Prescription medicine
Iopromide Brand names: Ultravist
Iopromide (Ultravist) is a prescription medicine with an FDA approval on record since 1995. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the iopromide FDA label on DailyMed (effective March 2, 2026, Bayer HealthCare Pharmaceuticals Inc.); the NDA 20220 record on Drugs@FDA; every iopromide label on DailyMed.
Highlights of the record
FDA label of March 2, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
NOT FOR INTRATHECAL USE WARNING: NOT FOR INTRATHECAL USE.
See full prescribing information for complete boxed warning. Intrathecal administration, even if inadvertent, may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. ULTRAVIST is not approved for intrathecal use.
Used for
From the label: indications and usageULTRAVIST ® Injection is an iodinated contrast agent indicated for: ULTRAVIST is a radiographic contrast agent indicated for: Intra-Arterial Procedures †
Cerebral arteriography and peripheral arteriography in adults ( 1.1 )
Coronary arteriography and left ventriculography, visceral angiography, and aortography in adults ( 1.1 )
Radiographic evaluation of cardiac chambers and related arteries in pediatric patien
Forms and strengths
- 300 mg/ml
- 370 mg/ml
Injection.
On the market
- Earliest approval on file
- May 10, 1995 Ultravist 150, Bayer Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing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)
- No recall recorded
- FAERS reports
- 4,026 through July 30, 2026
What is iopromide used for?
From the label: indications and usageULTRAVIST ® Injection is an iodinated contrast agent indicated for: ULTRAVIST is a radiographic contrast agent indicated for: Intra-Arterial Procedures †
Cerebral arteriography and peripheral arteriography in adults ( 1.1 )
Coronary arteriography and left ventriculography, visceral angiography, and aortography in adults ( 1.1 )
Radiographic evaluation of cardiac chambers and related arteries in pediatric patients aged 2 years and older ( 1.1 ) Intravenous Procedures †
Excretory urography in adults and pediatric patients aged 2 years and older ( 1.2 )
Contrast computed tomography (CT) of head and body in adults and pediatric patients aged 2 years and older ( 1.2 )
Contrast mammography in adults as an adjunct following mammography and/or ultrasound ( 1.2 ) † Specific concentrations and presentations are recommended for each type of imaging procedure. […]
FDA pharmacologic class: Radiographic Contrast Agent.
Source: FDA drug label (Ultravist), Bayer HealthCare Pharmaceuticals Inc., effective March 2, 2026 (SPL set df917c3a-59a2-4ed1-8470-8a5394c73325), via openFDA; the full label on DailyMed
Is there a generic for iopromide (Ultravist)?
No generic iopromide is approved (Drugs@FDA, October 8, 2026).
- 1995 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the iopromide label say about other medicines?
The iopromide 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, biguanides can cause lactic acidosis. |
Source: FDA drug label (Ultravist), Bayer HealthCare Pharmaceuticals Inc., effective March 2, 2026 (SPL set df917c3a-59a2-4ed1-8470-8a5394c73325), via openFDA; the full label on DailyMed
What do FAERS reports show for iopromide?
The FDA Adverse Event Reporting System holds 4,026 reports that list iopromide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 330 are coded as a death and 1,317 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
- Iopromide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other