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Magnevist

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Magnevist

Magnevist Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Magnevist (gadopentetate dimeglumine) Injection is used to help diagnose certain disorders of the heart, brain, blood vessels, and spinal tissues. It is a contrast agent that is used in combination with magnetic resonance imaging (MRI) to allow blood vessels, organs, and other non-bony tissues to be seen more clearly on the MRI. Common side effects include headache, dizziness, anxiety, nausea, vomiting, loss of appetite, increased thirst, chills, numbness or tingly feeling, cold feeling, warmth, pain, or burning where the injection was given, stuffy nose, or sore throat.

The recommended dosage of Magnevist Injection is 0.2 mL/kg (0.1 mmol/kg) administered intravenously, at a rate not to exceed 10 mL per 15 seconds. Other drugs may interact with Magnevist. Tell your doctor all medications and supplements you use. During pregnancy, Magnevist should be used only if prescribed. This drug can pass into breast milk and may harm a nursing baby. Consult your doctor before breastfeeding.

Our Magnevist (gadopentetate dimeglumine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Magnevist in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers 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; or
  • swelling, bruising, redness, itching, burning, or skin changes where the injection was given.

Less serious side effects may include:

  • headache, dizziness;
  • nausea;
  • feeling unusually hot;
  • unusual or unpleasant taste in your mouth;
  • flushing (warmth, redness, or tingly feeling);
  • numbness; or
  • cold feeling, warmth, pain, 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Magnevist (Gadopentetate Dimeglumine) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Magnevist FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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 reactions, including phlebitis, pain, localized warmth, localized edema, and burning sensation; substernal chest pain, back pain, pyrexia, asthenia, feeling cold, generalized warmth, fatigue, and chest tightness, and anaphylactoid reactions characterized by cardiovascular, respiratory and/or cutaneous symptoms, such as dyspnea, bronchospasm, and cough. (See WARNINGS AND PRECAUTIONS.)

Cardiovascular: Hypotension, hypertension, tachycardia, migraine, syncope, vasodilatation, pallor.

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

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

Respiratory System: Throat irritation, rhinitis, sneezing.

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

Special Senses: Conjunctivitis, 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 (see BOXED WARNING) and acute reactions including cardiac or respiratory arrest, anaphylactic shock, shock, respiratory distress, and laryngeal edema. Life threatening and/or fatal adverse reactions have been reported. 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 (see WARNINGS AND PRECAUTIONS), body temperature decreased, tremor, shivering (chills).

Hypersensitivity Reactions: Anaphylactic/anaphylactoid reactions that may be fatal and include cardiac or respiratory arrest, respiratory distress, cyanosis, laryngeal edema, laryngospasm, pharyngeal edema, and angioedema (see WARNINGS AND PRECAUTIONS).

Delayed hypersensitivity reactions have been reported up to several hours after administration of Magnevist.

Renal and Urinary: Acute renal failure, worsening renal impairment (see WARNINGS AND PRECAUTIONS), urinary incontinence, urinary urgency.

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

Cardiac: Cardiac arrest, heart rate decreased, arrhythmia.

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.

Skin: Erythema multiforme, pustules (rash pustular).

Read the entire FDA prescribing information for Magnevist (Gadopentetate Dimeglumine) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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