Prescription medicine
Gadoterate Brand names: Dotarem, Clariscan
Gadoterate (Dotarem) is a prescription medicine with an FDA approval on record since 2013. FDA's NDC Directory lists it from 3 generic labelers.
- Generic listed
- A presentation discontinued
- Boxed warning
Check it at the source: the gadoterate FDA label on DailyMed (effective March 14, 2025, Guerbet LLC); the NDA 204781 record on Drugs@FDA; every gadoterate label on DailyMed.
Highlights of the record
FDA label of March 14, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
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 [see Warnings and Precautions ( 5.1 )]. Nephrogenic Systemic Fibrosis GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of DOTAREM in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs. The risk for NSF appears highest among patients with: Chronic, severe kidney disease (GFR < 30 mL/min/1.73 m 2 ), or Acute kidney injury. Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g. age > 60 years, hypertension, diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing ( 5.1 ). For patients at highest risk for NSF, do not exceed the recommended DOTAREM dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration [see Warnings and Precautions ( 5.2 )]. […]
Used for
From the label: indications and usageDOTAREM 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.
Forms and strengths
- 376.9 mg/ml
Injection; injection (solution).
On the market
- Earliest approval on file
- March 20, 2013 Dotarem, Guerbet; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 4 first November 1, 2019; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 4 of which 3 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- None current 8 past records
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 3,653 through July 30, 2026
What is gadoterate used for?
From the label: indications and usageDOTAREM 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. 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.
FDA pharmacologic class: Gadolinium-based Contrast Agent.
Source: FDA drug label (DOTAREM), Guerbet LLC, effective March 14, 2025 (SPL set e2c4a5ac-2df2-4cf4-a2d3-6fbe2d898ebc), via openFDA; the full label on DailyMed
What does the patient leaflet for gadoterate say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about DOTAREM?GBCAs like DOTAREM may cause serious side effects including death, coma, encephalopathy, and seizures when it is given intrathecally (injection given into the spinal canal). It is not known if DOTAREM is safe and effective with intrathecal use. DOTAREM is not approved for this use. DOTAREM contains a metal called gadolinium. Small amounts of gadolinium can stay in your body including the brain, bones, skin and other parts of your body for a long time (several months to years). It is not known how gadolinium may affect you, but so far, studies have not found harmful effects in patients with normal kidneys. Rarely patients have reported pains, tiredness, and skin, muscle or bone ailments for a long time, but these symptoms have not been directly linked to gadolinium. There are different GBCAs that can be used for your MRI exam. The amount of gadolinium that stays in the body is different for different gadolinium medicines. Gadolinium stays in the body more after Omniscan or Optimark than after Eovist, Magnevist or MultiHance. Gadolinium stays in the body the least after Dotarem, Gadavist or ProHance. People who get many doses of gadolinium medicines, women who are pregnant and young children may be at increased risk from gadolinium staying in the body. Some people with kidney problems who get gadolinium medicines can develop a condition with severe thickening of the skin, muscles and other organs in the body (nephrogenic systemic fibrosis). Your healthcare provider should screen you to see how well your kidneys are working before you receive DOTAREM.
Source: FDA drug label (DOTAREM), Guerbet LLC, effective March 14, 2025 (SPL set e2c4a5ac-2df2-4cf4-a2d3-6fbe2d898ebc), via openFDA; the full label on DailyMed
Is there a generic for gadoterate (Dotarem)?
The FDA approved the first generic gadoterate on November 1, 2019. 4 generic applications are approved; 3 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists gadoterate from 3 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2013 earliest approval on file
- 2019 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is gadoterate in shortage?
No gadoterate presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 8 records are all marked to be discontinued, the latest updated June 30, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Gadoterate Meglumine, Injection, 376.9 mg/1 mL (NDC 65219-080-05) | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | To Be Discontinued | May 21, 2026 |
| Gadoterate Meglumine, Injection, 376.9 mg/1 mL (NDC 65219-080-05) | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | To Be Discontinued | June 30, 2026 |
| Gadoterate Meglumine, Injection, 376.9 mg/1 mL (NDC 65219-082-10) | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | To Be Discontinued | May 21, 2026 |
| Gadoterate Meglumine, Injection, 376.9 mg/1 mL (NDC 65219-082-10) | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | To Be Discontinued | June 30, 2026 |
| Gadoterate Meglumine, Injection, 376.9 mg/1 mL (NDC 65219-084-15) | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | To Be Discontinued | May 21, 2026 |
| Gadoterate Meglumine, Injection, 376.9 mg/1 mL (NDC 65219-084-15) | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | To Be Discontinued | June 30, 2026 |
| Gadoterate Meglumine, Injection, 376.9 mg/1 mL (NDC 65219-086-20) | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | To Be Discontinued | May 21, 2026 |
| Gadoterate Meglumine, Injection, 376.9 mg/1 mL (NDC 65219-086-20) | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | To Be Discontinued | June 30, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
What does the gadoterate label say about other medicines?
The gadoterate label names 5 other medicines in its interaction, contraindication or warning sections. The labels of 7 other medicines name gadoterate. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Gadobenate | warnings and precautions | At equivalent doses, gadolinium retention varies among the linear agents with Omniscan (gadodiamide) and Optimark (gadoversetamide) causing greater retention than other linear agents [Eovist (gadoxetate disodium), Magnevist (gadopentetate dimeglumine), MultiHance (gadobenate dimeglumine)]. |
| Gadobutrol | warnings and precautions | Retention is lowest and similar among the macrocyclic GBCAs [Dotarem (gadoterate meglumine), Gadavist (gadobutrol), ProHance (gadoteridol)]. |
| Gadodiamide | warnings and precautions | At equivalent doses, gadolinium retention varies among the linear agents with Omniscan (gadodiamide) and Optimark (gadoversetamide) causing greater retention than other linear agents [Eovist (gadoxetate disodium), Magnevist (gadopentetate dimeglumine), MultiHance (gadobenate dimeglumine)]. |
| Gadoteridol | warnings and precautions | Retention is lowest and similar among the macrocyclic GBCAs [Dotarem (gadoterate meglumine), Gadavist (gadobutrol), ProHance (gadoteridol)]. |
| Gadoxetate | warnings and precautions | At equivalent doses, gadolinium retention varies among the linear agents with Omniscan (gadodiamide) and Optimark (gadoversetamide) causing greater retention than other linear agents [Eovist (gadoxetate disodium), Magnevist (gadopentetate dimeglumine), MultiHance (gadobenate dimeglumine)]. |
Source: FDA drug label (DOTAREM), Guerbet LLC, effective March 14, 2025 (SPL set e2c4a5ac-2df2-4cf4-a2d3-6fbe2d898ebc), via openFDA; the full label on DailyMed
What do FAERS reports show for gadoterate?
The FDA Adverse Event Reporting System holds 3,653 reports that list gadoterate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 72 are coded as a death and 911 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other gadolinium-based contrast agents
- the pharmacologic class, with prices and generics
- Gadoterate side effects
- the label's list beside FAERS reports
- Gadoterate shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other