Is Iodixanol registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 14 valid registrations of Iodixanol, including TRIOSOF 320MG/ML INJECTION (652 mg/ml, Solution for injection, SAR 65.65); VISIPAQUE (270 mg/ml, Solution for injection, SAR 1343.00); VISIPAQUE (320 mg/ml, Solution for injection, SAR 1480.15); VISIPAQUE 270MG/ML SOLUTION FOR INJECTION (550 mg/ml, Solution for injection, SAR 590.40); VISIPAQUE 320MG/ML SOLUTION FOR INJECTION (652 mg/ml, Solution for injection, SAR 1304.80).

Is Iodixanol approved by the US FDA?

Drugs@FDA lists 5 application product lines for Iodixanol, including VISIPAQUE 270 (Prescription); VISIPAQUE 320 (Prescription); VISIPAQUE 320 (Prescription); IODIXANOL (Prescription); VISIPAQUE 270 (Discontinued).

Are there safety signals or safety updates for Iodixanol?

EMA PRAC: 2 entries; US FDA: 4 entries (latest 2026-06-11).

Active substance

Iodixanol

SFDA 16
US FDA 5
Health Canada 4
Safety 6

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
TRIOSOF 320MG/ML INJECTION	652 mg/ml	Solution for injection · Intravenous use	1 Vial	SAR 65.65	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
TRIOSOF 320MG/ML INJECTION	652 mg/ml	Solution for injection · Intravenous use	1 Vial	SAR 109.65	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
VISIPAQUE	270 mg/ml	Solution for injection · Intravenous use	10 Vial	SAR 1343.00	Generic · Prescription	GE Healthcare AS	Valid
VISIPAQUE	270 mg/ml	Solution for injection · Intravenous use	6 Vial	SAR 1363.25	Generic · Prescription	GE HEALTHCARE	Valid
VISIPAQUE	320 mg/ml	Solution for injection · Intravenous use	10 Vial	SAR 1480.15	Generic · Prescription	GE Healthcare AS	Valid
VISIPAQUE	320 mg/ml	Solution for injection · Intravenous use	10 Vial	SAR 425.40	Generic · Prescription	GE HEALTHCARE	Valid
VISIPAQUE	320 mg/ml	Solution for injection · Intravenous use	10 Vial	SAR 886.30	Generic · Prescription	GE Healthcare AS	Valid
VISIPAQUE	320 mg/ml	Solution for injection · Intravenous use	6 Vial	SAR 1556.45	Generic · Prescription	GE HEALTHCARE	Valid
VISIPAQUE	270 mg/ml	Solution for injection · Intravenous use	10 Vial	SAR 764.65	Generic · Prescription	GE Healthcare AS	Valid
VISIPAQUE	270 mg/ml	Solution for injection · Intravenous use	10 Vial	SAR 370.80	Generic · Prescription	GE HEALTHCARE	Valid
VISIPAQUE 270MG/ML SOLUTION FOR INJECTION	550 mg/ml	Solution for injection · Intravenous use	10 Bottle	SAR 590.40	Generic · Prescription	GE HEALTHCARE	Valid
VISIPAQUE 270MG/ML SOLUTION FOR INJECTION	550 mg/ml	Solution for injection · Intravenous use	10 Bottle	SAR 1134.80	Generic · Prescription	GE HEALTHCARE	Valid
VISIPAQUE 320MG/ML SOLUTION FOR INJECTION	652 mg/ml	Solution for injection · Intravenous use	10 Bottle	SAR 1304.80	Generic · Prescription	GE HEALTHCARE	Valid
VISIPAQUE 320MG/ML SOLUTION FOR INJECTION	652 mg/ml	Solution for injection · Intravenous use	10 Bottle	SAR 690.00	Generic · Prescription	GE HEALTHCARE	Valid
VISIPAQUE	305 mg/ml	Solution for injection · Intravenous use	10 Vial	SAR 425.75	Generic · Prescription	GE HEALTHCARE	Invalid · Not Marketed
VISIPAQUE	305 mg/ml	Solution for injection · Intravenous use	6 Vial	SAR 895.00	Generic · Prescription	GE HEALTHCARE	Invalid · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
VISIPAQUE 270	55%	injectable · injection	GE HEALTHCARE	Prescription	22 Mar 1996
VISIPAQUE 320	65.2%	injectable · injection	GE HEALTHCARE	Prescription	22 Mar 1996
VISIPAQUE 320	65.2%	injectable · injection	GE HEALTHCARE	Prescription	29 Aug 1997
IODIXANOL	55%; 65.2%	injectable · injection	HENGRUI PHARMA	Prescription	19 May 2022
VISIPAQUE 270	55%	injectable · injection	GE HEALTHCARE	Discontinued	29 Aug 1997

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
IODIXANOL INJECTION 270	02553953	550 MG / ML	SOLUTION · INTRAVENOUS; INTRA-ARTERIAL	FRESENIUS KABI CANADA LTD
IODIXANOL INJECTION 320	02553961	652 MG / ML	SOLUTION · INTRA-ARTERIAL; INTRAVENOUS	FRESENIUS KABI CANADA LTD
VISIPAQUE 270	02145766	550 MG / ML	SOLUTION · INTRA-ARTERIAL; INTRAVENOUS	GE HEALTHCARE CANADA INC
VISIPAQUE 320	02145774	652 MG / ML	SOLUTION · INTRAVENOUS; INTRA-ARTERIAL	GE HEALTHCARE CANADA INC

Safety signals and safety-related labeling changes

EMA PRAC 11 Jun 2026 PRAC signal: Fixed drug eruption
Action for MAH: update of the product information: Yes
EMA PRAC 15 Jan 2026 PRAC signal: Fixed drug eruption
Action for MAH: update of the product information: No
US FDA 25 Apr 2023 VISIPAQUE 270 — 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 25 Apr 2023 VISIPAQUE 270 — 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 25 Apr 2023 VISIPAQUE 320 — 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 25 Apr 2023 VISIPAQUE 320 — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for iodixanol →

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.