Gadoterate Meglumine

Gadoterate is a paramagnetic molecule that develops a magnetic moment when placed in a magnetic field. The magnetic moment enhances the relaxation rates of water protons in its vicinity, leading to an increase in signal intensity (brightness) of tissues.

• Clariscan is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity. Clariscan is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.

• History of clinically important hypersensitivity reactions to Clariscan [see Warnings and Precautions (5.3) ]. Clinically important hypersensitivity reactions to Clariscan.contraindicated

Adult and pediatric patients: The recommended dose of Clariscan is 0.2 mL/kg (0.1 mmol/kg) body weight administered as an intravenous bolus injection at a flow rate of approximately 2 mL/second for adults and 1 to 2 mL/second for pediatric patients (including term neonates). The dose is delivered by manual or power injection. ( 2 ) 2.1 Dosing Guidelines For adult and pediatric patients (including term neonates), the recommended dose of Clariscan is 0.2 mL/kg (0.1 mmol/kg) body weight administered as an intravenous bolus injection, manually or by power injector, at a flow rate of approximately 2 mL/second for adults and 1 to 2 mL/second for pediatric patients. Table 1 provides weight-adjusted dose volumes. Table 1: Volumes of Clariscan Injection by Body Weight Body Weight Volume Pounds (lb) Kilograms (kg) Milliliters (mL) 5.5 2.5 0.5 11 5 1 22 10 2 44 20 4 66 30 6 88 40 8 110 50 10 132 60 12 154 70 14 176 80 16 198 90 18 220 100 20 242 110 22 264 120 24 286 130 26 308 140 28 330 150 30 To ensure complete injection of Clariscan, the injection may be followed by normal saline flush. Contrast MRI can begin immediately following Clariscan injection. 2.2 Drug Handling Visually inspect Clariscan for particulate matter prior to administration. Do not use the solution if particulate matter is present or if the container appears damaged. Clariscan should be a clear, colorless to yellow solution. Do not mix with other drugs or parenteral nutrition. Discard any unused portions of the drug.

Hypersensitivity Reactions: Anaphylactoid/anaphylactic reactions with cardiovascular, respiratory or cutaneous manifestations, ranging from mild to severe, including death, have uncommonly occurred. Monitor patients closely for need of emergency cardiorespiratory support. ( 5.3 ) Gadolinium Retention: Gadolinium is retained for months or years in brain, bone, and other organs. ( 5.4 ) 5.1 Risk Associated with Intrathecal Use Intrathecal administration of GBCAs can cause serious adverse reactions including death, coma, encephalopathy, and seizures. The safety and effectiveness of Clariscan have not been established with intrathecal use. Clariscan is not approved for intrathecal use [see Dosage and Administration (2.1) ]. 5.2 Nephrogenic Systemic Fibrosis GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of Clariscan among these patients unless the diagnostic information is essential and not available with non-contrast MRI or other modalities. The GBCA-associated NSF risk appears highest for patients with chronic, severe kidney disease (GFR < 30 mL/min/1.73 m 2 ) as well as patients with acute kidney injury. The risk appears lower for patients with chronic, moderate kidney disease (GFR 30 to 59 mL/min/1.73 m 2 ) and little, if any, for patients with chronic, mild kidney disease (GFR 60 to 89 mL/min/1.73 m 2 ). NSF may result in fatal or debilitating fibrosis affecting the skin, muscle, and internal organs.

The following clinically significant adverse reactions are described elsewhere in the labeling: Nephrogenic systemic fibrosis [see Warnings and Precautions (5.2) ] Hypersensitivity reactions [see Warnings and Precautions (5.3) ] Gadolinium Retention [see Warnings and Precautions (5.4) ] The most frequent (≥ 0.2%) adverse reactions in clinical studies were nausea, headache, injection site pain, injection site coldness, and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 1-800-654-0118 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The data described below reflect gadoterate meglumine exposure in 2867 patients, representing 2682 adults and 185 pediatric patients. Overall, 55% of the patients were men. In clinical trials where ethnicity was recorded, the ethnic distribution was 81% Caucasian, 11% Asian, 4% Black, and 4% others. The average age was 53 years (range from < 1 week to 97 years). Overall, 4% of patients reported at least one adverse reaction, primarily occurring immediately or within 24 hours following gadoterate meglumine administration. Most adverse reactions were mild or moderate in severity and transient in nature. Table 2 lists adverse reactions that occurred in ≥ 0.2% patients who received gadoterate meglumine.

Pregnancy: Use only if imaging is essential during pregnancy and cannot be delayed. ( 8.1 ) 8.1 Pregnancy Risk Summary GBCAs cross the human placenta and result in fetal exposure and gadolinium retention. The human data on the association between GBCAs and adverse fetal outcomes are limited and inconclusive (see Data ) . In animal reproduction studies, there were no adverse developmental effects observed in rats or rabbits with intravenous administration of gadoterate meglumine during organogenesis at doses up to 16 and 10 times, respectively, the recommended human dose (see Data ) . Because of the potential risks of gadolinium to the fetus, use Clariscan only if imaging is essential during pregnancy and cannot be delayed. The estimated background risk of major birth defects and miscarriage for the indicated population(s) are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data Contrast enhancement is visualized in the placenta and fetal tissues after maternal GBCA administration.

Metabolism

The pharmacokinetics of total gadolinium assessed up to 48 hours following an intravenously administered 0.1 mmol/kg dose of gadoterate meglumine in healthy adult subjects demonstrated a mean elimination half-life (reported as mean ± SD) of about 1.4 ± 0.2 hours and 2.0 ± 0.7 hours in female and male subjects, respectively.

Clariscan administered to healthy volunteers and to adult patients at cumulative doses up to 0.3 mmol/kg was tolerated in a manner similar to lower doses. Adverse reactions to overdosage with gadoterate meglumine have not been reported. Gadoterate meglumine can be removed from the body by hemodialysis [see Clinical Pharmacology (12.3) ].

• Mar 20, 2013NDANDA204781Guerbet
• Nov 1, 2019ANDAANDA210016Ge Healthcare
• Apr 11, 2022ANDAANDA215304Hengrui Pharma
• Jun 17, 2024ANDAANDA218073Hainan Poly

Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

• Gadoterate Meglumine, Injection, 376.9 mg/1 mL (NDC 65219-080-05)To be discontinued
  Sponsor: Jiangsu Hengrui Pharmaceuticals Co., Ltd.
  Updated May 21, 2026
• Gadoterate Meglumine, Injection, 376.9 mg/1 mL (NDC 65219-082-10)To be discontinued
  Sponsor: Jiangsu Hengrui Pharmaceuticals Co., Ltd.
  Updated May 21, 2026
• Gadoterate Meglumine, Injection, 376.9 mg/1 mL (NDC 65219-084-15)To be discontinued
  Sponsor: Jiangsu Hengrui Pharmaceuticals Co., Ltd.
  Updated May 21, 2026
• Gadoterate Meglumine, Injection, 376.9 mg/1 mL (NDC 65219-086-20)To be discontinued
  Sponsor: Jiangsu Hengrui Pharmaceuticals Co., Ltd.
  Updated May 21, 2026

1. 1Urticaria63318%
2. 2Dyspnoea53615%
3. 3Nausea51114%
4. 4Pruritus47013%
5. 5Erythema41412%
6. 6Vomiting40811%
7. 7Cough2868.0%
8. 8Rash2597.3%
9. 9Headache2075.8%
10. 10Dizziness2035.7%
11. 11Product Use In Unapproved Indication1915.4%
12. 12Paraesthesia1624.5%
13. 13Throat Irritation1614.5%
14. 14Fatigue1283.6%
15. 15Sneezing1283.6%

Recent PubMed references pinned to Gadoterate Meglumine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Cerebral Accumulation of Gadolinium (Gd(3+)) and Related Cellular Stress Pathways in Rat Brain Tissue.
  Tomography (Ann Arbor, Mich.) · 2026 · Tuzcu G, Çildağ B, Çildağ S, et al.
  PMID 41893832DOI 10.3390/tomography12030037
• Prepubertal exposure to gadolinium-based contrast agents impairs sperm quality and elevates oxidative stress in adult rats.
  Toxicology · 2025 · Britto CC, Oliveira AS, Crepaldi LM, et al.
  PMID 40876586DOI 10.1016/j.tox.2025.154270
• Comparison of gadobutrol and meglumine gadoterate for dynamic contrast-enhanced MRI of pituitary macroadenomas.
  Scientific reports · 2025 · Hwang K, Bae YJ, Kim CY, et al.
  PMID 40691479DOI 10.1038/s41598-025-10702-x
• Gadopiclenol Versus Gadoterate Meglumine for Pediatric Brain MRI: An Intraindividual Comparison of Contrast Enhancement.
  AJR. American journal of roentgenology · 2025 · Valencia S, Cortes-Albornoz MC, Ferracioli SF, et al.
  PMID 40557986DOI 10.2214/AJR.25.33201
• Contrast Agent-Specific Parameter Optimization for T 1 -Weighted Fast Spoiled Gradient Echo Imaging : Use Cases for Gadoterate Meglumine and Gadobutrol at 1.5T and 3.0T.
  Investigative radiology · 2025 · Gkotsis DE, Bherwani A, Kapsalaki EZ, et al.
  PMID 40328243DOI 10.1097/RLI.0000000000001205
• Safety of Gadoterate Meglumine: A Review of 35 Years of Clinical Use and More Than 170 Million Doses.
  Investigative radiology · 2025 · Shahid I, Morvan J, Darmon-Kern E, et al.
  PMID 40300199DOI 10.1097/RLI.0000000000001200
• Exploring gadolinium deposition in maternal and offspring mice: Impacts of gestational and lactational exposure.
  Toxicology letters · 2025 · Kong Y, Liu K, Qiu S, et al.
  PMID 40185213DOI 10.1016/j.toxlet.2025.03.010
• NSF evaluation of gadolinium biodistribution in renally impaired rats: Using novel metabolic Gd2O3 nanoparticles coated with β-cyclodextrin (Gd2O3@PCD) in MR molecular imaging.
  Magnetic resonance imaging · 2024 · Ashouri H, Riyahi Alam N, Khoobi M, et al.
  PMID 38215955DOI 10.1016/j.mri.2024.01.003

The 10 most recently updated of 66 ClinicalTrials.gov registrations naming Gadoterate Meglumine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Developing a New Metabolic Imaging Approach (aMRI) for Evaluating Neurological Disease in Patients With Gliomas
  Completed · Observational · 4 enrolled · OHSU Knight Cancer Institute
  NCT05937776updated 2026-06-05
• Neuronavigation-guided FUS-induced BBB Opening in Alzheimer's Disease Patients and Its Effects on Brain Amyloid and Tau
  Not yet recruiting · Phase 1 · Interventional · 6 enrolled · Columbia University
  NCT06600880updated 2026-05-13
• Advanced Imaging to Assess the Effect of Immunosuppression on Progressive Fibrosis
  Recruiting · Phase 2 · Interventional · 15 enrolled · Peter Caravan
  NCT07572383updated 2026-05-07
• Advanced Imaging for Pulmonary Fibrosis
  Recruiting · Phase 2 · Interventional · 60 enrolled · Peter Caravan
  NCT06532071updated 2026-04-22
• Efficacy of Dotarem® (Gd-DOTA) Versus Gadovist® (Gd-DO3A-butrol) for Late Gadolinium Enhancement Cardiac Magnetic Resonance
  Completed · Interventional · 120 enrolled · The Methodist Hospital Research Institute
  NCT03057561updated 2026-04-20
• Collagen-targeted PET Imaging for Early Interstitial Lung Disease
  Recruiting · Phase 2 · Interventional · 30 enrolled · Massachusetts General Hospital
  NCT05417776updated 2026-04-20
• The Effect of Pulse Field Ablation of Atrial Fibrillation Involving Posterior Wall Ablation on Atrial Mechancis Assessed by Cardiac Magnetic Resonance Imaging
  Not yet recruiting · Interventional · 39 enrolled · Assistance Publique - Hôpitaux de Paris
  NCT07499531updated 2026-03-30
• Dotarem vs Gadobutrol Contrast for Breast MRI
  Completed · Phase 4 · Interventional · 300 enrolled · University of Massachusetts, Worcester
  NCT03730051updated 2026-03-17
• Value of PET/MR Enterography in the Assessment of Crohn's Disease Using a Collagen-binding Radiotracer.
  Recruiting · Observational · 25 enrolled · Massachusetts General Hospital
  NCT06252493updated 2026-03-12
• Performance of Elucirem in DSC-MRI Perfusion of Brain Gliomas
  Completed · Phase 3 · Interventional · 138 enrolled · Guerbet
  NCT06057168updated 2026-01-29

Frequently asked questions

How does Gadoterate Meglumine work?

Gadoterate is a paramagnetic molecule that develops a magnetic moment when placed in a magnetic field. The magnetic moment enhances the relaxation rates of water protons in its vicinity, leading to an increase in signal intensity (brightness) of tissues.

What is Gadoterate Meglumine used for?

According to FDA labeling, Gadoterate Meglumine carries indications including: Clariscan is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity. Clariscan is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Gadoterate Meglumine?

Gadoterate Meglumine is classified as Magnetic Resonance Contrast Activity.

What are the contraindications for Gadoterate Meglumine?

Gadoterate Meglumine labeling lists contraindications including: History of clinically important hypersensitivity reactions to Clariscan [see Warnings and Precautions (5.3) ]. Clinically important hypersensitivity reactions to Clariscan.. Always consult the full prescribing information and a clinician.