Gadoteridol Side Effects

Some side effects of gadoteridol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to gadoteridol: injectable solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking gadoteridol: 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;

• fast, uneven heart rate;

• seizure (convulsions); or

• feeling like you might pass out.

Less serious side effects of gadoteridol may include:

• nausea;

• mild itching;

• unusual or unpleasant taste in your mouth;

• flushing (warmth, redness, or tingly feeling);

• headache, dizziness;

• 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.

For Healthcare Professionals

Applies to gadoteridol: injectable solution

Cardiovascular

Cardiovascular side effects have included prolonged P-R Interval, hypotension, elevated heart rate, A-V nodal rhythm, cardiac arrest, bradycardia, hypertension, and death in association with pre-existing cardiovascular disorders.

Respiratory

Respiratory side effects have included dyspnea, rhinitis, cough, apnea, and wheezing.

Other

Other side effects have included voice alteration; transitory deafness and tinnitus.

Nervous system

Nervous system side effects have included headache, anxiety, dizziness, paresthesia, mental status decline, loss of coordination in arm, staring episodes, seizure, syncope, stupor, tremor, tingling sensation in extremities and digits, and loss of consciousness.

Hypersensitivity

Hypersensitivity side effects have included anaphylactoid reactions rarely resulting in death.

Dermatologic

Dermatologic side effects have included pruritus, rash, macular papular rash, urticaria, hives, itching, sweating, and cyanosis.

Gastrointestinal

Gastrointestinal side effects have included edematous and/or itching tongue, gingivitis dry mouth, loose bowel, vomiting, abdominal cramps, increased salivation, and dysphagia.

General

General side effects have included facial edema, neck rigidity, pain, chest pain, fever, tingling sensation in throat, laryngismus, flushed feeling, vasovagal reaction, and generalized edema.

Genitourinary

Genitourinary side effects have included urinary incontinence.

Local

Local side effects have included pain at injection site and injection site reaction.

Ocular

Ocular side effects have included watery eyes.

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