Gadopentetate dimeglumine Side Effects

Some side effects of gadopentetate dimeglumine 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 gadopentetate dimeglumine: injectable solution

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

Tell your caregivers 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

• swelling, bruising, redness, itching, burning, or skin changes where the injection was given.

Less serious side effects of gadopentetate dimeglumine may include:

• headache, dizziness;

• nausea;

• feeling unusually hot;

• unusual or unpleasant taste in your mouth;

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

• numbness; 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.

For Healthcare Professionals

Applies to gadopentetate dimeglumine: injectable solution

Cardiovascular

Cardiovascular side effects have included hypotension, hypertension, arrhythmia, tachycardia, syncope, vasodilation, pallor, nonspecific ECG changes, angina pectoris, death related to myocardial infarction, phlebitis, thrombophlebitis, deep venous thrombophlebitis, and compartment syndrome requiring surgery.

Gastrointestinal

Gastrointestinal side effects have included gastrointestinal distress, stomach pain, increased salivation, abdominal pain, vomiting, constipation, thirst, anorexia, dry mouth, and diarrhea.

Nervous system

Nervous system side effects have included agitation, anxiety, migraine, nystagmus, drowsiness, stupor, paresthesia, and convulsions.

Ocular

Ocular side effects have included diplopia, conjunctivitis, visual field defect, lacrimation disorder, eye irritation, and eye pain.

Respiratory

Respiratory side effects have included throat irritation, rhinorrhea, sneezing, dyspnea, wheezing, laryngismus, cough, and respiratory complaints.

Dermatologic

Dermatologic side effects have included rash, sweating, pruritus, urticaria, facial edema, erythema multiforme, epidural necrolysis, and pustules.

Local

Local side effects have included pain, localized warmth, and burning sensation at the injection site.

Hypersensitivity

Hypersensitivity side effects have included substernal chest pain, back pain, fever, weakness, generalized coldness, generalized warmth, localized edema, tiredness, chest tightness, trembling, shivering, tension in the extremities, regional lymphangitis, pelvis pain, and anaphylactoid reactions.

Other

Other side effects have included tinnitus and taste abnormalities.

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