Gadoterate Meglumine: uses, dosing, side effects & brands
Gadoterate Meglumine is a medicine sold in the U.S. under 2 brand and generic names. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Available as
- Injectable
- Sold as
- 2 products — Dotarem and Gadoterate Meglumine
- Prescription?
- Prescription only
- Generic available?
- Yes
- Boxed warning
- Boxed warning
How gadoterate meglumine is dosed
From the FDA label for Dotarem (application NDA204781). Other gadoterate meglumine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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. 2.1 Dosing Guidelines For adult and pediatric patients (including term neonates), the recommended dose of DOTAREM 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 - 2 mL/second for pediatric patients. Table 1 provides weight-adjusted dose volumes. Table 1: Volumes of DOTAREM 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 DOTAREM the injection may be followed by normal saline flush. Contrast MRI can begin immediately following DOTAREM injection. 2.2 Drug Handling Visually inspect DOTAREM for particulate matter prior to administration. Do not use the solution if particulate matter is present or if the container appears damaged. DOTAREM should be a clear, colorless to yellow solution. Do not mix…
Gadoterate Meglumine side effects
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 GUERBET LLC at 1-877-729-6679 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 DOTAREM 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 DOTAREM administration. Most adverse…
Who shouldn’t take gadoterate meglumine
History of clinically important hypersensitivity reactions to DOTAREM [see Warnings and Precautions ( 5.2 )]. Clinically important hypersensitivity reactions to DOTAREM.
Gadoterate Meglumine drug interactions
Gadoterate does not interfere with serum and plasma calcium measurements determined by colorimetric assays. Specific drug interaction studies with DOTAREM have not been conducted.
Every gadoterate meglumine product we track (2)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Injectable | No data | — | View → | |
| 2 | Not yet rated | Prescription | Injectable | No data | — | View → |
How long gadoterate meglumine keeps
No gadoterate meglumine label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does gadoterate meglumine expire? The in-use limits and storage rules from its labelsWhat people report to the FDA about gadoterate meglumine
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 157 reports naming gadoterate meglumine, and the FDA flagged 93% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- nausea20 reports
- dyspnoea14 reports
- rash14 reports
- vomiting12 reports
- oedema peripheral11 reports
- pruritus11 reports
- erythema10 reports
- abdominal pain9 reports
Read these as a signal, not a rate. A report does not mean gadoterate meglumine caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is gadoterate meglumine?
DOTAREM (gadoterate meglumine) is a paramagnetic macrocyclic ionic contrast agent administered for magnetic resonance imaging.
Can you take gadoterate meglumine with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run gadoterate meglumine against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is gadoterate meglumine sold under?
We track 2 gadoterate meglumine-containing products in the U.S.: Dotarem and Gadoterate Meglumine. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does gadoterate meglumine come in?
Across the brands we track, gadoterate meglumine is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic gadoterate meglumine?
Yes. Our catalog lists 1 generic gadoterate meglumine product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Gadoterate Meglumine: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/gadoterate-meglumine
- MLA
- “Gadoterate Meglumine: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/gadoterate-meglumine.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for gadoterate meglumine on DailyMed (NIH) ↗ — including its boxed warning in full.