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Hexabrix (Ioxaglate) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Hexabrix (Ioxaglate) 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 (25)
Death (2)
Life Threatening Events (9)

Reports by Reaction Type

Shock (5)Hypersensitivity (4)Cardio-Respiratory Arrest (4)Anaphylactic Shock (3)Face Oedema (3)Drug Rash With Eosinophilia and Systemic Symptoms (3)Hypertension (3)Pruritus (2)Anaphylactic Reaction (2)Urticaria (2)Erythema (2)Generalised Oedema (2)

Possible Hexabrix side effects in 47 year old female

Reported by a individual with unspecified qualification from Brazil on 2012-08-08

Patient: 47 year old female

Reactions: Cardio-Respiratory Arrest, Vomiting, Nausea, Chest Pain, Shock

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Hexabrix



Possible Hexabrix side effects in

Reported by a individual with unspecified qualification from Turkey on 2012-08-08

Patient:

Reactions: Hypotension, Retroperitoneal Haemorrhage

Drug(s) suspected as cause:
Hexabrix

Other drugs received by patient: Acetylcysteine; Nebivolol; Nacl 0.94% (Sodium Chloride)



Possible Hexabrix side effects in 77 year old male

Reported by a individual with unspecified qualification from Brazil on 2012-08-08

Patient: 77 year old male

Reactions: Cardio-Respiratory Arrest, Anaphylactic Shock, Cardiogenic Shock, Paraesthesia

Adverse event resulted in: death

Drug(s) suspected as cause:
Hexabrix
    Dosage: 50 ml (50 ml, 1 in 1 total)
    Indication: Catheterisation Cardiac
    Start date: 2012-04-19
    End date: 2012-04-19

Xenetix (Iobitridol)
    Dosage: 50 ml (50 ml, 1 in 1 total)
    Indication: Catheterisation Cardiac

Other drugs received by patient: Heparin; Monocordil (Isosorbide Mononitrate) (Isosorbide Mononitrate); Xylocaine (Lidocaine) (Lidocaine)



Possible Hexabrix side effects in 61 year old female

Reported by a individual with unspecified qualification from Brazil on 2012-08-08

Patient: 61 year old female

Reactions: Cardio-Respiratory Arrest, Shock

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Hexabrix



Possible Hexabrix side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-01

Patient: female, weighing 57.0 kg (125.4 pounds)

Reactions: Pruritus, Dysphagia, Urticaria

Drug(s) suspected as cause:
Hexabrix
    Dosage: unk unk, single
    Indication: Arthrogram
    Start date: 2011-10-25
    End date: 2011-10-25

Optimark
    Dosage: 5 ml, single
    Indication: Arthrogram
    Start date: 2011-10-25
    End date: 2011-10-25

Sodium Chloride
    Dosage: 12 ml, single
    Indication: Arthrogram
    Start date: 2011-10-25
    End date: 2011-10-25



Possible Hexabrix side effects in 61 year old male

Reported by a individual with unspecified qualification from Turkey on 2012-08-01

Patient: 61 year old male

Reactions: Sialoadenitis, Haemodialysis

Drug(s) suspected as cause:
Hexabrix



Possible Hexabrix side effects in 65 year old female

Reported by a individual with unspecified qualification from Brazil on 2012-07-31

Patient: 65 year old female

Reactions: Apparent Life Threatening Event, Erythema, Hypertension, Tremor

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Hexabrix

Other drugs received by patient: Heparin; Xylocaine (Lidocaine) (Lidocaine); Monocordil (Isosorbide Mononitrate) (Isosorbide Monitrate)



Possible Hexabrix side effects in 61 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-31

Patient: 61 year old female

Reactions: Haemoglobin Decreased, Septic Shock, Drug Rash With Eosinophilia and Systemic Symptoms, Pericardial Effusion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ciprofloxacin
    Dosage: 400 mg/200 ml intravenous drip
    Indication: Endocarditis
    Start date: 2011-07-18
    End date: 2011-07-29

Claforan
    Dosage: intravenous drip
    Indication: Endocarditis
    Start date: 2011-07-03
    End date: 2011-07-29

Fluconazole
    Dosage: 2 mg/ml intravenous drip
    Indication: Endocarditis
    Start date: 2011-07-18
    End date: 2011-07-29

Hexabrix
    Dosage: (1 in 1 total) intravenous (not otherwise specified)
    Indication: Angiogram
    Start date: 2011-07-13
    End date: 2011-07-13

Nexium
    Dosage: (40 mg) intravenous (not otherwise specified)
    Indication: Endocarditis
    Start date: 2011-07-03
    End date: 2011-08-08

Vancomycin
    Indication: Endocarditis
    Start date: 2011-07-13
    End date: 2011-07-29



Possible Hexabrix side effects in 61 year old male

Reported by a individual with unspecified qualification from Brazil on 2012-07-23

Patient: 61 year old male

Reactions: Anaphylactic Shock, Hypertension, Erythema

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Hexabrix

Other drugs received by patient: Heparin; Xylocaine (Lidocaine)(lidocaine); Monocordil (Isosorbide Mononitrate)(isosorbide Mononitrate)



Possible Hexabrix side effects in 61 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-17

Patient: 61 year old female

Reactions: Drug Rash With Eosinophilia and Systemic Symptoms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ciprofloxacin Hydrochloride
    Dosage: unk
    Start date: 2011-07-18
    End date: 2011-07-29

Claforan
    Dosage: unk
    Start date: 2011-07-03
    End date: 2011-07-29

Fluconazole
    Dosage: 2 mg/ml
    Start date: 2011-07-18
    End date: 2011-07-29

Hexabrix
    Dosage: 1 df, single
    Start date: 2011-07-13
    End date: 2011-07-13

Nexium
    Dosage: unk
    Start date: 2011-07-03
    End date: 2011-08-08

Vancomycin Hychloride
    Dosage: unk
    Start date: 2011-07-03
    End date: 2011-07-29



Possible Hexabrix side effects in 61 year old female

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

Patient: 61 year old female

Reactions: Septic Shock, Drug Rash With Eosinophilia and Systemic Symptoms, Pericardial Effusion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ciprofloxacin
    Dosage: unk
    Start date: 2011-07-18
    End date: 2011-07-29

Claforan
    Dosage: unk
    Indication: Antibiotic Therapy
    Start date: 2011-07-03
    End date: 2011-07-29

Fluconazole
    Dosage: unk
    Start date: 2011-07-18
    End date: 2011-07-29

Hexabrix
    Dosage: unk
    Indication: Angiogram
    Start date: 2011-07-13
    End date: 2011-07-13

Nexium
    Dosage: unk
    Start date: 2011-07-03
    End date: 2011-08-08

Vancomycin
    Dosage: unk
    Indication: Antibiotic Therapy
    Start date: 2011-07-03
    End date: 2011-07-29



Possible Hexabrix side effects in 45 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-06-11

Patient: 45 year old male

Reactions: Chest Discomfort, Wheezing, Hypertension, Oropharyngeal Discomfort

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Hexabrix



Possible Hexabrix side effects in 78 year old female

Reported by a individual with unspecified qualification from Brazil on 2012-05-10

Patient: 78 year old female

Reactions: Face Oedema, Anaphylactic Reaction, Therapeutic Response Delayed, Circulatory Collapse, Generalised Oedema, Shock

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hexabrix
    Dosage: 100 ml (100 ml, 1 in 1 d)
    Indication: Cardiac Ventriculogram
    Start date: 2011-10-19
    End date: 2011-10-19

Hexabrix
    Dosage: 100 ml (100 ml, 1 in 1 d)
    Indication: Arteriogram Coronary
    Start date: 2011-10-19
    End date: 2011-10-19

Other drugs received by patient: ASS Infantil (Acetlsalicylic Acid) (Acetylsalicylic Acid)



Possible Hexabrix side effects in 78 year old female

Reported by a individual with unspecified qualification from Brazil on 2012-04-25

Patient: 78 year old female

Reactions: Eyelid Oedema, Face Oedema, Oedema Genital, Shock, Generalised Oedema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hexabrix
    Dosage: 100 ml (100 ml, 1 in 1 total);
    Indication: Cardiovascular Evaluation
    Start date: 2011-10-19
    End date: 2011-10-19

Hexabrix
    Dosage: 100 ml (100 ml, 1 in 1 total);
    Indication: Cardiac Ventriculogram
    Start date: 2011-10-19
    End date: 2011-10-19

Other drugs received by patient: Aramin (Metaraminol Bitartrate); AAS Infantil (Acetylsalicylic Acid); Cortisonal (Hydrocortisone); Nerepinephrine



Possible Hexabrix side effects in 72 year old female

Reported by a individual with unspecified qualification from France on 2012-04-05

Patient: 72 year old female

Reactions: Acute Pulmonary Oedema, Dizziness Postural, Urticaria, Hypotension, Face Oedema, Throat Irritation, Feeling of Body Temperature Change, Blood Pressure Fluctuation, Histamine Level Increased, Oxygen Saturation Decreased, Blood Immunoglobulin E Increased

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Heparin Sodium
    Dosage: 5000 iu (5000 iu,1 in 1 total) intra-arterial
    Indication: Arteriogram Coronary
    Start date: 2012-02-09
    End date: 2012-02-09

Hexabrix
    Dosage: 371 ml (371 ml, 1 in 1 total), intravenous (not otherwise specified)
    Indication: Arteriogram Coronary
    Start date: 2012-02-09
    End date: 2012-02-09

Isoptin
    Dosage: 2.5 mg (2.5 mg,1 in 1 total) 1) intra-arterial
    Indication: Arteriogram Coronary
    Start date: 2012-02-09
    End date: 2012-02-09

Other drugs received by patient: Perindopril / Indapamide Mylan (Indapamide, Perindopril)(indapamide, PER; Inegy (Ezetimibe, Simvastatin)(ezetimibe, Simvastatin); Amlodipine; Kardegic (Acetylsalicylate Lysine)(acetylsalicylate Lysine)



Possible Hexabrix side effects in 74 year old male

Reported by a individual with unspecified qualification from France on 2012-03-28

Patient: 74 year old male

Reactions: Hypersensitivity, Presyncope, Procedural Complication, Skin Test Positive, Oropharyngeal Discomfort, Haemodynamic Instability

Drug(s) suspected as cause:
Heparin
    Dosage: 5000 iu (5000i-u) intravenous
    Start date: 2011-11-29

Hexabrix
    Dosage: (1 in 1 tot- 2) intravenous
    Start date: 2011-11-29



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

Visipaque
    Dosage: 30 ml, 1 in 1 total
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-21
    End date: 2012-02-21



Possible Hexabrix side effects in 65 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-24

Patient: 65 year old female

Reactions: Hypersensitivity, Respiratory Distress

Drug(s) suspected as cause:
Hexabrix



Possible Hexabrix side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-16

Patient:

Reactions: Hypersensitivity, Respiratory Distress

Drug(s) suspected as cause:
Hexabrix



Possible Hexabrix side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-10

Patient: female

Reactions: Respiratory Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Hexabrix



Possible Hexabrix side effects in 49 year old male

Reported by a pharmacist from France on 2012-01-06

Patient: 49 year old male

Reactions: Anaphylactic Shock

Drug(s) suspected as cause:
Hexabrix
    Dosage: 320 mg;once;iv
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-10-21
    End date: 2011-10-21

Integrilin
    Dosage: 5 ml;once;iv
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-10-21
    End date: 2011-10-21

Isosorbide Dinitrate
    Dosage: 2 mg;once;incor
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-10-21
    End date: 2011-10-21

Midazolam
    Dosage: 1 iu;once;iv
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-10-21
    End date: 2011-10-21

Sufentanyl (Sufentanil)
    Dosage: 1 df;once;iv
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-10-21
    End date: 2011-10-21

Other drugs received by patient: Alprazolam; Lysine Aspirin; Clopidogrel Bisulfate; Tenecteplase; Sodium Chloride; Bisoprolol Fumarate; Enoxaparin



Possible Hexabrix side effects in 76 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2011-12-14

Patient: 76 year old male

Reactions: Platelet Count Decreased, Shock

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Hexabrix



Possible Hexabrix side effects in female

Reported by a individual with unspecified qualification from France on 2011-12-08

Patient: female

Reactions: Confusional State, Hot Flush, Hypersensitivity, Hyperthermia, Chills, Influenza Like Illness

Drug(s) suspected as cause:
Hexabrix



Possible Hexabrix side effects in 86 year old female

Reported by a individual with unspecified qualification from Brazil on 2011-11-10

Patient: 86 year old female

Reactions: Flushing, Respiratory Rate Increased, Pruritus, Dyspnoea, Oedema

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Hexabrix
    Dosage: intravenous (not otherwise specified)
    Indication: Abdomen Scan
    Start date: 2011-10-17
    End date: 2011-10-17

Hexabrix
    Dosage: intravenous (not otherwise specified)
    Indication: Arteriogram Coronary
    Start date: 2011-10-17
    End date: 2011-10-17

Hexabrix
    Dosage: intravenous (not otherwise specified)
    Indication: Catheterisation Cardiac
    Start date: 2011-10-17
    End date: 2011-10-17

Hexabrix
    Dosage: intravenous (not otherwise specified)
    Indication: Arteriogram Renal
    Start date: 2011-10-17
    End date: 2011-10-17



Possible Hexabrix side effects in 78 year old female

Reported by a individual with unspecified qualification from Brazil on 2011-11-09

Patient: 78 year old female

Reactions: Anaphylactic Reaction, Distributive Shock

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Hexabrix

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