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Visipaque (Iodine Intravascular) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Visipaque (Iodine Intravascular) 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 (74)
Death (6)
Life Threatening Events (12)
Disability (3)

Reports by Reaction Type

Pyrexia (10)Renal Failure Acute (10)Infusion Site Extravasation (7)Hyperkalaemia (6)Headache (6)Lactic Acidosis (6)Nausea (6)Diarrhoea (6)Abdominal Pain (5)Confusional State (5)Chills (5)Pain (5)

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

Possible Visipaque side effects in female

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

Patient: female

Reactions: Speech Disorder, Syncope, Dyspnoea, Pelvic Pain, Micturition Urgency, Loss of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Visipaque
    Indication: Varicocele Ovarian
    Start date: 2012-06-06
    End date: 2012-06-06

Aetoxisclerol 3%



Possible Visipaque side effects in male

Reported by a physician from France on 2012-08-24

Patient: male

Reactions: Vasculitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Visipaque
    Dosage: dose not reported
    Indication: Therapeutic Embolisation
    Start date: 2012-07-09
    End date: 2012-07-09

Visipaque
    Dosage: dose not reported
    Start date: 2012-07-10
    End date: 2012-07-10



Possible Visipaque side effects in male

Reported by a physician from France on 2012-08-15

Patient: male

Reactions: Vasculitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Visipaque
    Dosage: dose not reported
    Indication: Therapeutic Embolisation
    Start date: 2012-07-09
    End date: 2012-07-09

Visipaque
    Dosage: dose not reported
    Start date: 2012-07-10
    End date: 2012-07-10



Possible Visipaque side effects in 72 year old female

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

Patient: 72 year old female

Reactions: Burning Sensation, Vomiting, Nausea, Anaphylactic Reaction, Chest Pain, Swollen Tongue

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Visipaque
    Indication: Liver Disorder
    Start date: 2012-07-30
    End date: 2012-07-30

Visipaque
    Indication: Diagnostic Procedure



Possible Visipaque side effects in female

Reported by a physician from France on 2012-08-09

Patient: female, weighing 56.5 kg (124.3 pounds)

Reactions: Dysgeusia, Weight Decreased, Fatigue, Nausea, Headache, Salivary Hypersecretion, Decreased Appetite

Drug(s) suspected as cause:
Visipaque

Other drugs received by patient: Altim



Possible Visipaque side effects in 30 year old female

Reported by a physician from Spain on 2012-08-01

Patient: 30 year old female

Reactions: Eyelid Oedema, Dyspnoea, Pruritus, Laryngeal Oedema, Papule, Cough

Drug(s) suspected as cause:
Visipaque



Possible Visipaque side effects in 52 year old male

Reported by a physician from Ukraine on 2012-07-31

Patient: 52 year old male

Reactions: Back Pain, Body Temperature Increased, Chills, Asthenia, Cold Sweat, Blood Pressure Decreased

Drug(s) suspected as cause:
Visipaque



Possible Visipaque side effects in female

Reported by a physician from France on 2012-07-31

Patient: female, weighing 56.5 kg (124.3 pounds)

Reactions: Dysgeusia, Weight Decreased, Fatigue, Nausea, Headache, Decreased Appetite

Drug(s) suspected as cause:
Visipaque

Other drugs received by patient: Altim



Possible Visipaque side effects in female

Reported by a physician from France on 2012-07-31

Patient: female, weighing 56.5 kg (124.3 pounds)

Reactions: Weight Decreased, Dysgeusia, Fatigue, Nausea, Headache, Decreased Appetite

Drug(s) suspected as cause:
Visipaque

Other drugs received by patient: Altim



Possible Visipaque side effects in 54 year old male

Reported by a pharmacist from United States on 2012-07-27

Patient: 54 year old male, weighing 122.3 kg (269.1 pounds)

Reactions: Coagulopathy, International Normalised Ratio Increased, Wound, Gangrene, TOE Amputation, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Visipaque
    Dosage: 320ml once iv recent
    Indication: Scan With Contrast

Lovenox
    Dosage: 120mg once iv recent

Warfarin Sodium
    Dosage: 12.5 mg po qd chronic
    Administration route: Oral
    Indication: Peripheral Arterial Occlusive Disease

Other drugs received by patient: Norvasc; Vitamin D; Plavix; Novolog; Furosemide; Carvedilol; Lipitor; Warfarin Sodium; Metolazone; Metformin Hydrochloride; Diovan; Aspirin; Lantus



Possible Visipaque side effects in 81 year old female

Reported by a pharmacist from United States on 2012-07-27

Patient: 81 year old female, weighing 86.4 kg (190.1 pounds)

Reactions: Pain in Extremity, Dermatitis Exfoliative, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Doripenem
    Dosage: 250 mg q12h ivpb recent
    Indication: Urinary Tract Infection

Visipaque
    Dosage: 100 m iv recent
    Indication: Scan With Contrast

Other drugs received by patient: Cyanocobalamin; Aspirin; Coumadin; Benadryl; Ventolin; Proventil; Tylenol; **drug Illegible**



Possible Visipaque side effects in female

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

Patient: female, weighing 57.0 kg (125.4 pounds)

Reactions: Photosensitivity Reaction, Hyperaesthesia, Hypersensitivity, Urticaria, Urticaria Cholinergic

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Visipaque
    Indication: Haematuria
    Start date: 2010-12-07
    End date: 2010-12-07

Visipaque
    Indication: Abdominal Pain



Possible Visipaque side effects in 88 year old male

Reported by a individual with unspecified qualification from France on 2012-07-19

Patient: 88 year old male

Reactions: Rash Papular, Purpura, Toxic Skin Eruption

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Visipaque

Other drugs received by patient: Bisoprolol Fumarate; Coversyl Arginine; Sintrom; Alfuzosin Hydrochloride; Calciparine



Possible Visipaque side effects in male

Reported by a individual with unspecified qualification from France on 2012-06-19

Patient: male

Reactions: Hypersensitivity, Urticaria, Feeling Hot, Vasoplegia Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Visipaque
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-05-24
    End date: 2012-05-24

Plavix

Other drugs received by patient: Atorvastatin; Metformin HCL; Valium; Lercanidipine; Omeprazole; Aspirin; Fluindione; Valsartan



Possible Visipaque side effects in 64 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-06-13

Patient: 64 year old male

Reactions: Overdose, Urticaria, Feeling Hot, Vasoplegia Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Plavix
    Administration route: Oral
    Start date: 2012-05-24
    End date: 2012-05-24

Visipaque
    Start date: 2012-05-24
    End date: 2012-05-24

Other drugs received by patient: Aspirin; Atorvastatin; Valium; Valsartan; Omeprazole; Lercanidipine; Metformin HCL



Possible Visipaque side effects in 71 year old female

Reported by a health professional (non-physician/pharmacist) on 2012-06-06

Patient: 71 year old female

Reactions: Viral Rash, Idiopathic Urticaria, Post Procedural Complication, Type III Immune Complex Mediated Reaction, Rash Pruritic, Rash Erythematous, Rash Maculo-Papular, Toxic Skin Eruption

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Plavix
    Dosage: (1 in 1 d)
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-08-22

Tocopheryl Acetate (Tocopheryl Acetate)
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-08-21
    End date: 2009-08-21

Solu-Medrol
    Indication: Premedication
    Start date: 2009-08-21
    End date: 2009-08-21

Lovenox
    Dosage: subcutaneous
    Indication: Premedication
    Start date: 2009-08-21
    End date: 2009-08-21

Repaglinide
    Dosage: 1.5 mg (1.5 mg,1 in 1 d),oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-08-22
    End date: 2009-08-28

Visipaque
    Dosage: intravenous
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-08-21
    End date: 2009-08-21

Metformin HCL
    Dosage: 500 mg thrice/day (500 mg,3 in 1 d),oral
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    Start date: 2009-08-22
    End date: 2009-08-28

Isosorbide Dinitrate
    Indication: Premedication
    Start date: 2009-08-21
    End date: 2009-08-21

Betadine
    Dosage: topical
    Administration route: Topical
    Indication: Infection Prophylaxis
    Start date: 2009-08-21
    End date: 2009-08-21

Isoptin
    Indication: Premedication
    Start date: 2009-08-21
    End date: 2009-08-21

Aspirin
    Dosage: (1 in 1 d),oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-08-22

Amlodipine Besylate
    Dosage: (1 in 1 d),oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-08-22

Other drugs received by patient: Nordaz (Nordazepam); Havlane (Loprazolam Mesilate); Januvia (Sitaglipitn Phosphate); Ebastine; Daflon (Diosmin); Aerius (Ebastine); Polyethylene Glycol



Possible Visipaque side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-06-01

Patient: male

Reactions: Drug Eruption, Rash Generalised, Skin Exfoliation, Lymphopenia, Pyrexia, Purpura, Neutropenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rifabutin

Ethambutol Hydrochloride

Colchicine

Tramadol HCL

Nefopam Hydrochloride (Acupan)

Visipaque
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-10-13
    End date: 2011-10-13

Clarithromycin



Possible Visipaque side effects in 71 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-05-31

Patient: 71 year old female

Reactions: Pruritus, Rash Erythematous, Rash Maculo-Papular

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Isosorbide Dinitrate
    Dosage: unk
    Indication: Premedication
    Start date: 2009-08-21
    End date: 2009-08-21

Tocopheryl Acetate
    Dosage: unk
    Start date: 2009-08-21
    End date: 2009-08-21

Isoptin
    Dosage: unk
    Indication: Premedication
    Start date: 2009-08-21
    End date: 2009-08-21

Repaglinide
    Dosage: 1.5 mg, 1x/day
    Administration route: Oral
    Start date: 2009-08-22
    End date: 2009-08-28

Aspirin
    Dosage: 160 mg, 1x/day
    Administration route: Oral
    Start date: 2009-08-22

Amlodipine Besylate
    Dosage: 10 mg, 1x/day
    Administration route: Oral
    Start date: 2009-08-22

Plavix
    Dosage: 75 mg, 1x/day
    Administration route: Oral
    Start date: 2009-08-22

Metformin HCL
    Dosage: 500 mg, 3x/day
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    Start date: 2009-08-22
    End date: 2009-08-28

Betadine
    Dosage: unk
    Administration route: Topical
    Indication: Infection Prophylaxis
    Start date: 2009-08-21
    End date: 2009-08-21

Visipaque
    Dosage: unk
    Start date: 2009-08-21
    End date: 2009-08-21

Lovenox
    Dosage: unk
    Indication: Premedication
    Start date: 2009-08-21
    End date: 2009-08-21

Solu-Medrol
    Dosage: unk
    Indication: Premedication
    Start date: 2009-08-21
    End date: 2009-08-21

Other drugs received by patient: Daflon; Januvia; Ebastine; Havlane; Polyethylene Glycol; Desloratadine; Nordaz



Possible Visipaque side effects in 71 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-05-31

Patient: 71 year old female

Reactions: Pruritus, Idiopathic Urticaria, Rash Erythematous, Urticaria, Rash Maculo-Papular

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Metformin HCL
    Dosage: 500 mg, tid, unk
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    Start date: 2009-08-22
    End date: 2009-08-28

Heparin
    Dosage: unk
    Start date: 2009-08-21
    End date: 2009-08-21

Visipaque
    Dosage: unk
    Start date: 2009-08-21
    End date: 2009-08-21

Betadine
    Dosage: unk
    Start date: 2009-08-21
    End date: 2009-08-21

Repaglinide
    Dosage: 0.5 mg, tid , unk
    Administration route: Oral
    Start date: 2009-08-22
    End date: 2009-08-28

Aspirin
    Dosage: 160.000000 mg, qd, unk
    Administration route: Oral
    Start date: 2009-08-22

Clopidogrel Bisulfate
    Dosage: 75.000000 mg, qd, unk
    Administration route: Oral
    Start date: 2009-08-22

Tocopheryl Acetate
    Dosage: unk
    Start date: 2009-08-21
    End date: 2009-08-21

Isoptin
    Dosage: unk
    Start date: 2009-08-21
    End date: 2009-08-21

Solu-Medrol
    Dosage: unk
    Start date: 2009-08-21
    End date: 2009-08-21

Amlodipine Besylate
    Dosage: 10 mg, qd , unk
    Administration route: Oral
    Start date: 2009-08-22

Other drugs received by patient: Daflon; Ebastine; Loprazolam Mesilate; Macrogol



Possible Visipaque side effects in 75 year old male

Reported by a physician from Thailand on 2012-05-25

Patient: 75 year old male

Reactions: Paraplegia, Pancytopenia, Hepatitis, Anuria

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Visipaque
    Indication: Colon Cancer

Visipaque
    Indication: Flatulence
    Start date: 2010-01-26
    End date: 2010-01-26

Other drugs received by patient: Furosemide; Senna Alexandrina (Senokot); Lorazepam; Aspirin; Colchicine; Bisoprolol Fumarate (Concor); Lipitor; Manidipine Hydrochloride (Madiplot); Allopurinol; Clarithromycin; Isosorbide Mononitrate; Trimetazidine Hydrochloride (Vastarel); Glipizide (Minidiab); Budesonide W / Formoterol Fumarate (Symbicort); Doxazosin Mesylate (Cardura XL); Omeprazole



Possible Visipaque side effects in male

Reported by a physician from Italy on 2012-05-25

Patient: male

Reactions: Pain in Extremity, Oedema Peripheral, Haematoma

Drug(s) suspected as cause:
Visipaque

Other drugs received by patient: Lansoprazole; Prednisone (Deltacortene); Ticlopidine HCL; Chlorpheniramine Maleate (Trimeton)



Possible Visipaque side effects in male

Reported by a physician from France on 2012-05-25

Patient: male

Reactions: Rash Generalised, Skin Exfoliation, Drug Ineffective, Adverse Drug Reaction, General Physical Health Deterioration, Purpura, Pyrexia, Hyperhidrosis, Erythema, Liver Function Test Abnormal, Neutropenia, Leukopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clarithromycin
    Start date: 2011-11-14

Ethambutol Hydrochloride
    Administration route: Oral
    Indication: Atypical Mycobacterial Infection
    Start date: 2011-10-07
    End date: 2011-10-13

Tramadol HCL
    Administration route: Oral
    Indication: Arthralgia
    Start date: 2011-09-24
    End date: 2011-10-17

Visipaque
    Dosage: once
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-10-13

Rifabutin
    Administration route: Oral
    Indication: Atypical Mycobacterial Infection
    Start date: 2011-10-07
    End date: 2011-10-13

Ethambutol Hydrochloride
    Start date: 2011-11-17

Ethambutol Hydrochloride
    Start date: 2011-10-15
    End date: 2011-10-17

Colchicine
    Dosage: 3 1st day; 2 2nd + 3rd day; 1 since 4th
    Administration route: Oral
    Indication: Arthralgia
    Start date: 2011-10-04
    End date: 2011-10-17

Rifabutin
    Start date: 2011-10-15
    End date: 2011-10-17

Rifabutin
    Start date: 2011-11-20

Clarithromycin
    Administration route: Oral
    Indication: Atypical Mycobacterial Infection
    Start date: 2011-10-07
    End date: 2011-10-13

Acupan
    Administration route: Oral
    Indication: Pain
    Start date: 2011-10-03
    End date: 2011-10-07

Clarithromycin
    Start date: 2011-10-15
    End date: 2011-10-17



Possible Visipaque side effects in 47 year old male

Reported by a consumer/non-health professional from United States on 2012-05-11

Patient: 47 year old male, weighing 63.5 kg (139.7 pounds)

Reactions: Bone Pain, Musculoskeletal Chest Pain

Drug(s) suspected as cause:
Prohance
    Indication: Nuclear Magnetic Resonance Imaging
    Start date: 2012-04-13
    End date: 2012-04-13

Visipaque
    Indication: Computerised Tomogram
    Start date: 2012-04-06
    End date: 2012-04-06



Possible Visipaque side effects in 28 year old male

Reported by a individual with unspecified qualification from France on 2012-05-03

Patient: 28 year old male

Reactions: Malaise, Bradycardia

Drug(s) suspected as cause:
Visipaque

Other drugs received by patient: Lidocaine



Possible Visipaque side effects in female

Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-04-18

Patient: female, weighing 60.0 kg (132.0 pounds)

Reactions: Anaphylactoid Shock

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Visipaque



Possible Visipaque side effects in 68 year old male

Reported by a pharmacist from United States on 2012-04-04

Patient: 68 year old male, weighing 120.6 kg (265.3 pounds)

Reactions: Gastrointestinal Haemorrhage, Dehydration, Contrast Media Reaction, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aspirin
    Dosage: 81mg daily po chronic
    Administration route: Oral
    Indication: Coronary Artery Disease

Plavix
    Dosage: 75mg / daily / po recent
    Administration route: Oral
    Indication: Stent Placement

Visipaque
    Dosage: recent

Other drugs received by patient: Ferrous Sulfate TAB; Coreg; Bicalutamide; VIT D3; Calcium Carbonate; Lasix; Percocet; Humalog



Possible Visipaque side effects in 59 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-04-03

Patient: 59 year old female

Reactions: Angioedema, Dermatitis Bullous, Rash

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Visipaque

Other drugs received by patient: Neurontin; Paroxetine Hydrochloride



Possible Visipaque side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-03-30

Patient: male

Reactions: Nausea, Clonus, Bradycardia, Hypoaesthesia, Cardiac Arrest, Neurogenic Shock

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Aetoxisclerol
    Start date: 2010-11-09
    End date: 2010-11-09

Visipaque
    Indication: Varicocele Repair
    Start date: 2010-11-09
    End date: 2010-11-09

Other drugs received by patient: Lidocaine



Possible Visipaque side effects in male

Reported by a physician from France on 2012-03-12

Patient: male

Reactions: Hypotension, Respiratory Arrest, Bradycardia, Erythema, Cardiac Arrest

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Heparin Sodium
    Indication: Arteriogram Coronary
    Start date: 2012-02-03
    End date: 2012-02-03

Xylocaine
    Dosage: once/single administration
    Indication: Arteriogram Coronary
    Start date: 2012-02-03
    End date: 2012-02-03

Visipaque
    Dosage: 270 mg of iodine / ml, 210 ml once/single administration
    Indication: Arteriogram Coronary
    Start date: 2012-02-03
    End date: 2012-02-03

Isoptin
    Dosage: 5 mg / 2 ml, 1 df once/single administration
    Indication: Arteriogram Coronary
    Start date: 2012-02-03
    End date: 2012-02-03

Other drugs received by patient: Clopidogrel Bisulfate and Aspirin; Carvedilol; Isosorbide Dinitrate; Perindopril Erbumine; Atorvastatin; Nexium



Possible Visipaque side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-06

Patient: male

Reactions: Cardio-Respiratory Arrest

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Visipaque
    Dosage: 30 ml, 1 in 1 total
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-21
    End date: 2012-02-21

Hexabrix
    Dosage: 24 ml, 1 in 1 total
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-21
    End date: 2012-02-21

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