Prescription medicine
Gadodiamide Brand names: Omniscan
Gadodiamide (Omniscan) is a prescription medicine with an FDA approval on record since 1993. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the gadodiamide FDA label on DailyMed (effective April 18, 2025, GE Healthcare Inc.); the NDA 20123 record on Drugs@FDA; every gadodiamide label on DailyMed.
Highlights of the record
FDA label of April 18, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
RISK ASSOCIATED WITH INTRATHECAL.
USE and NEPHROGENIC SYSTEMIC FIBROSIS WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS See full prescribing information for complete boxed warning. Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. OMNISCAN is not approved for intrathecal use ( 5.1 ). GBCAs increase the risk for nephrogenic systemic fibrosis among patients with impaired elimination of the drugs. Avoid use of OMNISCAN in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. Do not administer OMNISCAN to patients with: chronic, severe kidney disease (GFR < 30 mL/min/1.73m 2 ), or acute kidney injury ( 4 ). Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g., age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing ( 5.2 ). Risk Associated with Intrathecal Use Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. OMNISCAN is not approved for intrathecal use [see Warnings and Precautions (5.1) ]. […]
Used for
From the label: indications and usageOMNISCAN is a gadolinium-based contrast agent for diagnostic magnetic resonance imaging (MRI) indicated for intravenous use to: Visualize lesions with abnormal vascularity in the brain, spine, and associated tissues ( 1.1 ) Facilitate the visualization of lesions with abnormal vascularity within the thoracic, abdominal, pelvic cavities, and the retroperitoneal space ( 1.2 ) 1.1 CNS (Central Nervous System) OMNISCAN i
Forms and strengths
- 287 mg/ml
Injection.
On the market
- Earliest approval on file
- January 8, 1993 Omniscan, Ge Healthcare; 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
- 3,355 through July 30, 2026
What is gadodiamide used for?
From the label: indications and usageOMNISCAN is a gadolinium-based contrast agent for diagnostic magnetic resonance imaging (MRI) indicated for intravenous use to: Visualize lesions with abnormal vascularity in the brain, spine, and associated tissues ( 1.1 ) Facilitate the visualization of lesions with abnormal vascularity within the thoracic, abdominal, pelvic cavities, and the retroperitoneal space ( 1.2 ) 1.1 CNS (Central Nervous System) OMNISCAN is a gadolinium-based contrast agent indicated for intravenous use in MRI to visualize lesions with abnormal vascularity (or those thought to cause abnormalities in the blood-brain barrier) in the brain (intracranial lesions), spine, and associated tissues [see Clinical Studies […]
FDA pharmacologic class: Paramagnetic Contrast Agent.
Source: FDA drug label (OMNISCAN), GE Healthcare Inc., effective April 18, 2025 (SPL set 1e9a37e2-f28a-4373-bf0f-3e9b60f42d8a), via openFDA; the full label on DailyMed
What does the patient leaflet for gadodiamide say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about OMNISCAN?GBCAs like OMNISCAN may cause serious side effects including death, coma, encephalopathy, and seizures when it is given intrathecally (injection given into the spinal canal). It is not known if OMNISCAN is safe and effective with intrathecal use. OMNISCAN is not approved for this use. OMNISCAN contains a metal called gadolinium. Small amounts of gadolinium can stay in your body including the brain, bones, skin and other parts of your body for a long time (several months to years). It is not known how gadolinium may affect you, so far, studies have not found harmful effects in patients with normal kidneys. Rarely, patients have reported pains, tiredness, and skin, muscle or bone ailments for a long time, but these symptoms have not been directly linked to gadolinium. There are different GBCAs that can be used for your MRI exam. The amount of gadolinium that stays in the body is different for different gadolinium medicines. Gadolinium stays in the body more after Omniscan or Optimark than after Eovist, Magnevist, or MultiHance. Gadolinium stays in the body the least after Dotarem, Gadavist, or ProHance. People who get many doses of gadolinium medicines, women who are pregnant and young children may be at increased risk from gadolinium staying in the body. Some people with kidney problems who get gadolinium medicines can develop a condition with severe thickening of the skin, muscles and other organs in the body (nephrogenic systemic fibrosis). Your healthcare provider should screen you to see how well your kidneys are working before you receive OMNISCAN.
Source: FDA drug label (OMNISCAN), GE Healthcare Inc., effective April 18, 2025 (SPL set 1e9a37e2-f28a-4373-bf0f-3e9b60f42d8a), via openFDA; the full label on DailyMed
Is there a generic for gadodiamide (Omniscan)?
No generic gadodiamide is approved (Drugs@FDA, October 8, 2026).
- 1993 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the gadodiamide label say about other medicines?
The gadodiamide label names 5 other medicines in its interaction, contraindication or warning sections. The labels of 7 other medicines name gadodiamide. 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 |
|---|---|---|
| Gadobenate | warnings and precautions | At equivalent doses, gadolinium retention varies among the linear agents with Omniscan (gadodiamide) and Optimark (gadoversetamide) causing greater retention than other linear agents [Eovist (gadoxetate disodium), Magnevist (gadopentetate dimeglumine), MultiHance (gadobenate dimeglumine)]. |
| Gadobutrol | warnings and precautions | Retention is lowest and similar among the macrocyclic GBCAs [Dotarem (gadoterate meglumine), Gadavist (gadobutrol), ProHance (gadoteridol)]. |
| Gadoterate | warnings and precautions | Retention is lowest and similar among the macrocyclic GBCAs [Dotarem (gadoterate meglumine), Gadavist (gadobutrol), ProHance (gadoteridol)]. |
| Gadoteridol | warnings and precautions | Retention is lowest and similar among the macrocyclic GBCAs [Dotarem (gadoterate meglumine), Gadavist (gadobutrol), ProHance (gadoteridol)]. |
| Gadoxetate | warnings and precautions | At equivalent doses, gadolinium retention varies among the linear agents with Omniscan (gadodiamide) and Optimark (gadoversetamide) causing greater retention than other linear agents [Eovist (gadoxetate disodium), Magnevist (gadopentetate dimeglumine), MultiHance (gadobenate dimeglumine)]. |
Source: FDA drug label (OMNISCAN), GE Healthcare Inc., effective April 18, 2025 (SPL set 1e9a37e2-f28a-4373-bf0f-3e9b60f42d8a), via openFDA; the full label on DailyMed
What do FAERS reports show for gadodiamide?
The FDA Adverse Event Reporting System holds 3,355 reports that list gadodiamide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 373 are coded as a death and 313 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 paramagnetic contrast agents
- the pharmacologic class, with prices and generics
- Gadodiamide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other