Gadoteric acid 5mmol/10ml solution for injection pre-filled syringes
Requires a prescription from a doctor or prescriber
Safety information for pregnancy and breastfeeding
Pregnancy
Gadoterate 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.
Always consult your doctor or midwife before taking any medicine during pregnancy or while breastfeeding. Source: DrugBank (CC BY-NC 4.0).
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Suspected adverse reactions reported for Gadoteric acid
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Data from the MHRA Yellow Card scheme. A reported reaction does not necessarily mean the medicine caused it. Contains public sector information licensed under the Open Government Licence v3.0.
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Suspected adverse reactions reported for Gadoteric acid
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2 branded products available
MHRA licensed products
View all licensed products for Gadoteric acid on the MHRA register
Clariscan 5mmol/10ml solution for injection pre-filled syringes
Dotarem 5mmol/10ml solution for injection pre-filled syringes
Therapeutically similar medicines
Similarity is based on WHO Anatomical Therapeutic Chemical (ATC) classification and on a factual NHS dm+d therapeutic-grouping code prefix. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
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Pharmacy links redirect to the retailer's own search and do not represent real-time stock levels. Shortage and safety information sourced from MHRA drug safety updates (gov.uk, Crown Copyright under OGL v3.0).
Codes for healthcare professionals and prescribing systems
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NHS UK identifiers
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SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. BNF code shown is the factual mapping value distributed by NHS Business Services Authority (NHSBSA) in the dm+d supplementary file under OGL v3.0; it is not affiliated with, nor licensed from, the publishers of the British National Formulary. ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Academic studies and reviews for this medicine's active substance
Showing the 50 most relevant studies.
Reviews & meta-analyses: 4 · 1965–2026
Showing the 50 most relevant studies, sorted by most relevant.
Liu Y, Shi X
2026
Abstract Background & Aims: Posthepatectomy liver failure (PHLF) is a major cause of morbidity and mortality following liver resection. Accurate preoperative prediction of posthepatectomy liver failure (PHLF) remains a clinical challenge. Gadoxetic acid-enhanced MRI (Gd-EOB-MRI) enables quantitative assessment of liver function. This systematic review and meta-analysis aims to determine the diagnostic accuracy of Gd-EOB-MRI quantitative parameters for predicting PHLF and to explore sources of heterogeneity. Methods: A systematic search of PubMed, Embase, Web of Science, and Cochrane Library was conducted from January 2011 to June 2025 for studies evaluating Gd-EOB-MRI parameters for PHLF prediction in adults undergoing hepatectomy. The bivariate random-effects model was used to calculate the pooled area under the curve (AUC). Heterogeneity was assessed using the I² statistic. Subgroup, threshold effect, and publication bias analyses were performed. Results: Nineteen studies involving 3,658 patients were included. Future liver remnant (FLR)-based parameters (14 studies) demonstrated high diagnostic accuracy with a pooled AUC of 0.85 (95% CI: 0.82–0.89) and moderate heterogeneity (I² = 27.9%). Whole liver-based parameters (7 studies) also showed good performance (pooled AUC = 0.80, 95% CI: 0.76–0.84). Subgroup analyses revealed no significant differences based on MRI parameters， study design, region, sample size, or PHLF definition. However, studies using 3.0T MRI scanners showed a significantly higher pooled AUC than those using 1.5T (0.859 vs. 0.763, p=0.018). A significant threshold effect was observed for FLR parameters (Spearman's ρ = 0.744, p=0.006) but not for whole liver parameters. No significant publication bias was detected. Conclusions: FLR-based Gd-EOB-MRI parameters provide excellent diagnostic performance for predicting PHLF, outperforming to whole liver-based assessment. This supports the integration of functional FLR assessment into preoperative risk stratification. However, the presence of a threshold effect underscores the need for standardized protocols and validated diagnostic cut-offs in future prospective multicenter studies. Prospective multicenter studies with standardized protocols and predefined diagnostic thresholds are needed to validate these findings and facilitate clinical translation.
Abstract licence: CC BY
J. Horton, J. Goldstein, Michael S. Brown
The Journal of clinical investigation, 2002
P. Chomczyński, N. Sacchi
Analytical biochemistry, 1987
H. Ohkawa, N. Ohishi, K. Yagi
Analytical biochemistry, 1979
V. L. Singleton, J. Rossi
American Journal of Enology and Viticulture, 1965
P. K. Smith, R. Krohn, G. Hermanson, et al.
Analytical biochemistry, 1985
R. Heath, L. Packer
Archives of biochemistry and biophysics, 1968
P. Ng, S. Henikoff
Nucleic acids research, 2003
S. Henikoff, J. Henikoff
Proceedings of the National Academy of Sciences of the United States of America, 1992
H. Harding, Yuhong Zhang, H. Zeng, et al.
Molecular cell, 2003
Sources: aggregated from Europe PMC (EMBL-EBI), OpenAlex, Crossref, PubMed and other open scholarly databases. Retracted articles are excluded. Study information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
None known
Half-life
0.2 hr
Mechanism
Gadoterate is a paramagnetic molecule that develops a magnetic moment when placed in a magnetic field.
Food interactions
None known
Human targets
None mapped
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
[L49911]
Following…
Half-life
0.2 hr
Protein binding
[L49911]
Volume of distribution
35 mL
Metabolism
[L49911]
Elimination
17.0%
Clearance
0.12 mL/min/kg
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
Gadoterate is approved by the FDA under the brand name DOTAREM on 20th March 2013 for intravenous uses with magnetic resonance imaging (MRI) in the brain (intracranial), spine, and associated tissues in adult and pediatric patients (2 years of age and older) to detect and visualize areas with disruption of the blood-brain barrier (BBB) and/or abnormal vascularity.[L49921]
[L49911]
Known interactions with other medications. Always consult a healthcare professional.
Showing 50 of 732 interactions
Because of the potential risks of gadolinium to the fetus, use gadoterate only if imaging is essential during pregnancy and cannot be delayed.
[L49911]
Gadoterate 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 have not been reported. Gadoterate can be removed from the body by hemodialysis.
[L49911]
Long-term animal studies have not been performed to evaluate the carcinogenic potential of gadoterate meglumine.
[L49911]
Gadoterate meglumine did not demonstrate mutagenic potential in in vitro bacterial reverse mutation assays (Ames test) using Salmonella typhimurium, in an in vitro chromosome aberration assay in Chinese hamster ovary cells, in an in vitro gene mutation assay in Chinese hamster lung cells, nor in an in vivo mouse micronucleus assay.
[L49911]
No impairment of male or female fertility and reproductive performance were observed in rats after intravenous administration of gadoterate meglumine at the maximum tested dose of 10 mmol/kg/day (16 times the maximum human dose based on surface area), given during more than 9 weeks in males and more than 4 weeks in females.
Sperm counts and sperm motility were not adversely affected by treatment with the drug.
[L49911]
Local intolerance reactions, including moderate irritation associated with infiltration of inflammatory cells were observed after perivenous injection in rabbits suggesting the possibility of local irritation if the contrast medium leaks around the veins in a clinical setting.
Toxicity of gadoterate meglumine was evaluated in neonatal and juvenile (pre- and post-weaning) rats following a single or repeated intravenous administration at doses 1, 2, and 4 times the MHD based on BSA. Gadoterate meglumine was well tolerated at all dose levels tested and had no effect on growth, pre-weaning development, behavior, or sexual maturation.
In magnetic resonance imaging (MRI), visualization of normal and pathological tissue depends in part on variations in the radiofrequency signal intensity that occur with differences in proton density, spin-lattice or longitudinal relaxation times (T1), and differences in the spin-spin or transverse relaxation time (T2). When placed in a magnetic field, gadoterate shortens the T1 and T2 relaxation times in target tissues. At recommended doses, the effect is observed with greatest sensitivity in the T1-weighted sequences.[L49911]
the relaxivity of the gadoterate molecule. The relaxivity values for gadoterate are similar across the spectrum of magnetic
field strengths used in clinical MRI (0.2-1.5 T). Disruption of the blood-brain barrier or abnormal vascularity allows the distribution of gadoterate in lesions such as neoplasms, abscesses, and infarcts.[L49911]
How the body processes this drug — absorption, distribution, metabolism, and elimination
[L49911]
Following the administration of 0.1 mmol/kg of gadoterate meglumine in healthy volunteers, the Cmax, Tmax, AUC0-t, and AUC0-∞ were measured to be 799.03 (192.63) µmol/L, 5.00 (0.10-10.00) min, 953.51 (76.22) µmol*h/L, and 970.72 (73.34) µmol*h/L for female and 836.85 (451.02) µmol/L, 5.00 (0.11-10.00) min, 1038.74 (240.46) µmol*h/L, and 1061.16 (239.24) µmol*h/L for male subjects respectively.
[L49916]
[L49911]
[L49911]
[L49911]
[L49911]
[L49911]
ATC V08CA02
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
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Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Gadoteric acid
DrugBank citations
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Structured knowledge from the free knowledge base
ATC classifications (Wikidata)
Linked open data from Wikidata (Q1490905), a free and open knowledge base operated by the Wikimedia Foundation. Data is available under the Creative Commons CC0 1.0 Public Domain Dedication. WHO INN from the World Health Organization.