Prescription medicine
Iopamidol Brand names: Isovue, Isovue-M; first approved as Isovue-250
Iopamidol (Isovue) is a prescription medicine with an FDA approval on record since 1985. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
- Boxed warning
Check it at the source: the iopamidol FDA label on DailyMed (effective March 10, 2026, BRACCO DIAGNOSTICS INC); the NDA 18735 record on Drugs@FDA; every iopamidol label on DailyMed.
Highlights of the record
FDA label of March 10, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
RISKS ASSOCIATED WITH INTRATHECAL ADMINISTRATION.
Intrathecal administration of ISOVUE, even if inadvertent, can 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 )]. ISOVUE is for intra-arterial, intravenous, or oral use only [see Dosage and Administration ( 2.2 , 2.3 , 2.4 , 2.5 )]. WARNING: RISKS ASSOCIATED WITH INTRATHECAL ADMINISTRATION Intrathecal administration of ISOVUE, even if inadvertent, can cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. ISOVUE is for intra-arterial, intravenous, or oral use only.
Used for
From the label: indications and usageISOVUE is a radiographic contrast agent indicated for: Intra-arterial Procedures † ( 1.1 ) Cerebral arteriography in adults Peripheral arteriography in adults Selective visceral arteriography and aortography in adults Coronary arteriography and cardiac ventriculography in adults Angiocardiography in pediatric patients Intravenous Procedures † ( 1.2 ) Excretory urography in adults and pediatric patients Computed tomog
Forms and strengths
- 408 mg/ml
- 510 mg/ml
- 612 mg/ml
- 755 mg/ml
Injection (solution).
On the market
- Earliest approval on file
- December 31, 1985 Isovue-250, Bracco; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 11 first November 6, 1996; 2 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)
- 2 since 2012 2 Class I among all firms' recalls; latest November 21, 2012
- FAERS reports
- 2,937 through July 30, 2026
What is iopamidol used for?
From the label: indications and usageISOVUE is a radiographic contrast agent indicated for: Intra-arterial Procedures † ( 1.1 ) Cerebral arteriography in adults Peripheral arteriography in adults Selective visceral arteriography and aortography in adults Coronary arteriography and cardiac ventriculography in adults Angiocardiography in pediatric patients Intravenous Procedures † ( 1.2 ) Excretory urography in adults and pediatric patients Computed tomography (CT) of head and body in adults and pediatric patients Peripheral venography in adults Oral Procedures † ( 1.3 ) CT of the abdomen and pelvis to delineate the gastrointestinal tract in adults and pediatric patients † Specific concentrations are recommended for each type of imaging procedure. […]
FDA pharmacologic class: Radiographic Contrast Agent.
Source: FDA drug label (ISOVUE 200), BRACCO DIAGNOSTICS INC, effective March 10, 2026 (SPL set ae8c18c9-3e7d-4515-b980-120025a88fc1), via openFDA; the full label on DailyMed
Is there a generic for iopamidol (Isovue)?
The FDA approved the first generic iopamidol on November 6, 1996. 11 generic applications are approved; 2 of them carry 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 iopamidol 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.
- 1985 earliest approval on file
- 1996 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has iopamidol been recalled?
The FDA's Enforcement Report lists 2 recalls naming iopamidol since 2012: 2 Class I (the most serious), 0 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| November 21, 2012 | Class I | Bracco Diagnostic Inc | Presence of Particulate Matter; fibers identified as cellulose and polyvinyl |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for iopamidol?
The FDA Adverse Event Reporting System holds 2,937 reports that list iopamidol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 263 are coded as a death and 1,062 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
- Iopamidol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other