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Review Gadolinium Severe upper respiratory inflammation & irritation, face swelled up in View Gadolinium Adverse Event Reports: patient, 65 years of age, weighting 192.0 lb, took Gadolinium Patient was hospitalized.

Learn What Others Think about Gadolinium Side Effects. Have Your experienced Gadolinium Side Effects? You are not alone. Many patients report unusual symptoms after using Gadolinium. This forum raises awareness about Gadolinium Side Effects.

What Are Your Gadolinium Side Effects
Abnormal Pigmentation (6)
Muscle Weakness (6)
Burning (4)
Tremor (4)
Rash (3)
Dehydration (2)
Fever Joints Pains (2)
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Common Gadolinium Side Effects

top 5 Gadolinium|Abnormal p|Muscle wea|Burning|Tremor|Rash|Dehydratio|Fever join adverse effects

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Showing 1-25 of 143 

Immediate Post-injection Reaction, Loss Of Consciousness, Blood Pressure Decreased, Contrast Media Reaction, Vomiting, Nausea (8076381-7)
on Jan 27, 2012 Female patient from UNITED STATES , 65 years of age, weighting 192.0 lb, was treated with Gadolinium(View Usage). Patient experienced the following unwanted or unexpected effects: immediate post-injection reaction, loss of consciousness, blood pressure decreased, contrast media reaction, vomiting, nausea (nausea Questions). Gadolinium dosage: N/A. Patient was hospitalized.

Hypoaesthesia, Pruritus, Injection Site Mass, Hyperhidrosis, Paraesthesia, Oedema Peripheral, Weight Increased, Night Sweats, Muscle Twitching (8011236-5)
Patient was taking Gadolinium (View Usage). Patient had the following 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 patient , 44 years of age, weighting 175.0 lb, was diagnosed with
  • optic neuritis
  • investigation
and. Gadolinium dosage: 1 Injection.

Ear Pruritus (7828548-8)
Adverse event was reported on Oct 20, 2011 by a Male patient taking Gadolinium (View Usage) (Dosage: N/A) was diagnosed with
  • diagnostic procedure
and. Location: UNITED STATES , 20 years of age, After Gadolinium was administered, patient had the following side effects: ear pruritus.

Crying, Gait Disturbance, Tremor, Back Pain, Acne, Meningioma, Condition Aggravated, Skin Ulcer (7759512-5)
on Sep 19, 2011 Female patient from UNITED STATES , 50 years of age, weighting 162.0 lb, was diagnosed with
  • decreased appetite
  • crying
  • gait disturbance
  • tremor
  • muscular weakness
  • pain (pain Questions)
  • flank pain
and was treated with Gadolinium Mri Contrast Dye (View Usage). Patient experienced the following unwanted or unexpected effects: crying, gait disturbance, tremor, back pain (back pain Questions), acne (acne Questions), meningioma, condition aggravated, skin ulcer. Gadolinium Mri Contrast Dye dosage: ?.


Abasia, Dysstasia, Back Pain (7685768-3)
on Aug 15, 2011 Male patient from UNITED STATES , 36 years of age, weighting 140.0 lb, was treated with Gadolinium Used For Mri(View Usage). Patient had the following side effects: abasia, dysstasia, back pain (back pain Questions). Gadolinium Used For Mri dosage: N/A.

Joint Stiffness, Bone Pain, Fall, Progressive Multiple Sclerosis, Movement Disorder (7582903-2)
Patient was taking Gadolinium-based Contrast Agents (View Usage). After Gadolinium was administered, patient had the following side effects: joint stiffness, bone pain, fall (fall Questions), progressive multiple sclerosis, movement disorder (movement disorder Questions) on Jun 27, 2011 from UNITED STATES Additional patient health information: Female patient , weighting 130.0 lb, was diagnosed with
  • progressive multiple sclerosis
  • nuclear magnetic resonance imaging
and. Gadolinium-based Contrast Agents dosage: 1 Time Iv.

Contrast Media Reaction, Dizziness, Brain Oedema, Influenza Like Illness, Urticaria, Nausea, Nerve Injury, Headache, Pain (7370997-9)
Adverse event was reported on Mar 21, 2011 by a Female patient taking Gadolinium Based Contrast Agents (View Usage) (Dosage: Once) was diagnosed with
  • nuclear magnetic resonance imaging
  • scan with contrast
and. Location: UNITED STATES , 44 years of age, weighting 115.0 lb, Patient experienced the following unwanted or unexpected effects: contrast media reaction, dizziness (dizziness Questions), brain oedema, influenza like illness, urticaria, nausea (nausea Questions), nerve injury, headache (headache Questions), pain (pain Questions).

Myalgia, Muscle Spasms, Malaise, Pruritus, Pain, Chest Discomfort, Rash (7329391-9)
on Feb 25, 2011 Male patient from UNITED STATES , 57 years of age, weighting 208.0 lb, was diagnosed with
  • nuclear magnetic resonance imaging
and was treated with Gadolinium N/a N/a (View Usage). Patient had the following side effects: myalgia, muscle spasms, malaise, pruritus, pain (pain Questions), chest discomfort, rash (rash Questions). Gadolinium N/a N/a dosage: -injection Type Dve.

Tremor, Feeling Abnormal (7328897-6)
on Feb 25, 2011 Female patient from UNITED STATES , 65 years of age, weighting 115.0 lb, was treated with Gadolinium(View Usage). After Gadolinium was administered, patient had the following side effects: tremor, feeling abnormal. Gadolinium dosage: Iv. Patient was hospitalized.

Dialysis, Contraindication To Medical Treatment (7274371-5)
Patient was taking Gadolinium (View Usage). Patient experienced the following unwanted or unexpected effects: dialysis (dialysis Questions), contraindication to medical treatment on Feb 01, 2011 from UNITED STATES Additional patient health information: Female patient , 34 years of age, weighting 157.4 lb, was diagnosed with
  • nuclear magnetic resonance imaging
and. Gadolinium dosage: Gadolinium Once Iv Bolus. Patient was hospitalized.

Contrast Media Reaction, Lung Disorder, Musculoskeletal Stiffness, Radiation Injury, Trismus (7175775-1)
Adverse event was reported on Dec 15, 2010 by a Female patient taking Gadolinium (View Usage) (Dosage: N/A) . Location: UNITED STATES , weighting 120.0 lb, Patient had the following side effects: contrast media reaction, lung disorder, musculoskeletal stiffness, radiation injury, trismus.

Arthralgia, Bone Pain, Dyspepsia, Dyspnoea Exertional, Epilepsy, Fatigue, Gait Disturbance, Gastrooesophageal Reflux Disease (7050339-9)
on Oct 11, 2010 Male patient from DENMARK , 69 years of age, was diagnosed with
  • scan with contrast
  • nuclear magnetic resonance imaging brain
and was treated with Gadolinium Contrast (View Usage). After Gadolinium was administered, patient had the following side effects: arthralgia, bone pain, dyspepsia, dyspnoea exertional, epilepsy (epilepsy Questions), fatigue, gait disturbance, gastrooesophageal reflux disease. Gadolinium Contrast dosage: N/A.
Patient was taking other medications: Patient was hospitalized and became disabled.

Appetite Disorder, Arthralgia, Asthenia, Calcinosis, Fatigue, Gait Disturbance, Gastric Ulcer Haemorrhage, Hypoaesthesia, Joint Range Of Motion Decreased (6973396-4)
on Aug 27, 2010 Male patient from DENMARK , 61 years of age, weighting 191.8 lb, was diagnosed with
  • scan with contrast
and was treated with Gadolinium Contrast -unk Mah(View Usage). Patient experienced the following unwanted or unexpected 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 (6963583-3)
Patient was taking Gadolinium Contrast (View Usage). Patient had the following 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 patient , 67 years of age, weighting 187.4 lb, was diagnosed with and. Gadolinium Contrast dosage: N/A.
Patient was taking other medications:

Contusion, Deformity, Pruritus, Rash Papular, Skin Discolouration (6868762-1)
Adverse event was reported on Jul 21, 2010 by a Female patient taking Gadolinium (View Usage) (Dosage: N/A) was diagnosed with
  • neck pain
and. Location: UNITED STATES , 51 years of age, weighting 135.0 lb, After Gadolinium was administered, patient had the following side effects: contusion, deformity, pruritus, rash papular, skin discolouration.

Abdominal Distension, Abdominal Pain, Flatulence (6763272-4)
on Jun 08, 2010 Female patient from UNITED STATES , 68 years of age, weighting 144.0 lb, was diagnosed with
  • nuclear magnetic resonance imaging
and was treated with Gadolinium ?? ?? (View Usage). Patient experienced the following unwanted or unexpected effects: abdominal distension, abdominal pain (abdominal pain Questions), flatulence. Gadolinium ?? ?? dosage: N/A.

Pruritus, Urticaria (6703004-9)
on Apr 29, 2010 Male patient from UNITED STATES , 49 years of age, was diagnosed with
  • nuclear magnetic resonance imaging
and was treated with Gadolinium(View Usage). Patient had the following side effects: pruritus, urticaria. Gadolinium dosage: N/A.
Patient was taking other medications:

Hypoaesthesia, Muscle Tightness, Muscular Weakness, Musculoskeletal Stiffness, Nephrogenic Systemic Fibrosis, Paraesthesia (6617338-X)
Patient was taking Gadolinium (View Usage). After Gadolinium was administered, patient had the following 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 patient , 58 years of age, was diagnosed with and. Gadolinium dosage: N/A.
Patient was taking other medications:

Burning Sensation, Gait Disturbance, Mobility Decreased, Nephrogenic Systemic Fibrosis, Pain In Extremity, Skin Hypertrophy (6617312-3)
Adverse event was reported on Nov 16, 2009 by a Female patient taking Gadolinium (View Usage) (Dosage: N/A) was diagnosed with
  • nuclear magnetic resonance imaging
and. Location: UNITED STATES , 57 years of age, Patient experienced the following unwanted or unexpected effects: burning sensation, gait disturbance, mobility decreased, nephrogenic systemic fibrosis, pain in extremity, skin hypertrophy.

Contrast Media Reaction, Nausea (6614137-X)
on Mar 03, 2010 Female patient from UNITED STATES , 64 years of age, was diagnosed with
  • nuclear magnetic resonance imaging
and was treated with Gadolinium Injection (View Usage). Patient had the following side effects: contrast media reaction, nausea (nausea Questions). Gadolinium Injection dosage: 15 Ml X1 Iv.

Anxiety, Asthenia, Muscle Spasms, Musculoskeletal Stiffness, Neuromyopathy, Pain (6608394-3)
on Feb 25, 2010 Female patient from UNITED STATES , weighting 114.2 lb, was diagnosed with
  • adenomyosis
  • optic neuritis
and was treated with Gadolinium Injection(View Usage). After Gadolinium was administered, patient had the following side effects: anxiety (anxiety Questions), asthenia, muscle spasms, musculoskeletal stiffness, neuromyopathy, pain (pain Questions). Gadolinium Injection dosage: N/A.

Diabetic End Stage Renal Disease, Muscular Weakness, Peritoneal Dialysis (6596852-X)
Patient was taking Gadolinium (View Usage). Patient experienced the following unwanted or unexpected effects: diabetic end stage renal disease, muscular weakness, peritoneal dialysis on Feb 22, 2010 from UNITED STATES Additional patient health information: Male patient , weighting 167.0 lb, was diagnosed with
  • nuclear magnetic resonance imaging
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 (6544212-X)
Adverse event was reported on Jan 19, 2010 by a Male patient taking Gadolinium (View Usage) (Dosage: Injections During Test) was diagnosed with
  • nuclear magnetic resonance imaging
and. Location: UNITED STATES , 56 years of age, weighting 253.0 lb, Patient had the following side effects: abasia, arthralgia, burning sensation, impaired driving ability, oedema peripheral, pain in extremity, radiation skin injury, rash (rash Questions).

Cardiac Failure, Nephrogenic Systemic Fibrosis, Systemic Sclerosis (6543171-3)
on Jan 14, 2010 Male patient from SWEDEN , 47 years of age, weighting 116.8 lb, was diagnosed with
  • scan with contrast
and was treated with Gadoliniumholdig Kontrast -unk Mah (View Usage). After Gadolinium was administered, patient had the following 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 (6539827-9)
on Jan 04, 2010 Male patient from SWEDEN , 47 years of age, weighting 116.8 lb, was treated with Gadoliniumholdig Kontrast -unk Mah(View Usage). Patient experienced the following unwanted or unexpected effects: cardiac failure, nephrogenic systemic fibrosis, systemic sclerosis. Gadoliniumholdig Kontrast -unk Mah dosage: N/A. Patient was hospitalized and became disabled.

Showing 1-25 of 143 


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Gadolinium Adverse Effect Reports (FDA)

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

Gadolinium safety alerts: 2010 2007 2006

Reported deaths: 4

Reported hospitalizations: 20

1Muscle Weakness
2Abnormal Pigmentation
3Burning
4Tremor
5Rash
6Migraine
7Foot Tuning Inward
8Nausea
9Swelling
10Dehydration
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Burning joints and muscles. Cramping and inflexible

Feet and hands swelled. Writhing and gyrating.

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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]

further research and contacting my doctor

When did you start feeling unusual symptoms? what was the first symptom? Did your symptoms get worse over time? Did you have similar symptoms before using Gadolinium? What did Your doctor say? Share Your Story

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Gadolinium Adverse Reactions
Nephrogenic Fibrosing Dermopathy ( 27 Reports)
Nephrogenic Systemic Fibrosis ( 25 Reports)
Pruritus ( 18 Reports)
Arthralgia ( 17 Reports)
Oedema Peripheral ( 16 Reports)
Dyspnoea ( 13 Reports)
Gait Disturbance ( 13 Reports)
Musculoskeletal Stiffness ( 13 Reports)
Pain In Extremity ( 12 Reports)
Hypoaesthesia ( 11 Reports)
Muscular Weakness ( 11 Reports)
Pain ( 11 Reports) Pain Questions
Erythema ( 10 Reports)
Asthenia ( 9 Reports)
Headache ( 9 Reports) Headache Questions
Nausea ( 9 Reports) Nausea Questions
Paraesthesia ( 8 Reports)
Vomiting ( 8 Reports)
Contrast Media Reaction ( 7 Reports)
Mobility Decreased ( 7 Reports)
Myalgia ( 7 Reports)
Skin Hypertrophy ( 7 Reports)
Urticaria ( 7 Reports)
Burning Sensation ( 6 Reports)
Dialysis ( 6 Reports) Dialysis Questions
Dizziness ( 6 Reports) Dizziness Questions
Malaise ( 6 Reports)
Fatigue ( 5 Reports)
Ill-defined Disorder ( 5 Reports)
Muscle Tightness ( 5 Reports)

side effects
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