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Magnevist (Gadopentetate) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Magnevist (Gadopentetate) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (732)
Death (45)
Life Threatening Events (7)
Disability (45)

Reports by Reaction Type

Nephrogenic Systemic Fibrosis (284)Pain (217)Skin Induration (158)Anxiety (135)Mobility Decreased (134)Pruritus (128)Skin Tightness (125)Oedema Peripheral (122)Emotional Distress (118)Skin Hypertrophy (110)Urticaria (103)Joint Range of Motion Decreased (102)

Below are a few examples of reports where side effects / adverse reactions may be related to Magnevist (Gadopentetate). For a complete list or a specific selection of reports, please use the links above.

Possible Magnevist side effects in 48 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: 48 year old female

Reactions: Pruritus, Nausea, Urticaria

Drug(s) suspected as cause:
Magnevist



Possible Magnevist side effects in

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient:

Reactions: Throat Irritation, Cough

Drug(s) suspected as cause:
Gadavist

Magnevist



Possible Magnevist side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient:

Reactions: NO Adverse Event

Drug(s) suspected as cause:
Magnevist



Possible Magnevist side effects in 79 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: 79 year old male

Reactions: Joint Contracture, Skin Disorder, Muscular Weakness, Hypoaesthesia, Nephrogenic Systemic Fibrosis, Skin Induration, Muscle Rigidity, Balance Disorder, Grip Strength Decreased, Musculoskeletal Stiffness, Oedema, Depression, Gait Disturbance, Asthenia, Mobility Decreased

Drug(s) suspected as cause:
Gadolinium IN Unspecified Drug
    Dosage: unk
    Start date: 2005-08-06

Gadolinium IN Unspecified Drug
    Dosage: unk
    Start date: 2006-02-01
    End date: 2006-02-01

Gadolinium IN Unspecified Drug
    Dosage: unk
    Indication: Nuclear Magnetic Resonance Imaging
    Start date: 2003-11-28
    End date: 2003-11-28

Gadolinium IN Unspecified Drug
    Dosage: unk, once
    Start date: 2006-09-27
    End date: 2006-09-27

Magnevist
    Dosage: 20 ml, once
    Indication: Nuclear Magnetic Resonance Imaging Abdominal
    Start date: 2006-11-20
    End date: 2006-11-20

Other drugs received by patient: Nephrocaps [vit C,vit H,b12,b9,b3,pantothen Ac,b6,b2,b1 Hcl]; Toprol-XL; Allopurinol; Reglan; Simvastatin; Gabapentin; Insulin; Warfarin Sodium; Phoslo; Prevacid



Possible Magnevist side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: male

Reactions: Joint Contracture, Skin Disorder, Muscular Weakness, Hypoaesthesia, Skin Induration, Nephrogenic Systemic Fibrosis, Muscle Rigidity, Balance Disorder, Grip Strength Decreased, Musculoskeletal Stiffness, Oedema, Depression, Gait Disturbance, Asthenia, Mobility Decreased

Adverse event resulted in: death

Drug(s) suspected as cause:
Gadolinium IN Unspecified Drug
    Dosage: unk, once
    Indication: Nuclear Magnetic Resonance Imaging
    Start date: 2006-09-27
    End date: 2006-09-27

Gadolinium IN Unspecified Drug
    Dosage: unk unk, once
    Start date: 2003-11-28
    End date: 2003-11-28

Gadolinium IN Unspecified Drug

Gadolinium IN Unspecified Drug
    Dosage: unk
    Start date: 2006-02-01
    End date: 2006-02-01

Gadolinium IN Unspecified Drug
    Dosage: unk
    Start date: 2005-08-06

Magnevist
    Dosage: 20 ml, once
    Indication: Nuclear Magnetic Resonance Imaging
    Start date: 2006-11-20
    End date: 2006-11-20

Magnevist
    Indication: Pancreatic Mass

Other drugs received by patient: Nephrocaps; Gabapentin; Phoslo; Toprol-XL; Reglan; Warfarin Sodium; Allopurinol; Insulin; Prevacid; Simvastatin



Possible Magnevist side effects in 50 year old female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: 50 year old female, weighing 95.5 kg (210.2 pounds)

Reactions: Pain, Skin Induration, Skin Hyperpigmentation, Nephrogenic Systemic Fibrosis, Rash, Anxiety, Emotional Distress, Anhedonia, Skin Discolouration, Post Thrombotic Syndrome, Skin Mass, Ocular Icterus, Injury, Depression, Mobility Decreased

Adverse event resulted in: death, disablity

Drug(s) suspected as cause:
Magnevist
    Dosage: unk
    Indication: Cardiac Imaging Procedure
    Start date: 2003-08-12
    End date: 2003-08-12

Magnevist
    Dosage: unk
    Indication: Renal Scan
    Start date: 2003-08-07
    End date: 2003-08-07

Magnevist
    Dosage: unk
    Start date: 2004-02-03
    End date: 2004-02-03

Other drugs received by patient: Clonidine; Sodium Bicarbonate; Calcium Carbonate; Lopressor; Sevelamer Hydrochloride; Atorvastatin; Warfarin Sodium; Rapamune; Epogen; Diltiazem; Benicar



Possible Magnevist side effects in 74 year old male

Reported by a consumer/non-health professional from China on 2012-08-23

Patient: 74 year old male

Reactions: Hyperventilation, Agitation, Laryngeal Oedema, Salivary Hypersecretion, Somnolence

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Magnevist



Possible Magnevist side effects in 56 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23

Patient: 56 year old male

Reactions: Cellulitis, Oedema Peripheral, Inflammation

Drug(s) suspected as cause:
Magnevist



Possible Magnevist side effects in 49 year old male

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: 49 year old male

Reactions: Hypersensitivity, Erythema

Drug(s) suspected as cause:
Magnevist



Possible Magnevist side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-20

Patient:

Reactions: Injection Site Haemorrhage

Drug(s) suspected as cause:
Magnevist



Possible Magnevist side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-20

Patient:

Reactions: Injection Site Haemorrhage

Drug(s) suspected as cause:
Magnevist



Possible Magnevist side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: male

Reactions: Pain, Abasia, Nephrogenic Systemic Fibrosis, Skin Tightness, Anxiety, Anhedonia, Balance Disorder, Skin Lesion, Depression, Mobility Decreased, Extremity Contracture

Adverse event resulted in: death

Drug(s) suspected as cause:
Gadolinium IN Unspecified Drug
    Dosage: unk
    Indication: Nuclear Magnetic Resonance Imaging Abdominal
    Start date: 2006-11-13

Magnevist

Omniscan

Other drugs received by patient: Hectorol; Coumadin; Metoclopramide; Aspirin; Klor-CON



Possible Magnevist side effects in 61 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17

Patient: 61 year old male, weighing 124.0 kg (272.8 pounds)

Reactions: Wheelchair User, Pain, Hypoaesthesia, Nephrogenic Systemic Fibrosis, Skin Induration, Paraesthesia, Skin Tightness, Pruritus Generalised, Joint Range of Motion Decreased, Skin Discolouration, Oedema Peripheral, Musculoskeletal Stiffness, Asthenia, Extremity Contracture, Mobility Decreased

Adverse event resulted in: death

Drug(s) suspected as cause:
Gadolinium IN Unspecified Drug
    Indication: Nuclear Magnetic Resonance Imaging
    Start date: 2005-01-01
    End date: 2005-01-01

Magnevist
    Dosage: 15 ml (daily dose), once,
    Indication: Nuclear Magnetic Resonance Imaging
    Start date: 2000-08-11
    End date: 2000-08-11

Magnevist
    Dosage: 15 ml (daily dose), once,
    Start date: 2001-07-27
    End date: 2001-07-27

Other drugs received by patient: Nephrocaps; Phoslo; Metronidazole; Renagel; Coreg; Prinivil; Atenolol; Warfarin Sodium; Darvocet; Vancocin Hydrochloride; Sodium Bicarbonate; Iron [iron]; Amoxicillin; Nephrocaps [vit C,vit H,b12,b9,b3,pantothen Ac,b6,b2,b1 Hcl]; Hydrocodone Bitartrate and Acetaminophen; Tylenol with Codein #3; Phoslo; Solivito N [vit C,vit H,b12,b9,b3,pantothenic Ac,b6,b2,b1 Hcl]; Aspirin; Vitamin B6; Coreg; Epogen; Diltiazem; Plendil; Plendil; Lisinopril



Possible Magnevist side effects in 47 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17

Patient: 47 year old female

Reactions: Injection Site Urticaria, Urticaria

Drug(s) suspected as cause:
Magnevist



Possible Magnevist side effects in 47 year old female

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: 47 year old female

Reactions: Fear of Death, Pain, Fear, General Physical Health Deterioration, Skin Induration, Nephrogenic Systemic Fibrosis, Deformity, Joint Stiffness, Anxiety, Emotional Distress, Anhedonia, Joint Range of Motion Decreased, Injury, Depression, Nervousness, Scar

Drug(s) suspected as cause:
Magnevist



Possible Magnevist side effects in 9 year old female

Reported by a health professional (non-physician/pharmacist) from Poland on 2012-08-16

Patient: 9 year old female, weighing 33.0 kg (72.6 pounds)

Reactions: Hypoacusis, Visual Impairment, Headache

Drug(s) suspected as cause:
Magnevist



Possible Magnevist side effects in 9 year old female

Reported by a health professional (non-physician/pharmacist) from Poland on 2012-08-16

Patient: 9 year old female, weighing 33.0 kg (72.6 pounds)

Reactions: Hypoacusis, Visual Impairment, Headache

Drug(s) suspected as cause:
Magnevist



Possible Magnevist side effects in 58 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-16

Patient: 58 year old male, weighing 118.0 kg (259.6 pounds)

Reactions: Skin Exfoliation, Quality of Life Decreased, Pain, Erythema, Joint Stiffness, Skin Discolouration, Joint Range of Motion Decreased, Oedema Peripheral, Injury, Fibrosis, Blood Creatinine Increased, Extremity Contracture, Blister, Muscle Contracture, Rash Papular, Contrast Media Reaction, Skin Disorder, General Physical Health Deterioration, Skin Induration, Nephrogenic Systemic Fibrosis, Skin Hypertrophy, Deformity, Skin Tightness, Skin Plaque, Emotional Distress, Anxiety, Burning Sensation, Renal Failure

Adverse event resulted in: death

Drug(s) suspected as cause:
Magnevist

Other drugs received by patient: Calcium Acetate; Irbesartan; Clonidine; Hydralazine HCL; Visipaque; Visipaque; Glipizide; Ferrous Sulfate TAB; Nephrovite [vit C,vit H,b5,b12,b9,b3,b6,b2,b1 Hcl]; Metoprolol Tartrate; Sevelamer Hydrochloride; Terazosin Hydrochloride; Dovonex; Contrast Media; Contrast Media; Synthroid; Aspirin; Felodipine; Contrast Media; Lasix; Omniscan; Folic Acid; Iron; Insulin; EPO



Possible Magnevist side effects in male

Reported by a lawyer from United States on 2012-08-14

Patient: male, weighing 91.0 kg (200.2 pounds)

Reactions: Nephrogenic Systemic Fibrosis

Adverse event resulted in: death

Drug(s) suspected as cause:
Contrast Media
    Indication: Diabetic Foot
    Start date: 2002-11-05
    End date: 2002-11-05

Contrast Media
    Indication: Nuclear Magnetic Resonance Imaging
    Start date: 2002-11-05
    End date: 2002-11-05

Contrast Media
    Start date: 2005-01-14
    End date: 2005-01-14

Contrast Media
    Indication: Osteomyelitis
    Start date: 2002-11-05
    End date: 2002-11-05

Magnevist
    Indication: Nuclear Magnetic Resonance Imaging
    Start date: 2002-10-16
    End date: 2002-10-16

Magnevist
    Dosage: once
    Start date: 2002-11-15
    End date: 2002-11-15

Magnevist
    Dosage: once
    Start date: 2004-07-16
    End date: 2004-07-16

Magnevist
    Dosage: once
    Indication: Angiogram
    Start date: 2005-01-25
    End date: 2005-01-25

Prohance
    Indication: Angiogram
    Start date: 2002-10-16
    End date: 2002-10-16

Prohance
    Indication: Nuclear Magnetic Resonance Imaging
    Start date: 2002-10-16
    End date: 2002-10-16

Other drugs received by patient: Accupril; Epogen; Diatx; Fosrenol; Clonidine; Insulin Human; Temazepam; Sevelamer Hydrochloride; Vitamins NOS; Insulin; Coumadin; Minoxidil; Lasix; Calcium Acetate



Possible Magnevist side effects in 69 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-14

Patient: 69 year old male

Reactions: Subcutaneous Nodule, Pain in Extremity, Skin Exfoliation, Abasia, Muscular Weakness, Skin Induration, DRY Skin, Nephrogenic Systemic Fibrosis, Skin Hyperpigmentation, Muscle Tightness, Skin Fissures, Skin Plaque, Hand Deformity, Skin Discolouration, Oedema Peripheral, Nodule, Injury, Mobility Decreased

Drug(s) suspected as cause:
Gadolinium IN Unspecified Drug
    Dosage: unk
    Indication: Nuclear Magnetic Resonance Imaging Abdominal
    Start date: 2004-04-21
    End date: 2004-04-21

Gadolinium IN Unspecified Drug
    Dosage: unk
    Indication: Angiogram
    Start date: 2004-04-13
    End date: 2004-04-13

Magnevist
    Dosage: unk
    Indication: Nuclear Magnetic Resonance Imaging Spinal
    Start date: 2005-02-22
    End date: 2005-02-22

Other drugs received by patient: Nephrovite [vit C,vit H,b5,b12,b9,b3,b6,b2,b1 Hcl]; Minoxidil; Zemplar; Doxazosin Mesylate; Sensipar; Folic Acid; Isosorbide; Allopurinol; Oxycontin; Epogen; Crestor; Phoslo



Possible Magnevist side effects in 24 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-13

Patient: 24 year old female

Reactions: Productive Cough, Pruritus, Nausea, Dizziness, Cough

Drug(s) suspected as cause:
Magnevist



Possible Magnevist side effects in 55 year old female

Reported by a consumer/non-health professional from United States on 2012-08-13

Patient: 55 year old female

Reactions: Contrast Media Allergy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Magnevist



Possible Magnevist side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-10

Patient: male, weighing 91.0 kg (200.2 pounds)

Reactions: Pain, Joint Contracture, Muscle Fibrosis, Muscle Tightness, Myosclerosis, Fatigue, Anhedonia, Joint Range of Motion Decreased, Oedema Peripheral, Depression, Injury, Extremity Contracture, Nephrogenic Systemic Fibrosis, Skin Induration, Skin Tightness, Anxiety, Emotional Distress, Activities of Daily Living Impaired, Frustration

Adverse event resulted in: death

Drug(s) suspected as cause:
Gadolinium IN Unspecified Drug
    Indication: Osteomyelitis

Gadolinium IN Unspecified Drug
    Indication: Diabetic Foot

Gadolinium IN Unspecified Drug
    Dosage: unk
    Indication: Nuclear Magnetic Resonance Imaging
    Start date: 2002-11-05
    End date: 2002-11-05

Gadolinium IN Unspecified Drug
    Dosage: unk
    Start date: 2005-01-14
    End date: 2005-01-14

Magnevist
    Dosage: 15 ml, once
    Indication: Angiogram
    Start date: 2002-10-16
    End date: 2002-10-16

Magnevist
    Dosage: unk unk, once
    Start date: 2005-01-25
    End date: 2005-01-25

Magnevist
    Dosage: unk unk, once
    Indication: Nuclear Magnetic Resonance Imaging
    Start date: 2002-11-15
    End date: 2002-11-15

Magnevist
    Dosage: 19 ml, once
    Start date: 2004-07-16
    End date: 2004-07-16

Multihance
    Indication: Angiogram

Multihance
    Indication: Nuclear Magnetic Resonance Imaging

Omniscan
    Indication: Angiogram

Omniscan
    Indication: Nuclear Magnetic Resonance Imaging

Optimark
    Indication: Nuclear Magnetic Resonance Imaging

Optimark
    Indication: Angiogram

Prohance
    Dosage: unk unk, once
    Indication: Angiogram
    Start date: 2002-10-16
    End date: 2002-10-16

Prohance
    Indication: Nuclear Magnetic Resonance Imaging

Other drugs received by patient: Clonidine; Fosrenol; Accupril; Renagel; Phoslo; Diatx; Vitamins NOS; Temazepam; Novolin R; Minoxidil; Insulin [insulin]; Coumadin; Procrit; Lasix



Possible Magnevist side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-08

Patient: male

Reactions: Pain, Abasia, Joint Contracture, Sensory Loss, Skin Hyperpigmentation, Anhedonia, Balance Disorder, Skin Lesion, Depression, Extremity Contracture, Muscle Contracture, General Physical Health Deterioration, Nephrogenic Systemic Fibrosis, Skin Induration, Skin Tightness, Anxiety, Grip Strength Decreased, Skin Fibrosis, Mobility Decreased

Adverse event resulted in: death

Drug(s) suspected as cause:
Gadolinium IN Unspecified Drug
    Dosage: unk
    Indication: Nuclear Magnetic Resonance Imaging
    Start date: 2006-11-13

Gadolinium IN Unspecified Drug
    Indication: Renal Transplant

Magnevist
    Indication: Nuclear Magnetic Resonance Imaging

Omniscan
    Dosage: unk
    Indication: Nuclear Magnetic Resonance Imaging

Other drugs received by patient: Metoclopramide; Klor-CON; Hectorol; Coumadin; Aspirin



Possible Magnevist side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-08

Patient:

Reactions: Influenza Like Illness

Drug(s) suspected as cause:
Magnevist



Possible Magnevist side effects in

Reported by a consumer/non-health professional from United States on 2012-08-08

Patient:

Reactions: Influenza Like Illness

Drug(s) suspected as cause:
Magnevist



Possible Magnevist side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-08

Patient:

Reactions: NO Adverse Event

Drug(s) suspected as cause:
Magnevist



Possible Magnevist side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-07

Patient: male

Reactions: Pain, Abasia, Nephrogenic Systemic Fibrosis, Skin Tightness, Anxiety, Anhedonia, Balance Disorder, Skin Lesion, Depression, Extremity Contracture, Mobility Decreased

Adverse event resulted in: death

Drug(s) suspected as cause:
Gadolinium IN Unspecified Drug
    Dosage: unk
    Indication: Nuclear Magnetic Resonance Imaging Abdominal
    Start date: 2006-11-13

Magnevist

Omniscan

Other drugs received by patient: Coumadin; Aspirin; Klor-CON; Metoclopramide; Hectorol



Possible Magnevist side effects in 37 year old female

Reported by a physician from United States on 2012-08-07

Patient: 37 year old female, weighing 59.0 kg (129.8 pounds)

Reactions: Pruritus, Feeling Hot, Contrast Media Allergy

Drug(s) suspected as cause:
Magnevist



Possible Magnevist side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-07

Patient: male, weighing 80.0 kg (176.0 pounds)

Reactions: Hyperkeratosis, Pain in Extremity, Bone Pain, Pain, Musculoskeletal Pain, Nephrogenic Systemic Fibrosis, Skin Hyperpigmentation, Hypoaesthesia, DRY Skin, Arthralgia, Oedema, Skin Fibrosis

Drug(s) suspected as cause:
Gadolinium IN Unspecified Drug
    Dosage: unk unk, once
    Indication: Nuclear Magnetic Resonance Imaging
    Start date: 2005-06-06
    End date: 2005-06-06

Gadolinium IN Unspecified Drug
    Indication: Pancreatic Mass

Magnevist

Magnevist
    Dosage: 20 ml, once
    Indication: Nuclear Magnetic Resonance Imaging
    Start date: 2003-05-07
    End date: 2003-05-07

Omniscan
    Dosage: 20 ml (daily dose), once, intravenous
    Indication: Nuclear Magnetic Resonance Imaging Brain
    Start date: 2002-08-12
    End date: 2002-08-12

Other drugs received by patient: Norvasc; Labetalol HCL; Accupril; Nifedipine; Sensipar; Lisinopril; Dicyclomine; Nitroprusside Sodium; Epoetin NOS; Carvedilol; Hyoscyamine Sulfate; Epogen; Phenytoin; Minoxidil; Sucralfate; Losartan Potassium; Clonidine; Lopressor; Phoslo; Procardia XL; Valtrex; Hydralazine HCL; Coumadin; Renagel; Divalproex Sodium; Nifedipine

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