Magnevist Side Effects

Please note - some side effects for Magnevist may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Magnevist - for the Consumer

Magnevist

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Magnevist:

Dizziness; headache; minor pain, swelling, coldness, or redness at the injection site; nausea.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in vision; fast or irregular heartbeat; muscle weakness; numbness in an arm or leg; pain, redness, or swelling of the skin; severe stomach pain; sharp or crushing chest pain; skin lesions; sudden leg pain; sudden severe headache; sudden shortness of breath; tightness or thickening of the skin.

Magnevist Side Effects - for the Professional

Magnevist

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.

OVERDOSAGE

Systemic consequences associated with overdosage of Magnevist Injection have not been reported.

Side Effects by Body System

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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