What the label lists and what reports show
Gadobenate side effects
Gadobenate's FDA label: “The most commonly reported adverse reactions are nausea (1.3%) and headache (1.2%).” FAERS holds 4,380 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 pain (623 reports).
- No generic listed
- Boxed warning
Check it at the source: the gadobenate FDA label on DailyMed (effective March 16, 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 MULTIHANCE?See “What is the most important information I should know about MULTIHANCE?” Allergic reactions. MULTIHANCE 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 MULTIHANCE include: nausea, headache, feeling hot, or burning at the injection site. These are not all the possible side effects of MULTIHANCE. 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 16, 2025 (SPL set f63abe56-46d9-4e32-afb1-f4e22370717d), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most commonly reported adverse reactions are nausea (1.3%) and headache (1.2%).
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Reaction | TABLE 2: ADVERSE REACTIONS REPORTED IN ≥ 0.5% OF ADULT SUBJECTS WHO RECEIVED MULTIHANCE… |
|---|---|
| Number of subjects dosed | 4967 |
| Number of subjects with any adverse reaction | 517 (10.4%) |
| Nausea | 67 (1.3%) |
| Injection Site Reaction | 54 (1.1%) |
| Feeling Hot | 49 (1.0%) |
| Headache | 60 (1.2%) |
| Dysgeusia | 33 (0.7%) |
| Paresthesia | 24 (0.5%) |
| Dizziness | 24 (0.5%) |
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 adverse reactions are discussed in greater detail in other sections of the label: Nephrogenic systemic fibrosis [see Warnings and Precautions (5.2) ] Hypersensitivity reactions [see Warnings and Precautions (5.3) ] The most commonly reported adverse reactions are nausea (1.3%) and headache (1.2%). (6) 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. Adults In clinical trials with MultiHance, a total of 4967 adult subjects (137 healthy volunteers and 4830 patients) received MultiHance at doses ranging from 0.005 to 0.4 mmol/kg. There were 2838 (57%) men and 2129 (43%) women with a mean age of 56.5 years (range 18 to 93 years). A total of 4403 (89%) subjects were Caucasian, 134 (3%) Black, 275 (6%) Asian, 40 (1%) Hispanic, 70 (1%) in other racial groups, and for 45 (1%) subjects, race was not reported. The most commonly reported adverse reactions in adult subjects who received MultiHance were nausea (1.3%) and headache (1.2%). Most adverse reactions were mild to moderate in intensity. …
Source: FDA drug label, BRACCO DIAGNOSTICS INC, effective March 16, 2025 (SPL set f63abe56-46d9-4e32-afb1-f4e22370717d), via openFDA; the full label on DailyMed
What do FAERS reports show?
4,380 reports list gadobenate among the medicines taken, each a report of something that happened, not proof the medicine caused it; 206 are coded as a death and 775 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, 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?
- Gadobenate: 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