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Gadolinium Side Effects

Report Gadolinium Side Effects

If you experienced any harmful or unwanted effects of Gadolinium, please share your experience. This could help to raise awareness about Gadolinium side effects, identify uknown risks and inform health professionals and patients taking Gadolinium.

Examples: headache, dizziness


The most commonly reported Gadolinium side effects are:
Muscle Weakness (10 reports)
Abnormal Pigmentation (6 reports)
Burning (6 reports)
Tremor (6 reports)
Fever Joints Pains (4 reports)
Nausea (4 reports)
Dehydration (3 reports)
Rash (3 reports)
Foot Tuning Inward (2 reports)

If you have experienced a side effect listed above, you can check a box to report it.


To view a complete list of submitted side effects, please follow the link Gadolinium side effects . You can also compare Gadolinium side effects or view FDA reports.

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).
The 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 identified a causal relationship between the drug and the listed risk.

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Appetite Disorder, Arthralgia, Asthenia, Calcinosis, Fatigue, Gait Disturbance, Gastric Ulcer Haemorrhage, Hypoaesthesia, Joint Range Of Motion Decreased
on Aug 27, 2010 Male from DENMARK , 61 years of age, weighting 191.8 lb, was diagnosed with and was treated with Gadolinium Contrast -unk Mah. Directly after, patient experienced the unwanted or unexpected Gadolinium side effects: appetite disorder, arthralgia, asthenia, calcinosis, fatigue, gait disturbance, gastric ulcer haemorrhage, hypoaesthesia, joint range of motion decreased. Gadolinium Contrast -unk Mah dosage: N/A.

Asthenia, Burning Sensation, Diarrhoea, Erythema, Hyperkeratosis, Myalgia, Nephrogenic Systemic Fibrosis, Peripheral Sensorimotor Neuropathy, Restless Legs Syndrome
Patient was taking Gadolinium Contrast. Patient felt the following Gadolinium side effects: asthenia, burning sensation, diarrhoea, erythema, hyperkeratosis, myalgia, nephrogenic systemic fibrosis, peripheral sensorimotor neuropathy, restless legs syndrome on Aug 24, 2010 from DENMARK Additional patient health information: Male , 67 years of age, weighting 187.4 lb, was diagnosed with and. Gadolinium Contrast dosage: N/A.
Multiple prescriptions taken:
  • Prednisolone
  • Bisocor
  • Coversyl Comp
  • Methotrexate Sodium
  • Ferro Duretter
  • Folinsyre Sad
  • Iodine Contrast (Via Nephrostomy Catheter)
  • Iodine Contrast (Via Nephrostomy Catheter)


Contusion, Deformity, Pruritus, Rash Papular, Skin Discolouration
Adverse event was reported on Jul 21, 2010 by a Female taking Gadolinium (Dosage: N/A) was diagnosed with and. Location: UNITED STATES , 51 years of age, weighting 135.0 lb, After Gadolinium was administered, patient encountered several Gadolinium side effects: contusion, deformity, pruritus, rash papular, skin discolouration.

Abdominal Distension, Abdominal Pain, Flatulence
on Jun 08, 2010 Female from UNITED STATES , 68 years of age, weighting 144.0 lb, was diagnosed with and was treated with Gadolinium ?? ??. Directly after, patient experienced the unwanted or unexpected Gadolinium side effects: abdominal distension, abdominal pain, flatulence. Gadolinium ?? ?? dosage: N/A.


Pruritus, Urticaria
on Apr 29, 2010 Male from UNITED STATES , 49 years of age, was diagnosed with and was treated with Gadolinium. Patient felt the following Gadolinium side effects: pruritus, urticaria. Gadolinium dosage: N/A.
Multiple prescriptions taken:
  • Truvada
  • Ritonavir
  • Levothyroxine
  • Atazanavir
  • Metoprolol Xl


Hypoaesthesia, Muscle Tightness, Muscular Weakness, Musculoskeletal Stiffness, Nephrogenic Systemic Fibrosis, Paraesthesia
Patient was taking Gadolinium. After Gadolinium was administered, patient encountered several Gadolinium side effects: hypoaesthesia, muscle tightness, muscular weakness, musculoskeletal stiffness, nephrogenic systemic fibrosis, paraesthesia on Nov 16, 2009 from UNITED STATES Additional patient health information: Male , 58 years of age, was diagnosed with and. Gadolinium dosage: N/A.
Multiple concurrent drugs taken:

Burning Sensation, Gait Disturbance, Mobility Decreased, Nephrogenic Systemic Fibrosis, Pain In Extremity, Skin Hypertrophy
Adverse event was reported on Nov 16, 2009 by a Female taking Gadolinium (Dosage: N/A) was diagnosed with and. Location: UNITED STATES , 57 years of age, Directly after, patient experienced the unwanted or unexpected Gadolinium side effects: burning sensation, gait disturbance, mobility decreased, nephrogenic systemic fibrosis, pain in extremity, skin hypertrophy.

Contrast Media Reaction, Nausea, Vomiting
on Mar 03, 2010 Female from UNITED STATES , 64 years of age, was diagnosed with and was treated with Gadolinium Injection. Patient felt the following Gadolinium side effects: contrast media reaction, nausea, vomiting. Gadolinium Injection dosage: 15 Ml X1 Iv.

Anxiety, Asthenia, Muscle Spasms, Musculoskeletal Stiffness, Neuromyopathy, Pain
on Feb 25, 2010 Female from UNITED STATES , weighting 114.2 lb, was diagnosed with and was treated with Gadolinium Injection. After Gadolinium was administered, patient encountered several Gadolinium side effects: anxiety, asthenia, muscle spasms, musculoskeletal stiffness, neuromyopathy, pain. Gadolinium Injection dosage: N/A.

Diabetic End Stage Renal Disease, Muscular Weakness, Peritoneal Dialysis
Patient was taking Gadolinium. Directly after, patient experienced the unwanted or unexpected Gadolinium side effects: diabetic end stage renal disease, muscular weakness, peritoneal dialysis on Feb 22, 2010 from UNITED STATES Additional patient health information: Male , weighting 167.0 lb, was diagnosed with and. Gadolinium dosage: 20 Ml Once Iv. Patient was hospitalized.

Abasia, Arthralgia, Burning Sensation, Impaired Driving Ability, Oedema Peripheral, Pain In Extremity, Radiation Skin Injury, Rash
Adverse event was reported on Jan 19, 2010 by a Male taking Gadolinium (Dosage: Injections During Test) was diagnosed with and. Location: UNITED STATES , 56 years of age, weighting 253.0 lb, Patient felt the following Gadolinium side effects: abasia, arthralgia, burning sensation, impaired driving ability, oedema peripheral, pain in extremity, radiation skin injury, rash.

Cardiac Failure, Nephrogenic Systemic Fibrosis, Systemic Sclerosis
on Jan 14, 2010 Male from SWEDEN , 47 years of age, weighting 116.8 lb, was diagnosed with and was treated with Gadoliniumholdig Kontrast -unk Mah. After Gadolinium was administered, patient encountered several Gadolinium side effects: cardiac failure, nephrogenic systemic fibrosis, systemic sclerosis. Gadoliniumholdig Kontrast -unk Mah dosage: N/A. Patient was hospitalized and became disabled.

Cardiac Failure, Nephrogenic Systemic Fibrosis, Systemic Sclerosis
on Jan 04, 2010 Male from SWEDEN , 47 years of age, weighting 116.8 lb, was treated with Gadoliniumholdig Kontrast -unk Mah. Directly after, patient experienced the unwanted or unexpected Gadolinium side effects: cardiac failure, nephrogenic systemic fibrosis, systemic sclerosis. Gadoliniumholdig Kontrast -unk Mah dosage: N/A. Patient was hospitalized and became disabled.

Nausea, Vomiting
Patient was taking Gadolinium Contrast. Patient felt the following Gadolinium side effects: nausea, vomiting on Dec 24, 2009 from UNITED STATES Additional patient health information: Female , 28 years of age, . Gadolinium Contrast dosage: 20ml X1 Iv.

Fluid Retention, Gait Disturbance, Hepatic Function Abnormal, Hepatitis Toxic, Hypoaesthesia, Muscular Weakness, Nephrogenic Systemic Fibrosis, Oedema Peripheral, Pruritus
Adverse event was reported on Nov 25, 2009 by a Male taking Gadolinium Based Contrast Media (Dosage: N/A) was diagnosed with and. Location: SWEDEN , 47 years of age, weighting 121.3 lb, After Gadolinium was administered, patient encountered several Gadolinium side effects: fluid retention, gait disturbance, hepatic function abnormal, hepatitis toxic, hypoaesthesia, muscular weakness, nephrogenic systemic fibrosis, oedema peripheral, pruritus. Patient was hospitalized and became disabled.

Arthralgia, Cardiac Failure, Joint Contracture, Muscle Atrophy, Muscle Tightness, Musculoskeletal Stiffness, Myalgia, Nephrogenic Systemic Fibrosis, Oedema
on Nov 20, 2009 Female from SWEDEN , 47 years of age, weighting 116.8 lb, was diagnosed with and was treated with Gadolinium Based Contrast Agent. Directly after, patient experienced the unwanted or unexpected Gadolinium side effects: arthralgia, cardiac failure, joint contracture, muscle atrophy, muscle tightness, musculoskeletal stiffness, myalgia, nephrogenic systemic fibrosis, oedema. Gadolinium Based Contrast Agent dosage: N/A.
Associated medications used:
  • Furix
  • Centyl With Potassium Chloride
  • Voltaren
  • Mixtard Human Insulin
  • Actrapid Human Insulin
  • Calcium Carbonate
Patient was hospitalized and became disabled.

Nephrogenic Systemic Fibrosis
on Nov 24, 2009 Male from UNITED STATES , 67 years of age, was diagnosed with and was treated with Gadolinium. Patient felt the following Gadolinium side effects: nephrogenic systemic fibrosis. Gadolinium dosage: N/A.

Burning Sensation, Gait Disturbance, Mobility Decreased, Nephrogenic Systemic Fibrosis, Pain In Extremity, Skin Hypertrophy
Patient was taking Gadolinium. After Gadolinium was administered, patient encountered several Gadolinium side effects: burning sensation, gait disturbance, mobility decreased, nephrogenic systemic fibrosis, pain in extremity, skin hypertrophy on Nov 16, 2009 from UNITED STATES Additional patient health information: Female , 57 years of age, was diagnosed with and. Gadolinium dosage: N/A.

Hypoaesthesia, Muscle Tightness, Muscular Weakness, Musculoskeletal Stiffness, Nephrogenic Systemic Fibrosis, Paraesthesia
Adverse event was reported on Nov 16, 2009 by a Male taking Gadolinium (Dosage: N/A) was diagnosed with and. Location: UNITED STATES , 58 years of age, Directly after, patient experienced the unwanted or unexpected Gadolinium side effects: hypoaesthesia, muscle tightness, muscular weakness, musculoskeletal stiffness, nephrogenic systemic fibrosis, paraesthesia.
Associated medications used:

Nephrogenic Systemic Fibrosis
on Nov 24, 2009 Male from UNITED STATES , 63 years of age, was diagnosed with and was treated with Gadolinium. Patient felt the following Gadolinium side effects: nephrogenic systemic fibrosis. Gadolinium dosage: N/A.

Arthralgia, Cardiac Failure, Haemodialysis, Joint Contracture, Muscle Atrophy, Muscle Tightness, Musculoskeletal Stiffness, Myalgia, Nephrogenic Systemic Fibrosis
on Nov 20, 2009 Female from SWEDEN , 47 years of age, weighting 116.8 lb, was diagnosed with and was treated with Gadolinium Based Contrast Agent. After Gadolinium was administered, patient encountered several Gadolinium side effects: arthralgia, cardiac failure, haemodialysis, joint contracture, muscle atrophy, muscle tightness, musculoskeletal stiffness, myalgia, nephrogenic systemic fibrosis. Gadolinium Based Contrast Agent dosage: N/A.
Multiple concurrent drugs taken:
  • Furix
  • Centyl With Potassium Chloride
  • Voltaren
  • Mixtard Human Insulin
  • Actrapid Human Insulin
  • Calcium Carbonate
Patient was hospitalized and became disabled.

Burning Sensation, Gait Disturbance, Mobility Decreased, Nephrogenic Systemic Fibrosis, Pain In Extremity, Skin Hypertrophy
Patient was taking Gadolinium. Directly after, patient experienced the unwanted or unexpected Gadolinium side effects: burning sensation, gait disturbance, mobility decreased, nephrogenic systemic fibrosis, pain in extremity, skin hypertrophy on Nov 16, 2009 from UNITED STATES Additional patient health information: Female , 57 years of age, was diagnosed with and. Gadolinium dosage: N/A.

Hypoaesthesia, Muscle Tightness, Muscular Weakness, Musculoskeletal Stiffness, Nephrogenic Systemic Fibrosis, Paraesthesia
Adverse event was reported on Nov 16, 2009 by a Male taking Gadolinium (Dosage: N/A) was diagnosed with and. Location: UNITED STATES , 58 years of age, Patient felt the following Gadolinium side effects: hypoaesthesia, muscle tightness, muscular weakness, musculoskeletal stiffness, nephrogenic systemic fibrosis, paraesthesia.
Multiple prescriptions taken:

Arthralgia, Dizziness, Headache, Mobility Decreased, Muscular Weakness, Nephrogenic Systemic Fibrosis, Pruritus, Rash
on Oct 20, 2009 Patient from SWEDEN , 74 years of age, was diagnosed with and was treated with Gadolinium Based Contrast. After Gadolinium was administered, patient encountered several Gadolinium side effects: arthralgia, dizziness, headache, mobility decreased, muscular weakness, nephrogenic systemic fibrosis, pruritus, rash. Gadolinium Based Contrast dosage: N/A.
Multiple concurrent drugs taken:
  • Neorecormon
  • Venofer
  • Plendil
  • Magnyl/ Asa
  • Diural [furosemide]
  • Hexapress
  • Zyrtec
  • Phos-ex


Fluid Retention, Gait Disturbance, Hepatic Function Abnormal, Hepatitis Toxic, Hypoaesthesia, Muscular Weakness, Nephrogenic Systemic Fibrosis, Oedema Peripheral, Pruritus
on Feb 27, 2009 Male from SWEDEN , 47 years of age, was diagnosed with and was treated with Gadolinium Based Contrast Media. Directly after, patient experienced the unwanted or unexpected Gadolinium side effects: fluid retention, gait disturbance, hepatic function abnormal, hepatitis toxic, hypoaesthesia, muscular weakness, nephrogenic systemic fibrosis, oedema peripheral, pruritus. Gadolinium Based Contrast Media dosage: N/A. Patient was hospitalized and became disabled.

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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.

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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.

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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