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Gadolinium Side Effects

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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.

Gadolinium Side Effects Reported to FDA



Gadolinium Side Effect Report#9999001
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 health 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): Contrast Media Reaction, Urticaria, Rash, Immune System Disorder, Arthropathy, Skin Disorder, Muscle Disorder 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.
Gadolinium Side Effect Report#9842155
Anaphylactic Reaction, Pulseless Electrical Activity
This report suggests a potential Gadolinium Anaphylactic Reaction 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. After starting Gadolinium the patient began experiencing various side effects, including: Anaphylactic Reaction, Pulseless Electrical ActivityAdditional 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.
Gadolinium Side Effect Report#9768943
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 using Gadolinium, the patient experienced the following unwanted symptoms/side effects: Nephrogenic Systemic FibrosisAlthough 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.
Gadolinium Side Effect Report#9768583
Nephrogenic Systemic Fibrosis
This Nephrogenic Systemic Fibrosis side effect was reported by a health professional from DK. A 40-year-old female patient (weight:NA) experienced the following symptoms/conditions: pain in extremity,paraesthesia.The patient was prescribed Gadolinium (drug dosage: NA), which was initiated on
Apr 07, 2006. Concurrently used drugs: NA..After starting to take Gadolinium the consumer reported adverse symptoms, such as: Nephrogenic Systemic FibrosisThese side effects may potentially be related to Gadolinium.
Gadolinium Side Effect Report#9656036
Anaphylactic Shock, Cardio-respiratory Arrest, Pain Of Skin, Burning Sensation, Feeling Cold, Lip Swelling, Swollen Tongue, Dyspnoea, Visual Impairment
This is a report of a 58-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Gadolinium (dosage: NA, start time:
Nov 15, 2013), combined with: NA. and developed a serious reaction and side effect(s): Anaphylactic Shock, Cardio-respiratory Arrest, Pain Of Skin, Burning Sensation, Feeling Cold, Lip Swelling, Swollen Tongue, Dyspnoea, Visual Impairment after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Gadolinium treatment in female patients, resulting in Anaphylactic Shock side effect. The patient was hospitalized.
Gadolinium Side Effect Report#9549080
Respiratory Disorder, Cough, Rash, Renal Impairment, Skin Ulcer, Eye Pain, Vision Blurred, Fall
This report suggests a potential Gadolinium Respiratory Disorder side effect(s) that can have serious consequences. A 54-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Gadolinium (dosage: NA) starting NS. After starting Gadolinium the patient began experiencing various side effects, including: Respiratory Disorder, Cough, Rash, Renal Impairment, Skin Ulcer, Eye Pain, Vision Blurred, FallAdditional drugs used concurrently: NA. Although Gadolinium demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Respiratory Disorder, may still occur.
Gadolinium Side Effect Report#9548660
Nausea, Sleep Disorder, Hyperhidrosis, Temperature Intolerance
This Nausea problem was reported by a consumer or non-health professional from US. A 54-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Gadolinium (dosage: NA). The following drugs were being taken at the same time: NA. When using Gadolinium, the patient experienced the following unwanted symptoms/side effects: Nausea, Sleep Disorder, Hyperhidrosis, Temperature IntoleranceThe patient was hospitalized and became disabled.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Nausea, may become evident only after a product is in use by the general population.
Gadolinium Side Effect Report#9393479
Respiratory Distress, Abdominal Pain, Flushing, Respiratory Rate Increased, Intra-abdominal Pressure Increased
This Respiratory Distress side effect was reported by a pharmacist from US. A 48-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Gadolinium (drug dosage: NA), which was initiated on
May 29, 2013. Concurrently used drugs: NA..After starting to take Gadolinium the consumer reported adverse symptoms, such as: Respiratory Distress, Abdominal Pain, Flushing, Respiratory Rate Increased, Intra-abdominal Pressure IncreasedThese side effects may potentially be related to Gadolinium.
Gadolinium Side Effect Report#9114885
Anaphylactic Shock
This is a report of a 47-year-old patient (weight: NA) from US, suffering from the following health symptoms/conditions: nuclear magnetic resonance imaging spinal,scan with contrast, who was treated with Gadolinium (dosage: During Mri, start time:
Feb 08, 2013), combined with: NA. and developed a serious reaction and side effect(s): Anaphylactic Shock after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Gadolinium treatment in patients, resulting in Anaphylactic Shock side effect.
Gadolinium Side Effect Report#8889428
Respiratory Distress
This report suggests a potential Gadolinium Respiratory Distress side effect(s) that can have serious consequences. A 70-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: mri and used Gadolinium (dosage: NA) starting
Jul 03, 2012. After starting Gadolinium the patient began experiencing various side effects, including: Respiratory DistressAdditional drugs used concurrently: NA.The patient was hospitalized. Although Gadolinium demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Respiratory Distress, may still occur.
Gadolinium Side Effect Report#8839502
Dyspnoea, Eye Irritation, Dysuria, Bronchitis, Sensory Disturbance
This Dyspnoea problem was reported by a consumer or non-health professional from US. A 30-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Gadolinium (dosage: NA). The following drugs were being taken at the same time: NA. When using Gadolinium, the patient experienced the following unwanted symptoms/side effects: Dyspnoea, Eye Irritation, Dysuria, Bronchitis, Sensory DisturbanceThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Dyspnoea, may become evident only after a product is in use by the general population.
Gadolinium Side Effect Report#8784736
Chemical Injury, Nephrogenic Systemic Fibrosis
This Chemical Injury side effect was reported by a consumer or non-health professional from US. A 54-year-old male patient (weight:NA) experienced the following symptoms/conditions: cardiac disorder.The patient was prescribed Gadolinium (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Gadolinium the consumer reported adverse symptoms, such as: Chemical Injury, Nephrogenic Systemic FibrosisThese side effects may potentially be related to Gadolinium.
Gadolinium Side Effect Report#8076381-7
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 (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Gadolinium (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Immediate Post-injection Reaction, Loss Of Consciousness, Blood Pressure Decreased, Contrast Media Reaction, Vomiting, Nausea after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Gadolinium treatment in female patients, resulting in Immediate Post-injection Reaction side effect. The patient was hospitalized.
Gadolinium Side Effect Report#8011236-5
Hypoaesthesia, Pruritus, Injection Site Mass, Hyperhidrosis, Paraesthesia, Oedema Peripheral, Weight Increased, Night Sweats, Muscle Twitching
This report suggests a potential Gadolinium Hypoaesthesia side effect(s) that can have serious consequences. A 44-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: optic neuritis,investigation and used Gadolinium (dosage: 1 Injection) starting
Sep 06, 2011. After starting Gadolinium the patient began experiencing various side effects, including: Hypoaesthesia, Pruritus, Injection Site Mass, Hyperhidrosis, Paraesthesia, Oedema Peripheral, Weight Increased, Night Sweats, Muscle TwitchingAdditional drugs used concurrently: NA. Although Gadolinium demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hypoaesthesia, may still occur.
Gadolinium Side Effect Report#7828548-8
Ear Pruritus
This Ear Pruritus problem was reported by a pharmacist from United States. A 20-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: diagnostic procedure. On
Sep 15, 2011 this consumer started treatment with Gadolinium (dosage: NA). The following drugs were being taken at the same time: NA. When using Gadolinium, the patient experienced the following unwanted symptoms/side effects: Ear PruritusAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Ear Pruritus, may become evident only after a product is in use by the general population.
Gadolinium Side Effect Report#7759512-5
Crying, Gait Disturbance, Tremor, Back Pain, Pain, Acne, Meningioma, Condition Aggravated, Skin Ulcer
This Crying side effect was reported by a health professional from United States. A 50-year-old female patient (weight:NA) experienced the following symptoms/conditions: decreased appetite,crying,gait disturbance,tremor,muscular weakness,pain,flank pain.The patient was prescribed Gadolinium Mri Contrast Dye (drug dosage: ?), which was initiated on
Dec 15, 2010. Concurrently used drugs: NA..After starting to take Gadolinium Mri Contrast Dye the consumer reported adverse symptoms, such as: Crying, Gait Disturbance, Tremor, Back Pain, Pain, Acne, Meningioma, Condition Aggravated, Skin UlcerThese side effects may potentially be related to Gadolinium Mri Contrast Dye.
Gadolinium Side Effect Report#7685768-3
Abasia, Dysstasia, Back Pain
This is a report of a 36-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Gadolinium Used For Mri (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Abasia, Dysstasia, Back Pain after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Gadolinium Used For Mri treatment in male patients, resulting in Abasia side effect.
Gadolinium Side Effect Report#7582903-2
Joint Stiffness, Bone Pain, Fall, Progressive Multiple Sclerosis, Movement Disorder
This report suggests a potential Gadolinium-based Contrast Agents Joint Stiffness side effect(s) that can have serious consequences. A female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: progressive multiple sclerosis,nuclear magnetic resonance imaging and used Gadolinium-based Contrast Agents (dosage: 1 Time Iv) starting
Jun 07, 2011. After starting Gadolinium-based Contrast Agents the patient began experiencing various side effects, including: Joint Stiffness, Bone Pain, Fall, Progressive Multiple Sclerosis, Movement DisorderAdditional drugs used concurrently: NA. Although Gadolinium-based Contrast Agents demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Joint Stiffness, may still occur.
Gadolinium Side Effect Report#7370997-9
Contrast Media Reaction, Dizziness, Brain Oedema, Influenza Like Illness, Urticaria, Nausea, Nerve Injury, Headache, Pain
This Contrast Media Reaction problem was reported by a health professional from United States. A 44-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: nuclear magnetic resonance imaging,scan with contrast. On
Mar 15, 2011 this consumer started treatment with Gadolinium Based Contrast Agents (dosage: Once). The following drugs were being taken at the same time: NA. When using Gadolinium Based Contrast Agents, the patient experienced the following unwanted symptoms/side effects: Contrast Media Reaction, Dizziness, Brain Oedema, Influenza Like Illness, Urticaria, Nausea, Nerve Injury, Headache, PainAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Contrast Media Reaction, may become evident only after a product is in use by the general population.
Gadolinium Side Effect Report#7329391-9
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 (drug dosage: -injection Type Dve), which was initiated on
Feb 18, 2011. Concurrently used drugs: NA..After starting to take Gadolinium N/a N/a the consumer reported adverse symptoms, such as: Myalgia, Muscle Spasms, Malaise, Pruritus, Pain, Chest Discomfort, RashThese side effects may potentially be related to Gadolinium N/a N/a.
Gadolinium Side Effect Report#7328897-6
Tremor, Feeling Abnormal
This is a report of a 65-year-old female patient (weight: NA) from United States, suffering from the following health 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): Tremor, Feeling Abnormal 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.
Gadolinium Side Effect Report#7274371-5
Dialysis, Contraindication To Medical Treatment
This report suggests a potential Gadolinium Dialysis 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. After starting Gadolinium the patient began experiencing various side effects, including: Dialysis, Contraindication To Medical TreatmentAdditional 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.
Gadolinium Side Effect Report#7187218
Nephrogenic Systemic Fibrosis, Pain, Deformity, Skin Hypertrophy, Systemic Sclerosis, Joint Range Of Motion Decreased, Fibrosis, Emotional Distress, Anhedonia
This Nephrogenic Systemic Fibrosis 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 using Gadolinium, the patient experienced the following unwanted symptoms/side effects: Nephrogenic Systemic Fibrosis, Pain, Deformity, Skin Hypertrophy, Systemic Sclerosis, Joint Range Of Motion Decreased, Fibrosis, Emotional Distress, AnhedoniaAlthough 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.
Gadolinium Side Effect Report#7175775-1
Contrast Media Reaction, Lung Disorder, Musculoskeletal Stiffness, Radiation Injury, Trismus
This Contrast Media Reaction side effect was reported by a consumer or non-health professional from United States. A female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Gadolinium (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Gadolinium the consumer reported adverse symptoms, such as: Contrast Media Reaction, Lung Disorder, Musculoskeletal Stiffness, Radiation Injury, TrismusThese side effects may potentially be related to Gadolinium.
Gadolinium Side Effect Report#7050339-9
Arthralgia, Bone Pain, Dyspepsia, Dyspnoea Exertional, Epilepsy, Fatigue, Gait Disturbance, Gastrooesophageal Reflux Disease
This is a report of a 69-year-old male patient (weight: NA) from Denmark, suffering from the following health symptoms/conditions: scan with contrast,nuclear magnetic resonance imaging brain, who was treated with Gadolinium Contrast (dosage: NA, start time:
Sep 05, 2000), combined with:
  • Omniscan (0.5 Millimole(s)/ml)
  • Omniscan (0.5 Millimole(s)/ml)
  • Epoitin Beta
  • Mirtazapin
  • Haloperidol
  • Quinine
  • Lactulose
  • Metoclopramid
and developed a serious reaction and side effect(s): Arthralgia, Bone Pain, Dyspepsia, Dyspnoea Exertional, Epilepsy, Fatigue, Gait Disturbance, Gastrooesophageal Reflux Disease after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Gadolinium Contrast treatment in male patients, resulting in Arthralgia side effect. The patient was hospitalized and became disabled.


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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.


Track Your Side Effects

Note Your Observations

It is really important to keep track of your health 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

    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.

    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.

    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.

    Discuss Gadolinium Side Effects

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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