Applies to gadoteridol: intravenous solution.

Serious side effects of Gadoteridol

Along with its needed effects, gadoteridol may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking gadoteridol:

Rare

• Absence of or decrease in body movement
• arm, back, or jaw pain
• bluish color of the fingernails, lips, skin, palms, or nail beds
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain, discomfort, or tightness
• confusion
• cough
• decreased awareness or responsiveness
• difficult or labored breathing
• difficulty swallowing
• dizziness, fainting, or lightheadedness when getting up suddenly from a lying or sitting position
• false feeling of insects crawling on the skin
• fast, irregular, pounding, or racing heartbeat or pulse
• feeling of warmth
• fever
• general feeling of discomfort or illness
• headache, severe and throbbing
• hives, itching, skin rash
• hoarseness
• increased salivation
• loss of bladder control
• loss of consciousness
• low blood pressure or pulse
• nausea
• nervousness
• pounding in the ears
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness of the face, neck, arms, and occasionally, upper chest
• seizures
• shakiness in the legs, arms, hands, or feet
• slow, fast, or irregular breathing
• spasm of the throat
• sweating
• trembling or shaking of the hands or feet
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Incidence not known

• Agitation
• burning, dry, or itching eyes
• coughing that sometimes produces a pink frothy sputum
• decreased or uncontrolled urination
• difficult, fast, noisy breathing
• discharge, excessive tearing
• incoordination
• lack or loss of strength
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• muscle weakness
• numbness, tingling, pain, or weakness in the hands or feet
• paralysis or severe weakness of the legs
• slow heartbeat
• skin lesions (plaques)
• stiffness of the arms or legs
• swelling in the legs and ankles
• uncontrolled bowel movements
• uncontrolled movements of the body

Other side effects of Gadoteridol

Some side effects of gadoteridol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Rare

• Anxiety
• bad, unusual, or unpleasant (after) taste
• bleeding gums
• bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• continuing ringing or buzzing or other unexplained noise in the ears
• diarrhea
• dry mouth
• ear discomfort
• hearing loss
• irritation in the mouth
• loss of coordination in the arms
• mouth ulcers
• rash with flat lesions or small raised lesions on the skin
• redness and swelling of the gums
• runny or stuffy nose
• sneezing
• stomach cramps
• tingling sensation in the throat
• voice changes
• vomiting
• watery eyes

For Healthcare Professionals

Applies to gadoteridol: intravenous 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.^[Ref]

Respiratory

Respiratory side effects have included dyspnea, rhinitis, cough, apnea, and wheezing.^[Ref]

Other

Other side effects have included voice alteration; transitory deafness and tinnitus.^[Ref]

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.^[Ref]

Hypersensitivity

Hypersensitivity side effects have included anaphylactoid reactions rarely resulting in death.^[Ref]

Dermatologic

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

Gastrointestinal

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

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.^[Ref]

Genitourinary

Genitourinary side effects have included urinary incontinence.^[Ref]

Local

Local side effects have included pain at injection site and injection site reaction.^[Ref]

Ocular

Ocular side effects have included watery eyes.