- Clinician Information:
Gadavist Side Effects Center
Medical Editor: William C. Shiel Jr., MD, FACP, FACR
Gadavist (gadobutrol) is a contrast agent used with magnetic resonance imaging (MRI) in adults and children over two years of age. When used with MRI, Gadavist is used to detect and view disrupted areas of the brain and abnormal activity of the central nervous system.
Gadavist increases the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired kidney or liver function and, as a result, poor metabolism of drugs. Though rare, adverse reactions observed with use of Gadavist included headache, nausea, malaise, dizziness, abnormal taste, and feeling hot. There are no known drug interactions, but it is advised that Gadavist not be used with other drugs. Inform your doctor if you have a history of kidney disease or liver disease; have recently received a contrast agent, or are pregnant or breastfeeding.
Gadavist (gadobutrol) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Gadavist FDA Prescribing Information: Side Effects
The most serious reactions to Gadavist (gadobutrol) are nephrogenic systemic fibrosis and hypersensitivity reactions [see WARNINGS AND PRECAUTIONS].
Clinical Trial 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 Gadavist (gadobutrol) exposure in 4549 subjects (4411 adults and 138 children aged 2-17) who received a dose that ranged from < 0.09 to 0.51 mmol/kg body weight; the majority (n=2434) received the recommended dose of 0.1 (±0.01) mmol/kg body weight. Overall, 58.5% of the subjects were men and the ethnic distribution was 64.8% Caucasian, 27.3% Asian, 3% Hispanic, 1.3% Black, and 3.6% patients of other ethnic groups. The average age was 54.2 years (range from 2 to 93 years).
Overall, 4% of subjects reported one or more adverse reactions during a follow-up period that ranged from 24 hours to 7 days after Gadavist (gadobutrol) administration.
Adverse reactions associated with the use of Gadavist (gadobutrol) are usually mild to moderate in severity and transient in nature. Table 1 lists adverse reactions that occurred in ≥ 0.1% subjects who received Gadavist (gadobutrol) .
Table 1: Adverse Reactions
|Reaction|| Rate (%)
|Injection site reactions||0.6|
|Rash (includes generalized, macular, papular, pruritic)||0.3|
|Pruritus (includes generalized)||0.2|
Adverse reactions that occurred with a frequency of < 0.1% in subjects who received Gadavist (gadobutrol) include: hypersensitivity/anaphylactoid reactions (hypotension, urticaria, flushing, pallor), loss of consciousness, convulsion, parosmia, tachycardia, palpitation, dry mouth, malaise and feeling cold.
The following additional adverse reactions have been reported during postmarketing use of Gadavist (gadobutrol) . Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Cardiac arrest
- Nephrogenic Systemic Fibrosis (NSF)
- Hypersensitiviry/anaphylactoid reactions (anaphylactoid shock, circulatory collapse, blood pressure increased, chest pain, respiratory arrest, bronchospasm, cyanosis, oropharyngeal swelling, laryngeal edema, face edema, angioedema, conjunctivitis, eyelid edema, hyperhidrosis, cough, sneezing, and burning sensation) [see WARNINGS AND PRECAUTIONS]
Read the entire FDA prescribing information for Gadavist (gadobutrol) »
Additional Gadavist Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.