Is Ioversol registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 11 valid registrations of Ioversol, including OPTIRAY 300MG-ML SOLUTION FOR IV. Injection (300 mg/ml, Injection, SAR 3180.00); OPTIRAY 300MG-ML SOLUTION FOR IV. Injection* (300 mg/ml, Injection, SAR 1908.00); OPTIRAY 320MG-ML SOLUTION FOR IV. Injection* (320 mg/ml, Injection, SAR 3392.00); OPTIRAY 320MG-ML SOLUTION FOR IV. Injection* (350 mg/ml, Injection, SAR 1778.35); OPTIRAY 350MG-ML SOLUTION FOR IV. Injection* (350 mg/ml, Injection, SAR 4637.50).

Is Ioversol approved by the US FDA?

Drugs@FDA lists 9 application product lines for Ioversol, including OPTIRAY 320 (Prescription); OPTIRAY 300 (Prescription); OPTIRAY 350 (Prescription); OPTIRAY 320 (Prescription); OPTIRAY 350 (Prescription).

Are there safety signals or safety updates for Ioversol?

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

Active substance

Ioversol

SFDA 16
US FDA 9
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
OPTIRAY 300MG-ML SOLUTION FOR IV. Injection	300 mg/ml	Injection · Intravenous use	20 Vial	SAR 3180.00	Generic · Prescription	LIEBEL FLARSHEIM COMPANY LLC	Valid
OPTIRAY 300MG-ML SOLUTION FOR IV. Injection*	300 mg/ml	Injection · Intravenous use	12 Vial	SAR 1908.00	Generic · Prescription	LIEBEL FLARSHEIM COMPANY LLC	Valid
OPTIRAY 300MG-ML SOLUTION FOR IV. Injection*	300 mg/ml	Injection · Intravenous use	25 Vial	SAR 1987.50	Generic · Prescription	LIEBEL FLARSHEIM COMPANY LLC	Valid
OPTIRAY 320MG-ML SOLUTION FOR IV. Injection*	320 mg/ml	Injection · Intravenous use	20 Vial	SAR 3392.00	Generic · Prescription	LIEBEL FLARSHEIM COMPANY LLC	Valid
OPTIRAY 320MG-ML SOLUTION FOR IV. Injection*	320 mg/ml	Injection · Intravenous use	20 Vial	SAR 4240.00	Generic · Prescription	LIEBEL FLARSHEIM COMPANY LLC	Valid
OPTIRAY 320MG-ML SOLUTION FOR IV. Injection*	350 mg/ml	Injection · Intravenous use	12 Vial	SAR 1778.35	Generic · Prescription	LIEBEL FLARSHEIM COMPANY LLC	Valid
OPTIRAY 320MG-ML SOLUTION FOR IV. Injection*	320 mg/ml	Injection · Intravenous use	25 Vial	SAR 1852.45	Generic · Prescription	LIEBEL FLARSHEIM COMPANY LLC	Valid
OPTIRAY 350MG-ML SOLUTION FOR IV. Injection*	350 mg/ml	Injection · Intravenous use	20 Vial	SAR 4637.50	Generic · Prescription	LIEBEL FLARSHEIM COMPANY LLC	Valid
OPTIRAY 350MG-ML SOLUTION FOR IV. Injection*	350 mg/ml	Injection · Intravenous use	20 Vial	SAR 3710.00	Generic · Prescription	LIEBEL FLARSHEIM COMPANY LLC	Valid
OPTIRAY 350MG-ML SOLUTION FOR IV. Injection*	350 mg/ml	Injection · Intravenous use	12 Vial	SAR 2226.00	Generic · Prescription	LIEBEL FLARSHEIM COMPANY LLC	Valid
OPTIRAY 350MG-ML SOLUTION FOR IV. Injection*	350 mg/ml	Injection · Intravenous use	25 Vial	SAR 2318.75	Generic · Prescription	LIEBEL FLARSHEIM COMPANY LLC	Valid
OPTIRAY 160MG-ML SOLUTION FOR IV. Injection*	160 mg/ml	Injection · Intravenous use	25 Vial	SAR 1060.00	Generic · Prescription	LIEBEL FLARSHEIM COMPANY LLC	Withdrawn by MAH · Not Marketed
OPTIRAY 240MG-ML SOLUTION FOR IV. Injection*	240 mg/ml	Injection · Intravenous use	12 Vial	SAR 1526.40	Generic · Prescription	LIEBEL FLARSHEIM COMPANY LLC	Withdrawn by MAH · Not Marketed
OPTIRAY 240MG-ML SOLUTION FOR IV. Injection*	240 mg/ml	Injection · Intravenous use	20 Vial	SAR 3180.00	Generic · Prescription	LIEBEL FLARSHEIM COMPANY LLC	Withdrawn by MAH · Not Marketed
OPTIRAY 240MG-ML SOLUTION FOR IV. Injection*	240 mg/ml	Injection · Intravenous use	25 Vial	SAR 1590.00	Generic · Prescription	LIEBEL FLARSHEIM COMPANY LLC	Withdrawn by MAH · Not Marketed
OPTIRAY 300MG-ML SOLUTION FOR IV. Injection*	300 mg/ml	Injection · Intravenous use	20 Vial	SAR 3975.00	Generic · Prescription	LIEBEL FLARSHEIM COMPANY LLC	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
OPTIRAY 320	68%	injectable · injection	LIEBEL-FLARSHEIM	Prescription	30 Dec 1988
OPTIRAY 300	64%	injectable · injection	LIEBEL-FLARSHEIM	Prescription	30 Dec 1988
OPTIRAY 350	74%	injectable · injection	LIEBEL-FLARSHEIM	Prescription	30 Dec 1988
OPTIRAY 320	68%	injectable · injection	LIEBEL-FLARSHEIM	Prescription	29 May 1998
OPTIRAY 350	74%	injectable · injection	LIEBEL-FLARSHEIM	Prescription	29 May 1998
OPTIRAY 240	51%	injectable · injection	LIEBEL-FLARSHEIM	Discontinued	30 Dec 1988
OPTIRAY 160	34%	injectable · injection	LIEBEL-FLARSHEIM	Discontinued	30 Dec 1988
OPTIRAY 240	51%	injectable · injection	LIEBEL-FLARSHEIM	Discontinued	29 May 1998
OPTIRAY 300	64%	injectable · injection	LIEBEL-FLARSHEIM	Discontinued	29 May 1998

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 OPTIRAY 160 — 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 25 Apr 2023 OPTIRAY 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 25 Apr 2023 OPTIRAY 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 25 Apr 2023 OPTIRAY 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 25 Apr 2023 OPTIRAY 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 25 Apr 2023 OPTIRAY 320 — 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 25 Apr 2023 OPTIRAY 320 — 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 25 Apr 2023 OPTIRAY 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 25 Apr 2023 OPTIRAY 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

All safety entries for ioversol →

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.