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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
This is a report of a 41-year-old female patient (weight: NA) from US, suffering from the following symptoms/conditions: scan with contrast, who was treated with Gadolinium (dosage: NA, start time: Nov 15, 2013), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Contrast Media Reaction
  • Urticaria
  • Rash
  • Immune System Disorder
  • Arthropathy
  • Skin Disorder
  • Muscle Disorder
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Gadolinium treatment in female patients, resulting in contrast media reaction side effect.

Anaphylactic Reaction, Pulseless Electrical Activity
This report suggests a potential Gadolinium Anaphylactic Reaction, Pulseless Electrical Activity side effect(s) that can have serious consequences. A 80-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Gadolinium (dosage: NA) starting NS. Soon after starting Gadolinium the patient began experiencing various side effects, including:
  • Anaphylactic Reaction
  • Pulseless Electrical Activity
Drugs used concurrently: NA. Although Gadolinium demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as anaphylactic reaction, may still occur.

Nephrogenic Systemic Fibrosis
This Nephrogenic Systemic Fibrosis problem was reported by a consumer or non-health professional from CN. A 55-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: nuclear magnetic resonance imaging. On 201106 this consumer started treatment with Gadolinium (dosage: NA). The following drugs were being taken at the same time: NA. When commencing Gadolinium, the patient experienced the following unwanted symptoms/side effects:
  • Nephrogenic Systemic Fibrosis
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as nephrogenic systemic fibrosis, may become evident only after a product is in use by the general population.

Nephrogenic Systemic Fibrosis
This is a report of a 40-year-old female patient (weight: NA) from DK. The patient developed the following symptoms/conditions: pain in extremity,paraesthesia and was treated with Gadolinium (dosage: NA) starting Apr 07, 2006. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Nephrogenic Systemic Fibrosis
This opens a possibility that Gadolinium treatment could cause the above reactions, including nephrogenic systemic fibrosis, and some female subjects may be more susceptible.


Anaphylactic Shock, Cardio-respiratory Arrest, Pain Of Skin, Burning Sensation, Feeling Cold, Lip Swelling, Swollen Tongue, Dyspnoea, Visual Impairment
A 58-year-old female patient (weight: NA) from US with the following symptoms/conditions: NA started Gadolinium treatment (dosage: NA) on Nov 15, 2013. Soon after starting Gadolinium treatment, the subject experienced various side effects, including:
  • Anaphylactic Shock
  • Cardio-respiratory Arrest
  • Pain Of Skin
  • Burning Sensation
  • Feeling Cold
  • Lip Swelling
  • Swollen Tongue
  • Dyspnoea
  • Visual Impairment
Concurrently used drugs: NA.The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Gadolinium.

Respiratory Disorder, Cough, Rash, Renal Impairment, Skin Ulcer, Eye Pain, Vision Blurred, Fall
A 54-year-old female patient from US (weight: NA) experienced symptoms, such as: NA and was treated with Gadolinium(dosage: NA). The treatment was initiated on NS. After that a consumer reported the following side effect(s):
  • Respiratory Disorder
  • Cough
  • Rash
  • Renal Impairment
  • Skin Ulcer
  • Eye Pain
  • Vision Blurred
  • Fall
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Gadolinium efficacy: NA.

Nausea, Sleep Disorder, Hyperhidrosis, Temperature Intolerance
In this report, Gadolinium was administered for the following condition: NA.A 54-year-old female consumer from US (weight: NA) started Gadolinium treatment (dosage: NA) on NS.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Nausea
  • Sleep Disorder
  • Hyperhidrosis
  • Temperature Intolerance
A possible interaction with other drugs could have contributed to this reaction: NA.The patient was hospitalized and became disabled.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Gadolinium treatment could be related to the listed above side effect(s).

Respiratory Distress, Abdominal Pain, Flushing, Respiratory Rate Increased, Intra-abdominal Pressure Increased
This is a report of the following Gadolinium side effect(s):
  • Respiratory Distress
  • Abdominal Pain
  • Flushing
  • Respiratory Rate Increased
  • Intra-abdominal Pressure Increased
A 48-year-old male patient from US (weight: NA) presented with the following condition: NA and received a treatment with Gadolinium (dosage: NA) starting: May 29, 2013.The following concurrently used drugs could have generated interactions: NA.This report suggests that a Gadolinium treatment could be associated with the listed above side effect(s).

Anaphylactic Shock
This Gadolinium report was submitted by a 47-year-old consumer from US (weight: NA). The patient was diagnosed with: nuclear magnetic resonance imaging spinal,scan with contrast and Gadolinium was administered (dosage: During Mri,) starting: Feb 08, 2013. The consumer developed a set of symptoms:
  • Anaphylactic Shock
Other drugs used simultaneously: NA.Those unexpected symptoms could be linked to a Gadolinium treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Respiratory Distress
This is a report of a possible correlation between Gadolinium use and the following symptoms/side effect(s):
  • Respiratory Distress
which could contribute to an assessment of Gadolinium risk profile.A 70-year-old male consumer from US (weight: NA) was suffering from mri and was treated with Gadolinium (dosage: NA) starting Jul 03, 2012.Other concurrent medications: NA.The patient was hospitalized.

Dyspnoea, Eye Irritation, Dysuria, Bronchitis, Sensory Disturbance
A 30-year-old female patient from US (weight: NA) presented with the following symptoms: NA and after a treatment with Gadolinium (dosage: NA) experienced the following side effect(s):
  • Dyspnoea
  • Eye Irritation
  • Dysuria
  • Bronchitis
  • Sensory Disturbance
The treatment was started on NS. Gadolinium was used in combination with the following drugs: NA.The patient was hospitalized.This report could alert potential Gadolinium consumers.

Chemical Injury, Nephrogenic Systemic Fibrosis
In this report, a 54-year-old male patient from US (weight: NA) was affected by a possible Gadolinium side effect.The patient was diagnosed with cardiac disorder. After a treatment with Gadolinium (dosage: NA, start date: NS), the patient experienced the following side effect(s):
  • Chemical Injury
  • Nephrogenic Systemic Fibrosis
The following simultaneously used drugs could have led to this reaction: NA.The findings here stress that side effects should be taken into consideration when evaluating a Gadolinium treatment.

Immediate Post-injection Reaction, Loss Of Consciousness, Blood Pressure Decreased, Contrast Media Reaction, Vomiting, Nausea
This is a report of a 65-year-old female patient from UNITED STATES (weight: NA), who used Gadolinium (dosage: NA) for a treatment of NA. After starting a treatment on NS, the patient experienced the following side effect(s):
  • Immediate Post-injection Reaction
  • Loss Of Consciousness
  • Blood Pressure Decreased
  • Contrast Media Reaction
  • Vomiting
  • Nausea
The following drugs could possibly have interacted with the Gadolinium treatment NA.The patient was hospitalized.Taken together, these observations suggest that a Gadolinium treatment could be related to side effect(s), such as Immediate Post-injection Reaction, Loss Of Consciousness, Blood Pressure Decreased, Contrast Media Reaction, Vomiting, Nausea.

Hypoaesthesia, Pruritus, Injection Site Mass, Hyperhidrosis, Paraesthesia, Oedema Peripheral, Weight Increased, Night Sweats, Muscle Twitching
This hypoaesthesia side effect was reported by a consumer or non-health professional from UNITED STATES. A 44-year-old female patient (weight:NA) experienced the following symptoms/conditions: optic neuritis,investigation. The patient was prescribed Gadolinium (dosage: 1 Injection), which was started on Sep 06, 2011. Concurrently used drugs: NA. When starting to take Gadolinium the consumer reported the following symptoms:
  • Hypoaesthesia
  • Pruritus
  • Injection Site Mass
  • Hyperhidrosis
  • Paraesthesia
  • Oedema Peripheral
  • Weight Increased
  • Night Sweats
  • Muscle Twitching
These side effects may potentially be related to Gadolinium.

Ear Pruritus
This is a Gadolinium side effect report of a 20-year-old male patient (weight:NA) from UNITED STATES, suffering from the following symptoms/conditions: diagnostic procedure, who was treated with Gadolinium (dosage:NA, start time: Sep 15, 2011), combined with: NA., and developed a serious reaction and a ear pruritus side effect. The patient presented with:
  • Ear Pruritus
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Gadolinium treatment in male patients suffering from diagnostic procedure, resulting in ear pruritus.

Crying, Gait Disturbance, Tremor, Back Pain, Acne, Meningioma, Condition Aggravated, Skin Ulcer
This report suggests a potential Gadolinium Mri Contrast Dye crying side effect(s) that can have serious consequences. A 50-year-old female patient from UNITED STATES (weight:NA) was diagnosed with the following health condition(s): decreased appetite,crying,gait disturbance,tremor,muscular weakness,pain,flank pain and used Gadolinium Mri Contrast Dye (dosage: ?) starting Dec 15, 2010. Soon after starting Gadolinium Mri Contrast Dye the patient began experiencing various side effects, including:
  • Crying
  • Gait Disturbance
  • Tremor
  • Back Pain
  • Acne
  • Meningioma
  • Condition Aggravated
  • Skin Ulcer
Drugs used concurrently:NA. Although Gadolinium Mri Contrast Dye demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as crying, may still occur.

Abasia, Dysstasia, Back Pain
This abasia problem was reported by a consumer or non-health professional from UNITED STATES. A 36-year-old male patient (weight: NA) was diagnosed with the following medical condition(s): NA.On NS a consumer started treatment with Gadolinium Used For Mri (dosage: NA). The following drugs/medications were being taken at the same time: NA. When commencing Gadolinium Used For Mri, the patient experienced the following unwanted symptoms /side effects:
  • Abasia
  • Dysstasia
  • Back Pain
Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as abasia, may become evident only after a product is in use by the general population.

Joint Stiffness, Bone Pain, Fall, Progressive Multiple Sclerosis, Movement Disorder
This is a Gadolinium-based Contrast Agents side effect report of a female patient (weight: NA) from UNITED STATES. The patient developed the following symptoms/conditions: progressive multiple sclerosis,nuclear magnetic resonance imaging and was treated with Gadolinium-based Contrast Agents (dosage: 1 Time Iv) starting Jun 07, 2011. Concurrently used drugs: NA. Soon after that, the consumer experienced the following of symptoms:
  • Joint Stiffness
  • Bone Pain
  • Fall
  • Progressive Multiple Sclerosis
  • Movement Disorder
This opens a possibility that Gadolinium-based Contrast Agents could cause joint stiffness and that some female patients may be more susceptible.

Contrast Media Reaction, Dizziness, Brain Oedema, Influenza Like Illness, Urticaria, Nausea, Nerve Injury, Headache, Pain
A 44-year-old female patient (weight: NA) from UNITED STATES with the following symptoms: nuclear magnetic resonance imaging,scan with contrast started Gadolinium Based Contrast Agents treatment (dosage: Once) on Mar 15, 2011. Soon after starting Gadolinium Based Contrast Agents treatment, the consumer experienced several side effects, including:
  • Contrast Media Reaction
  • Dizziness
  • Brain Oedema
  • Influenza Like Illness
  • Urticaria
  • Nausea
  • Nerve Injury
  • Headache
  • Pain
. Concurrently used drugs: NA. This finding indicates that some patients can be more vulnerable to developing Gadolinium Based Contrast Agents side effects, such as contrast media reaction.

Myalgia, Muscle Spasms, Malaise, Pruritus, Pain, Chest Discomfort, Rash
This myalgia side effect was reported by a consumer or non-health professional from UNITED STATES. A 57-year-old male patient (weight:NA) experienced the following symptoms/conditions: nuclear magnetic resonance imaging.The patient was prescribed Gadolinium N/a N/a (dosage: -injection Type Dve), which was started on Feb 18, 2011. Concurrently used drugs: NA..When starting to take Gadolinium N/a N/a the consumer reported symptoms, such as:
  • Myalgia
  • Muscle Spasms
  • Malaise
  • Pruritus
  • Pain
  • Chest Discomfort
  • Rash
These side effects may potentially be related to Gadolinium N/a N/a.

Tremor, Feeling Abnormal
This is a report of a 65-year-old female patient (weight: NA) from UNITED STATES, suffering from the following symptoms/conditions: NA, who was treated with Gadolinium (dosage: Iv, start time: Apr 01, 2007), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Tremor
  • Feeling Abnormal
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Gadolinium treatment in female patients, resulting in tremor side effect. The patient was hospitalized.

Dialysis, Contraindication To Medical Treatment
This report suggests a potential Gadolinium Dialysis, Contraindication To Medical Treatment side effect(s) that can have serious consequences. A 34-year-old female patient (weight: NA) from UNITED STATES was diagnosed with the following symptoms/conditions: nuclear magnetic resonance imaging and used Gadolinium (dosage: Gadolinium Once Iv Bolus) starting Jan 16, 2011. Soon after starting Gadolinium the patient began experiencing various side effects, including:
  • Dialysis
  • Contraindication To Medical Treatment
Drugs used concurrently: NA.The patient was hospitalized. Although Gadolinium demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as dialysis, may still occur.

Nephrogenic Systemic Fibrosis, Pain, Deformity, Skin Hypertrophy, Systemic Sclerosis, Joint Range Of Motion Decreased, Emotional Distress, Anhedonia
This Nephrogenic Systemic Fibrosis, Pain, Deformity, Skin Hypertrophy, Systemic Sclerosis, Joint Range Of Motion Decreased, Emotional Distress, Anhedonia problem was reported by a consumer or non-health professional from US. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: imaging procedure,nuclear magnetic resonance imaging. On NS this consumer started treatment with Gadolinium (dosage: NA). The following drugs were being taken at the same time:
  • Magnevist
  • Omniscan
  • Optimark
  • Multihance
  • Prohance
  • Epoetin
  • Paricalcitol
  • Levothyroxine
When commencing Gadolinium, the patient experienced the following unwanted symptoms/side effects:
  • Nephrogenic Systemic Fibrosis
  • Pain
  • Deformity
  • Skin Hypertrophy
  • Systemic Sclerosis
  • Joint Range Of Motion Decreased
  • Emotional Distress
  • Anhedonia
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as nephrogenic systemic fibrosis, may become evident only after a product is in use by the general population.

Contrast Media Reaction, Lung Disorder, Musculoskeletal Stiffness, Radiation Injury, Trismus
This is a report of a female patient (weight: NA) from UNITED STATES. The patient developed the following symptoms/conditions: NA and was treated with Gadolinium (dosage: NA) starting NS. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Contrast Media Reaction
  • Lung Disorder
  • Musculoskeletal Stiffness
  • Radiation Injury
  • Trismus
This opens a possibility that Gadolinium treatment could cause the above reactions, including contrast media reaction, and some female subjects may be more susceptible.

Arthralgia, Bone Pain, Dyspepsia, Dyspnoea Exertional, Epilepsy, Fatigue, Gait Disturbance, Gastrooesophageal Reflux Disease
A 69-year-old male patient (weight: NA) from DENMARK with the following symptoms/conditions: scan with contrast,nuclear magnetic resonance imaging brain started Gadolinium Contrast treatment (dosage: NA) on Sep 05, 2000. Soon after starting Gadolinium Contrast treatment, the subject experienced various side effects, including:
  • Arthralgia
  • Bone Pain
  • Dyspepsia
  • Dyspnoea Exertional
  • Epilepsy
  • Fatigue
  • Gait Disturbance
  • Gastrooesophageal Reflux Disease
Concurrently used drugs:
  • Omniscan (0.5 Millimole(s)/ml)
  • Omniscan (0.5 Millimole(s)/ml)
  • Epoitin Beta
  • Mirtazapin
  • Haloperidol
  • Quinine
  • Lactulose
  • Metoclopramid
The patient was hospitalized and became disabled. This finding indicates that some male patients could be more vulnerable to Gadolinium Contrast.

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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

    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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    Yes, Moderate
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    How Effective is Gadolinium for You?

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    Gadolinium 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