Gadavist




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 Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Gadavist in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects of gadobutrol may occur up to several days after injection.

Call your doctor at once if you have a serious side effect such as:

  • urinating less than usual or not at all;
  • drowsiness, confusion, mood changes, increased thirst, loss of appetite;
  • swelling, weight gain, feeling short of breath;
  • seizure (convulsions);
  • breathing problems;
  • pounding heartbeats or fluttering in your chest; or
  • severe pain, burning, or irritation around the IV needle.

Less serious side effects may include:

  • headache, dizziness;
  • dry mouth, nausea, vomiting;
  • feeling unusually hot;
  • unusual or unpleasant taste in your mouth;
  • numbness or tingly feeling;
  • mild itching or rash; or
  • cold feeling, warmth, pain, or burning where the medicine was injected.

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.

Read the entire detailed patient monograph for Gadavist (gadobutrol)

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
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in labeling:

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 adverse reactions described in this section reflect Gadavist exposure in 6,330 subjects (including 184 pediatric patients, ages 0 to 17 years) with the majority receiving the recommended dose. Approximately 50% of the subjects were male and the ethnic distribution was 60% Caucasian, 30% Asian, 6% Hispanic, 2% Black, and 3% patients of other ethnic groups. The average age was 55 years (range from1 week to 93 years).

Overall, approximately 4% of subjects reported one or more adverse reactions during a follow-up period that ranged from 24 hours to 7 days after Gadavist administration.

Adverse reactions associated with the use of Gadavist were usually mild to moderate in severity and transient in nature.

Table 2 lists adverse reactions that occurred in ≥ 0.1% subjects who received Gadavist.

Table 2: Adverse Reactions

Reaction Rate (%)
n=6330
Headache 1.5
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
Pruritus (includes generalized) 0.2
Erythema 0.2
Hypersensitivity/Anaphylactoid* 0.1
Dyspnea 0.1
Paresthesia 0.1
*Hypersensitivity/anaphylactoid reaction may occur with one or more of the following adverse reactions: for example, hypotension, urticaria, face edema, eyelid edema, flushing

Adverse reactions that occurred with a frequency of < 0.1% in subjects who received Gadavist include: loss of consciousness, convulsion, parosmia, tachycardia, palpitation, dry mouth, malaise and feeling cold.

Postmarketing Experience

The following additional adverse reactions have been reported during postmarketing use of Gadavist. 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.

Read the entire FDA prescribing information for Gadavist (gadobutrol)

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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.


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