Is Iopamidol registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Iopamidol.

Is Iopamidol approved by the US FDA?

Drugs@FDA lists 37 application product lines for Iopamidol, including ISOVUE-M 200 (Prescription); ISOVUE-300 (Prescription); ISOVUE-370 (Prescription); ISOVUE-M 300 (Prescription); ISOVUE-200 (Prescription).

Are there safety signals or safety updates for Iopamidol?

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

Active substance

Iopamidol

SFDA 11
US FDA 37
Health Canada 5
Safety 13

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
IOPAMIRO 150 INJ	150 mg/ml	Solution for injection · Intravenous use	1 Vial	SAR 122.20	Generic · Prescription	BRACCO	Invalid · Not Marketed
IOPAMIRO 150 INJ	150 mg/ml	Solution for injection · Intravenous use	1 Vial	SAR 56.65	Generic · Prescription	BRACCO	Invalid · Not Marketed
IOPAMIRO 150 INJ	150 mg/ml	Solution for injection · Intravenous use	1 Vial	SAR 33.35	Generic · Prescription	BRACCO	Invalid · Not Marketed
IOPAMIRO 200 INJ	200 mg/ml	Solution for injection · Intravenous use	1 Ampoule	SAR 18.85	Generic · Prescription	BRACCO	Invalid · Not Marketed
IOPAMIRO 300 INJ.	300 mg/ml	Solution for injection · Intravenous use	1 Vial	SAR 93.85	Generic · Prescription	BRACCO	Invalid · Not Marketed
IOPAMIRO 300 INJ.	300 mg/ml	Solution for injection · Intravenous use	1 Vial	SAR 60.25	Generic · Prescription	BRACCO	Invalid · Not Marketed
IOPAMIRO 300 INJ.	300 mg/ml	Solution for injection · Intravenous use	1 Ampoule	SAR 21.65	Generic · Prescription	BRACCO	Invalid · Not Marketed
IOPAMIRO 300 INJ.	300 mg/ml	Solution for injection · Intravenous use	1 Ampoule	SAR 51.95	Generic · Prescription	BRACCO	Invalid · Not Marketed
IOPAMIRO 370 INJ	370 mg/ml	Solution for injection · Intravenous use	1 Vial	SAR 109.35	Generic · Prescription	BRACCO	Invalid · Not Marketed
IOPAMIRO 370 INJ	370 mg/ml	Solution for injection · Intravenous use	1 Vial	SAR 64.30	Generic · Prescription	BRACCO	Invalid · Not Marketed
IOPAMIRO 370 INJ	370 mg/ml	Solution for injection · Intravenous use	1 Vial	SAR 46.05	Generic · Prescription	BRACCO	Invalid · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
ISOVUE-M 200	41%	injectable · injection	BRACCO	Prescription	31 Dec 1985
ISOVUE-300	61%	injectable · injection	BRACCO	Prescription	31 Dec 1985
ISOVUE-370	76%	injectable · injection	BRACCO	Prescription	31 Dec 1985
ISOVUE-M 300	61%	injectable · injection	BRACCO	Prescription	31 Dec 1985
ISOVUE-200	41%	injectable · injection	BRACCO	Prescription	31 Dec 1985
ISOVUE-250	51%	injectable · injection	BRACCO	Prescription	31 Dec 1985
ISOVUE-300	61%	injectable · injection	BRACCO	Prescription	12 Oct 1994
ISOVUE-370	76%	injectable · injection	BRACCO	Prescription	12 Oct 1994
IOPAMIDOL	41%; 61%	injectable · injection	HAINAN POLY	Prescription	27 Feb 2023
IOPAMIDOL	41%; 51%; 61%; 76%	injectable · injection	HAINAN POLY	Prescription	27 Sep 2023
ISOVUE-128	26%	injectable · injection	BRACCO	Discontinued	31 Dec 1985
ISOVUE-200	41%	injectable · injection	BRACCO	Discontinued	12 Oct 1994
ISOVUE-250	51%	injectable · injection	BRACCO	Discontinued	12 Oct 1994
IOPAMIDOL	41%; 61%; 76%; 51%	injectable · injection	BAXTER HLTHCARE	Discontinued	6 Nov 1996
IOPAMIDOL-250	51%	injectable · injection	FRESENIUS KABI USA	Discontinued	2 Apr 1997
IOPAMIDOL-300	61%	injectable · injection	FRESENIUS KABI USA	Discontinued	2 Apr 1997
IOPAMIDOL-370	76%	injectable · injection	FRESENIUS KABI USA	Discontinued	2 Apr 1997
IOPAMIDOL-300 IN PLASTIC CONTAINER	61%	injectable · injection	HOSPIRA	Discontinued	3 Apr 1997
IOPAMIDOL-300	61%	injectable · injection	ABBVIE	Discontinued	30 Apr 1997
IOPAMIDOL-200 IN PLASTIC CONTAINER	41%	injectable · injection	HOSPIRA	Discontinued	30 Dec 1997
IOPAMIDOL-250 IN PLASTIC CONTAINER	51%	injectable · injection	HOSPIRA	Discontinued	30 Dec 1997
IOPAMIDOL-300 IN PLASTIC CONTAINER	61%	injectable · injection	HOSPIRA	Discontinued	30 Dec 1997
IOPAMIDOL-370 IN PLASTIC CONTAINER	76%	injectable · injection	HOSPIRA	Discontinued	30 Dec 1997
IOPAMIDOL-200	41%	injectable · injection	HOSPIRA	Discontinued	30 Dec 1997
IOPAMIDOL-250	51%	injectable · injection	HOSPIRA	Discontinued	30 Dec 1997

12 more — full table

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ISOVUE 200 INJECTION	02229013	41 % / %	SOLUTION · INTRAVASCULAR; SUBARACHNOIDAL	BRACCO IMAGING CANADA
ISOVUE 300 INJECTION	02229021	61 %	LIQUID · INTRAVASCULAR	BRACCO IMAGING CANADA
ISOVUE 370 INJECTION	02229048	76 %	LIQUID · INTRAVASCULAR	BRACCO IMAGING CANADA
ISOVUE MULTIPACK-300	02242122	61 %	LIQUID · INTRAVASCULAR	BRACCO IMAGING CANADA
ISOVUE MULTIPACK-370	02242121	76 %	LIQUID · INTRAVASCULAR	BRACCO IMAGING CANADA

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 13 Jan 2026 ISOVUE-200 — 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 13 Jan 2026 ISOVUE-250 — 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 13 Jan 2026 ISOVUE-300 — 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 13 Jan 2026 ISOVUE-370 — 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 10 Oct 2025 ISOVUE-128 — 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 10 Oct 2025 ISOVUE-200 — 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 10 Oct 2025 ISOVUE-250 — 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 10 Oct 2025 ISOVUE-300 — 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 10 Oct 2025 ISOVUE-370 — 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 10 Oct 2025 ISOVUE-M 200 — 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 10 Oct 2025 ISOVUE-M 300 — 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

All safety entries for iopamidol →

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.