Omniscan Side Effects

Generic name: gadodiamide

Note: This document contains side effect information about gadodiamide. Some of the dosage forms listed on this page may not apply to the brand name Omniscan.

Some side effects of Omniscan 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 gadodiamide: injectable solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking gadodiamide (the active ingredient contained in Omniscan) 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;

• seizure (convulsions);

• fast, slow, or uneven heart rate; or

• chest pain or heavy feeling, pain spreading to the arm or shoulder, sweating, general ill feeling.

Less serious side effects of gadodiamide may include:

• headache, dizziness;

• nausea, vomiting;

• unusual or unpleasant taste in your mouth;

• mild itching;

• fever, feeling unusually hot;

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

• numbness; 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 gadodiamide: injectable solution

Cardiovascular

Cardiovascular side effects have included cardiac failure, arrhythmia and myocardial infarction. Also reported include vasodilation, flushing, chest pain, deep thrombophlebitis, and rarely, arrhythmia and myocardial infarction resulting in death in patients with ischemic heart disease.

Nervous system

Nervous system side effects have included headache, tinnitus, taste loss, taste perversion, and dizziness. Convulsions including grand mal, ataxia, abnormal coordination, paresthesia, tremor, aggravated multiple sclerosis (characterized by sensory and motor disturbances), and aggravated migraine have been reported.

Gastrointestinal

Gastrointestinal side effects have included nausea, abdominal pain, diarrhea, eructation, dry mouth, vomiting, and melena.

Hypersensitivity

Hypersensitivity side effects have included anaphylactoid reactions (characterized by cardiovascular, respiratory, and cutaneous symptoms).

General

General side effects have included fever, hot flushes, rigors, fatigue, malaise, pain, and syncope.

Hepatic

Hepatic side effects have included abnormal hepatic function.

Respiratory

Respiratory side effects have included rhinitis and dyspnea.

Ocular

Ocular side effects have included abnormal vision.

Renal

Renal side effects have included acute reversible renal failure.

Musculoskeletal

Musculoskeletal side effects have included arthralgia and myalgia.

Dermatologic

Dermatologic side effects have included pruritus, rash, erythematous rash, increased sweating, and urticaria.

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