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Gadavist

Last reviewed on RxList: 9/14/2020
Gadavist Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Gadavist?

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.

What Are Side Effects of Gadavist?

Side effects of Gadavist are uncommon but may include:

  • headache,
  • nausea,
  • vomiting,
  • feeling unwell (malaise),
  • dizziness,
  • abnormal or unpleasant taste in your mouth,
  • feeling hot,
  • numbness or tingly feeling,
  • itching or rash,
  • skin redness, or
  • injection site reactions (cold feeling, warmth, pain, or burning).

Tell your doctor if you have serious side effects of Gadavist including:

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

Dosage for Gadavist?

The recommended dose of Gadavist for adult and pediatric patients (including term neonates) is 0.1 mL/kg body weight (0.1 mmol/kg).

What Drugs, Substances, or Supplements Interact with Gadavist?

Gadavist may interact with other medicines that may harm the kidneys including lithium, methotrexate, pain or arthritis medicines, medicines used to treat ulcerative colitis, medicines used to prevent organ transplant rejection, IV antibiotics, antiviral medicines, or cancer medicines. Tell your doctor all medications and supplements you use.

Gadavist During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Gadavist; it is unknown how it would affect a fetus. It is unknown if Gadavist passes into breast milk. Similar drugs (GBCAs) may be present in breast milk. Consider interrupting breastfeeding and pumping and discarding breast milk up to18 hours after Gadavist administration in order to minimize exposure to a breastfed infant.

Additional Information

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.

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Gadavist Consumer Information

Get emergency medical help if you have 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.

Gadobutrol can cause a life-threatening condition in people with advanced kidney disease. Call your doctor right away if you have any symptoms of this condition, such as:

  • burning, itching, swelling, scaling, and tightening or hardening of your skin;
  • muscle weakness;
  • joint stiffness in your arms, hands, legs, or feet;
  • deep bone pain in your ribs or your hips;
  • trouble moving; or
  • skin redness or discoloration.

Also call your doctor at once if you have:

  • kidney problems--little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath.

Common side effects may include:

  • headache;
  • nausea; or
  • dizziness.

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)

Gadavist Professional Information

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 6,809 subjects (including 184 pediatric patients, ages 0 to 17 years) with the majority receiving the recommended dose. Approximately 51% of the subjects were male and the ethnic distribution was 61% Caucasian, 29% Asian, 5% Hispanic, 2% Black, and 3% patients of other ethnic groups. The average age was 56 years (range from 1 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=6809
Headache 1.5
Nausea 1.1
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.

  • Cardiac arrest
  • Nephrogenic Systemic Fibrosis (NSF)
  • Hypersensitivity reactions (anaphylactic shock, circulatory collapse, respiratory arrest, pulmonary edema, bronchospasm, cyanosis, oropharyngeal swelling, laryngeal edema, blood pressure increased, chest pain, angioedema, conjunctivitis, hyperhidrosis, cough, sneezing, burning sensation, and pallor) [see WARNINGS AND PRECAUTIONS].
  • General Disorders and Administration Site Conditions: Adverse events with variable onset and duration have been reported after GBCA administration [see WARNINGS AND PRECAUTIONS]. These include fatigue, asthenia, pain syndromes, and heterogeneous clusters of symptoms in the neurological, cutaneous, and musculoskeletal systems.
  • Skin: Gadolinium associated plaques

Read the entire FDA prescribing information for Gadavist (gadobutrol)

Related Resources for Gadavist

© Gadavist Patient Information is supplied by Cerner Multum, Inc. and Gadavist Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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