Ioversol

Intravascular injection of ioversol opacifies vessels in the path of the flow of the contrast medium, permitting visualization of the internal structures until significant hemodilution occurs. In imaging of the body, iodinated contrast agents diffuse from the vascular into the extravascular space.

• OPTIRAY is indicated for: OPTIRAY is a radiographic contrast agent indicated for the following: Intra-arterial Procedures ( 1.1 ) Adults: Cerebral Arteriography (300, 320 mg iodine/mL) Peripheral Arteriography (300, 320, 350 mg iodine/mL ) Visceral and Renal Arteriography, Aortography (320 mg iodine/mL) Coronary Arteriography and Left Ventriculography (320, 350 mg iodine/mL) Pediatric Patients: Angiocardiography (320, 350 mg iodine/mL) Intravenous Procedures ( 1.2 ) Adults: Computed tomography (CT) Imaging of Head and Body (300, 320, 350 mg iodine/mL) Venography (300, 320, 350 mg iodine/mL) Intravenous Excretory Urography (300, 320, 350 mg iodine/mL) Intravenous Digital Subtraction Angiography (350 mg iodine/mL) Pediatric Patients: CT Imaging of the Head and Body, and Intravenous Excretory Urography (320 mg iodine/mL) 1.1 Intra-arterial In adults OPTIRAY 300: cerebral arteriography and peripheral arteriography. OPTIRAY 320: cerebral arteriography, peripheral arteriography, visceral and renal arteriography, aortography, coronary arteriography, and left ventriculography.

• Symptomatic Hyperthyroidism Symptomatic Hyperthyroidism ( 4 )contraindicated

Adjust the volume and concentration of OPTIRAY. Modify the dose accounting for factors such as age, body weight, vessel size, blood flow rate within the vessel. Please see details in full Prescribing Information. ( 2 ) 2.1 Important Administration Instructions OPTIRAY is for intravascular use only [see Boxed Warning, Contraindications ( 4 ), Warnings and Precautions ( 5.1 )] . Use sterile technique for all handling and administration of OPTIRAY. Inspect glass and plastic containers prior to use for breakage or other damage and do not use damaged containers. Warm OPTIRAY and administer at body or room temperature. Inspect OPTIRAY for particulate matter or discoloration before administration. Do not administer if OPTIRAY contains particulate matter or is discolored. Do not mix OPTIRAY with other drugs, solutions or total parenteral nutrition mixtures. Use the lowest dose necessary to obtain adequate visualization. Adjust the volume and concentration of OPTIRAY. Modify the dose accounting for factors such as age, body weight, vessel size, blood flow rate within the vessel, anticipated pathology, degree and extent of opacification required, structure(s) or area to be examined, disease processes affecting the patient, and equipment and technique to be employed. Avoid extravasation when injecting OPTIRAY; especially in patients with severe arterial or venous disease [see Warnings and Precautions ( 5.6 )]. Hydrate patients before and after OPTIRAY administration [see Warnings and Precautions ( 5.3 )]. Discard unused portion of OPTIRAY from single-dose container after use.

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 OPTIRAY is indicated for intravascular use only [see Dosage and Administration ( 2.1 )] . Inadvertent intrathecal administration can cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. 5.2 Hypersensitivity Reactions OPTIRAY can cause life-threatening or fatal hypersensitivity reactions including anaphylaxis and anaphylactic shock. Manifestations include respiratory arrest, laryngospasm, bronchospasm, angioedema, and shock. Most severe reactions develop shortly after the start of the injection (e.g. within 1 to 3 minutes), but delayed reactions may occur. 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), and 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 Acute 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 )] The most common reaction is nausea, occurring at a rate of 1 percent. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact LIEBEL-FLARSHEIM COMPANY LLC at 855-266-5037 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Adult Patients Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following listing shows adverse reactions based upon clinical trials with OPTIRAY (ioversol) in 4,187 patients. Adverse reactions are listed by organ system according to clinical importance. More severe reactions are listed before others in a system regardless of incidence. The most common reaction is nausea, occurring at a rate of 1 percent.

Lactation: A lactating woman may pump and discard breast milk for 8 hours after OPTIRAY administration. ( 8.2 ) 8.1 Pregnancy Risk Summary Postmarketing data with OPTIRAY use in pregnant women are insufficient to determine if there is a risk of drug-associated adverse developmental outcomes. Ioversol crosses the placenta and reaches fetal tissues in small amounts [see Data] . In animal reproduction studies, no adverse developmental effects were observed following daily intravenous administrations of ioversol to pregnant rats (from Gestation Day 7 to 17) and rabbits (Gestation Day 6 to 18) at doses 0.35 and 0.71 times, respectively, the maximum recommended human dose. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of major birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Human Data Literature reports show that ioversol crosses the placenta and is visualized in the digestive tract of exposed infants after birth.

Metabolism

In 12 healthy volunteers (6 receiving 50 mL and 6 receiving 150 mL of OPTIRAY 320), elimination half-life was 1.5 hours for both doses. Distribution In an in vitro human plasma study, ioversol did not bind to protein.

The adverse effects of overdosage are life-threatening and affect mainly the pulmonary and cardiovascular system. Treatment of an overdosage is directed toward the support of all vital functions and prompt institution of symptomatic therapy. Ioversol does not bind to plasma or serum protein and is, therefore, dialyzable.

• Dec 30, 1988NDANDA019710Liebel-flarsheim
• May 29, 1998NDANDA020923Liebel-flarsheim

1. 1Urticaria54314%
2. 2Dyspnoea45812%
3. 3Pruritus43111%
4. 4Rash2386.3%
5. 5Throat Irritation2155.7%
6. 6Nausea2135.6%
7. 7Sneezing2075.5%
8. 8Erythema2025.3%
9. 9Nephropathy Toxic2005.3%
10. 10Cough1895.0%
11. 11Anaphylactic Shock1734.6%
12. 12Vomiting1674.4%
13. 13Chest Discomfort1614.2%
14. 14Hypersensitivity1413.7%
15. 15Throat Tightness1413.7%

The 10 most recently updated of 18 ClinicalTrials.gov registrations naming Ioversol as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Evaluation of the Safety of LipiodolⓇ Embolization in Symptomatic Digital Osteoarthritis Refractory to Conventional Treatment
  Recruiting · Phase 1 · Phase 2 · Interventional · 15 enrolled · University Hospital, Grenoble
  NCT06611007updated 2026-05-05
• Low-acid Contrast Media for Preventing Post ERCP Pancreatitis
  Completed · Observational · 3,979 enrolled · Shandong University
  NCT07391787updated 2026-02-06
• Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis
  Recruiting · Phase 2 · Interventional · 50 enrolled · University of Chicago
  NCT06859164updated 2025-05-15
• Oil-based Vs. Water-based Contrast Medium in Hysterosalpingography for Infertile Women in Improving Fertility Outcome
  Completed · Interventional · 1,187 enrolled · International Peace Maternity and Child Health Hospital
  NCT06639152updated 2024-10-15
• Effect of Genicular Arteries Embolization in Symptomatic Knee Osteoarthritis LipioJoint-2
  Recruiting · Phase 3 · Interventional · 130 enrolled · Assistance Publique - Hôpitaux de Paris
  NCT06497140updated 2024-10-15
• Use of a Water Soluble Contrast-Based Protocol to Assist in the Management of Pediatric Adhesive Small Bowel Obstruction
  Completed · Observational · 136 enrolled · Children's Hospital Colorado
  NCT06101719updated 2024-08-23
• Safety and Efficacy of a Lipiodol Emulsion for the Embolization of Hypervascularizations in Patients With Knee Pain (LipioJoint1)
  Completed · Phase 1 · Interventional · 22 enrolled · Assistance Publique - Hôpitaux de Paris
  NCT04733092updated 2023-08-03
• Chemoembolization in Treating Patients With Primary Liver Cancer or Metastases to the Liver
  Completed · Phase 2 · Interventional · 50 enrolled · Eastern Cooperative Oncology Group
  NCT00003907updated 2023-07-05
• Serum Thyroid Function After Iodinated Contrast Administration
  Unknown · Observational · 400 enrolled · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  NCT05786846updated 2023-05-30
• Renal Protocol Protection in CKD Patients
  Unknown · Interventional · 52 enrolled · Seoul National University Hospital
  NCT04024514updated 2023-03-31

Frequently asked questions

How does Ioversol work?

Intravascular injection of ioversol opacifies vessels in the path of the flow of the contrast medium, permitting visualization of the internal structures until significant hemodilution occurs. In imaging of the body, iodinated contrast agents diffuse from the vascular into the extravascular space.

What is Ioversol used for?

According to FDA labeling, Ioversol carries indications including: OPTIRAY is indicated for: OPTIRAY is a radiographic contrast agent indicated for the following: Intra-arterial Procedures ( 1.1 ) Adults: Cerebral Arteriography (300, 320 mg iodine/mL) Peripheral Arteriography (300, 320, 350 mg iodine/mL ) Visceral and Renal Arteriography, Aortography (320 mg iodine/mL) Coronary Arteriography and Left Ventriculography (320, 350 mg iodine/mL) Pediatric Patients: Angiocardiography (320, 350 mg iodine/mL) Intravenous Procedures ( 1.2 ) Adults: Computed tomography (CT) Imaging of Head and Body (300, 320, 350 mg iodine/mL) Venography (300, 320, 350 mg iodine/mL) Intravenous Excretory Urography (300, 320, 350 mg iodine/mL) Intravenous Digital Subtraction Angiography (350 mg iodine/mL) Pediatric Patients: CT Imaging of the Head and Body, and Intravenous Excretory Urography (320 mg iodine/mL) 1.1 Intra-arterial In adults OPTIRAY 300: cerebral arteriography and peripheral arteriography. OPTIRAY 320: cerebral arteriography, peripheral arteriography, visceral and renal arteriography, aortography, coronary arteriography, and left ventriculography.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Ioversol?

Ioversol 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 Ioversol?

Ioversol labeling lists contraindications including: Symptomatic Hyperthyroidism Symptomatic Hyperthyroidism ( 4 ). Always consult the full prescribing information and a clinician.