DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Magnevist (Gadopentetate Dimeglumine) - Side Effects and Adverse Reactions



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 [see Warnings and Precautions]. 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.

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.

  • •Anaphylactic shock, respiratory distress, and laryngeal edema [see Warnings and Precautions ]
  • •Cardiac/respiratory arrest, shock
  • •Nephrogenic systemic fibrosis [see Warnings and Precautions]

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), injection site reactions including skin and soft tissue necrosis.

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 impairment.

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


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):

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):

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):
    Indication: Imaging Procedure
    Start date: 2005-05-26
    End date: 2005-05-26

Contrast Media
    Indication: Angiogram

    Indication: Imaging Procedure

    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

    Indication: Imaging Procedure

    Indication: Imaging Procedure

    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: 2014-06-11

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017