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Gadolinium Side Effects

Common Gadolinium Side Effects

The most commonly reported Gadolinium side effects (click to view or check a box to report):

Nephrogenic Systemic Fibrosis (31)
Nephrogenic Fibrosing Dermopathy (27)
Pruritus (18)
Arthralgia (18)
Oedema Peripheral (16)
Dyspnoea (15)
Gait Disturbance (13)
Musculoskeletal Stiffness (13)
Pain (12)
Pain In Extremity (12)
Muscular Weakness (11)
Hypoaesthesia (11)
Erythema (10)
Nausea (10)
Asthenia (9)
Paraesthesia (9)
Headache (9)
Rash (8)
Contrast Media Reaction (8)
Myalgia (8)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Gadolinium Side Effects Reported to FDA

The following Gadolinium reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Gadolinium on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Contrast Media Reaction, Urticaria, Rash, Immune System Disorder, Arthropathy, Skin Disorder, Muscle Disorder
on Mar 11, 2014 Female from US , 41 years of age, weighting 195.0 lb, was diagnosed with and was treated with Gadolinium. Directly after, patient experienced the unwanted or unexpected Gadolinium side effects: contrast media reaction, urticaria, rash, immune system disorder, arthropathy, skin disorder, muscle disorder. Gadolinium dosage: N/A.

Anaphylactic Reaction, Pulseless Electrical Activity
Patient was taking Gadolinium. Patient felt the following Gadolinium side effects: anaphylactic reaction, pulseless electrical activity on Jan 23, 2014 from US Additional patient health information: Female , 80 years of age, weighting 174.2 lb, . Gadolinium dosage: N/A.

Nephrogenic Systemic Fibrosis
Adverse event was reported on Dec 16, 2013 by a Male taking Gadolinium (Dosage: N/A) was diagnosed with and. Location: CN , 55 years of age, After Gadolinium was administered, patient encountered several Gadolinium side effects: nephrogenic systemic fibrosis.

Nephrogenic Systemic Fibrosis
on Dec 18, 2013 Female from DK , 40 years of age, weighting 127.9 lb, was diagnosed with and was treated with Gadolinium. Directly after, patient experienced the unwanted or unexpected Gadolinium side effects: nephrogenic systemic fibrosis. Gadolinium dosage: N/A.


Anaphylactic Shock, Cardio-respiratory Arrest, Pain Of Skin, Burning Sensation, Feeling Cold, Lip Swelling, Swollen Tongue, Dyspnoea, Visual Impairment
on Oct 29, 2013 Female from US , 58 years of age, weighting 173.0 lb, was treated with Gadolinium. Patient felt the following Gadolinium side effects: anaphylactic shock, cardio-respiratory arrest, pain of skin, burning sensation, feeling cold, lip swelling, swollen tongue, dyspnoea, visual impairment. Gadolinium dosage: N/A. Patient was hospitalized.

Respiratory Disorder, Cough, Rash, Renal Impairment, Skin Ulcer, Eye Pain, Vision Blurred, Fall
Patient was taking Gadolinium. After Gadolinium was administered, patient encountered several Gadolinium side effects: respiratory disorder, cough, rash, renal impairment, skin ulcer, eye pain, vision blurred, fall on Sep 23, 2013 from US Additional patient health information: Female , 54 years of age, weighting 163.0 lb, . Gadolinium dosage: N/A.

Nausea, Sleep Disorder, Hyperhidrosis, Temperature Intolerance
Adverse event was reported on Sep 23, 2013 by a Female taking Gadolinium (Dosage: N/A) . Location: US , 54 years of age, weighting 163.0 lb, Directly after, patient experienced the unwanted or unexpected Gadolinium side effects: nausea, sleep disorder, hyperhidrosis, temperature intolerance. Patient was hospitalized and became disabled.

Respiratory Distress, Abdominal Pain, Flushing, Respiratory Rate Increased, Intra-abdominal Pressure Increased
on Jul 09, 2013 Male from US , 48 years of age, weighting 191.8 lb, was treated with Gadolinium. Patient felt the following Gadolinium side effects: respiratory distress, abdominal pain, flushing, respiratory rate increased, intra-abdominal pressure increased. Gadolinium dosage: N/A.

Anaphylactic Shock
on Feb 20, 2013 Patient from US , 47 years of age, weighting 211.6 lb, was diagnosed with and was treated with Gadolinium. After Gadolinium was administered, patient encountered several Gadolinium side effects: anaphylactic shock. Gadolinium dosage: During Mri,.

Respiratory Distress
Patient was taking Gadolinium. Directly after, patient experienced the unwanted or unexpected Gadolinium side effects: respiratory distress on Nov 02, 2012 from US Additional patient health information: Male , 70 years of age, weighting 134.5 lb, was diagnosed with and. Gadolinium dosage: N/A. Patient was hospitalized.

Dyspnoea, Eye Irritation, Dysuria, Bronchitis, Sensory Disturbance
Adverse event was reported on Oct 12, 2012 by a Female taking Gadolinium (Dosage: N/A) . Location: US , 30 years of age, weighting 130.0 lb, Patient felt the following Gadolinium side effects: dyspnoea, eye irritation, dysuria, bronchitis, sensory disturbance. Patient was hospitalized.

Chemical Injury, Nephrogenic Systemic Fibrosis
on Sep 07, 2012 Male from US , 54 years of age, weighting 190.0 lb, was diagnosed with and was treated with Gadolinium. After Gadolinium was administered, patient encountered several Gadolinium side effects: chemical injury, nephrogenic systemic fibrosis. Gadolinium dosage: N/A.

Immediate Post-injection Reaction, Loss Of Consciousness, Blood Pressure Decreased, Contrast Media Reaction, Vomiting, Nausea
on Jan 27, 2012 Female from UNITED STATES , 65 years of age, weighting 192.0 lb, was treated with Gadolinium. Directly after, patient experienced the unwanted or unexpected Gadolinium side effects: immediate post-injection reaction, loss of consciousness, blood pressure decreased, contrast media reaction, vomiting, nausea. Gadolinium dosage: N/A. Patient was hospitalized.

Hypoaesthesia, Pruritus, Injection Site Mass, Hyperhidrosis, Paraesthesia, Oedema Peripheral, Weight Increased, Night Sweats, Muscle Twitching
Patient was taking Gadolinium. Patient felt the following Gadolinium side effects: hypoaesthesia, pruritus, injection site mass, hyperhidrosis, paraesthesia, oedema peripheral, weight increased, night sweats, muscle twitching on Dec 27, 2011 from UNITED STATES Additional patient health information: Female , 44 years of age, weighting 175.0 lb, was diagnosed with and. Gadolinium dosage: 1 Injection.

Ear Pruritus
Adverse event was reported on Oct 20, 2011 by a Male taking Gadolinium (Dosage: N/A) was diagnosed with and. Location: UNITED STATES , 20 years of age, After Gadolinium was administered, patient encountered several Gadolinium side effects: ear pruritus.

Crying, Gait Disturbance, Tremor, Back Pain, Acne, Meningioma, Condition Aggravated, Skin Ulcer
on Sep 19, 2011 Female from UNITED STATES , 50 years of age, weighting 162.0 lb, was diagnosed with and was treated with Gadolinium Mri Contrast Dye. Directly after, patient experienced the unwanted or unexpected Gadolinium side effects: crying, gait disturbance, tremor, back pain, acne, meningioma, condition aggravated, skin ulcer. Gadolinium Mri Contrast Dye dosage: ?.

Abasia, Dysstasia, Back Pain
on Aug 15, 2011 Male from UNITED STATES , 36 years of age, weighting 140.0 lb, was treated with Gadolinium Used For Mri. Patient felt the following Gadolinium side effects: abasia, dysstasia, back pain. Gadolinium Used For Mri dosage: N/A.

Joint Stiffness, Bone Pain, Fall, Progressive Multiple Sclerosis, Movement Disorder
Patient was taking Gadolinium-based Contrast Agents. After Gadolinium was administered, patient encountered several Gadolinium side effects: joint stiffness, bone pain, fall, progressive multiple sclerosis, movement disorder on Jun 27, 2011 from UNITED STATES Additional patient health information: Female , weighting 130.0 lb, was diagnosed with and. Gadolinium-based Contrast Agents dosage: 1 Time Iv.

Contrast Media Reaction, Dizziness, Brain Oedema, Influenza Like Illness, Urticaria, Nausea, Nerve Injury, Headache, Pain
Adverse event was reported on Mar 21, 2011 by a Female taking Gadolinium Based Contrast Agents (Dosage: Once) was diagnosed with and. Location: UNITED STATES , 44 years of age, weighting 115.0 lb, Directly after, patient experienced the unwanted or unexpected Gadolinium side effects: contrast media reaction, dizziness, brain oedema, influenza like illness, urticaria, nausea, nerve injury, headache, pain.

Myalgia, Muscle Spasms, Malaise, Pruritus, Pain, Chest Discomfort, Rash
on Feb 25, 2011 Male from UNITED STATES , 57 years of age, weighting 208.0 lb, was diagnosed with and was treated with Gadolinium N/a N/a. Patient felt the following Gadolinium side effects: myalgia, muscle spasms, malaise, pruritus, pain, chest discomfort, rash. Gadolinium N/a N/a dosage: -injection Type Dve.

Tremor, Feeling Abnormal
on Feb 25, 2011 Female from UNITED STATES , 65 years of age, weighting 115.0 lb, was treated with Gadolinium. After Gadolinium was administered, patient encountered several Gadolinium side effects: tremor, feeling abnormal. Gadolinium dosage: Iv. Patient was hospitalized.

Dialysis, Contraindication To Medical Treatment
Patient was taking Gadolinium. Directly after, patient experienced the unwanted or unexpected Gadolinium side effects: dialysis, contraindication to medical treatment on Feb 01, 2011 from UNITED STATES Additional patient health information: Female , 34 years of age, weighting 157.4 lb, was diagnosed with and. Gadolinium dosage: Gadolinium Once Iv Bolus. Patient was hospitalized.

Nephrogenic Systemic Fibrosis, Pain, Deformity, Skin Hypertrophy, Systemic Sclerosis, Joint Range Of Motion Decreased, Emotional Distress, Anhedonia
Adverse event was reported on Sep 07, 2012 by a Female taking Gadolinium (Dosage: N/A) was diagnosed with and. Location: US , weighting 157.0 lb, Patient felt the following Gadolinium side effects: nephrogenic systemic fibrosis, pain, deformity, skin hypertrophy, systemic sclerosis, joint range of motion decreased, emotional distress, anhedonia.
Multiple prescriptions taken:
  • Magnevist
  • Omniscan
  • Optimark
  • Multihance
  • Prohance
  • Epoetin
  • Paricalcitol
  • Levothyroxine


Contrast Media Reaction, Lung Disorder, Musculoskeletal Stiffness, Radiation Injury, Trismus
on Dec 15, 2010 Female from UNITED STATES , weighting 120.0 lb, was treated with Gadolinium. After Gadolinium was administered, patient encountered several Gadolinium side effects: contrast media reaction, lung disorder, musculoskeletal stiffness, radiation injury, trismus. Gadolinium dosage: N/A.

Arthralgia, Bone Pain, Dyspepsia, Dyspnoea Exertional, Epilepsy, Fatigue, Gait Disturbance, Gastrooesophageal Reflux Disease
on Oct 11, 2010 Male from DENMARK , 69 years of age, was diagnosed with and was treated with Gadolinium Contrast. Directly after, patient experienced the unwanted or unexpected Gadolinium side effects: arthralgia, bone pain, dyspepsia, dyspnoea exertional, epilepsy, fatigue, gait disturbance, gastrooesophageal reflux disease. Gadolinium Contrast dosage: N/A.
Associated medications used:
  • Omniscan (0.5 Millimole(s)/ml)
  • Omniscan (0.5 Millimole(s)/ml)
  • Epoitin Beta
  • Mirtazapin
  • Haloperidol
  • Quinine
  • Lactulose
  • Metoclopramid
Patient was hospitalized and became disabled.

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Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:

     

    Side Effects

    Scale

    Date & Time

    Other Medicine(s) or Treatment(s)

     

     

     

     

    Scale: 1 = very mild to 10 = very bad


    Track Online

  • User Sign In
  • Register to track your side effects

  • 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.

    Discuss Gadolinium Side Effects

    Did You Have a Gadolinium Side Effect?

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    How Effective is Gadolinium for You?

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    Safety Alerts, Active Ingredients, Usage Information

    More About Gadolinium

    Side Effects reported to FDA: 158

    Gadolinium safety alerts: 2010 2007 2006

    Reported deaths: 5

    Reported hospitalizations: 25

    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)

     

    [Posted 09/09/2010]

    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:

    • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
    • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 

     

    [09/09/2010 - Drug Safety Communication - FDA] 
    [08/13/2009 - Q&As - FDA]

    Previous MedWatch Alert

    [06/08/2006 - Gadolinium-containing Contrast Agents for Magnetic Resonance Imaging (MRI): Omniscan, OptiMARK, Magnevist, ProHance, and MultiHance]

    Latest Gadolinium clinical trials