What the label lists and what reports show
Gadoteridol side effects
Gadoteridol's FDA label: “The most commonly reported adverse reactions are nausea and taste perversion with an incidence ≥ 0.9% ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, Contact Bracco Diagnostics Inc.” FAERS holds 1,795 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 nephrogenic systemic fibrosis (585 reports).
- Generic listed
- Boxed warning
Check it at the source: the gadoteridol FDA label on DailyMed (effective March 14, 2025, Bracco Diagnostics Inc); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of PROHANCE?See “What is the most important information I should know about PROHANCE?” Allergic reactions. PROHANCE 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 PROHANCE include: nausea, distortion of the sense of taste, and headache. These are not all the possible side effects of PROHANCE. 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, Bracco Diagnostics Inc, effective March 14, 2025 (SPL set e8b76200-c0aa-491b-aad7-e22d2f68496f), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most commonly reported adverse reactions are nausea and taste perversion with an incidence ≥ 0.9% ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, Contact Bracco Diagnostics Inc.
Table 2 lists adverse reactions that occurred in ≥ 0.4% subjects who received ProHance.
| Reaction | Table 2: More frequent adverse reactions in clinical trials Rate (%) N = 3174 |
|---|---|
| Nausea | 1.4% |
| Dysgeusia | 0.9% |
| Headache | 0.7% |
| Dizziness | 0.4% |
| Urticaria | 0.4% |
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 serious adverse reactions are discussed in greater detail in other sections of the prescribing information: Nephrogenic systemic fibrosis [see Boxed Warning and Warnings and Precautions ( 5.2 )] Hypersensitivity reactions [see Contraindications ( 4 ) and Warnings and Precautions ( 5.3 )] The most commonly reported adverse reactions are nausea and taste perversion with an incidence ≥ 0.9% ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, Contact Bracco Diagnostics Inc. at 1-800-257-5181 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 practice. The adverse events described in this section were observed in clinical trials involving 3174 subjects (including 2896 adults and 278 pediatric subjects ages 0 to 17 years) exposed to ProHance. Approximately 48% of the subjects were men and ethnic distribution was 78% Caucasian, 6% Black, 3% Hispanic, 6% Asian, and 2% other. In 5% of the subjects, race was not reported. Average age was 47 years (range from 1 day to 91 years) and the exposure ranged from 0.03 to 0.3 mmol/kg. …
Source: FDA drug label, Bracco Diagnostics Inc, effective March 14, 2025 (SPL set e8b76200-c0aa-491b-aad7-e22d2f68496f), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,795 reports list gadoteridol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 160 are coded as a death and 374 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 25 reactions below, 9 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?
- Gadoteridol: 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