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Magnevist (Gadopentetate Dimeglumine) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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.



REPORTS OF SUSPECTED MAGNEVIST SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Magnevist. The information is not vetted and should not be considered as verified clinical evidence.

Possible Magnevist side effects / adverse reactions in 29 year old female

Reported by a consumer/non-health professional from United States on 2011-10-05

Patient: 29 year old female

Reactions: Pruritus, Urticaria, Rhinorrhoea, Cough

Suspect drug(s):
Magnevist



Possible Magnevist side effects / adverse reactions in 42 year old female

Reported by a physician from United States on 2011-10-05

Patient: 42 year old female

Reactions: Sneezing, Tongue Pruritus, Lacrimation Increased

Suspect drug(s):
Magnevist



Possible Magnevist side effects / adverse reactions in 58 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-05

Patient: 58 year old female weighing 70.0 kg (154.0 pounds)

Reactions: Pruritus, Scab, Skin Burning Sensation, Skin Hyperpigmentation, Joint Stiffness, Anhedonia, Skin Swelling, Peau D'orange, Pain in Extremity, Skin Disorder, Muscular Weakness, Nephrogenic Systemic Fibrosis, Skin Induration, Skin Hypertrophy, Livedo Reticularis, Anxiety, Scar, Mobility Decreased, Skin Fibrosis

Suspect drug(s):
Magnevist
    Indication: Imaging Procedure
    Start date: 2005-05-26
    End date: 2005-05-26

Contrast Media
    Indication: Angiogram

Prohance
    Indication: Imaging Procedure

Magnevist
    Dosage: 15 ml, unk
    Indication: Nuclear Magnetic Resonance Imaging Brain
    Start date: 2006-05-30

Contrast Media
    Indication: Nuclear Magnetic Resonance Imaging
    Start date: 2003-12-20
    End date: 2003-12-20

Omniscan
    Indication: Imaging Procedure

Optimark
    Indication: Imaging Procedure

Multihance
    Indication: Imaging Procedure

Other drugs received by patient: Phoslo; Folbee; Epogen; Colchicine; Calcitriol; Sensipar; Klonopin; Midodrine Hydrochloride; Plavix; Synthroid; Iron Supplement; Coumadin; Aspirin; Norvasc; Zemplar; Corticosteroids; Steroid Antibacterials; Levothyroxine Sodium; Nephrocaps; Renagel; Robaxin; Immunosuppressive Agents; Hormones and Related Agents; Neurontin; Gabapentin; Immunosuppressive Agents; Antithrombotic Agents



See index of all Magnevist side effect reports >>

Drug label data at the top of this Page last updated: 2009-05-29

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