Prescription medicine
Ioversol Brand names: Optiray
Ioversol (Optiray) is a prescription medicine with an FDA approval on record since 1988. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the ioversol FDA label on DailyMed (effective December 29, 2025, Liebel-Flarsheim Company LLC); the NDA 19710 record on Drugs@FDA; every ioversol label on DailyMed.
Highlights of the record
FDA label of December 29, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
NOT FOR INTRATHECAL USE.
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: NOT FOR INTRATHECAL USE See full prescribing information for complete boxed warning. Inadvertent intrathecal administration may cause death, convulsion, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema [see Warnings and Precautions ( 5.1 )].
Used for
From the label: indications and usageOPTIRAY is indicated for: OPTIRAY is a radiographic contrast agent indicated for the following: Intra-arterial Procedures ( 1.1 ) Adults: Cerebral Arteriography (320 mg iodine/mL) Peripheral Arteriography (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 i
Forms and strengths
- 636 mg/ml
- 678 mg/ml
- 741 mg/ml
Injection.
On the market
- Earliest approval on file
- December 30, 1988 Optiray 350, Liebel-Flarsheim; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2019 1 Class I among all firms' recalls; latest July 31, 2026
- FAERS reports
- 3,821 through July 30, 2026
What is ioversol used for?
From the label: indications and usageOPTIRAY is indicated for: OPTIRAY is a radiographic contrast agent indicated for the following: Intra-arterial Procedures ( 1.1 ) Adults: Cerebral Arteriography (320 mg iodine/mL) Peripheral Arteriography (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 (320, 350 mg iodine/mL) Venography (320, 350 mg iodine/mL) Intravenous Excretory Urography (320, 350 mg iodine/mL) Intravenous Digital Subtraction Angiography (350 mg iodine/mL) […]
FDA pharmacologic class: Radiographic Contrast Agent.
Source: FDA drug label (Optiray 320), Liebel-Flarsheim Company LLC, effective December 29, 2025 (SPL set 6cb6ca5f-b249-49b0-a9eb-8aa583da7c74), via openFDA; the full label on DailyMed
Is there a generic for ioversol (Optiray)?
No generic ioversol is approved (Drugs@FDA, October 8, 2026).
- 1988 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has ioversol been recalled?
The FDA's Enforcement Report lists 2 recalls naming ioversol since 2019: 1 Class I (the most serious), 1 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 31, 2026 | Class I | Liebel-Flarsheim Company LLC | Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass. |
| September 13, 2019 | Class II | GUERBET LLC | Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syringe as expired and will not allow injection of product by the … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the ioversol label say about other medicines?
The ioversol label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Metformin | drug interactions | DRUG INTERACTIONS 7.1 Drug-Drug Interactions Metformin In patients with renal impairment, metformin can cause lactic acidosis. |
Source: FDA drug label (Optiray 320), Liebel-Flarsheim Company LLC, effective December 29, 2025 (SPL set 6cb6ca5f-b249-49b0-a9eb-8aa583da7c74), via openFDA; the full label on DailyMed
What do FAERS reports show for ioversol?
The FDA Adverse Event Reporting System holds 3,821 reports that list ioversol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 232 are coded as a death and 1,005 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other radiographic contrast agents
- the pharmacologic class, with prices and generics
- Ioversol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other