What the label lists and what reports show
Gadoterate side effects
Gadoterate's FDA label: “The most frequently reported adverse reaction was headache (1.1%).” FAERS holds 3,653 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is urticaria (648 reports).
- 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 FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are possible side effects of DOTAREM?See What is the most important information I should know about DOTAREM? Allergic reactions. DOTAREM can cause allergic reactions that can sometimes be serious. Your healthcare provider will monitor you closely for symptoms of an allergic reaction. The most common side effects of DOTAREM include: nausea, headache, pain, or cold feeling at the injection site, and rash. These are not all the possible side effects of DOTAREM. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Source: FDA drug label, Guerbet LLC, effective March 14, 2025 (SPL set e2c4a5ac-2df2-4cf4-a2d3-6fbe2d898ebc), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most frequently reported adverse reaction was headache (1.1%).
Table 2: Adverse Reactions in Clinical Trials
| Reaction | Rate (%) n=2867 |
|---|---|
| Nausea | 0.6% |
| Headache | 0.4% |
| Injection Site Pain | 0.4% |
| Injection Site Coldness | 0.2% |
| Rash | 0.2% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe 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. …
Source: FDA drug label, 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?
3,653 reports list gadoterate among the medicines taken, 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. Of the 24 reactions below, 14 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Gadoterate: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions