The mean age of the 1272 patients who received MAGNEVIST Injection in clinical trials was 46.4 years (range 2 to 93 years). Of these patients, 55% (700) were male and 45% (572) were female. Of the 1271 patients who received MAGNEVIST Injection and for whom race was reported, 82.1% (1043) were Caucasian, 9.7% (123) were Black, 5.3% (67) were Hispanic, 2.1% (27) were Oriental/ Asian, and 0.9% (11) were other. The most common noted adverse event is headache with an incidence of 4.8%. The majority of headaches are transient and of mild to moderate severity. Nausea is the second most common adverse experience at 2.7%. Injection site coldness/localized coldness is the third most common adverse experience at 2.3%. Dizziness occurred in 1% of the patients.

The following additional adverse events occurred in fewer than 1% of the patients:

Body as a Whole: Injection site symptoms, namely, pain, localized warmth, and burning sensation; substernal chest pain, back pain, fever, weakness, generalized coldness, generalized warmth, localized edema, tiredness., chest tightness, trembling, shivering, tension in extremities, regional lymphangitis, pelvic pain, and anaphylactoid reactions (characterized by cardiovascular, respiratory and cutaneous symptoms) rarely resulting in death.

Cardiovascular: Hypotension, hypertension, arrhythmia, tachycardia, migraine, syncope, vasodilation, pallor, non- specific ECG changes, angina pectoris, death related to myocardial infarction or other undetermined causes, phlebitis, thrombophlebitis, deep vein thrombophlebitis, compartment syndrome requiring surgical intervention.

Digestive: Gastrointestinal distress, stomach pain, teeth pain, increased salivation, abdominal pain, vomiting, constipation, diarrhea.

Nervous System: Agitation, anxiety, thirst, anorexia, nystagmus, drowsiness, diplopia, stupor, convulsions (including grand mal), paresthesia.

Respiratory System: Throat irritation, rhinorrhea, sneezing, dyspnea, wheezing, laryngismus, cough, respiratory complaints.

Skin: Rash, sweating, pruritus, urticaria (hives), facial edema, erythema multiforme, epidermal necrolysis, pustules.

Special Senses: Tinnitus, conjunctivitis, visual field defect, taste abnormality, dry mouth, lacrimation disorder (tearing), eye irritation, eye pain, ear pain.

No information provided.

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