Molecule
Gadoterate is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult, among other approved uses. It is available as injection for intravenous use. MedsAcross supplies Gadoterate for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
DOTAREM 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.
Source: US FDA prescribing information
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. In magnetic resonance imaging (MRI), visualization of normal and pathological tissue depends in part on variations in the radiofrequency signal intensity that occurs with: differences in proton density differences of the spin-lattice or longitudinal relaxation times (T1) 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.
Source: US FDA prescribing information
Adult and pediatric patients: The recommended dose of DOTAREM 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 - 2 mL/second for pediatric patients (including term neonates). The dose is delivered by manual or power injection.
Source: US FDA prescribing information
History of clinically important hypersensitivity reactions to DOTAREM. Clinically important hypersensitivity reactions to DOTAREM.
Source: US FDA prescribing information
Boxed warning (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. DOTAREM is not approved for intrathecal use. 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. Gadolinium Retention: Gadolinium is retained for months or years in brain, bone, and other organs.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in the labeling: Nephrogenic systemic fibrosis. Hypersensitivity reactions. Gadolinium Retention The most frequent (≥ 0.2%) adverse reactions in clinical studies were nausea, headache, injection site pain, injection site coldness, and rash.
Source: US FDA prescribing information
Gadoterate does not interfere with serum and plasma calcium measurements determined by colorimetric assays. Specific drug interaction studies with DOTAREM have not been conducted.
Source: US FDA prescribing information
Storage Store at 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Should solidification occur in the vial because of exposure to the cold, bring DOTAREM to room temperature before use. If allowed to stand at room temperature for a minimum of 90 minutes, DOTAREM should return to a clear, colorless to yellow solution.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
15 presentations of Gadoterate, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Gadoterate 37690 mg/100 mL injectionIntravenousGeneric name | — | US FDA | Available on request |
| Dotarem 3769 mg/10 mL injectionIntravenous | Guerbet | US FDA | Available on request |
| Dotarem 5653.5 mg/15 mL injectionIntravenous | Guerbet | US FDA | Available on request |
| Dotarem 7538 mg/20 mL injectionIntravenous | Guerbet | US FDA | Available on request |
| Gadoterate 1884.5 mg/5 mL injectionIntravenousGeneric name | — | US FDA | Available on request |
| Gadoterate 3769 mg/10 mL injectionIntravenousGeneric name | — | US FDA | Available on request |
| Gadoterate 5653.5 mg/15 mL injectionIntravenousGeneric name | — | US FDA | Available on request |
| Gadoterate 7538 mg/20 mL injectionIntravenousGeneric name | — | US FDA | Available on request |
| Clariscan 3769 mg/10 mL injectionIntravenous | GE Healthcare | US FDA | Available on request |
| Clariscan 5653.5 mg/15 mL injectionIntravenous | GE Healthcare | US FDA | Available on request |
| Clariscan 7538 mg/20 mL injectionIntravenous | GE Healthcare | US FDA | Available on request |
| Dotarem 1884.5 mg/5 mL injectionIntravenous | Guerbet | US FDA | Available on request |
| Dotarem 37690 mg/100 mL injectionIntravenous | Guerbet | US FDA | Available on request |
| Clariscan 1884.5 mg/5 mL injectionIntravenous | GE Healthcare | US FDA | Available on request |
| Clariscan 37690 mg/100 mL injectionIntravenous | GE Healthcare | US FDA | Available on request |
2 brand names across 1 markets.
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 20 March 2013 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Yes, on request. MedsAcross lists 15 presentations of Gadoterate and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 2 brand names for Gadoterate, including Clariscan, Dotarem.
Yes. The US FDA first approved Gadoterate on 20 March 2013, according to Drugs@FDA.
No listed presentation of Gadoterate is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Gadoterate is classified under ATC code V08CA02 (Gadoterate).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.