Iodixanol

Intravascular injection of iodixanol opacifies vessels in the path of flow of the contrast agent, permitting visualization of internal structures. In imaging of the body, iodinated contrast agents diffuse from the vascular into the extravascular space.

• Iodixanol injection is indicated in for: Iodixanol injection is a radiographic contrast agent indicated for the following: Intra-arterial Procedures ( 1.1 ) Adults and pediatric patients 12 years of age and over Intra-arterial digital subtraction angiography (270 mg Iodine/mL and 320 mg Iodine/mL). Angiocardiography (left ventriculography and selective coronary arteriography), peripheral arteriography, visceral arteriography, and cerebral arteriography (320 mg Iodine/mL).

• Iodixanol is contraindicated for intrathecal use [see Warnings and Precautions (5.1) ] : Not indicated for intrathecal use.contraindicated

Individualize the combination of volume and concentration of iodixanol injection considering age, body weight, size of the vessel, rate of blood flow within the vessel, and other applicable factors. ( 2.1 , 2.2 , 2.3 , 2.4 ) For CT of the head and body, iodixanol injection may be used with an automated contrast injection system or contrast media management system cleared for use with iodixanol injection. (2.5) For the adult patients, the maximum recommended total dose of iodine is 80 grams. ( 2.1 ) Patients should be adequately hydrated prior to and following the intravascular administration of iodinated contrast agents. ( 2.1 , 5.3 ) See full prescribing information for complete dosing and administration information. (2) 2.1 Important Dosage and Administration Instructions Iodixanol injection is for intravascular use only [see Boxed Warning , Contraindications (4) , and Warnings and Precautions (5.1) ] Use sterile technique for all handling and administration of iodixanol injection. Do not use if tamper-evident ring is broken or missing. Warm iodixanol injection and administer at body or room temperature. Inspect iodixanol injection for particulate matter or discoloration before administration, whenever solution and container permit. Do not administer if iodixanol injection contains particulate matter or is discolored. Do not mix iodixanol injection with, or inject in intravenous lines containing, other drugs or total nutritional admixtures. Use the lowest dose necessary to obtain adequate visualization.

Hypersensitivity Reactions: Life-threatening or fatal reactions can occur. Always have emergency equipment and trained personnel available. ( 5.2 ) Contrast-Induced Acute Kidney Injury: Acute injury including renal failure can occur. Minimize dose and maintain adequate hydration to minimize risk. ( 5.3 ) Cardiovascular Adverse Reactions: Hemodynamic disturbances including shock and cardiac arrest may occur during or after administration. ( 5.4 ) Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age: Individualize thyroid function monitoring based on risk factors such as prematurity. ( 5.8 ) 5.1 Risks Associated with Inadvertent Intrathecal Administration Iodixanol is for intravascular use only and is contraindicated for intrathecal use [see Contraindications (4) and Dosage and Administration (2.1) ] . Inadvertent Intrathecal administration can cause death, convulsions/seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema. 5.2 Hypersensitivity Reactions Iodixanol can cause life-threatening or fatal hypersensitivity reactions including anaphylaxis. Manifestations include respiratory arrest, laryngospasm, bronchospasm, angioedema, and shock. Most severe reactions develop shortly after the start of the injection (within 3 minutes), but reactions can occur up to hours later. There is an increased risk in patients with a history of a previous reaction to contrast agent, and known allergies (i.e., bronchial asthma, drug, or food allergies) or other hypersensitivities.

The following clinically significant adverse reactions are described elsewhere in the labeling: Risks Associated with Inadvertent Intrathecal Administration [see Warnings and Precautions (5.1) ] Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] Contrast-Induced Kidney Injury [see Warnings and Precautions (5.3) ] Cardiovascular Adverse Reactions [see Warnings and Precautions (5.4) ] Thromboembolic Events [see Warnings and Precautions (5.5) ] Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age [see Warnings and Precautions (5.8) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.11) ] Most common adverse reactions (incidence greater than 0.5%) in adult patients after iodixanol injection: Discomfort, warmth, pain; Cardiovascular: angina. Gastrointestinal: diarrhea, nausea, vomiting. Nervous System: agitation, anxiety, insomnia, nervousness, dizziness, headache, migraine, unusual skin sensations, sensory disturbance, fainting, sensation of spinning. Skin: itchy rash, severe itching, hives. Special Senses: Smell, taste, and vision alteration. ( 6.1 ) Pediatric patients experienced similar adverse reactions. ( 6.3 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Lactation: A lactating woman may pump and discard breast milk for 10 hours after iodixanol administration. ( 8.2 ) Geriatrics: Exercise caution in dose selection for elderly patients. ( 8.5 ) 8.1 Pregnancy Risk Summary There are no data with iodixanol use in pregnant women to inform any drug-associated risks. In animal reproduction studies, no developmental toxicity occurred with intravenous iodixanol administration to rats and rabbits at doses up to 0.24 (rat) or 0.48 (rabbit) times the maximum recommended human intravenous dose (see Data) . All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Reproduction studies were performed in rats and rabbits with intravenous administration of iodixanol at doses up to 2 g Iodine/kg, daily, from implantation of the embryo (gestation day 7 in rat; 6 in rabbit) through closure of the hard palate (gestation day 17 in rats; 18 in rabbits). No maternal toxicity occurred, and no adverse effects occurred on fetal survival, embryo-fetal development, or the ability of dams to rear a litter.

Metabolism

Distribution In an in vitro human plasma study, iodixanol did not bind to protein. The volume of distribution in adults was 0.26 L/kg body weight, consistent with distribution to extracellular space.

The adverse effects of overdosage of any contrast agent may be life-threatening and affect mainly the pulmonary and cardiovascular systems. Treatment of an overdosage is directed toward the support of all vital functions and prompt institution of symptomatic therapy. Iodixanol injection does not bind to plasma or serum protein and can be dialyzed.

• Mar 22, 1996NDANDA020351Ge Healthcare
• Aug 29, 1997NDANDA020808Ge Healthcare
• May 19, 2022ANDAANDA214271Hengrui Pharma

1. 1Pruritus43613%
2. 2Rash2898.5%
3. 3Erythema2577.5%
4. 4Dyspnoea2487.3%
5. 5Urticaria2266.6%
6. 6Nausea1644.8%
7. 7Hypotension1534.5%
8. 8Vomiting1434.2%
9. 9Acute Kidney Injury1374.0%
10. 10Anaphylactic Reaction1243.6%
11. 11Contrast Media Allergy1093.2%
12. 12Rash Maculo-papular1043.1%
13. 13Renal Failure Acute1043.1%
14. 14Acute Generalised Exanthematous Pustulosis1002.9%
15. 15Chills962.8%

The 10 most recently updated of 67 ClinicalTrials.gov registrations naming Iodixanol as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Evaluation of the Efficacy of Suprascapular Nerve Block in Adhesive Capsulitis
  Recruiting · Interventional · 62 enrolled · CHU de Reims
  NCT06176248updated 2026-05-06
• Evaluation of the Predictive Value of 18F-fluorodeoxyglucose Positron Emission Tomography and Brain Perfusion Computed Tomography for the Efficacy of Anti-angiogenic Therapy (Bevacizumab) in Recurrent Glioblastoma
  Completed · Interventional · 14 enrolled · Centre Hospitalier Universitaire de Nīmes
  NCT04566185updated 2025-12-18
• Intra-discal Steroid Injection for MODIC I Discopathy
  Completed · Phase 4 · Interventional · 137 enrolled · Assistance Publique - Hôpitaux de Paris
  NCT00804531updated 2025-09-12
• Mechanisms for the Effect of Acetylcysteine on Renal Function After Exposure to Radiographic Contrast Material
  Completed · Phase 4 · Interventional · 107 enrolled · University of Edinburgh
  NCT00558142updated 2024-09-19
• Effect of Evolocumab on Coronary Atherosclerosis
  Completed · Phase 3 · Interventional · 55 enrolled · Cedars-Sinai Medical Center
  NCT03689946updated 2024-07-17
• Preoperative Embolization of Hypervascular Head and Neck Tumors to Improve Surgical Outcomes
  Withdrawn · Phase 1 · Interventional · 0 enrolled · University of Washington
  NCT05490381updated 2023-12-12
• Correlation Between Computer Tomography Angiography and D-Dimer Level for the Diagnosis of Pulmonary Embolism
  Completed · Observational · 28 enrolled · Zulekha Hospitals
  NCT05862220updated 2023-05-17
• Pediatric Risk of Hypothyroidism With Iodinated Contrast Media
  Withdrawn · Phase 4 · Interventional · 0 enrolled · GE Healthcare
  NCT03631771updated 2022-04-20
• Comparison of Icg's Route of Administration During Laparoscopic Cholecystectomy
  Unknown · Interventional · 240 enrolled · Aristotle University Of Thessaloniki
  NCT04908826updated 2022-03-10
• Post-Marketing Safety Study in ST-Segment Elevation Myocardial Infarction (STEMI) Participants Undergoing Primary Percutaneous Coronary Intervention (PCI) Procedure With VISIPAQUE® as the Contrast Medium
  Completed · Observational · 2,755 enrolled · GE Healthcare
  NCT03671603updated 2022-01-11

Frequently asked questions

How does Iodixanol work?

Intravascular injection of iodixanol opacifies vessels in the path of flow of the contrast agent, permitting visualization of internal structures. In imaging of the body, iodinated contrast agents diffuse from the vascular into the extravascular space.

What is Iodixanol used for?

According to FDA labeling, Iodixanol carries indications including: Iodixanol injection is indicated in for: Iodixanol injection is a radiographic contrast agent indicated for the following: Intra-arterial Procedures ( 1.1 ) Adults and pediatric patients 12 years of age and over Intra-arterial digital subtraction angiography (270 mg Iodine/mL and 320 mg Iodine/mL). Angiocardiography (left ventriculography and selective coronary arteriography), peripheral arteriography, visceral arteriography, and cerebral arteriography (320 mg Iodine/mL).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Iodixanol?

Iodixanol is classified as Watersoluble, nephrotropic, low osmolar X-ray contrast media, Radiographic Contrast Agent, Imaging Contrast Activity, X-Ray Contrast Activity.

What are the contraindications for Iodixanol?

Iodixanol labeling lists contraindications including: Iodixanol is contraindicated for intrathecal use [see Warnings and Precautions (5.1) ] : Not indicated for intrathecal use.. Always consult the full prescribing information and a clinician.