Prescription medicine
Iodixanol Brand names: Visipaque
Iodixanol (Visipaque) is a prescription medicine with an FDA approval on record since 1996. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
- Boxed warning
Check it at the source: the iodixanol FDA label on DailyMed (effective October 10, 2025, GE Healthcare Inc.); the NDA 20351 record on Drugs@FDA; every iodixanol label on DailyMed.
Highlights of the record
FDA label of October 10, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
NOT FOR INTRATHECAL USE.
Inadvertent intrathecal administration may cause death, convulsions/seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema [see Contraindications (4) and Adverse Reactions (5.1) ]. WARNING: NOT FOR INTRATHECAL USE See full prescribing information for complete boxed warning Inadvertent intrathecal administration may cause death, convulsions/seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema.
Used for
From the label: indications and usageVISIPAQUE is indicated for: VISIPAQUE 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 and 320 mg Iodine/mL).
Forms and strengths
- 270 mg/ml
- 320 mg/ml
Injection (solution).
On the market
- Earliest approval on file
- March 22, 1996 Visipaque 270, Ge Healthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first May 19, 2022; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 2 of which 1 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)
- No recall recorded
- FAERS reports
- 3,517 through July 30, 2026
What is iodixanol used for?
From the label: indications and usageVISIPAQUE is indicated for: VISIPAQUE 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 and 320 mg Iodine/mL). Angiocardiography (left ventriculography and selective coronary arteriography), peripheral arteriography, visceral arteriography, and cerebral arteriography (320 mg Iodine/mL). Pediatric patients less than 12 years of age Angiocardiography, cerebral arteriography, and visceral arteriography (320 mg Iodine/mL). […]
FDA pharmacologic class: Radiographic Contrast Agent.
Source: FDA drug label (Visipaque), GE Healthcare Inc., effective October 10, 2025 (SPL set e9d87b8c-7695-4c0f-8e81-000dedb5f66d), via openFDA; the full label on DailyMed
Is there a generic for iodixanol (Visipaque)?
The FDA approved the first generic iodixanol on May 19, 2022. 1 generic application is approved; 1 of it carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists iodixanol from 1 labeler under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1996 earliest approval on file
- 2022 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the iodixanol label say about other medicines?
The iodixanol label names 2 other medicines 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 |
|---|---|---|
| Epinephrine | drug interactions | Beta-adrenergic Blocking Agents The use of beta-adrenergic blocking agents lowers the threshold for and increases the severity of contrast reactions, and reduces the responsiveness of treatment of hypersensitivity reactions with epinephrine. |
| 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 (Visipaque), GE Healthcare Inc., effective October 10, 2025 (SPL set e9d87b8c-7695-4c0f-8e81-000dedb5f66d), via openFDA; the full label on DailyMed
What do FAERS reports show for iodixanol?
The FDA Adverse Event Reporting System holds 3,517 reports that list iodixanol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 271 are coded as a death and 1,420 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
- Iodixanol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other