Gadoteric acid 5mmol/10ml solution for injection vials
Prescription only
Requires a prescription from a doctor or prescriber
Active ingredients:
Gadoteric acid
1 safety notice
Safety information for pregnancy and breastfeeding
Pregnancy
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.
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.
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).
Official documents, adverse reaction reporting, and safety monitoring
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Official medicine documents
Source: MHRA Products DatabaseOGL 3.0
Updated 3 months ago(16 Jan 2026)Safety monitoring data
Yellow Card reports
MHRA
The MHRA Yellow Card scheme collects reports of suspected side effects from healthcare professionals and patients. View the Drug Analysis Profile (iDAP) for real-world adverse reaction data.
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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.
EudraVigilance
EMA
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Suspected adverse reactions reported for Gadoteric acid
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EudraVigilance data is published by the European Medicines Agency (EMA). A suspected adverse reaction is not necessarily caused by the medicine.
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Clinical guidelines and formulary information
British National Formulary
Gadoteric acid
BNF
Drug monograph — bnf.nice.org.ukSource: British National Formulary, NICE. Joint Formulary Committee. Contains public sector information licensed under the Open Government Licence v3.0.
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Supply & product information
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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 codes from NHS Business Services Authority (NHSBSA). ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
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Searching UK clinical trials...
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.
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
Within the studied dose range (0.1 to 0.3 mmol/kg), the kinetics of total gadolinium appear to be linear.
[L49911]
Following…
[L49911]
Following…
Half-life
0.2 hr
Following an intravenously administered 0.1 mmol/kg, gadoterate demonstrates a mean elimination half-life of about 1.4…
Protein binding
Gadoterate does not undergo protein binding in vitro.
[L49911]
[L49911]
Volume of distribution
35 mL
The volume of distribution at steady state of total gadolinium in healthy subjects is 179 ± 26 and 211 ± 35 mL/kg in female and male subjects…
Metabolism
Gadoterate is not known to be metabolized.
[L49911]
[L49911]
Elimination
17.0%
Following a 0.1 mmol/kg dose of gadoterate, total gadolinium is excreted primarily in the urine with 72.9…
Clearance
0.12 mL/min/kg
In healthy subjects, the renal and total clearance rates of total gadolinium are comparable (1.27…
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
Status:
Approved
Investigational
Small molecule
About this compound
Gadoteric acid, commonly used in the salt form gadoterate meglumine, is a macrocyclic, ionic gadolinium-based contrast agent (GBCA).[A263131] It is composed of the organic acid DOTA (1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid) used for its chelating properties, and gadolinium (Gd3+).[A263136] Gadoterate meglumine has one of the highest thermodynamic stability, apparent stability, and kinetic stability, partly due to its macrocyclic structure, and thus has a more favorable safety profile due to a decreased tendency of gadolinium dechelation.[A263141][A263106]
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]
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]
Properties:
View FDA drug labelliquid
Avg. mass: 558.65 Da
DrugBank indication
Gadoteric acid is indicated for intravenous use with magnetic resonance imaging (MRI) in the 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.
[L49911]
[L49911]
Also known as(5)
[2,2',2'',2'''-(1,4,7,10-tetraazacyclododecane-1,4,7,10-tetrayl-κ4N1,N4,N7,N10)tetraacetato(3−)]gadolinium
DOTA-Gd
Gadoterate
Gadoteric acid
Gd-DOTA
Dosage forms(20)
Injection, solution (Intra-articular) — 1.397 mg/ml
Injection, solution (Intravenous) — 376.9 mg/1mL
Injection (Intravenous) — 0.5 mmol/mL
Injection, solution (Intravenous) — 279.3 mg/ml
Solution (Intravenous) — 279.3 mg
Injection, solution (Intramuscular) — 0.5 mmol/ml
Injection, solution (Parenteral) — 0.5 MMOL/ML
Injection, solution (Intramuscular)
Molecular properties(19)
Drug interactions(732)
Known interactions with other medications. Always consult a healthcare professional.
Gadoteric acid may decrease effectiveness of Technetium Tc-99m oxidronate as a diagnostic agent.
Cyclosporine
Moderate
Cyclosporine may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Icosapent may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Cefotiam may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Mesalazine
Moderate
Mesalazine may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Cefmenoxime
Moderate
Cefmenoxime may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Cefmetazole
Moderate
Cefmetazole may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Pamidronic acid
Moderate
Pamidronic acid may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Tenofovir disoproxil
Moderate
Tenofovir disoproxil may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Indomethacin
Moderate
Indomethacin may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Cidofovir may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Cefpiramide
Moderate
Cefpiramide may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Ceftazidime
Moderate
Ceftazidime may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Loracarbef
Moderate
Loracarbef may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Cefalotin may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Nabumetone
Moderate
Nabumetone may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Ketorolac may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Tenoxicam may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Celecoxib may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Cefotaxime
Moderate
Cefotaxime may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Tolmetin may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Foscarnet may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Rofecoxib may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Piroxicam may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Methotrexate
Moderate
Methotrexate may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Cephalexin
Moderate
Cephalexin may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Fenoprofen
Moderate
Fenoprofen may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Valaciclovir
Moderate
Valaciclovir may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Valdecoxib
Moderate
Valdecoxib may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Diclofenac
Moderate
Diclofenac may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Sulindac may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Bacitracin
Moderate
Bacitracin may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Amphotericin B
Moderate
Amphotericin B may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Cephaloglycin
Moderate
Cephaloglycin may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Flurbiprofen
Moderate
Flurbiprofen may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Adefovir dipivoxil
Moderate
Adefovir dipivoxil may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Pentamidine
Moderate
Pentamidine may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Etodolac may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Mefenamic acid
Moderate
Mefenamic acid may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Acyclovir may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Naproxen may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Sulfasalazine
Moderate
Sulfasalazine may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Phenylbutazone
Moderate
Phenylbutazone may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Meloxicam may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Carprofen may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Cefaclor may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Diflunisal
Moderate
Diflunisal may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Tacrolimus
Moderate
Tacrolimus may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Ceforanide
Moderate
Ceforanide may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Salicylic acid
Moderate
Salicylic acid may decrease the excretion rate of Gadoteric acid which could result in a higher serum level.
Showing 50 of 732 interactions
Toxicity & overdose
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. 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 of 16 and 10 times, respectively, the recommended human dose.
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.
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.
How it works
Mechanism of action
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.[L49911]
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]
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]
Pharmacodynamics
Gadoterate affects proton relaxation times and consequently the MR signal, and the contrast obtained is characterized by
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]
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]
Pharmacokinetics
How the body processes this drug — absorption, distribution, metabolism, and elimination
Absorption
Within the studied dose range (0.1 to 0.3 mmol/kg), the kinetics of total gadolinium appear to be linear.
[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]
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]
Half-life
Following an intravenously administered 0.1 mmol/kg, gadoterate demonstrates a mean elimination half-life of about 1.4 ± 0.2 hr and 2.0 ± 0.7 hr in female and male subjects, respectively.L49911]
Protein binding
Gadoterate does not undergo protein binding in vitro.
[L49911]
[L49911]
Volume of distribution
The volume of distribution at steady state of total gadolinium in healthy subjects is 179 ± 26 and 211 ± 35 mL/kg in female and male subjects respectively, roughly equivalent to that of extracellular water. The extent of blood cell partitioning of gadoterate is not known.
[L49911]
[L49911]
Metabolism
Gadoterate is not known to be metabolized.
[L49911]
[L49911]
Route of elimination
Following a 0.1 mmol/kg dose of gadoterate, total gadolinium is excreted primarily in the urine with 72.9 ± 17.0% and 85.4 ± 9.7% (mean ± SD) eliminated within 48 hours, in female and male subjects, respectively. Similar values were achieved after a cumulative dose of 0.3 mmol/kg (0.1 + 0.2 mmol/kg, 20 minutes later), with 85.5 ± 13.2% and 92.0 ± 12.0% recovered in urine within 48 hrs in female and male subjects respectively.
[L49911]
[L49911]
Clearance
In healthy subjects, the renal and total clearance rates of total gadolinium are comparable (1.27 ± 0.32 and 1.74 ± 0.12 mL/min/kg in females; and 1.40 ± 0.31 and 1.64 ± 0.35 mL/min/kg in males, respectively) indicating that the drug is primarily cleared through the kidneys.
[L49911]
[L49911]
Scientific references(4)
Fallenberg E.M., Renz D.M., Karle B., Schwenke C., Ingod-Heppner B., Reles A., Engelken F.J., Huppertz A., Hamm B., Taupitz M.
Intraindividual, randomized comparison of the macrocyclic contrast agents gadobutrol and gadoterate meglumine in breast magnetic resonance imaging.
European Radiology
2015 Mar25(3):837-49. doi: 10.1007/s00330-014-3426-0. Epub 2014 Sep 25
Xiao Y., Xue R., You T., Li X., Pei F., Wang X., Lei H.
Gadolinium-1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid conjugate of arabinogalactan as a potential liver-targeting magnetic resonance imaging contrast agent.
Carbohydr Research
2014 Aug 18395:9-14. doi: 10.1016/j.carres.2014.05.022. Epub 2014 Jun 6
Ishiguchi T., Takahashi S.
Safety of gadoterate meglumine (Gd-DOTA) as a contrast agent for magnetic resonance imaging: results of a post-marketing surveillance study in Japan.
Drugs R D
201010(3):133-45. doi: 10.2165/11539140-000000000-00000
Robert P., Violas X., Grand S., Lehericy S., Idee J.M., Ballet S., Corot C.
Linear Gadolinium-Based Contrast Agents Are Associated With Brain Gadolinium Retention in Healthy Rats.
Invest Radiology
2016 Feb51(2):73-82. doi: 10.1097/RLI.0000000000000241
ATC classification(1 code)
ATC V08CA02
Salt forms(1)
Gadoterate meglumine(DBSALT001229)
External resources(1)
Commercial products(11)
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Show
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
If you use DrugBank data in your research, please cite the following publications:
Knox C., Wilson M., Klinger C.M., et al
DrugBank 6.
0: the DrugBank Knowledgebase for 2024
Nucleic Acids Res. 2024 Jan 552(D1):D1265-D1275
Wishart D.S., Feunang Y.D., Guo A.C., et al
DrugBank 5.
0: a major update to the DrugBank database for 2018
Nucleic Acids Res. 2017 Nov 846(D1):D1074-D1082
Show earlier publications
Law V., Knox C., Djoumbou Y., et al
DrugBank 4.
0: shedding new light on drug metabolism
Nucleic Acids Res. 2014 Jan 142(1):D1091-7
Knox C., Law V., Jewison T., et al
DrugBank 3.
0: a comprehensive resource for 'omics' research on drugs
Nucleic Acids Res. 2011 Jan39(Database issue):D1035-41
Wishart D.S., Knox C., Guo A.C., et al
DrugBank: a knowledgebase for drugs, drug actions and drug targets.
Nucleic Acids Research
2008 Jan36(Database issue):D901-6
Wishart D.S., Knox C., Guo A.C., et al
DrugBank: a comprehensive resource for in silico drug discovery and exploration.
Nucleic Acids Research
2006 Jan 134(Database issue):D668-72
Source: go.drugbank.comCC BY-NC 4.0
Updated about 1 month ago(4 Mar 2026)