Quick answers
- What is Gadodiamide used for?
- The FDA-approved label (Omniscan, GE Healthcare Inc., April 18, 2025) says: “OMNISCAN 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 Facilitate the visualization of lesions with abnormal vascularity within the thoracic, abdominal, pelvic cavities, and the retroperitoneal space 1.1 CNS (Central Nervous System) OMNISCAN is a …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Gadodiamide have a boxed warning?
- Yes. The FDA label for Omniscan has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Gadodiamide?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Gadodiamide been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Gadodiamide?
- 1 company lists prescription products of Gadodiamide in the FDA NDC Directory, including GE Healthcare Inc..
What Gadodiamide is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
OMNISCAN 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 Facilitate the visualization of lesions with abnormal vascularity within the thoracic, abdominal, pelvic cavities, and the retroperitoneal space 1.1 CNS (Central Nervous System) OMNISCAN is a …
— FDA label: Omniscan, GE Healthcare Inc., effective April 18, 2025. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
Forms and how it is given
| Dosage forms | Injection |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Omniscan |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- GE Healthcare Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020123 OMNISCAN | Ge Healthcare | January 8, 1993 | 34, latest March 5, 2025 2025: Labeling · 2024: Labeling · 2024: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| SPL set ID of the quoted label | 1e9a37e2-f28a-4373-bf0f-3e9b60f42d8a |
|---|---|
| FDA labels (SPL) | 1 |
| FDA applications | NDA020123 |
| Active ingredients (FDA) | GADODIAMIDE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Omniscan, GE Healthcare Inc., effective April 18, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →