IOHEXOL · AMNEAL
Iohexol helps clinicians visualize internal body structures during various diagnostic imaging procedures. It is used for patients undergoing scans of the heart, brain, blood vessels, and digestive system by making these areas clearer on X-rays and CT scans. Both adults and children receive this agent through several routes, including injections into veins or arteries, or by taking it orally or rectally. It is essential for
Details
- Status
- Prescription
- First Approved
- 1985-12-26
- Routes
- INJECTION, ORAL, RECTAL, INJECTION, ORAL
- Dosage Forms
- SOLUTION
IOHEXOL Approval History
What IOHEXOL Treats
10 indicationsIOHEXOL is approved for 10 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Myelography and CT myelography
- CT cisternography
- Cardiac ventriculography
- Aortography
- Coronary arteriography
- Cerebral arteriography
- Peripheral arteriography
- Intra-arterial digital subtraction angiography
- Pulmonary angiography
- Excretory urography
Same approved indications as OMNIPAQUE 140 (same active ingredient).
IOHEXOL Boxed Warning
RISKS ASSOCIATED WITH INTRATHECAL ADMINISTRATION OF IOHEXOL INJECTION 140 mg IODINE/mL and 350 mg IODINE/mL Use only the iohexol, iodine concentrations and presentations recommended for intrathecal procedure [see Dosage and Administration (2.2 , 2.8) ]. Intrathecal administration of iohexol of a wrong iodine concentration, even if inadvertent, may cause death, convulsions, seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthe...
WARNING: RISKS ASSOCIATED WITH INTRATHECAL ADMINISTRATION OF IOHEXOL INJECTION 140 mg IODINE/mL and 350 mg IODINE/mL Use only the iohexol, iodine concentrations and presentations recommended for intrathecal procedure [see Dosage and Administration (2.2 , 2.8) ]. Intrathecal administration of iohexol of a wrong iodine concentration, even if inadvertent, may cause death, convulsions, seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia and brain edema [see Warnings and Precautions (5.1) ]. WARNING: RISKS ASSOCIATED WITH INTRATHECAL ADMINISTRATION OF IOHEXOL INJECTION 140 mg IODINE/mL and 350 mg IODINE/mL Use only the iodine concentrations and presentations recommended for intrathecal procedures. Intrathecal administration of a wrong iodine concentration, even if inadvertent, may cause death, convulsions, seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia and brain edema. ( 2.2 , 2.8 , 5.1 )
AMNEAL's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
22 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06709521 | 23-0013 5UM1AI104681-12 | Ph 4 | recruiting | Optimization of Beta-lactam Dosing in Critically Ill Patients With Cystatin C (OPTIMIZE-GNI) |
| NCT03997370 | NRG-GY022 NCI-2019-04008, NRG-GY022 | Ph 1 | active not recruiting | Evaluation of Dosing Procedures of Chemotherapy Treatment (Carboplatin) With the Contrast Agent Iohexol |
| NCT04649229 | 2000028712 | Ph 4 | completed | Mechanisms Underlying Hypotensive Response to ARB/NEP Inhibition - Aim 3 |
| NCT02050269 IoxRea | PHAO13-SE / IoxRea 2013-003936-65, 2013-R49 | Ph 3 | completed | Measuring the Plasma Clearance of Iohexol to Estimate Glomerular Filtration Rate in Intensive Care Unit Patients: Preliminary Feasibility Study |
| NCT04113109 | #191228 | Ph 4 | completed | Mechanisms Underlying Hypotensive Response to ARB/NEP Inhibition - Aim 2 |
| NCT05105009 | 19-1131 | Ph 1 | completed | Furosemide and Creatinine Tubular Stress Test in Order to Measure Proximal Tubule Residual Function |
| NCT02772276 results posted | ORFM-2 | Ph 2 | completed | Pharmacokinetics of MB-102 and Use of the Non-invasive Optical Renal Function Monitor (ORFM) Device in Subjects With Normal and Impaired Renal Function and a Range of Skin Color Types |
| NCT05615467 | 18629 J2P-MC-LXBE | Ph 1 | completed | A Study of Effect of LY3556050 on Metformin in Healthy Participants |
| NCT05580250 | 18353 J2D-JE-CVAD | Ph 1 | withdrawn | A Study of LY3526318 in Healthy Male Japanese Participants |
| NCT03631771 | GE-012-103/19476/OPY-44-002 | Ph 4 | withdrawn | Pediatric Risk of Hypothyroidism With Iodinated Contrast Media |
| NCT04627831 | CE-Iohexol - Study 201 Ligand 201, CAP201 | Ph 2 | withdrawn | Comparison of Captisol-Enabled™ Iohexol and Omnipaque™ in Patients With Impaired Renal Function Undergoing Coronary Angiography |
| NCT04742816 | CCTG 605s | Ph 4 | completed | Renal Effects of Hormones/Biomarkers in Transgender PrEP Recipients |
| NCT01839526 | AGAL19110 2012-001966-14, MSC 12711 | Ph 1 | terminated | A Study of Renal Function in Treatment-naïve, Young Male Patients With Fabry Disease |
| NCT04156750 | 17612 J2P-MC-LXBA | Ph 1 | completed | A Study of LY3556050 in Healthy Participants |
| NCT03826602 | SGNTUC-020 | Ph 1 | completed | A Drug-Drug Interaction Study in Healthy Volunteers of the Effects of Tucatinib on Metformin |
| NCT03415997 | NSHA REB 1023119 | Ph 4 | completed | Dosing Iodinated Contrast Media According to Lean vs. Total Body Weight |
| NCT02884089 results posted | 16536 I3Y-MC-JPCK | Ph 1 | completed | A Study of the Effect of Abemaciclib on Metformin and Iohexol in Healthy Participants |
| NCT03545087 | 16007 I8D-MC-AZEN | Ph 1 | withdrawn | A Study of Lanabecestat in Participants With Severe Kidney Impairment Compared to Healthy Participants |
| NCT02246998 results posted | GS-US-236-0140 2014-002095-93 | Ph 4 | completed | Renal Effect of Stribild or Other Tenofovir DF-containing Regimens Compared to Ritonavir-boosted Atazanavir Plus Abacavir/Lamivudine in Antiretroviral Treatment-naive HIV-1 Infected Adults |
| NCT02522338 HIVOL | 1008078 2010-022272-31 | Ph 4 | completed | Measurement of Glomerular Filtration Rate (GFR) in HIV Patients: Single-center Study Comparing the Accuracy of Estimators of GFR Versus Iohexol Plasma Clearance |
| NCT07643467 FLARE | 105008 | Ph 4 | not yet recruiting | Fluorescent Probe for Assessment of Renal Elimination |
| NCT02961478 IOXSOR | PHRC2015-06 | Ph 3 | completed | Measurement of Iohexol Plasma Clearance in Patients Leaving ICU After Acute Renal Failure |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
IOHEXOL FDA Label Details
Indications & Usage
Iohexol is a radiographic contrast agent indicated for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular and body cavity imaging procedures in adults and pediatric patients. 1.1 Intrathecal Procedures ‡ Iohexol injection is indicated for: Myelography and computerized tomography (CT) myelography (lumbar, thoracic, cervical, total columnar) in adults and pediatric patients aged 2 weeks and older CT cisternography in adults and pediatric patients aged 2 weeks and older 1.2 Intra-arterial Procedures ‡ Iohexol injection is indicated for: Cardiac ventriculography in adults and p...
WARNING: RISKS ASSOCIATED WITH INTRATHECAL ADMINISTRATION OF IOHEXOL INJECTION 140 mg IODINE/mL and 350 mg IODINE/mL Use only the iohexol, iodine concentrations and presentations recommended for intrathecal procedure [see Dosage and Administration (2.2 , 2.8) ]. Intrathecal administration of iohexol...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.