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.

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; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Magnevist:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); changes in vision; fainting; fast or irregular heartbeat; fever or chills; joint stiffness; muscle weakness; numbness in an arm or leg; red or dark patches, pain, burning, or swelling of the skin; scaling, hardening, or tightening of the skin; seizures; severe stomach pain; sharp or crushing chest pain; skin lesions; sudden leg pain; sudden, severe headache; sudden shortness of breath; tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Magnevist Side Effects - for the Professional

Magnevist

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The mean age of the 1272 patients who received Magnevist Injection in pre-market 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 adverse reaction was headache (4.8%). The majority of headaches were transient and of mild to moderate severity. Other adverse reactions that occurred in ≥ 1% of patients included: nausea (2.7%), injection site coldness/localized coldness (2.3%) and dizziness (1%).

The following additional adverse reactions occurred in less than 1% of the patients:

General Disorders: Injection site symptoms, namely, pain, localized warmth, and burning sensation; substernal chest pain, back pain, pyrexia, asthenia, feeling cold, generalized warmth, localized edema, fatigue, and chest tightness, and anaphylactoid reactions characterized by cardiovascular, respiratory and/or cutaneous symptoms.

Cardiovascular: Hypotension, hypertension, tachycardia, migraine, syncope, vasodilatation, pallor, angina pectoris, phlebitis.

Digestive: Abdominal discomfort, teeth pain, increased salivation, abdominal pain, vomiting, constipation, diarrhea.

Nervous System: Agitation, anxiety, thirst, anorexia, nystagmus, somnolence, diplopia, loss of consciousness, convulsions (including grand mal), paresthesia.

Respiratory System: Throat irritation, rhinitis, sneezing, dyspnea, bronchospasm, cough.

Skin: Rash, sweating (hyperhidrosis), pruritus, urticaria (hives), facial edema, epidermal necrolysis.

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

Postmarketing Experience

The following additional adverse reactions have been identified during postmarketing use of Magnevist. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The most serious reactions were nephrogenic systemic fibrosis and acute reactions including cardiac or respiratory arrest, anaphylactic shock, shock, respiratory distress, and laryngeal edema. The most frequently reported adverse reactions in the postmarketing experience were nausea, vomiting, urticaria and rash.

General Disorders and Administration Site Conditions: Nephrogenic systemic fibrosis, body temperature decreased, tremor, shivering (chills), regional lymphangitis (lymphangitis), pelvic pain.

Hypersensitivity Reactions: Fatal cardiac or respiratory arrest, respiratory distress, cyanosis, laryngeal edema, laryngospasm, pharyngeal edema, angioedema, and anaphylactoid reactions characterized by cardiovascular, respiratory and/or cutaneous symptoms, rarely resulting in death..

Cardiac Disorders: Cardiac arrest, heart rate decreased, arrhythmia, non-specific ECG changes, death related to myocardial infarction or other undetermined causes.

Renal and Urinary Disorders: Acute renal failure, increased serum creatinine in patients with renal insufficiency urinary incontinence, urinary urgency.

Ear and Labyrinth Disorders: Hearing impaired.

Eye Disorders: Visual disturbance.

Musculoskeletal and Connective Tissue Disorder: Arthralgia.

Nervous System Disorders: Coma, parosmia, speech disorder.

Respiratory System: Respiratory arrest, pulmonary edema.

Vascular Disorders: Thrombophlebitis, deep vein thrombophlebitis, compartment syndrome requiring surgical intervention.

Skin Disorders: Erythema multiforme, pustules (rash pustular).

OVERDOSAGE

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

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Side Effects by Body System - for Healthcare Professionals

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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