BLEEDING); DIABETIC KETOACIDOSIS; FLUIDS AND VOLUME EXPANDERS-HYPOGLYCEMIA; HYPERKALEMIA; HYPOGLYCEMIA

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

Product	Strength	Form · route	Applicant	Status	First approved
DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	injectable · injection	BAXTER HLTHCARE	Prescription	25 Jan 1971
DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	injectable · injection	OTSUKA ICU MEDCL	Prescription	12 Feb 1971
DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML; 50MG/ML	injectable · injection	BAXTER HLTHCARE	Prescription	4 Mar 1971
DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML; 50MG/ML	injectable · injection	B BRAUN	Prescription	21 Dec 1973
DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	injectable · injection	OTSUKA ICU MEDCL	Prescription	28 Aug 1979
DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	injectable · injection	OTSUKA ICU MEDCL	Prescription	23 Mar 1982
DEXTROSE 40% IN PLASTIC CONTAINER	40GM/100ML	injectable · injection	OTSUKA ICU MEDCL	Prescription	23 Mar 1982
DEXTROSE 50% IN PLASTIC CONTAINER	50GM/100ML	injectable · injection	OTSUKA ICU MEDCL	Prescription	23 Mar 1982
DEXTROSE 20% IN PLASTIC CONTAINER	20GM/100ML	injectable · injection	OTSUKA ICU MEDCL	Prescription	23 Mar 1982
DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML	injectable · injection	OTSUKA ICU MEDCL	Prescription	26 Jan 1985
DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	injectable · injection	HOSPIRA	Prescription	15 Jul 1985
DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	injectable · injection	HOSPIRA	Prescription	17 Sep 1985
DEXTROSE 50%	500MG/ML	injectable · injection	HOSPIRA	Prescription	3 Jun 1986
DEXTROSE 25%	250MG/ML	injectable · injection	HOSPIRA	Prescription	3 Jun 1986
DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	injectable · injection	B BRAUN	Prescription	2 Feb 1988
DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	injectable · injection	B BRAUN	Prescription	2 Feb 1988
DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	injectable · injection	B BRAUN	Prescription	2 Feb 1988
DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	injectable · injection	OTSUKA ICU MEDCL	Prescription	26 Dec 1989
DEXTROSE 50% IN PLASTIC CONTAINER	50GM/100ML	injectable · injection	BAXTER HLTHCARE	Prescription	2 Jul 1991
DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	injectable · injection	BAXTER HLTHCARE	Prescription	2 Jul 1991
DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML; 50MG/ML	injectable · injection	BAXTER HLTHCARE	Prescription	7 Dec 1992
DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	injectable · injection	FRESENIUS KABI USA	Prescription	21 Oct 2016
DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	injectable · injection	FRESENIUS KABI USA	Prescription	16 Jul 2018
DEXTROSE 50%	500MG/ML	injectable · injection	INTL MEDICATION SYS	Prescription	26 Mar 2021
DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	injectable · injection	B BRAUN	Discontinued	21 Feb 1978

19 more — full table

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
10% DEXTROSE INJECTION USP	01924427	100 MG / ML	SOLUTION · INTRAVENOUS	B. BRAUN MEDICAL INC
10% DEXTROSE INJECTION, USP	00060364	10 G / 100 ML	SOLUTION · INTRAVENOUS	BAXTER CORPORATION
5% DEXTROSE INJECTION	02403536	50 MG / ML	SOLUTION · INTRAVENOUS	FRESENIUS KABI CANADA LTD
5% DEXTROSE INJECTION USP	01924281	50 MG / ML	SOLUTION · INTRAVENOUS	B. BRAUN MEDICAL INC
5% DEXTROSE INJECTION, USP	00060348	5 G / 100 ML	SOLUTION · INTRAVENOUS	BAXTER CORPORATION
70% DEXTROSE INJECTION USP	02014874	70 G / 100 ML	SOLUTION · INTRAVENOUS	BAXTER CORPORATION
DEXTROSE INJECTION	02517132	50 % / W/V	SOLUTION · INTRAVENOUS	OMEGA LABORATORIES LIMITED
DEXTROSE INJECTION USP	00037915	50 MG / ML	SOLUTION · INTRAVENOUS	ICU MEDICAL CANADA INC
DEXTROSE INJECTION USP	02468514	500 MG / ML	SOLUTION · INTRAVENOUS	PFIZER CANADA ULC

Safety signals and safety-related labeling changes

US FDA 24 Jul 2025 KABIVEN IN PLASTIC CONTAINER — 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 24 Jul 2025 PERIKABIVEN IN PLASTIC CONTAINER — 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 30 Jun 2017 PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations

All safety entries for dextrose →

Combinations containing Dextrose

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.