OPTIRAY 350 (ioversol)
Optiray 350 (ioversol) is an iodinated radiographic contrast agent used to visualize internal structures during diagnostic imaging. In adults, it is indicated for intravenous procedures including CT imaging of the head and body, venography, excretory urography, and digital subtraction angiography (IV-DSA). It is also indicated for adult intra-arterial procedures, specifically peripheral arteriography, coronary arteriography, and left ventriculography. In pediatric patients, the use of the 350 mg iodine/mL concentration is indicated specifically for intra-arterial angiocardiography.
How OPTIRAY 350 Works
Ioversol provides radiographic contrast by opacifying blood vessels in the path of flow, permitting visualization of internal structures until significant hemodilution occurs. In body imaging, the agent diffuses from the vascular system into the extravascular space. Ioversol does not
Details
- Status
- Prescription
- First Approved
- 1988-12-30
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
OPTIRAY 350 Approval History
What OPTIRAY 350 Treats
8 indicationsOPTIRAY 350 is approved for 8 conditions since its original approval in 1988. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cerebral Arteriography
- Peripheral Arteriography
- Visceral Arteriography
- Renal Arteriography
- Aortography
- Coronary Arteriography
- Left Ventriculography
- Angiocardiography
OPTIRAY 350 Boxed Warning
RISKS WITH INADVERTENT INTRATHECAL ADMINISTRATION FOR INTRA-ARTERIAL AND INTRAVENOUS USE ONLY Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. [see Warnings and Precautions ( 5.1 )] WARNING: RISKS WITH INADVERTENT INTRATHECAL ADMINISTRATION FOR INTRA-ARTERIAL AND INTRAVENOUS USE ONLY Inadvertent intrathecal administration may cause...
WARNING: RISKS WITH INADVERTENT INTRATHECAL ADMINISTRATION FOR INTRA-ARTERIAL AND INTRAVENOUS USE ONLY Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. [see Warnings and Precautions ( 5.1 )] WARNING: RISKS WITH INADVERTENT INTRATHECAL ADMINISTRATION FOR INTRA-ARTERIAL AND INTRAVENOUS USE ONLY Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. ( 5.1 )
OPTIRAY 350 Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03631771 | GE-012-103/19476/OPY-44-002 | Ph 4 | withdrawn | Pediatric Risk of Hypothyroidism With Iodinated Contrast Media |
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.
OPTIRAY 350 FDA Label Details
Indications & Usage
FDA Label (PDF)OPTIRAY 350 is indicated for the treatment of Cerebral Arteriography; Peripheral Arteriography; Visceral Arteriography; Renal Arteriography; Aortography; Coronary Arteriography; Left Ventriculography; Angiocardiography.
WARNING: RISKS WITH INADVERTENT INTRATHECAL ADMINISTRATION FOR INTRA-ARTERIAL AND INTRAVENOUS USE ONLY Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.