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Omniscan Side Effects, and Drug Interactions - Gadodiamide

Omniscan Side Effects, and Drug Interactions - Gadodiamide

SIDE EFFECTS

The most frequent adverse events observed during OMNISCAN clinical trials were nausea, headache, and dizziness that occurred in 3% or less of the patients; other adverse events that occurred in 1% or less of the patients are listed below. This includes all reported adverse events regardless of attribution. The majority of these adverse events were of mild to moderate intensity. Dose and adverse event relationships are not fully clarified.

The following adverse events occurred in 1% or less of the patients:

Application Site Disorders: Injection site reaction.

Autonomic Nervous System Disorders: Vasodilation.

Body as a Whole-General Disorders: Anaphylactoid reactions (characterized by cardiovascular, respiratory, and cutaneous symptoms), asthenia, chest pain, fatigue, fever, hot flushes, malaise, pain, rigors, syncope.

Cardiovascular Disorders: Cardiac failure, rare arrhythmia and myocardial infarction resulting in death in patients with ischemic heart disease, flushing, deep thrombophlebitis.

Central and Peripheral Nervous System Disorders: Aggravated migraine, ataxia, convulsions (including grand mal), abnormal coordination, aggravated multiple sclerosis (characterized by sensory and motor disturbances), paresthesia, tremor.

Gastrointestinal System Disorders: Abdominal pain, diarrhea, eructation, melena, dry mouth, vomiting.

Hearing and Vestibular Disorders: Tinnitus.

Liver and Biliary System Disorders: Abnormal hepatic function.

Musculoskeletal System Disorders: Arthralgia, myalgia.

Psychiatric Disorders: Anorexia, anxiety, personality disorder, somnolence.

Respiratory System Disorders: Rhinitis, dyspnea.

Skin and Appendage Disorders: Pruritus, rash, erythematous rash, skin discoloration, sweating increased, urticaria.

Special Senses, Other Disorders: Taste loss, taste perversion.

Urinary System Disorders: Acute reversible renal failure.

Vision Disorders: Abnormal vision.

DRUG INTERACTIONS

LABORATORY TEST FINDINGS

Asymptomatic, transitory changes in serum iron have been observed. The clinical significance is unknown.

Omniscan interferes with serum calcium measurements with some colorimetric (complexometric) methods commonly used in hospitals, resulting in serum calcium concentrations lower than the true values. Thus, it is recommended not to use such methods for 12-24 hours after administration of Omniscan. If such measurements are necessary, the use of other methods is recommended. All patients in whom this effect was observed remained asymptomatic.

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