Is Iohexol registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 16 valid registrations of Iohexol, including ILLUSOF 300 mg/ml solution for injection/infusion (300 mg/ml, Injection, SAR 57.15); Illusof (350 mg/ml, Solution for injection, SAR 140.65); Iohexol PPI (300 mg/ml, Solution for injection, SAR 530.90); OMNIPAQUE (350 mg/ml, Solution for injection, SAR 955.80); OMNIPAQUE (300 mg/ml, Solution for injection, SAR 816.80).

Is Iohexol approved by the US FDA?

Drugs@FDA lists 15 application product lines for Iohexol, including OMNIPAQUE 180 (Prescription); OMNIPAQUE 240 (Prescription); OMNIPAQUE 300 (Prescription); OMNIPAQUE 350 (Prescription); OMNIPAQUE 140 (Prescription).

Is Iohexol on the WHO Model List of Essential Medicines?

Yes — 14.2. Diagnostic agents > Radiocontrast media (core list): X-ray contrast media, iodinated.

Are there safety signals or safety updates for Iohexol?

EMA PRAC: 2 entries; US FDA: 9 entries (latest 2026-06-11).

Active substance

Iohexol

SFDA 26
US FDA 15
Health Canada 3
WHO EML 1
Safety 11

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ILLUSOF 300 mg/ml solution for injection/infusion	300 mg/ml	Injection · Intravenous use	1 Bottle	SAR 57.15	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
ILLUSOF 300 mg/ml solution for injection/infusion	300 mg/ml	Injection · Intravenous use	1 Bottle	SAR 113.15	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
Illusof	350 mg/ml	Solution for injection · Intravenous use	1 Vial	SAR 140.65	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
Illusof	350 mg/ml	Solution for injection · Intravenous use	1 Vial	SAR 65.75	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
Iohexol PPI	300 mg/ml	Solution for injection · Intravenous use	1 Vial	SAR 530.90	Generic · Prescription	Pharma Pharmaceutical Industries & Biological Products	Valid
OMNIPAQUE	350 mg/ml	Solution for injection · Intravenous use	10 Vial	SAR 955.80	NCE · Prescription	GE HEALTHCARE	Valid
OMNIPAQUE	350 mg/ml	Solution for injection · Intravenous use	10 Vial	SAR 1894.25	NCE · Prescription	GE HEALTHCARE	Valid
OMNIPAQUE	300 mg/ml	Solution for injection · Intravenous use	10 Vial	SAR 816.80	NCE · Prescription	GE HEALTHCARE	Valid
OMNIPAQUE	300 mg/ml	Solution for injection · Intravenous use	10 Vial	SAR 1616.20	NCE · Prescription	GE HEALTHCARE	Valid
OMNIPAQUE	240 mg/ml	Solution for injection · Intravenous use	10 Vial	SAR 651.70	NCE · Prescription	GE HEALTHCARE	Valid
OMNIPAQUE	240 mg/ml	Solution for injection · Intravenous use	25 Vial	SAR 799.40	NCE · Prescription	GE HEALTHCARE	Valid
OMNIPAQUE	300 mg/ml	Solution for injection · Intravenous use	10 Vial	SAR 212.25	NCE · Prescription	GE HEALTHCARE	Valid
OMNIPAQUE 300MG/ML SOLUTION FOR INJECTION	300 mg/ml	Solution for injection · Intravenous use	10 Bottle	SAR 1320.20	NCE · Prescription	GE Healthcare AS	Valid
OMNIPAQUE 300MG/ML SOLUTION FOR INJECTION	300 mg/ml	Solution for injection · Intravenous use	10 Bottle	SAR 676.60	NCE · Prescription	GE Healthcare AS	Valid
OMNIPAQUE 350MG/ML SOLUTION FOR INJECTION	350 mg/ml	Solution for injection · Intravenous use	10 Bottle	SAR 1480.80	NCE · Prescription	GE Healthcare AS	Valid
OMNIPAQUE 350MG/ML SOLUTION FOR INJECTION	350 mg/ml	Solution for injection · Intravenous use	10 Bottle	SAR 692.25	NCE · Prescription	GE Healthcare AS	Valid
OMNIPAQUE	350 mg/ml	Solution for injection · Intravenous use	6 Vial	SAR 292.60	NCE · Prescription	GE HEALTHCARE	Invalid · Not Marketed
OMNIPAQUE	350 mg/ml	Solution for injection · Intravenous use	6 Vial	SAR 2125.90	NCE · Prescription	GE HEALTHCARE	Invalid · Not Marketed
OMNIPAQUE	350 mg/ml	Solution for injection · Intravenous use	25 Vial	SAR 1128.95	NCE · Prescription	GE HEALTHCARE	Invalid · Not Marketed
OMNIPAQUE	300 mg/ml	Solution for injection · Intravenous use	6 Vial	SAR 263.70	NCE · Prescription	GE HEALTHCARE	Invalid · Not Marketed
OMNIPAQUE	300 mg/ml	Solution for injection · Intravenous use	25 Vial	SAR 999.25	NCE · Prescription	GE HEALTHCARE	Invalid · Not Marketed
OMNIPAQUE	240 mg/ml	Solution for injection · Intravenous use	10 Vial	SAR 251.10	NCE · Prescription	GE HEALTHCARE	Invalid · Not Marketed
OMNIPAQUE	240 mg/ml	Solution for injection · Intravenous use	6 Vial	SAR 1261.90	NCE · Prescription	GE HEALTHCARE	Invalid · Not Marketed
OMNIPAQUE	240 mg/ml	Solution for injection · Intravenous use	6 Vial	SAR 275.60	NCE · Prescription	GE HEALTHCARE	Invalid · Not Marketed
OMNIPAQUE	180 mg/ml	Solution for injection · Intravenous use	10 Vial	SAR 273.55	NCE · Prescription	GE HEALTHCARE	Invalid · Not Marketed

1 more — full table

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

Product	Strength	Form · route	Applicant	Status	First approved
OMNIPAQUE 180	38.8%	solution · injection, oral, rectal	GE HEALTHCARE	Prescription	26 Dec 1985
OMNIPAQUE 240	51.8%	solution · injection, oral, rectal	GE HEALTHCARE	Prescription	26 Dec 1985
OMNIPAQUE 300	64.7%	solution · injection, oral, rectal	GE HEALTHCARE	Prescription	26 Dec 1985
OMNIPAQUE 350	75.5%	solution · injection, oral	GE HEALTHCARE	Prescription	26 Dec 1985
OMNIPAQUE 140	30.2%	injectable · injection	GE HEALTHCARE	Prescription	26 Dec 1985
OMNIPAQUE 9	1.9%	solution · oral	GE HEALTHCARE	Prescription	26 Dec 1985
OMNIPAQUE 12	2.6%	solution · oral	GE HEALTHCARE	Prescription	26 Dec 1985
OMNIPAQUE 300	64.7%	solution · injection, oral, rectal	GE HEALTHCARE	Prescription	24 Oct 1995
OMNIPAQUE 350	75.5%	solution · injection, oral	GE HEALTHCARE	Prescription	24 Oct 1995
IOHEXOL	64.7%	solution · injection, oral, rectal	AMNEAL	Prescription	13 Nov 2025
IOHEXOL	75.5%	solution · injection, oral	AMNEAL	Prescription	13 Nov 2025
OMNIPAQUE 210	45.3%	injectable · injection	GE HEALTHCARE	Discontinued	26 Dec 1985
OMNIPAQUE 70	15.1%	solution · urethral	GE HEALTHCARE	Discontinued	26 Dec 1985
OMNIPAQUE 240	51.8%	solution · injection, oral, rectal	GE HEALTHCARE	Discontinued	24 Oct 1995
ORALTAG	9.7GM/BOT	for solution · oral	INTERPHARMA PRAHA AS	Discontinued	26 Mar 2015

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
OMNIPAQUE 240	02172739	518 MG / ML	SOLUTION · INTRAVASCULAR; INTRA-ARTICULAR; ORAL; RECTAL; SUBARACHNOIDAL	GE HEALTHCARE CANADA INC
OMNIPAQUE 300	02172747	647 MG / ML	SOLUTION · ORAL; SUBARACHNOIDAL; RECTAL; INTRA-ARTICULAR; INTRAVASCULAR	GE HEALTHCARE CANADA INC
OMNIPAQUE 350	02172755	755 MG / ML	SOLUTION · INTRAVASCULAR; ORAL	GE HEALTHCARE CANADA INC

WHO WHO Model List of Essential Medicines (2025)

14.2. Diagnostic agents > Radiocontrast media · core
X-ray contrast media, iodinated
Parenteral > General injections > unspecified: 140 to 350 mg iodine per mL in 5 mL ampoule; 140 to 350 mg iodine per mL in 10 mL ampoule; 140 to 350 mg iodine per mL in 20 mL ampoule

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 8 Oct 2024 OMNIPAQUE 140 — 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
US FDA 8 Oct 2024 OMNIPAQUE 180 — 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
US FDA 8 Oct 2024 OMNIPAQUE 210 — 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
US FDA 8 Oct 2024 OMNIPAQUE 240 — 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
US FDA 8 Oct 2024 OMNIPAQUE 240 — 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
US FDA 8 Oct 2024 OMNIPAQUE 300 — 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
US FDA 8 Oct 2024 OMNIPAQUE 300 — 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
US FDA 8 Oct 2024 OMNIPAQUE 350 — 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
US FDA 8 Oct 2024 OMNIPAQUE 70 — 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

All safety entries for iohexol →

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.