What the label lists and what reports show
Gadobutrol side effects
Gadobutrol's FDA label: “Most common adverse reactions (incidence ≥ 0.5%) are headache, nausea, and dizziness ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals Inc.” FAERS holds 4,851 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 (1,178 reports).
- Generic listed
- A presentation discontinued
- Boxed warning
Check it at the source: the gadobutrol FDA label on DailyMed (effective May 1, 2026, Bayer HealthCare Pharmaceuticals 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 GADAVIST?See " What is the most important information I should know about GADAVIST? " Allergic reactions. GADAVIST can cause allergic reactions that can sometimes be serious. Your healthcare provider will monitor you closely for symptoms of an allergic reaction. A serious lung problem called acute respiratory distress syndrome (ARDS). Call your healthcare provider right away if you have shortness of breath with or without a fever, trouble breathing, or a fast rate of breathing after receiving GADAVIST. The most common side effects of GADAVIST include: headache, nausea, and dizziness. These are not all the possible side effects of GADAVIST. 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, Bayer HealthCare Pharmaceuticals Inc., effective May 1, 2026 (SPL set bd28560f-de4d-4140-874e-31df823f4dbb), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥ 0.5%) are headache, nausea, and dizziness ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals Inc.
Table 2: Adverse Reactions Reported in ≥0.1% Subjects who Received GADAVIST in Clinical Trials
| Adverse Reaction | GADAVIST n=7,713 Rate (%) |
|---|---|
| Headache | 1.7 |
| Nausea | 1.2 |
| Dizziness | 0.5 |
| Dysgeusia | 0.4 |
| Feeling Hot | 0.4 |
| Injection site reactions | 0.4 |
| Vomiting | 0.4 |
| Rash (includes generalized, macular, papular, pruritic) | 0.3 |
| Erythema | 0.2 |
| Paresthesia | 0.2 |
| Pruritus (includes generalized) | 0.2 |
| Dyspnea | 0.1 |
| Urticaria | 0.1 |
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 discussed elsewhere in labeling: Nephrogenic Systemic Fibrosis [see Warnings and Precautions (5.2) ] Hypersensitivity reactions [see Contraindications (4) and Warnings and Precautions (5.3) ] Acute Respiratory Distress Syndrome [see Warnings and Precautions (5.4) ] Most common adverse reactions (incidence ≥ 0.5%) are headache, nausea, and dizziness ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals Inc. at 1-888-842-2937 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 safety of GADAVIST was evaluated in 7,713 subjects (including 184 pediatric population, ages 0 to 17 years) who received GADAVIST in clinical trials. Approximately 52% of the subjects were male and the racial and ethnic distribution was 62% White, 28% Asian, 5% Hispanic or Latino, 2.5% Black or African American, and 2.5% other ethnic groups. The average age was 56 years (range from 1 week to 93 years). Table 2 lists adverse reactions that occurred in ≥ 0.1% subjects who received GADAVIST.
Source: FDA drug label, Bayer HealthCare Pharmaceuticals Inc., effective May 1, 2026 (SPL set bd28560f-de4d-4140-874e-31df823f4dbb), via openFDA; the full label on DailyMed
What do FAERS reports show?
4,851 reports list gadobutrol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 187 are coded as a death and 717 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, 15 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?
- Gadobutrol: 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