Gadoversetamide

1-10%

Headache (9.4%)

Vasodilation (6.4%)

Dizziness (3.7%)

Nausea (3.2%)

Paresthesia (2.2%)

Diarrhea (1.9%)

Abdominal pain (1.8%)

Rhinitis (2%)

Injection site reaction (2%)

Back pain (1%)

Dyspepsia (1%)

<1%

Seizures

Amblyopia

Anorexia

Cough

Diplopia

Dry skin

Dystonia

Flatulence

Hyponatremia

Neck pain

Pallor

Parosmia

Rash

Seizure

Postmarketing Reports

Seizures

Nephrogenic systemic fibrosis

Hypersensitivity reactions including bronchospasm and laryngeal/pharyngeal edema

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

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; or
• fast, uneven heart rate.

Less serious side effects may include:

• headache, dizziness;
• nausea, diarrhea;
• flushing (warmth, redness, or tingly feeling);
• unusual or unpleasant taste in your mouth;
• numbness, burning pain, or tingling in your hands or feet; or
• cold feeling, warmth, pain, bruising, swelling, 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.

Gadoversetamide can cause a life-threatening condition in people with advanced kidney disease. The symptoms of this condition include:

• 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.

Before receiving this medication, tell your doctor if you have kidney disease or if you are on dialysis. You may not be able to receive gadoversetamide. Also tell your doctor if you have recently received any contrast agents similar to gadoversetamide.

To make sure you can safely receive this medication, tell your doctor if you have any of these other conditions:

• diabetes;

• high blood pressure;

• liver disease (or liver transplant);

• a heart rhythm disorder;

• anemia or other red blood cell disorder;

• a history of seizures (convulsions);

• a personal or family history of Long QT Syndrome;

• asthma, hay fever, or a history of food or drug allergies;

• if you are over 60 years old;

• if you have ever had any type of reaction to a contrast agent; or

• if you have recently had an injury, surgery, or severe infection.

FDA pregnancy category C. It is not known whether gadoversetamide will harm an unborn baby. Before you receive this medication, tell your doctor if you are pregnant.

It is not known whether gadoversetamide passes into breast milk or if it could harm a nursing baby. Do not breast-feed for at least 72 hours after receiving gadoversetamide. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby.

• If you have an allergy to gadolinium, versetamide, or any other part of gadoversetamide.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have kidney problems.
• If you are breast-feeding. Do not breast-feed for at least 72 hours after getting this medicine.

This is not a list of all drugs or health problems that interact with gadoversetamide.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Very bad dizziness or passing out.
• Flushing.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Applies to gadoversetamide: intravenous solution

Data not available

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Substance Name

Gadoversetamide

CAS Registry Number

131069-91-5

Drug Class

Contrast Media

Diagnostic Agents