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Omniscan (Gadodiamide) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Omniscan (Gadodiamide) 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 (250)
Death (29)
Life Threatening Events (3)
Disability (56)

Reports by Reaction Type

Nephrogenic Systemic Fibrosis (229)Pain (163)Skin Induration (108)Skin Tightness (97)Mobility Decreased (94)Skin Hypertrophy (93)Oedema Peripheral (92)Anxiety (85)Pain in Extremity (80)Emotional Distress (79)Joint Range of Motion Decreased (78)Musculoskeletal Stiffness (70)

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

Possible Omniscan 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 Omniscan 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 Omniscan side effects in male

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

Patient: male

Reactions: Abasia, Pain, 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, Limb Discomfort, Grip Strength Decreased, Mobility Decreased, Skin Fibrosis

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

Gadolinium IN Unspecified Drug
    Indication: Renal Transplant

Omniscan
    Dosage: unk
    Indication: Nuclear Magnetic Resonance Imaging

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



Possible Omniscan 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 Omniscan 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



Possible Omniscan 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 Omniscan side effects in 49 year old male

Reported by a lawyer from United States on 2012-08-02

Patient: 49 year old male, weighing 77.1 kg (169.6 pounds)

Reactions: Pain, Joint Contracture, Erythema, Muscle Tightness, Joint Stiffness, Myosclerosis, Rash Pruritic, Joint Range of Motion Decreased, Skin Lesion, Oedema Peripheral, Musculoskeletal Stiffness, Oedema, Depression, Extremity Contracture, General Physical Health Deterioration, Muscular Weakness, Nephrogenic Systemic Fibrosis, Skin Hypertrophy, Skin Induration, Skin Tightness, Skin Plaque, Joint Swelling, Quadriparesis, Mobility Decreased

Drug(s) suspected as cause:
Gadolinium IN Unspecified Drug
    Start date: 2004-05-19
    End date: 2004-05-19

Magnevist
    Indication: Nuclear Magnetic Resonance Imaging
    Start date: 2006-05-19
    End date: 2006-05-19

Magnevist
    Dosage: 15 ml, unk
    Indication: Nuclear Magnetic Resonance Imaging Brain
    Start date: 2006-10-13
    End date: 2006-10-13

Magnevist
    Dosage: 20 ml, unk
    Start date: 2006-10-17
    End date: 2006-10-17

Multihance
    Indication: Product Used FOR Unknown Indication

Omniscan

Omniscan
    Dosage: 50 ml omniscan+co2
    Indication: Fistulogram
    Start date: 2006-08-04
    End date: 2006-08-04

Omniscan
    Dosage: 20 ml, once
    Indication: Nuclear Magnetic Resonance Imaging
    Start date: 2006-08-05
    End date: 2006-08-05

Optimark
    Indication: Product Used FOR Unknown Indication

Prohance
    Indication: Computerised Tomogram Head
    Start date: 2004-05-19
    End date: 2004-05-19

Other drugs received by patient: Coumadin; Renagel; Aranesp; Lyrica; Norvasc; Lamisil; Percocet; Gentamicin; Procardia XL; Ferrous Sulfate TAB; Sodium Bicarbonate; Acetaminophen; Venofer; Coreg; Actos; Prinivil; Synthroid; Amitriptline Hydrochloride TAB; Nateglinide; Pentoxifylline; Phoslo; Procrit; Epogen; Nexium; Elavil; Lipitor; Lantus; Trental; Benadryl; Avelox; Pletal; Tambocor; Atenolol; Zyvox; Lopid; Nephrocaps; Bactrim DS; Restoril; Clonidine; Starlix; Accupril; Vancomycin; Lasix; Potassium Chloride; Glucotrol; Renagel; Nicotine



Possible Omniscan side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-01

Patient: female

Reactions: Pruritus, Pain, Joint Contracture, Myosclerosis, Skin Ulcer, Injury, Fibrosis, General Physical Health Deterioration, Skin Hypertrophy, Skin Induration, Nephrogenic Systemic Fibrosis, DRY Skin, Deformity, Skin Plaque, Skin Tightness, Emotional Distress, Anxiety, Arthralgia, Tendon Disorder, Disability

Drug(s) suspected as cause:
Magnevist
    Dosage: unk
    Indication: Nuclear Magnetic Resonance Imaging

Magnevist
    Indication: Angiogram

Multihance
    Indication: Nuclear Magnetic Resonance Imaging

Multihance
    Indication: Angiogram

Omniscan
    Indication: Angiogram

Omniscan
    Indication: Nuclear Magnetic Resonance Imaging

Optimark
    Indication: Angiogram

Optimark
    Indication: Nuclear Magnetic Resonance Imaging

Prohance
    Indication: Nuclear Magnetic Resonance Imaging

Prohance
    Indication: Angiogram



Possible Omniscan side effects in male

Reported by a lawyer from United States on 2012-08-01

Patient: male

Reactions: Quality of Life Decreased, Pain, General Physical Health Deterioration, Nephrogenic Systemic Fibrosis, Deformity, Anxiety, Emotional Distress, Fibrosis, Injury, Scar, Mobility Decreased

Drug(s) suspected as cause:
Magnevist
    Dosage: unk
    Start date: 2004-11-23

Magnevist
    Dosage: unk
    Indication: Imaging Procedure
    Start date: 2003-05-10

Omniscan
    Dosage: unk
    Indication: Imaging Procedure
    Start date: 2004-06-25

Omniscan
    Dosage: unk
    Start date: 2004-10-15

Omniscan
    Dosage: unk
    Start date: 2004-10-04

Omniscan
    Dosage: unk
    Start date: 2005-03-18



Possible Omniscan side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-27

Patient: female

Reactions: Pruritus, Pain, Muscle Contracture, General Physical Health Deterioration, DRY Skin, Nephrogenic Systemic Fibrosis, Deformity, Skin Plaque, Emotional Distress, Anxiety, Skin Ulcer, Arthralgia, Fibrosis, Injury, Disability

Drug(s) suspected as cause:
Magnevist
    Dosage: unk
    Indication: Nuclear Magnetic Resonance Imaging

Magnevist
    Indication: Angiogram

Multihance
    Indication: Nuclear Magnetic Resonance Imaging

Multihance
    Indication: Angiogram

Omniscan
    Indication: Nuclear Magnetic Resonance Imaging

Omniscan
    Indication: Angiogram

Optimark
    Indication: Angiogram

Optimark
    Indication: Nuclear Magnetic Resonance Imaging

Prohance
    Indication: Angiogram

Prohance
    Indication: Nuclear Magnetic Resonance Imaging



Possible Omniscan side effects in 53 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-26

Patient: 53 year old female

Reactions: Arthralgia, Induration, Musculoskeletal Stiffness, Skin Induration, Nephrogenic Systemic Fibrosis, Skin Tightness

Drug(s) suspected as cause:
Omniscan
    Indication: Diagnostic Procedure

Omniscan
    Indication: Product Used FOR Unknown Indication



Possible Omniscan side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-26

Patient: male, weighing 80.0 kg (176.0 pounds)

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

Drug(s) suspected as cause:
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: Divalproex Sodium; Coumadin; Sensipar; Lisinopril; Nitroprusside Sodium; Nifedipine; Carvedilol; Sucralfate; Valtrex; Clonidine; Nifedipine; Accupril; Phenytoin; Phoslo; Hyoscyamine Sulfate; Norvasc; Procardia XL; Lopressor; Labetalol HCL; Hydralazine HCL; Epoetin NOS; Dicyclomine; Minoxidil



Possible Omniscan side effects in female

Reported by a physician from Japan on 2012-07-24

Patient: female

Reactions: Eyelid Oedema, Oropharyngeal Pain, Cough

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Omniscan
    Indication: Endometriosis

Omniscan
    Indication: Uterine Leiomyoma
    Start date: 2012-06-05
    End date: 2012-06-05



Possible Omniscan side effects in male

Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-07-20

Patient: male, weighing 93.0 kg (204.6 pounds)

Reactions: Pain in Extremity, Motor Dysfunction, Nephrogenic Systemic Fibrosis, Arthralgia, Joint Swelling, Sensory Disturbance, Musculoskeletal Stiffness, Mobility Decreased

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Omniscan



Possible Omniscan side effects in 79 year old female

Reported by a physician from United States on 2012-07-20

Patient: 79 year old female, weighing 63.6 kg (140.0 pounds)

Reactions: Skin Wrinkling, Pruritus, Pain, Muscle Rigidity, Erythema, Joint Stiffness, Fatigue, Joint Range of Motion Decreased, Musculoskeletal Stiffness, Oedema, Injury, Extremity Contracture, Skin Hypertrophy, DRY Skin, Nephrogenic Systemic Fibrosis, Skin Induration, Skin Tightness, Emotional Distress, Anxiety, Arthralgia

Adverse event resulted in: death

Drug(s) suspected as cause:
Gadolinium Zeolite
    Indication: Nuclear Magnetic Resonance Imaging Abdominal
    Start date: 2001-04-25
    End date: 2001-04-25

Gadolinium Zeolite
    Start date: 2005-08-16
    End date: 2005-08-16

Gadolinium Zeolite
    Start date: 2001-05-03
    End date: 2001-05-03

Gadolinium Zeolite
    Indication: Nuclear Magnetic Resonance Imaging Brain
    Start date: 2001-03-05
    End date: 2001-03-05

Magnevist
    Indication: Nuclear Magnetic Resonance Imaging Abdominal
    Start date: 2001-04-25
    End date: 2001-04-25

Magnevist
    Indication: Angiogram
    Start date: 2001-05-03
    End date: 2001-05-03

Magnevist
    Indication: Nuclear Magnetic Resonance Imaging Brain

Multihance
    Indication: Nuclear Magnetic Resonance Imaging Abdominal

Multihance
    Indication: Angiogram

Multihance
    Indication: Nuclear Magnetic Resonance Imaging

Omniscan
    Dosage: dose reported as eight 20ml vials (160ml)
    Start date: 2005-09-20
    End date: 2005-09-20

Omniscan
    Dosage: route reported as ^first via distal port and then via the proximal port^
    Indication: Angiogram
    Start date: 2003-12-04
    End date: 2003-12-04

Omniscan
    Indication: Nuclear Magnetic Resonance Imaging Abdominal
    Start date: 2003-05-23
    End date: 2003-05-23

Omniscan
    Dosage: dose reported as ^11^ 20ml vials
    Indication: Nuclear Magnetic Resonance Imaging
    Start date: 2005-09-01
    End date: 2005-09-01

Optimark
    Indication: Nuclear Magnetic Resonance Imaging Abdominal
    Start date: 2005-08-16
    End date: 2005-08-16

Optimark
    Indication: Angiogram

Optimark
    Indication: Nuclear Magnetic Resonance Imaging

Prohance
    Indication: Nuclear Magnetic Resonance Imaging Abdominal

Prohance
    Indication: Angiogram

Prohance
    Indication: Nuclear Magnetic Resonance Imaging

Other drugs received by patient: Epogen; Imdur; Folic Acid; Potassium Chloride; Lovastatin; Diltiazem; Furosemide; Nephrovite [vit C,vit H,b5,b12,b9,b3,b6,b2,b1 Hcl]; Renagel; Potassium Chloride; Amiodarone HCL; Hydralazine HCL; Aspirin; Niferex; Coreg; Plendil; Venofer; Zemplar



Possible Omniscan side effects in 44 year old female

Reported by a physician from United States on 2012-07-18

Patient: 44 year old female, weighing 130.0 kg (286.0 pounds)

Reactions: Pain, Fear, Scleroderma, Hand Deformity, Skin Discolouration, Oedema, Musculoskeletal Stiffness, Injury, Systemic Sclerosis, Pain of Skin, Nephrogenic Systemic Fibrosis, Skin Tightness, Sclerodactylia, Anxiety, Emotional Distress, Arthralgia, Gait Disturbance, Mobility Decreased

Drug(s) suspected as cause:
Magnevist
    Dosage: unk
    Indication: Nuclear Magnetic Resonance Imaging

Omniscan
    Indication: Nuclear Magnetic Resonance Imaging

Omniscan
    Indication: Angiogram

Optimark

Optimark
    Dosage: unk
    Indication: Nuclear Magnetic Resonance Imaging
    Start date: 2004-02-06

Optimark
    Dosage: unk
    Indication: Angiogram
    Start date: 2005-05-31

Optimark
    Dosage: unk
    Start date: 2005-08-31

Other drugs received by patient: Nephrovite [vit C,vit H,b5,b12,b9,b3,b6,b2,b1 Hcl]; Coumadin; Accupril; Atenolol; Epogen; Renagel; Calcitriol; Diovan; Norvasc



Possible Omniscan side effects in 49 year old female

Reported by a consumer/non-health professional from United States on 2012-07-18

Patient: 49 year old female, weighing 55.0 kg (121.0 pounds)

Reactions: Skin Wrinkling, Joint Stiffness, Oedema Peripheral, Melanocytic Naevus, Fibrosis, Arthrofibrosis, General Physical Health Deterioration, Hypoaesthesia, Skin Induration, Skin Hypertrophy, Nephrogenic Systemic Fibrosis, Paraesthesia, Skin Tightness, Scar, Abasia, Pain, Joint Contracture, Skin Hyperpigmentation, Muscle Tightness, Tendon Pain, Joint Range of Motion Decreased, Skin Lesion, Musculoskeletal Stiffness, Injury, Joint Ankylosis, Extremity Contracture, Myocardial Fibrosis, Dyspnoea, Rash Papular, Musculoskeletal Pain, Skin Disorder, Muscular Weakness, Rash Macular, Pulmonary Fibrosis, Arthralgia, Gait Disturbance, Skin Fibrosis

Drug(s) suspected as cause:
Magnevist
    Start date: 2004-05-20
    End date: 2004-05-20

Magnevist
    Start date: 1999-11-09
    End date: 1999-11-09

Magnevist
    Indication: Nuclear Magnetic Resonance Imaging Abdominal
    Start date: 1997-04-30
    End date: 1997-04-30

Magnevist
    Start date: 1998-12-31
    End date: 1998-12-31

Magnevist
    Indication: Nuclear Magnetic Resonance Imaging
    Start date: 1996-10-30
    End date: 1996-10-30

Magnevist
    Start date: 2002-01-30
    End date: 2002-01-30

Magnevist
    Start date: 2005-01-30
    End date: 2005-01-30

Magnevist
    Start date: 1997-11-17
    End date: 1997-11-17

Magnevist
    Dosage: 9.7 ml, once
    Start date: 2003-03-20
    End date: 2003-03-20

Magnevist
    Start date: 2000-11-08
    End date: 2000-11-08

Omniscan
    Indication: Nuclear Magnetic Resonance Imaging
    Start date: 2005-01-30
    End date: 2005-01-30

Omniscan
    Start date: 2005-03-20
    End date: 2005-03-20

Omniscan
    Dosage: unk

Other drugs received by patient: Thyroid Therapy; Ferrous Sulfate TAB; Miacalcin; Cytoxan; Oxandrin; Folic Acid; Procardia; Synthroid; Nephrovite [vit C,vit H,b5,b12,b9,b3,b6,b2,b1 Hcl]; Advair Diskus 100 / 50; Zemplar; Aranesp; Aleve; Prograf; Epogen; Exforge; Activase; Celebrex; Zestril; Renagel; Metoprolol Succinate; Amigen; Prempro; Rocaltrol; Spironolactone; Demadex; Sensipar; Myfortic; Prednisone; Clonidine; Amlodipine Besylate



Possible Omniscan side effects in 54 year old male

Reported by a lawyer from United States on 2012-07-17

Patient: 54 year old male

Reactions: Pruritus, Muscle Contractions Involuntary, Pain, Abasia, Muscle Rigidity, Neuropathic Ulcer, Erythema, Neuropathy Peripheral, Oedema Peripheral, Musculoskeletal Stiffness, Injury, Fibrosis, Muscle Spasms, Excoriation, Nephrogenic Systemic Fibrosis, Skin Hypertrophy, Emotional Distress, Arthralgia, Mobility Decreased

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Gadolinium IN Unspecified Drug
    Indication: Nuclear Magnetic Resonance Imaging

Gadolinium IN Unspecified Drug
    Dosage: unk
    Indication: Nuclear Magnetic Resonance Imaging Abdominal
    Start date: 2000-11-29

Omniscan
    Dosage: unk
    Indication: Nuclear Magnetic Resonance Imaging
    Start date: 2000-12-12
    End date: 2000-12-12

Omniscan
    Indication: Arthralgia

Omniscan
    Indication: Sepsis

Other drugs received by patient: Lansoprazole; Atacand HCT; Vitamin E; Verapamil HCL; Minoxidil; Misoprostol; Lorazepam; Amiodarone HCL; Humulin R; Phoslo; Vitamin D; Epoetin Alfa; Cytotec; Calcium Acetate; Cefazolin Sodium



Possible Omniscan side effects in 58 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-12

Patient: 58 year old female, weighing 78.0 kg (171.6 pounds)

Reactions: Skin Exfoliation, Pain, Skin Hyperpigmentation, Erythema, Joint Stiffness, Fatigue, Joint Range of Motion Decreased, Oedema Peripheral, Musculoskeletal Stiffness, Oedema, Fibrosis, Cellulitis, Pain of Skin, Skin Disorder, Nephrogenic Systemic Fibrosis, Skin Induration, Rash, Skin Hypertrophy, Deformity, Skin Plaque, Skin Tightness, Gait Disturbance, Skin Fibrosis, Mobility Decreased, Scar

Drug(s) suspected as cause:
Gadolinium IN Unspecified Drug
    Dosage: unk
    Indication: Nuclear Magnetic Resonance Imaging
    Start date: 2005-05-20
    End date: 2005-05-20

Gadolinium IN Unspecified Drug
    Indication: Nuclear Magnetic Resonance Imaging Abdominal

Gadolinium IN Unspecified Drug
    Indication: Angiogram

Gadolinium IN Unspecified Drug
    Dosage: unk
    Indication: Nuclear Magnetic Resonance Imaging Brain
    Start date: 2004-10-31
    End date: 2004-10-31

Magnevist
    Dosage: 20 ml, once
    Start date: 2005-05-19
    End date: 2005-05-19

Magnevist
    Dosage: unk
    Indication: Computerised Tomogram Abdomen
    Start date: 2004-10-03
    End date: 2004-10-03

Magnevist
    Dosage: unk
    Start date: 2004-11-10
    End date: 2004-11-10

Magnevist
    Dosage: unk, once
    Indication: Nuclear Magnetic Resonance Imaging Brain
    Start date: 2004-01-15
    End date: 2004-01-15

Magnevist
    Dosage: unk
    Start date: 2004-07-01
    End date: 2004-07-01

Magnevist
    Dosage: unk
    Indication: Imaging Procedure
    Start date: 2004-10-29
    End date: 2004-10-29

Magnevist
    Dosage: unk
    Indication: Angiogram
    Start date: 2005-02-17
    End date: 2005-02-17

Magnevist
    Dosage: 20 ml, unk
    Indication: Nuclear Magnetic Resonance Imaging
    Start date: 2003-09-27
    End date: 2003-09-27

Magnevist
    Dosage: unk
    Start date: 2004-12-13
    End date: 2004-12-13

Omniscan
    Indication: Nuclear Magnetic Resonance Imaging

Optimark
    Indication: Nuclear Magnetic Resonance Imaging

Other drugs received by patient: Sensipar; Ativan; Lisinopril; Loperamide; Folic Acid; Tylenol W / Codeine NO. 3; Magnesium Oxide; Plavix; Epogen; Calcijex; Zosyn; Ambien; Vitamin K1; Clonidine; Albumin (Human); Roxanol; Velcade; Adenosine; Aspirin; Dexamethasone; Acetaminophen; Compazine; Dilaudid; Foltx; Diflucan; Vancomycin; Potassium Chloride; Bactrim DS; Ciprofloxacin HCL; Hydroxyzine; Acyclovir; Mucomyst; Biaxin; Metoprolol Tartrate; Atarax; Cyclophosphamide; Norco; Neurontin; Digoxin; Ativan; Prevacid; Dexamethasone; Zoloft; Vitamin K1; Ocean; Senokot; Neupogen; Bicitra; Allopurinol; Pravachol; Levaquin; Phoslo; Gentamicin; Nephrocaps; Adriamycin PFS; Simethicone; Zemplar; Plendil; Midodrine Hydrochloride; Renaphro; Renagel; Ativan; Oxacillin; Etoposide; Reglan; Reglan; Compazine; Warfarin Sodium; Prograf



Possible Omniscan side effects in 51 year old female

Reported by a lawyer from United States on 2012-07-09

Patient: 51 year old female, weighing 64.1 kg (141.0 pounds)

Reactions: Peripheral Coldness, Pruritus, Skin Exfoliation, Pain, Erythema, Skin Fissures, Joint Stiffness, Skin Discolouration, Dermatitis, Joint Range of Motion Decreased, Oedema Peripheral, Skin Haemorrhage, Fibrosis, Injury, Pain in Extremity, Motor Dysfunction, DRY Skin, Nephrogenic Systemic Fibrosis, Skin Hypertrophy, Skin Induration, Sclerodactylia, Skin Tightness, Emotional Distress, Anxiety, Burning Sensation, Dysstasia, Activities of Daily Living Impaired, Insomnia, Mobility Decreased, Scar

Drug(s) suspected as cause:
Magnevist
    Dosage: unk, once
    Indication: Nuclear Magnetic Resonance Imaging
    Start date: 2001-01-11
    End date: 2001-01-11

Magnevist
    Indication: Arteriovenous Fistula Operation
    Start date: 2006-11-28
    End date: 2006-11-28

Magnevist
    Dosage: unk, once
    Indication: Venous Pressure Increased
    Start date: 2004-12-09
    End date: 2004-12-09

Magnevist
    Indication: Dialysis Efficacy Test
    Start date: 2006-09-26
    End date: 2006-09-26

Magnevist
    Indication: Dialysis Device Insertion

Multihance
    Indication: Fistulogram

Multihance
    Indication: Venogram

Multihance
    Indication: Nuclear Magnetic Resonance Imaging

Omniscan
    Indication: Nuclear Magnetic Resonance Imaging

Omniscan
    Indication: Fistulogram

Omniscan
    Indication: Venogram

Optimark
    Indication: Nuclear Magnetic Resonance Imaging

Optimark
    Indication: Venogram

Optimark
    Indication: Fistulogram

Prohance
    Indication: Venogram

Prohance
    Indication: Fistulogram

Prohance
    Indication: Nuclear Magnetic Resonance Imaging

Other drugs received by patient: Levothroid; Atenolol; Phoslo; Epoetin NOS; PEG-3350 and Electrolytes; Levothroid; Calcium Carbonate; Renagel; Epogen; Procardia XL; Pravachol; Sensipar; Vitamin B12; Imodium; Cardizem; Prednisone; Amiodarone HCL; Allopurinol; Immune Globulin NOS; Benadryl; Omeprazole; Protonix; Renagel; Plendil; Immune Globulin NOS; Acetaminophen; Pravastatin; Atenolol; Coumadin; Reglan; Vicodin; Nephro-Vite [vitamins Nos]; Immune Globulin NOS; Immune Globulin NOS; Acetaminophen; Nitroglycerin; Tramadol HCL; Coumadin; Calcium Carbonate; Sensipar; Cyclosporine; Acetaminophen; Benadryl; Benadryl; Calcitriol; Fosrenol; Metoclopramide; Metoprolol Tartrate; Nifedipine; Acetaminophen; Benadryl; Ureacin; Loperamide; Corticosteroids; Coumadin; Protonix; Allopurinol; Prilosec; Immune Globulin NOS; Acetaminophen; Acetaminophen; Benadryl



Possible Omniscan side effects in male

Reported by a individual with unspecified qualification from Denmark on 2012-07-06

Patient: male, weighing 87.0 kg (191.4 pounds)

Reactions: Pain in Extremity, Motor Dysfunction, Muscular Weakness, Nephrogenic Systemic Fibrosis, Skin Hypertrophy, Headache, Activities of Daily Living Impaired, Cerebral Calcification, Carpal Tunnel Syndrome, Gait Disturbance, Open Wound, Mobility Decreased, Neuralgia

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Omniscan
    Indication: Renal Transplant
    Start date: 2004-08-31
    End date: 2004-08-31

Omniscan
    Start date: 2006-06-08
    End date: 2006-06-08



Possible Omniscan side effects in male

Reported by a individual with unspecified qualification from Denmark on 2012-07-06

Patient: male, weighing 93.0 kg (204.6 pounds)

Reactions: Impaired Work Ability, Motor Dysfunction, Nephrogenic Systemic Fibrosis, Arthralgia, Skin Discolouration, Joint Swelling, Musculoskeletal Stiffness, Skin Atrophy, Mobility Decreased

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Omniscan



Possible Omniscan side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-06

Patient: female

Reactions: Pain, Nephrogenic Systemic Fibrosis, Deformity, Skin Plaque, Emotional Distress, Anxiety, Fibrosis, Injury, Disability

Drug(s) suspected as cause:
Magnevist
    Indication: Angiogram

Magnevist
    Dosage: unk
    Indication: Nuclear Magnetic Resonance Imaging

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
    Indication: Nuclear Magnetic Resonance Imaging

Prohance
    Indication: Angiogram



Possible Omniscan side effects in female

Reported by a physician from Germany on 2012-07-03

Patient: female

Reactions: Maternal Exposure During Pregnancy, Abortion Spontaneous

Drug(s) suspected as cause:
Omniscan



Possible Omniscan side effects in 54 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-02

Patient: 54 year old male

Reactions: Pruritus, Muscle Contractions Involuntary, Pain, Abasia, Neuropathic Ulcer, Erythema, Muscle Rigidity, Neuropathy Peripheral, Oedema Peripheral, Musculoskeletal Stiffness, Injury, Fibrosis, Muscle Spasms, Excoriation, Skin Hypertrophy, Nephrogenic Systemic Fibrosis, Emotional Distress, Arthralgia, Mobility Decreased

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Gadolinium IN Unspecified Drug
    Dosage: unk
    Indication: Nuclear Magnetic Resonance Imaging Abdominal
    Start date: 2000-11-29

Gadolinium IN Unspecified Drug
    Dosage: unk
    Indication: Nuclear Magnetic Resonance Imaging
    Start date: 2000-12-12
    End date: 2000-12-12

Magnevist

Omniscan

Optimark

Other drugs received by patient: Epoetin Alfa; Phoslo; Lorazepam; Misoprostol; Cefazolin Sodium; Vitamin E; Vitamin D; Amiodarone Hydrochloride; Lansoprazole; Humulin R; Calcium Acetate; Verapamil HCL; Atacand HCT; Minoxidil; Cytotec



Possible Omniscan side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-28

Patient: male, weighing 83.0 kg (182.6 pounds)

Reactions: Pruritus, Pain, Quality of Life Decreased, Muscular Weakness, Orthostatic Hypotension, DRY Skin, Stasis Dermatitis, Nephrogenic Systemic Fibrosis, Rash, Skin Hypertrophy, Skin Tightness, Joint Range of Motion Decreased, Skin Discolouration, Oedema Peripheral, Mobility Decreased

Drug(s) suspected as cause:
Magnevist

Magnevist
    Indication: Angiogram

Magnevist
    Indication: Nuclear Magnetic Resonance Imaging Brain

Magnevist
    Dosage: 20 ml, once
    Indication: Nuclear Magnetic Resonance Imaging
    Start date: 1998-05-18
    End date: 1998-05-18

Multihance
    Indication: Nuclear Magnetic Resonance Imaging

Multihance
    Indication: Angiogram

Omniscan
    Indication: Nuclear Magnetic Resonance Imaging

Omniscan
    Indication: Angiogram

Optimark
    Indication: Angiogram

Optimark
    Indication: Nuclear Magnetic Resonance Imaging

Prohance
    Indication: Angiogram

Prohance
    Indication: Nuclear Magnetic Resonance Imaging

Other drugs received by patient: Pepcid; Meclizine; Prednisone TAB; Diovan; Plavix; Nexium; Flomax; Warfarin Sodium; Covera-HS; Norvasc; Nephrocaps [vit C,vit H,b12,b9,b3,pantothen Ac,b6,b2,b1 Hcl]; Coumadin; Epogen; Monopril; Cytoxan; Accupril; Aspirin; Sensipar; Novolin [insulin]; Hydralazine Hydrochloride; Ancef; Acetaminophen; Kayexalate; Humulin [insulin Human Injection, Isophane]; Norvasc; Phoslo; Catapres; Prevacid; Renvela; Lasix; Amiodarone Hydrochloride; Ascorbic Acid; Fish OIL; Sodium Polystyrene Sulfonate; Procrit; Zaroxolyn; Diuril; Darvocet; Neurontin; Renagel; Clonidine; Levothyroxine; Demadex; Potassium Chloride; Verapamil; Percocet; Lopressor; Lipitor



Possible Omniscan side effects in 65 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-26

Patient: 65 year old female

Reactions: Back Pain, Dysstasia, Dyskinesia, Pulse Absent

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Omniscan
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-14
    End date: 2012-06-14

Omniscan
    Indication: Diagnostic Procedure



Possible Omniscan side effects in female

Reported by a physician from France on 2012-06-25

Patient: female, weighing 58.0 kg (127.6 pounds)

Reactions: Myoclonus, Grand MAL Convulsion, Eye Movement Disorder, Salivary Hypersecretion, Loss of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Omniscan



Possible Omniscan side effects in 58 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-25

Patient: 58 year old female, weighing 77.6 kg (170.6 pounds)

Reactions: Skin Exfoliation, Pain, Skin Hyperpigmentation, Erythema, Joint Stiffness, Fatigue, Joint Range of Motion Decreased, Oedema Peripheral, Musculoskeletal Stiffness, Oedema, Fibrosis, Cellulitis, Pain of Skin, Skin Hypertrophy, Nephrogenic Systemic Fibrosis, Skin Induration, Rash, Deformity, Skin Plaque, Skin Tightness, Scar, Skin Fibrosis, Mobility Decreased

Drug(s) suspected as cause:
Gadolinium IN Unspecified Drug
    Dosage: unk
    Indication: Nuclear Magnetic Resonance Imaging Brain
    Start date: 2004-10-31
    End date: 2004-10-31

Gadolinium IN Unspecified Drug
    Indication: Nuclear Magnetic Resonance Imaging Abdominal

Gadolinium IN Unspecified Drug
    Indication: Angiogram

Gadolinium IN Unspecified Drug
    Dosage: unk
    Indication: Nuclear Magnetic Resonance Imaging
    Start date: 2005-05-20
    End date: 2005-05-20

Magnevist
    Dosage: unk
    Indication: Computerised Tomogram Abdomen
    Start date: 2004-10-03
    End date: 2004-10-03

Magnevist
    Dosage: unk
    Indication: Imaging Procedure
    Start date: 2004-10-29
    End date: 2004-10-29

Magnevist
    Dosage: unk
    Start date: 2004-12-13
    End date: 2004-12-13

Magnevist
    Dosage: unk
    Start date: 2004-07-01
    End date: 2004-07-01

Magnevist
    Dosage: unk
    Indication: Angiogram
    Start date: 2005-02-17
    End date: 2005-02-17

Magnevist
    Dosage: 20 ml, unk
    Indication: Nuclear Magnetic Resonance Imaging
    Start date: 2003-09-27
    End date: 2003-09-27

Magnevist
    Dosage: unk
    Start date: 2004-11-10
    End date: 2004-11-10

Magnevist
    Dosage: 20 ml, once
    Start date: 2005-05-19
    End date: 2005-05-19

Magnevist
    Dosage: unk, once
    Indication: Nuclear Magnetic Resonance Imaging Brain
    Start date: 2004-01-15
    End date: 2004-01-15

Omniscan
    Indication: Nuclear Magnetic Resonance Imaging

Optimark
    Indication: Nuclear Magnetic Resonance Imaging

Other drugs received by patient: Bicitra; Foltx; Plavix; Dexamethasone; Acetaminophen; Adriamycin PFS; Compazine; Dilaudid; Pravachol; Phoslo; Vitamin K1; Etoposide; Reglan; Hydroxyzine; Plendil; Neupogen; Acyclovir; Digoxin; Mucomyst; Renagel; Calcijex; Levaquin; Simethicone; Renaphro; Sensipar; Biaxin; Dexamethasone; Zosyn; Ciprofloxacin; Ocean; Loperamide; Senokot; Clonidine; Albumin (Human); Diflucan; Magnesium Oxide; Potassium Chloride; Gentamicin; Ambien; Compazine; Velcade; Adenosine; Ativan; Lisinopril; Epogen; Oxacillin; Reglan; Zemplar; Roxanol; Allopurinol; Tylenol W / Codeine NO. 3; Ativan; Zoloft; Nephrocaps; Vitamin K1; Cyclophosphamide; Norco; Midodrine Hydrochloride; Warfarin Sodium; Prograf; Folic Acid; Ativan; Aspirin; Prevacid; Metoprolol Tartrate; Vancomycin; Bactrim DS; Atarax; Neurontin



Possible Omniscan side effects in 58 year old female

Reported by a consumer/non-health professional from United States on 2012-06-22

Patient: 58 year old female, weighing 70.0 kg (154.0 pounds)

Reactions: Pruritus, Scab, Skin Burning Sensation, Skin Hyperpigmentation, Joint Stiffness, Anhedonia, Oedema Peripheral, Skin Swelling, Peau D'orange, Pain in Extremity, Muscular Weakness, Skin Disorder, Skin Induration, Livedo Reticularis, Skin Hypertrophy, Nephrogenic Systemic Fibrosis, Rash Macular, Anxiety, Mobility Decreased, Scar, Skin Fibrosis

Drug(s) suspected as cause:
Magnevist
    Dosage: 20 ml, unk
    Indication: Imaging Procedure
    Start date: 2003-12-20

Magnevist
    Indication: Nuclear Magnetic Resonance Imaging Brain
    Start date: 2005-05-26
    End date: 2005-05-26

Magnevist
    Dosage: 15 ml, unk
    Indication: Angiogram
    Start date: 2006-05-30

Multihance
    Indication: Imaging Procedure

Omniscan
    Indication: Imaging Procedure

Optimark
    Indication: Imaging Procedure

Prohance
    Indication: Imaging Procedure

Other drugs received by patient: Klonopin; Calcitriol; Norvasc; Zemplar; Epogen; Folbee; Immunosuppressive Agents; Sensipar; Plavix; Colchicine; Renagel; Robaxin; Synthroid; Levothyroxine Sodium; Phoslo; Immunosuppressive Agents; Corticosteroids; Hormones and Related Agents; Coumadin; Gabapentin; Antithrombotic Agents; Steroid Antibacterials; Midodrine Hydrochloride; Aspirin; Neurontin; Iron Supplement; Nephrocaps

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