Prescription medicine
Gadopiclenol Brand names: Elucirem, Vueway
Gadopiclenol (Vueway) is a prescription medicine with an FDA approval on record since 2022. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the gadopiclenol FDA label on DailyMed (effective February 22, 2026, Guerbet LLC); the NDA 216986 record on Drugs@FDA; every gadopiclenol label on DailyMed.
Highlights of the record
FDA label of February 22, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
RISK ASSOCIATED WITH INTRATHECAL.
USE and NEPHROGENIC SYSTEMIC FIBROSIS Risk Associated with Intrathecal Use Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. ELUCIREM is not approved for intrathecal use [see Warnings and Precautions ( 5.1 )]. Nephrogenic Systemic Fibrosis GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of ELUCIREM in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs. The risk for NSF appears highest among patients with: Chronic, severe kidney disease (GFR < 30 mL/min/1.73 m 2 ), or Acute kidney injury. 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, diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing. For patients at highest risk for NSF, do not exceed the recommended ELUCIREM dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration [see Warnings and Precautions ( 5.2 )]. […]
Used for
From the label: indications and usageELUCIREM 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).
Forms and strengths
- 485.1 mg/ml
Injection.
On the market
- Earliest approval on file
- September 21, 2022 Elucirem, Guerbet; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- January 17, 2040 Elucirem injection; not a generic launch date
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
- 243 through July 30, 2026
What is gadopiclenol used for?
From the label: indications and usageELUCIREM 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). ELUCIREM is a gadolinium-based contrast agent 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). […]
Source: FDA drug label (ELUCIREM), Guerbet LLC, effective February 22, 2026 (SPL set ca582f31-1042-487f-82e4-533f1b541902), via openFDA; the full label on DailyMed
What does the patient leaflet for gadopiclenol 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 ELUCIREM?GBCAs like ELUCIREM 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 ELUCIREM is safe and effective with intrathecal use. ELUCIREM is not approved for this use. ELUCIREM 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, but 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 gadodiamide than after gadoxetate disodium or gadobenate dimeglumine. Gadolinium stays in the body the least after, gadoterate meglumine, gadobutrol, gadoteridol, and gadopiclenol. 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 ELUCIREM.
Source: FDA drug label (ELUCIREM), Guerbet LLC, effective February 22, 2026 (SPL set ca582f31-1042-487f-82e4-533f1b541902), via openFDA; the full label on DailyMed
Is there a generic for gadopiclenol (Vueway)?
No generic gadopiclenol is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 4 patents for Elucirem injection: the compound patent runs to August 6, 2039, and the last listed entry to January 17, 2040. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2022 earliest approval on file
- 2040 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the gadopiclenol label say about other medicines?
The gadopiclenol label names 6 other medicines in its interaction, contraindication or warning sections. The labels of 3 other medicines name gadopiclenol. 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 gadodiamide causing greater retention than other linear agents such as gadoxetate disodium and gadobenate dimeglumine. |
| Gadobutrol | warnings and precautions | Retention is lowest and similar among the macrocyclic GBCAs such as gadoterate meglumine, gadobutrol, gadoteridol, and gadopiclenol. |
| Gadodiamide | warnings and precautions | At equivalent doses, gadolinium retention varies among the linear agents with gadodiamide causing greater retention than other linear agents such as gadoxetate disodium and gadobenate dimeglumine. |
| Gadoterate | warnings and precautions | Retention is lowest and similar among the macrocyclic GBCAs such as gadoterate meglumine, gadobutrol, gadoteridol, and gadopiclenol. |
| Gadoteridol | warnings and precautions | Retention is lowest and similar among the macrocyclic GBCAs such as gadoterate meglumine, gadobutrol, gadoteridol, and gadopiclenol. |
| Gadoxetate | warnings and precautions | At equivalent doses, gadolinium retention varies among the linear agents with gadodiamide causing greater retention than other linear agents such as gadoxetate disodium and gadobenate dimeglumine. |
Source: FDA drug label (ELUCIREM), Guerbet LLC, effective February 22, 2026 (SPL set ca582f31-1042-487f-82e4-533f1b541902), via openFDA; the full label on DailyMed
What do FAERS reports show for gadopiclenol?
The FDA Adverse Event Reporting System holds 243 reports that list gadopiclenol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3 are coded as a death and 28 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.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Gadopiclenol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other