Gadolinium Side Effects
How can Gadolinium Side Effects affect You? | PatientsVille.com
View and Submit Gadolinium Side Effects
Your Gadolinium Side Effect submission can play a very important role. Reporting your experience could help identify an unknown risk and inform other patients and health care professionals.
Record and Track Your Side Effects
It is very important to keep track of all side effects and discuss them with your doctor. If you think you may have a medical emergency, call your doctor or 911 immediately.
Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.
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.
Side Effects reported to FDA: 143. View Gadolinium Adverse Reports
Reported deaths: 4
Reported hospitalizations: 20
Gadolinium-based Contrast Agents: Class Labeling Change - Risk of Nephrogenic Systemic Fibrosis
Ablavar (gadofosveset trisodium), Eovist (gadoxetate disodium), Magnevist (gadopentetate dimeglumine), Multihance (gadobenate dimeglumine), Omniscan (gadodiamide), Optimark (gadoversetamide injection), Prohance (gadoteridol)
AUDIENCE: Radiology, Nephrology, Dermatology
ISSUE: FDA is requiring changes in the professional labeling for gadolinium-based contrast agents (GBCAs) to minimize the risk of nephrogenic systemic fibrosis (NSF), a rare, but serious, condition associated with the use of GBCAs in certain patients with kidney dysfunction. NSF has not been reported in patients with normal kidney function. Patients at greatest risk for developing NSF after receiving GBCAs are those with impaired elimination of the drug, including patients with acute kidney injury or chronic, severe kidney disease.
BACKGROUND: GBCAs are intravenous drugs used in diagnostic imaging procedures to enhance the quality of magnetic resonance imaging or magnetic resonance angiography.
RECOMMENDATION: Healthcare professionals should screen patients prior to administration of a GBCA to identify those with acute kidney injury or chronic, severe, kidney disease. See the Drug Safety Communication for the complete list of recommendations to healthcare professionals and patients.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Previous MedWatch Alert
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Gadolinium Adverse Reactions
Nephrogenic Fibrosing Dermopathy ( 27 Reports)|Nephrogenic Systemic Fibrosis ( 25 Reports)|Pruritus ( 18 Reports)|Arthralgia ( 17 Reports)|Oedema Peripheral ( 16 Reports)|Dyspnoea ( 13 Reports)|Gait Disturbance ( 13 Reports)|Musculoskeletal Stiffness ( 13 Reports)|Pain In Extremity ( 12 Reports)|Hypoaesthesia ( 11 Reports)|Muscular Weakness ( 11 Reports)|Pain ( 11 Reports)|Erythema ( 10 Reports)|Asthenia ( 9 Reports)|Headache ( 9 Reports)|Nausea ( 9 Reports)|Paraesthesia ( 8 Reports)|Vomiting ( 8 Reports)|Contrast Media Reaction ( 7 Reports)|Mobility Decreased ( 7 Reports)|Myalgia ( 7 Reports)|Skin Hypertrophy ( 7 Reports)|Urticaria ( 7 Reports)|Burning Sensation ( 6 Reports)|Dialysis ( 6 Reports)|Dizziness ( 6 Reports)|Malaise ( 6 Reports)|Fatigue ( 5 Reports)|Ill-defined Disorder ( 5 Reports)|Muscle Tightness ( 5 Reports)|