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Optimark (Gadoversetamide) - Off Label Use - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Off Label Use ()

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Optimark (Gadoversetamide) where reactions include off label use. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Optimark side effects in female

Reported by a physician from United States on 2012-06-18

Patient: female

Reactions: Abdominal Pain, Pulmonary Hypertension, Pruritus, Contusion, Nocturia, Hyperhidrosis, Cardiomegaly, Pericardial Effusion, Off Label Use, Biliary Dilatation, Melanocytic Naevus, Open Wound, Nephrogenic Systemic Fibrosis, Joint Swelling, Impaired Gastric Emptying, Mobility Decreased, Renal Transplant, Wheezing, Chills, Morganella Infection, Polyuria, Constipation, Splenic Infarction, Gastritis, Myalgia, Weight Increased, Fatigue, Hepatomegaly, Skin Ulcer, Dizziness, Pleural Effusion, Musculoskeletal Stiffness, Cholecystitis, Splenomegaly, Decreased Appetite, Device Related Sepsis, Nausea, Muscular Weakness, Rash, Hypercoagulation, Cerebrovascular Accident, Ascites, Arthralgia, Bradycardia, Renal Tubular Necrosis, Proteus Infection

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Optimark
    Dosage: unk
    Indication: Nuclear Magnetic Resonance Imaging
    Start date: 2006-08-02
    End date: 2006-08-02

Optimark
    Dosage: 20 ml, single
    Indication: Angiogram
    Start date: 2006-08-05
    End date: 2006-08-05

Other drugs received by patient: Metoclopramide; Procardia XL; Epogen; Lisinopril; Renagel; Colace; Micardis; Terazosin HCL; Calcium Acetate; Novolog; Levaquin; Metoprolol Succinate Extended Release; Flagyl



Possible Optimark side effects in female

Reported by a physician from United States on 2012-05-04

Patient: female

Reactions: Pulmonary Hypertension, Abdominal Pain, Renal Transplant, Chills, Hyperhidrosis, Cardiomegaly, Splenic Infarction, Pericardial Effusion, Gastritis, Weight Increased, Off Label Use, Hepatomegaly, Biliary Dilatation, Pleural Effusion, Musculoskeletal Stiffness, Cholecystitis, Splenomegaly, Decreased Appetite, Device Related Sepsis, Nausea, Nephrogenic Systemic Fibrosis, Hypercoagulation, Cerebrovascular Accident, Ascites, Renal Tubular Necrosis, Bradycardia, Impaired Gastric Emptying, Proteus Infection

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Optimark
    Dosage: unk
    Indication: Nuclear Magnetic Resonance Imaging
    Start date: 2006-08-02
    End date: 2006-08-02

Optimark
    Dosage: 20 ml, single
    Indication: Angiogram
    Start date: 2006-08-05
    End date: 2006-08-05

Other drugs received by patient: Lisinopril; Novolog; Metoclopramide; Procardia XL; Flagyl; Levaquin; Colace; Metoprolol Succinate Extended Release; Terazosin HCL; Micardis; Renagel; Calcium Acetate; Epogen



Possible Optimark side effects in

Reported by a physician from United States on 2012-04-23

Patient:

Reactions: Abdominal Pain, Transplant Failure, Sudden Hearing Loss, Vitamin D Deficiency, Constipation, Off Label Use, Weight Increased, Oedema Peripheral, Depression, Exostosis, Myocardial Infarction, Back Pain, Nephrogenic Systemic Fibrosis, Drug Prescribing Error, Osteoarthritis, Diarrhoea, Dehydration, Zinc Deficiency, Spinal Osteoarthritis, Sleep Apnoea Syndrome

Drug(s) suspected as cause:
Omniscan
    Dosage: 35 ml (cc), single
    Indication: Fistulogram
    Start date: 2005-10-06
    End date: 2005-10-06

Omniscan
    Dosage: 90 ml (cc), single
    Indication: Arteriogram
    Start date: 2006-01-05
    End date: 2006-01-05

Optimark
    Dosage: 40 ml (cc), unk
    Indication: Angiogram
    Start date: 2004-02-05
    End date: 2004-02-05

Other drugs received by patient: Propoxyphene Napsylate W / Paracetamol; Aspirin; Metoprolol Tartrate; Neurontin; Insulin; Prograf; Vitamin D; Actos; Mycophenolate Mofetil (Cellcept); Humalog; Sodium Bicarbonate; Phosphorus; Hydrochlorothiazide; Pletal; Atropine W / Diphenoxylate / 00034001 /; Acyclovir; Centrum Silver / 01292501 /; Amitriptyline HCL; Prograf; Lantus; Sulfamethoxazole and Trimethoprim; Nexium; Sulfa / 00150702 /; Hydrochlorothiazide; Humalog; Prednisone TAB; Docusate; Actos; Mycophenolate Mofetil (Cellcept); Promethazine; MAG-OX; Plavix; Vytorin; Zinc Sulfate; Darvocet



Possible Optimark side effects in female

Reported by a physician from United States on 2012-02-27

Patient: female, weighing 82.4 kg (181.3 pounds)

Reactions: Electrocardiogram ST Segment Depression, Periorbital Cellulitis, Hypertensive Emergency, Electrocardiogram QT Shortened, Angina Unstable, Vascular Graft Thrombosis, Haematemesis, Off Label Use, Ileus, Electrocardiogram T Wave Abnormal, Arteriovenous Fistula Site Complication, Dysphagia, Nausea, Nephrogenic Systemic Fibrosis, Hyperlipidaemia, Renal Failure, Diarrhoea, QRS Axis Abnormal

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Optimark
    Dosage: 20 ml, single
    Indication: Nuclear Magnetic Resonance Imaging
    Start date: 2005-03-24
    End date: 2005-03-24

Prohance
    Dosage: 17 ml, single
    Indication: Nuclear Magnetic Resonance Imaging
    Start date: 2004-04-27
    End date: 2004-04-27

Other drugs received by patient: Norvasc; Synthroid; Zemplar; Atacand; Nephrocaps; Epogen; Renagel; Ferrlecit / 00345601 /; Insulin; Catapres / 00171101 /



Possible Optimark side effects in male

Reported by a physician from United States on 2011-10-11

Patient: male

Reactions: Hypersensitivity, Abasia, Chills, Neuropathic Arthropathy, Osteomyelitis, Pyrexia, Erectile Dysfunction, Erythema, Off Label Use, Skin Ulcer, Oedema Peripheral, Ingrowing Nail, Coagulation Time Prolonged, Lethargy, Blister, Cellulitis, Pain in Extremity, Anaemia, Cystitis, Nephrogenic Systemic Fibrosis, Arthralgia, Heart Rate Increased, Insomnia, Leukocytosis, Blood Pressure Decreased, Asthenia, Disability

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Omniscan
    Dosage: 20 ml, single
    Indication: Nuclear Magnetic Resonance Imaging Brain
    Start date: 2006-10-19
    End date: 2006-10-19

Optimark
    Dosage: 15 ml, single
    Indication: Nuclear Magnetic Resonance Imaging
    Start date: 2007-04-12
    End date: 2007-04-12

Magnevist
    Dosage: 20 ml, single
    Indication: Nuclear Magnetic Resonance Imaging
    Start date: 2007-07-25
    End date: 2007-07-25

Omniscan

Other drugs received by patient: Lantus; Novolin / 00030501 /; Lasix; Coumadin; Novolog; Epogen

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