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Iohexol

Generic Name
Iohexol
Brand Names
Omnipaque, Oraltag
Drug Type
Small Molecule
Chemical Formula
C19H26I3N3O9
CAS Number
66108-95-0
Unique Ingredient Identifier
4419T9MX03

Overview

Iohexol is an effective non-ionic, water-soluble contrast agent which is used in myelography, arthrography, nephroangiography, arteriography, and other radiographic procedures. Its low systemic toxicity is the combined result of low chemotoxicity and low osmolality.

Indication

Iohexol ia used in myelography, arthrography, nephroangiography, arteriography, and other radiographic procedures.

Associated Conditions

No associated conditions information available.

Research Report

Published: Aug 5, 2025

A Comprehensive Monograph on Iohexol

Executive Summary

Iohexol is a second-generation, non-ionic, low-osmolality, water-soluble iodinated radiographic contrast agent that stands as a cornerstone of modern diagnostic imaging. Marketed under brand names such as Omnipaque and Oraltag, its development represented a significant advancement in patient safety compared to older, first-generation high-osmolality ionic agents. Its chemical structure, featuring a tri-iodinated benzene ring with hydrophilic, non-ionizing side chains, allows for high concentrations of iodine necessary for X-ray attenuation while maintaining an osmolality closer to that of physiological fluids, thereby reducing systemic toxicity and improving patient tolerance.[1]

The clinical utility of Iohexol is exceptionally broad, encompassing a vast array of procedures across nearly all medical specialties. Its primary applications involve enhancing visualization during X-ray and Computed Tomography (CT) examinations. It is administered via multiple routes—intravascularly, intrathecally, orally, rectally, and into body cavities—to opacify vascular structures, the central nervous system (brain and spinal cord), the urinary tract, joints, and the gastrointestinal (GI) tract.[1] This versatility has secured its place on the World Health Organization's List of Essential Medicines.[1]

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2024/11/29
Phase 4
Recruiting
2024/06/05
Phase 4
Recruiting
2024/01/23
Early Phase 1
Recruiting
Alison Stopeck
2023/08/01
Phase 4
Recruiting
Jung Im Jung
2023/07/05
Not Applicable
Recruiting
Erasme University Hospital
2023/03/06
Early Phase 1
Recruiting
2022/11/14
Phase 1
Completed
2022/10/14
Phase 1
Withdrawn
2022/09/07
N/A
ENROLLING_BY_INVITATION
2022/07/05
N/A
Recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
GE Healthcare Inc.
0407-1414
INTRAVENOUS, INTRAVASCULAR, ORAL, RECTAL
350 mg in 1 mL
4/25/2023
GE Healthcare Inc.
0407-1414
ORAL, INTRAVASCULAR, INTRAVENOUS
350 mg in 1 mL
2/1/2024
GE Healthcare
0407-1413
INTRAVENOUS
300 mg in 1 mL
4/30/2023
GE Healthcare
0407-1414
INTRAVENOUS
350 mg in 1 mL
4/25/2023
GE Healthcare Inc.
0407-1412
INTRATHECAL, INTRAVASCULAR, INTRAVENOUS, ORAL
240 mg in 1 mL
2/1/2024
GE Healthcare Inc.
0407-1413
INTRAVENOUS, INTRAVASCULAR, INTRATHECAL, ORAL, RECTAL
300 mg in 1 mL
5/8/2023
GE Healthcare
0407-1413
INTRAVENOUS
300 mg in 1 mL
4/25/2023
GE Healthcare
0407-1414
INTRAVENOUS
350 mg in 1 mL
4/30/2023
GE Healthcare Inc.
0407-1413
INTRAVENOUS, INTRAVASCULAR, INTRATHECAL, ORAL, RECTAL
300 mg in 1 mL
4/25/2023
Interpharma Praha, a.s.
54702-501
ORAL
4.5 g in 1 1
1/5/2023

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
OMNIPAQUE 240
ge healthcare canada inc
02172739
Solution - Intravascular ,  Intra-Articular ,  Oral ,  Subarachnoidal ,  Rectal
518 MG / ML
5/26/1998
OMNIPAQUE 300
ge healthcare canada inc
02172747
Solution - Oral ,  Subarachnoidal ,  Intravascular ,  Rectal ,  Intra-Articular
647 MG / ML
3/5/1998
OMNIPAQUE 350
ge healthcare canada inc
02172755
Solution - Oral ,  Intravascular
755 MG / ML
3/5/1998
OMNIPAQUE 180
ge healthcare canada inc
02172720
Solution - Subarachnoidal
388 MG / ML
3/8/1998

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
OMNIPAQUE 240 mg Iodo /ml SOLUCION INYECTABLE
Ge Healthcare Bio-Sciences, S.A.U.
62017
SOLUCIÓN INYECTABLE
Uso Hospitalario Y Centros De Diagnóstico Autorizados
Commercialized
OMNIPAQUE 300 mg Iodo /ml SOLUCION INYECTABLE
Ge Healthcare Bio-Sciences, S.A.U.
62018
SOLUCIÓN INYECTABLE
Uso Hospitalario Y Centros De Diagnóstico Autorizados
Commercialized
OMNIPAQUE 350 mg Iodo /ml SOLUCION INYECTABLE
Ge Healthcare Bio-Sciences, S.A.U.
62019
SOLUCIÓN INYECTABLE
Uso Hospitalario Y Centros De Diagnóstico Autorizados
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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