Quick answers
- What is Gadopiclenol used for?
- The FDA-approved label (Elucirem, Guerbet LLC, February 22, 2026) says: “ELUCIREM is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: the central nervous system (brain, spine, and associated tissues), the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system). …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Gadopiclenol have a boxed warning?
- Yes. The FDA label for Elucirem has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Gadopiclenol?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Gadopiclenol been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Gadopiclenol?
- 2 companies list prescription products of Gadopiclenol in the FDA NDC Directory, including Guerbet LLC and Bracco Diagnostics Inc.
What Gadopiclenol is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ELUCIREM is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: the central nervous system (brain, spine, and associated tissues), the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system). …
— FDA label: Elucirem, Guerbet LLC, effective February 22, 2026. Read the full label on DailyMed →
The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
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 →
2 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
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.
- Guerbet LLC9 products
- Bracco Diagnostics Inc5 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA216986 ELUCIREM | Guerbet | September 21, 2022 | 5, latest February 20, 2026 2026: Efficacy · 2025: 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 | ca582f31-1042-487f-82e4-533f1b541902 |
|---|---|
| FDA labels (SPL) | 2 |
| FDA applications | NDA216986 |
| Active ingredients (FDA) | GADOPICLENOL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Elucirem, Guerbet LLC, effective February 22, 2026; 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 →