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Muscle Weakness (8)
Abnormal Pigmentation (6)
Tremor (5)
Burning (5)
Dehydration (3)
Fever Joints Pains (3)
Nausea (3)
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Gadolinium Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 143 

Nausea, Vomiting (6519383-1)
on Dec 24, 2009 Female from UNITED STATES , 28 years of age, was treated with Gadolinium Contrast. Directly after, patient experienced the unwanted or unexpected Gadolinium side effects: nausea, vomiting. Gadolinium Contrast dosage: 20ml X1 Iv.

Fluid Retention, Gait Disturbance, Hepatic Function Abnormal, Hepatitis Toxic, Hypoaesthesia, Muscular Weakness, Nephrogenic Systemic Fibrosis, Oedema Peripheral, Pruritus (6479732-X)
Patient was taking Gadolinium Based Contrast Media. Patient felt the following Gadolinium side effects: fluid retention, gait disturbance, hepatic function abnormal, hepatitis toxic, hypoaesthesia, muscular weakness, nephrogenic systemic fibrosis, oedema peripheral, pruritus on Nov 25, 2009 from SWEDEN Additional patient health information: Male , 47 years of age, weighting 121.3 lb, was diagnosed with
  • scan with contrast
and. Gadolinium Based Contrast Media dosage: N/A. Patient was hospitalized and became disabled.

Arthralgia, Cardiac Failure, Joint Contracture, Muscle Atrophy, Muscle Tightness, Musculoskeletal Stiffness, Myalgia, Nephrogenic Systemic Fibrosis, Oedema (6479726-4)
Adverse event was reported on Nov 20, 2009 by a Female taking Gadolinium Based Contrast Agent (Dosage: N/A) was diagnosed with
  • scan with contrast
and. Location: SWEDEN , 47 years of age, weighting 116.8 lb, After Gadolinium was administered, patient encountered several Gadolinium side effects: arthralgia, cardiac failure, joint contracture, muscle atrophy, muscle tightness, musculoskeletal stiffness, myalgia, nephrogenic systemic fibrosis, oedema.
Multiple concurrent drugs taken:
  • Furix
  • Centyl With Potassium Chloride
  • Voltaren
  • Mixtard Human Insulin
  • Actrapid Human Insulin
  • Calcium Carbonate
Patient was hospitalized and became disabled.

Nephrogenic Systemic Fibrosis (6477836-9)
on Nov 24, 2009 Male from UNITED STATES , 67 years of age, was diagnosed with
  • angioplasty
  • angiogram
and was treated with Gadolinium. Directly after, patient experienced the unwanted or unexpected Gadolinium side effects: nephrogenic systemic fibrosis. Gadolinium dosage: N/A.


Burning Sensation, Gait Disturbance, Mobility Decreased, Nephrogenic Systemic Fibrosis, Pain In Extremity, Skin Hypertrophy (6477606-1)
on Nov 16, 2009 Female from UNITED STATES , 57 years of age, was diagnosed with
  • nuclear magnetic resonance imaging
and was treated with Gadolinium. Patient felt the following Gadolinium side effects: burning sensation, gait disturbance, mobility decreased, nephrogenic systemic fibrosis, pain in extremity, skin hypertrophy. Gadolinium dosage: N/A.

Hypoaesthesia, Muscle Tightness, Muscular Weakness, Musculoskeletal Stiffness, Nephrogenic Systemic Fibrosis, Paraesthesia (6477603-6)
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
  • nuclear magnetic resonance imaging brain
  • atrial fibrillation
and. Gadolinium dosage: N/A.
Multiple concurrent drugs taken:
  • Warfarin Sodium


Nephrogenic Systemic Fibrosis (6477334-2)
Adverse event was reported on Nov 24, 2009 by a Male taking Gadolinium (Dosage: N/A) was diagnosed with
  • angiogram
  • angioplasty
and. Location: UNITED STATES , 63 years of age, Directly after, patient experienced the unwanted or unexpected Gadolinium side effects: nephrogenic systemic fibrosis.

Arthralgia, Cardiac Failure, Haemodialysis, Joint Contracture, Muscle Atrophy, Muscle Tightness, Musculoskeletal Stiffness, Myalgia, Nephrogenic Systemic Fibrosis (6476181-5)
on Nov 20, 2009 Female from SWEDEN , 47 years of age, weighting 116.8 lb, was diagnosed with
  • scan with contrast
and was treated with Gadolinium Based Contrast Agent. Patient felt the following 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 prescriptions 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 (6462512-9)
on Nov 16, 2009 Female from UNITED STATES , 57 years of age, was diagnosed with
  • nuclear magnetic resonance imaging
and was treated with 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. Gadolinium dosage: N/A.

Hypoaesthesia, Muscle Tightness, Muscular Weakness, Musculoskeletal Stiffness, Nephrogenic Systemic Fibrosis, Paraesthesia (6462510-5)
Patient was taking Gadolinium. Directly after, patient experienced the unwanted or unexpected 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
  • nuclear magnetic resonance imaging brain
  • atrial fibrillation
and. Gadolinium dosage: N/A.
Associated medications used:
  • Warfarin Sodium


Arthralgia, Dizziness, Headache, Mobility Decreased, Muscular Weakness, Nephrogenic Systemic Fibrosis, Pruritus, Rash (6422998-2)
Adverse event was reported on Oct 20, 2009 by a Patient taking Gadolinium Based Contrast (Dosage: N/A) was diagnosed with
  • scan with contrast
and. Location: SWEDEN , 74 years of age, Patient felt the following Gadolinium side effects: arthralgia, dizziness, headache, mobility decreased, muscular weakness, nephrogenic systemic fibrosis, pruritus, rash.
Multiple prescriptions 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 (6420001-1)
on Feb 27, 2009 Male from SWEDEN , 47 years of age, was diagnosed with
  • scan with contrast
and was treated with Gadolinium Based Contrast Media. 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. Gadolinium Based Contrast Media dosage: N/A. Patient was hospitalized and became disabled.

Contrast Media Reaction, Feeling Abnormal, Gastrointestinal Disorder, Pain, Renal Disorder (6356542-5)
on Sep 11, 2009 Female from UNITED STATES , 51 years of age, weighting 155.0 lb, was diagnosed with
  • nuclear magnetic resonance imaging
and was treated with Gadolinium. Directly after, patient experienced the unwanted or unexpected Gadolinium side effects: contrast media reaction, feeling abnormal, gastrointestinal disorder, pain, renal disorder. Gadolinium dosage: 12cc Once Iv.

Pruritus, Urticaria (6355789-1)
Patient was taking Gadolinium. Patient felt the following Gadolinium side effects: pruritus, urticaria on Sep 11, 2009 from UNITED STATES Additional patient health information: Female , 35 years of age, . Gadolinium dosage: Xi Iv.

Abdominal Pain Upper, Arthralgia, Erythema, Eye Pain, Pain In Extremity, Pruritus, Skin Disorder (6317457-1)
Adverse event was reported on Aug 20, 2009 by a Male taking Gadolinium Based Contrast Agent (Dosage: N/A) was diagnosed with
  • musculoskeletal discomfort
  • nuclear magnetic resonance imaging
and. Location: UNITED STATES , weighting 165.0 lb, After Gadolinium was administered, patient encountered several Gadolinium side effects: abdominal pain upper, arthralgia, erythema, eye pain, pain in extremity, pruritus, skin disorder.

Blood Pressure Fluctuation, Dysstasia, Gait Disturbance, Hypersensitivity, Malaise, Oedema Peripheral, Pain In Extremity, Skin Fibrosis (6300977-3)
on Aug 06, 2009 Male from UNITED STATES , 38 years of age, weighting 210.0 lb, was treated with Gadolinium Contrast Dye. Directly after, patient experienced the unwanted or unexpected Gadolinium side effects: blood pressure fluctuation, dysstasia, gait disturbance, hypersensitivity, malaise, oedema peripheral, pain in extremity, skin fibrosis. Gadolinium Contrast Dye dosage: N/A. Patient was hospitalized and became disabled.

Urticaria (6295699-1)
on Aug 03, 2009 Female from UNITED STATES , 84 years of age, was diagnosed with
  • nuclear magnetic resonance imaging
and was treated with Gadolinium Contrast Dye. Patient felt the following Gadolinium side effects: urticaria. Gadolinium Contrast Dye dosage: 17cc X1 Iv.

Dyspnoea, Wheezing (6232230-0)
Patient was taking Gadolinium. After Gadolinium was administered, patient encountered several Gadolinium side effects: dyspnoea, wheezing on Jun 16, 2009 from UNITED STATES Additional patient health information: Female , 54 years of age, weighting 140.0 lb, was diagnosed with
  • nuclear magnetic resonance imaging
  • scan with contrast
and. Gadolinium dosage: 14ml X1 Iv.

Asthma, Chest Discomfort, Contrast Media Allergy (6213938-X)
Adverse event was reported on Jun 01, 2009 by a Female taking Gadolinium (Dosage: N/A) was diagnosed with
  • nuclear magnetic resonance imaging
and. Location: UNITED STATES , 33 years of age, weighting 122.0 lb, Directly after, patient experienced the unwanted or unexpected Gadolinium side effects: asthma, chest discomfort, contrast media allergy.

Pharyngeal Disorder, Pruritus (6189002-5)
on May 12, 2009 Female from UNITED STATES , 79 years of age, weighting 200.0 lb, was diagnosed with
  • nuclear magnetic resonance imaging brain
and was treated with Gadolinium. Patient felt the following Gadolinium side effects: pharyngeal disorder, pruritus. Gadolinium dosage: 15ml X1 Iv.

Dyspnoea, Throat Tightness (6188996-1)
on May 12, 2009 Female from UNITED STATES , 55 years of age, was diagnosed with
  • nuclear magnetic resonance imaging
and was treated with Gadolinium. After Gadolinium was administered, patient encountered several Gadolinium side effects: dyspnoea, throat tightness. Gadolinium dosage: 15 Ml X1 Iv.

Fibromyalgia, Lyme Disease, Nephrogenic Systemic Fibrosis, Scleroderma, Systemic Sclerosis, Weight Fluctuation (6130003-0)
Patient was taking Gadolinium. Directly after, patient experienced the unwanted or unexpected Gadolinium side effects: fibromyalgia, lyme disease, nephrogenic systemic fibrosis, scleroderma, systemic sclerosis, weight fluctuation on Mar 23, 2009 from UNITED STATES Additional patient health information: Female , 51 years of age, was diagnosed with
  • nuclear magnetic resonance imaging abnormal
and. Gadolinium dosage: N/A.
Associated medications used:
  • Mri Procedure


Arthropathy, Hypokalaemia, Joint Lock, Muscle Contractions Involuntary, Nephrogenic Systemic Fibrosis, Pain, Rash Macular, Skin Lesion (6122101-2)
Adverse event was reported on Mar 16, 2009 by a Male taking Gadolinium (Dosage: N/A) was diagnosed with
  • enzyme abnormality
  • hepatitis
  • nuclear magnetic resonance imaging
and. Location: UNITED STATES , 56 years of age, weighting 178.0 lb, Patient felt the following Gadolinium side effects: arthropathy, hypokalaemia, joint lock, muscle contractions involuntary, nephrogenic systemic fibrosis, pain, rash macular, skin lesion.

Amnesia, Confusional State, Fatigue, Headache, Influenza Like Illness, Post Procedural Complication (6094116-4)
on Feb 24, 2009 Male from UNITED STATES , 45 years of age, weighting 180.0 lb, was diagnosed with
  • nuclear magnetic resonance imaging brain
and was treated with Gadolinium. After Gadolinium was administered, patient encountered several Gadolinium side effects: amnesia, confusional state, fatigue, headache, influenza like illness, post procedural complication. Gadolinium dosage: Iv.

Arthralgia, Musculoskeletal Stiffness, Pallor, Swelling (6072214-9)
on Feb 06, 2009 Female from UNITED STATES , 36 years of age, weighting 194.0 lb, was diagnosed with
  • computerised tomogram
and was treated with Gadolinium. Directly after, patient experienced the unwanted or unexpected Gadolinium side effects: arthralgia, musculoskeletal stiffness, pallor, swelling. Gadolinium dosage: Iv One Tiem Dose For Mri.

Showing 1-25 of 143 

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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.

Gadolinium Information

More About Gadolinium

Side Effects reported to FDA: 143. View Gadolinium Adverse Reports

Gadolinium safety alerts: 2010 2007 2006

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)

 

[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]

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