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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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