Gadopiclenol
Gadopiclenol is a gadolinium-based contrast agent, given by IV, that helps MRI scans show lesions with abnormal blood vessel growth in the brain, spine, and body. It is sold as Elucirem and Vueway.
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The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
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Gadopiclenol (Elucirem, Vueway) is a gadolinium contrast agent given by IV during an MRI, making lesions with an unusual blood supply in the brain, spine and body show up brighter; it is one of the newer agents, designed for a strong signal with less gadolinium. Most people tolerate it well, noticing at most pain or a warm or cool feeling at the IV site, a headache or mild nausea. Its boxed warning covers nephrogenic systemic fibrosis (NSF, a rare but potentially fatal hardening of the skin and organs) in people with severe kidney disease or acute kidney injury, and it must never be injected into the spinal fluid.
Clinical pearls
- Before the scan, tell the imaging team about kidney disease, past contrast dye reactions, asthma, allergies, pregnancy or breastfeeding.
- If you are over 60 or have diabetes or high blood pressure, expect a kidney blood test before the injection.
- Report skin thickening or tightening, or joint and muscle stiffness after the scan, especially if your kidneys are weak.
- Some gadolinium lingers in bone and brain for months or years, so keep contrast MRIs to the ones truly needed.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Gadopiclenol must never be injected into the spinal fluid (intrathecal use). This can cause death, coma, brain dysfunction (encephalopathy), and seizures. Elucirem is not approved for this use.
Gadolinium-based contrast agents also raise the risk of nephrogenic systemic fibrosis (NSF) in people whose bodies cannot clear the drug well. NSF can cause fatal or disabling hardening of the skin, muscles, and internal organs. The risk appears highest in people with chronic, severe kidney disease or acute kidney injury. These patients should receive it only if the scan is essential and cannot be done another way. Your care team should screen your kidney function first, especially if you are over 60 or have high blood pressure or diabetes. Watch for skin thickening or tightening and joint or muscle stiffness after the scan, and report them to your doctor.
Patient information guide — a plain-language walkthrough of Gadopiclenol, written from its FDA label.
What Gadopiclenol is used for
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Gadopiclenol is a contrast agent used to make MRI images clearer.
- Elucirem (IV injection): used with MRI to detect and visualize lesions with abnormal vascularity in the brain, spine, and associated tissues, and in the body (head and neck, chest, abdomen, pelvis, and musculoskeletal system). It is approved for adults and children, including term newborns.
- Vueway (IV injection): used with MRI for the same purposes in the same age groups.
How Gadopiclenol works
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Gadopiclenol is a paramagnetic molecule, meaning it becomes magnetic when placed in a magnetic field. It is a macrocyclic, non-ionic complex, which means the gadolinium is held inside a ring-shaped molecule.
Inside the MRI machine, this changes how water in nearby tissue behaves and makes those tissues appear brighter. That extra brightness helps lesions stand out.
Gadopiclenol dosage
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A healthcare professional gives gadopiclenol through a vein as a single quick injection, followed by a saline flush. Elucirem and Vueway are each dosed by body weight. For children, the injection speed and flush volume are adjusted by age.
- The MRI can begin right after the injection.
- Food and missed doses are not a concern, since it is given only at the imaging visit.
- Your imaging team follows the product label and your prescriber's orders.
Dosing details from the FDA-approved label
From the Gadopiclenol prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Adult and pediatric patients, including term neonates (contrast MRI)
- 0.05 mmol/kg actual body weight (equivalent to 0.1 mL/kg) administered intravenously at approximately 2 mL/sec
- For pediatric patients, adjust the flow rate and flush volume based on age
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION The recommended dose for adult and pediatric patients, including term neonates, is 0.05 mmol/kg actual body weight (equivalent to 0.1 mL/kg) administered intravenously at approximately 2 mL/sec. ( 2.1 ) 2.1 Recommended Dosage The recommended dose of ELUCIREM for adult and pediatric patients, including term neonates, is 0.05 mmol/kg actual body weight (equivalent to 0.1 mL/kg) administered intravenously at approximately 2 mL/sec. 2.2 Administration and Imaging Instructions Administer ELUCIREM as an intravenous bolus injection, manually or by compatible power injector, at approximately 2 mL/sec followed by a flush of 0.9% sodium chloride injection. For pediatric patients, adjust the flow rate and flush volume based on age. Use aseptic technique for all handling and administration of ELUCIREM. Visually inspect ELUCIREM for particulate matter and discoloration prior to administration. Do not use the solution if any particulate matter is present or the solution is discolored. Do not mix with other medications because of the potential for chemical incompatibility. Prime intravenous line before use. Contrast MRI can begin immediately following the injection of ELUCIREM. 2.3 Directions for Use of Single-Dose Vial and Pre-filled Syringe Vial Pierce the rubber stopper only once. Aseptically draw up ELUCIREM into a disposable syringe and use immediately. If solidification occurs in the vial due to cold exposure, bring the vial of ELUCIREM to room temperature before use and inspect to ensure that the solution is clear and colorless to yellow without any particulate matter or discoloration. Discard any unused portion. Pre-filled syringe Remove the tip cap of the syringe, screw the plunger rod and use immediately. All luer connections should be gently hand tightened without over tightening, to ensure secure connections and to prevent damage to the device. Pre-filled syringes must not be frozen. Frozen pre-filled syringes of ELUCIREM should be discarded. Discard any unused portion. 2.4 Directions for Use of Pharmacy Bulk Package ELUCIREM Pharmacy Bulk Package (PBP) is not for direct infusion. Perform the transfer of ELUCIREM from the PBP in an aseptic work area, such as laminar flow hood, using aseptic technique and suitable transfer device for filling empty sterile syringes. Penetrate the closure only one time.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Gadopiclenol side effects
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Common side effects
- Pain at the injection site
- Headache
- Nausea
- Warmth or coldness at the injection site
- Dizziness
- Swelling near the injection site
- Redness of the skin (erythema)
When to get medical help
- Tell the staff right away if you have trouble breathing, swelling, hives, or feel faint during or after the injection. These can be signs of a serious allergic reaction, which usually starts within minutes.
- Call your doctor if you notice thickening, tightening, or hardening of your skin, or joint or muscle stiffness, especially if you have kidney problems. These can be signs of nephrogenic systemic fibrosis (NSF).
- Tell your care team about pain, swelling, or irritation at the IV site, since the medicine can irritate tissue if it leaks out of the vein.
- Report new or unusual symptoms after the scan, such as severe belly pain (acute pancreatitis has been reported), shortness of breath, or lasting pain or skin changes.
Most people have no problems. About 4.6% of people in studies had at least one side effect. The most common were:
- Injection site pain
- Headache
- Nausea
- Injection site warmth or coldness
- Dizziness
- Localized swelling
- Redness of the skin
Serious allergic reactions, NSF, and acute kidney injury have been reported with this class of drug. Tell your care team right away about breathing trouble, swelling, or skin tightening.
Gadopiclenol warnings and precautions
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- Not for injection into the spinal fluid. Intrathecal use of gadolinium-based contrast agents can cause death, coma, encephalopathy, and seizures.
- NSF risk with kidney problems. It can be fatal or disabling. Kidney function should be checked in people at risk.
- Serious allergic reactions. They usually start within minutes. Staff should be ready to treat them.
- Gadolinium retention. Gadolinium stays in the body for months or years, most in bone. Repeat scans should be limited.
- Acute kidney injury. This has occurred in people with chronically reduced kidney function. The recommended dose should not be exceeded.
- IV leakage. Leakage outside the vein can irritate tissue.
- Hidden lesions. The contrast may hide lesions seen on non-contrast MRI.
Before taking Gadopiclenol
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- Do not use Elucirem if you have had an allergic reaction to it.
- Kidney disease or acute kidney injury raises NSF risk. Tell your team.
- Age over 60, high blood pressure, and diabetes can reduce kidney function and may call for a blood test first.
- A history of reactions to contrast dye, asthma, or allergies may raise allergy risk.
- Pregnancy: use only if the scan is essential and cannot be delayed.
- Breastfeeding: your doctor will weigh the benefits against possible effects on the baby.
- Children: studied in children, including term newborns. Safety has not been established in preterm newborns.
- Older adults: kidney function may be monitored because it is more likely to be reduced.
Gadopiclenol overdose
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In people who received six times the recommended dose, headache and nausea were the most commonly reported effects. Gadopiclenol can be removed from the body by hemodialysis.
What Gadopiclenol does in the body
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Inside an MRI magnetic field, gadopiclenol shortens the T1 and T2 relaxation times in the tissues it reaches (this is how quickly water in the tissue returns to its resting state). This increases the signal brightness. It has a high relaxivity compared with other gadolinium contrast agents. At six times the recommended dose, it did not meaningfully prolong the QT interval (a heart rhythm measure).
How your body processes Gadopiclenol
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After IV injection, gadopiclenol spreads through the fluid outside the body's cells and binds very little to proteins. It is not metabolized. The kidneys clear it, and about 98% of a dose was found in urine within 48 hours. Its half-life is about 1.5 hours. In children, levels fell within the range seen in adults.
How to store Gadopiclenol
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Store at 25°C (77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) . Do not freeze Pre-filled syringes.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Gadopiclenol: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Gadopiclenol — the kind of thing our pharmacy team would talk through with you at the counter.
What is this injection for?
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How will I get it, and do I need to prepare?
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What side effects should I expect?
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I have kidney disease. Is this safe for me?
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Is it okay if I'm pregnant or breastfeeding?
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Does the gadolinium stay in my body?
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Is Gadopiclenol available over the counter?
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When was Gadopiclenol first available?
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Who makes Gadopiclenol?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Gadopiclenol on HelloPharmacist
Gadopiclenol forms and strengths (how it comes)
Gadopiclenol is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Elucirem is used with MRI to detect and visualize lesions with abnormal vascularity in the brain, spine, and body in adults and children, including term newborns.
- Vueway is used with MRI to detect and visualize lesions with abnormal vascularity in the brain, spine, and body in adults and children, including term newborns.
- Elucirem is given as an IV bolus injection followed by a saline flush, and it is not approved for injection into the spinal fluid.
- Vueway is given as an IV bolus injection followed by a saline flush.
- For children, Elucirem and Vueway flow rate and flush volume are adjusted by age.
Gadopiclenol on the U.S. market: products, makers and brands
How Gadopiclenol appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
2 companies list 35 Gadopiclenol product records with the FDA, mostly as injection; the earliest marketing or approval year on record is 2022. Brand names on the directory include Elucirem, Vueway; the rest are generics.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Compare Gadopiclenol products
A representative set of FDA-listed product records for Gadopiclenol — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 485.1 mg/mL | Intravenous | Bracco Diagnostics Inc × 10 listings | NDA | View NDC → |
| 485.1 mg/mL | Intravenous | Guerbet LLC × 25 listings | NDA | View NDC → |
Showing 35 of 35 products — FDA National Drug Code Directory. See every product, package size and price: browse all 35 Gadopiclenol NDCs →
Gadopiclenol side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Gadopiclenol — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Gadopiclenol in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Gadopiclenol FDA approval history
How Gadopiclenol went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Gadopiclenol recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Gadopiclenol recalls since July 2021.
✅No Gadopiclenol recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
Gadopiclenol supply and shortage status
Whether Gadopiclenol is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Gadopiclenol brand names
Gadopiclenol is sold under 2 brand names in the FDA directory — Elucirem, Vueway. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Gadopiclenol: manufacturers and labelers
2 companies list Gadopiclenol products with the FDA. By number of product records, the largest are Guerbet LLC, Bracco Diagnostics Inc. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Gadopiclenol drug class (RxNorm)
Gadopiclenol belongs to the Paramagnetic contrast media class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Gadopiclenol page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Guerbet LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →