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Review Iodixanol Safety Reports submitted to FDA

Total Iodixanol reports: 7.
Iodixanol FDA safety alerts: No.
   Reported hospitalizations: 5.
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FDA Reported Iodixanol Side Effects: contrast media reaction, renal failure acute, pyrexia, blood creatinine increased, nephropathy, acute respiratory distress syndrome, nephropathy toxic, hypotension, renal tubular necrosis, pancreatic cyst, oxygen consumption increased.
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Iodixanol Side Effects Report #5650384-1
Pharmacist from UNITED STATES reported IODIXANOL problem on Mar 04, 2008. Female patient, 61 years of age, weighting 152.1 lb, was diagnosed with fistulogram and was treated with IODIXANOL. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation, dyspnoea, lip oedema, stridor, tongue oedema. IODIXANOL dosage: 150 ML ONCE IV BOLUS. During the same period patient was treated with LISINOPRIL, ACETAMINOPHEN, ASPIRIN, CLOPIDOGREL, OMEPRAZOLE, ATORVASTATIN CALCIUM, FOSRENOL. Patient was hospitalized. Patient recovered.

Iodixanol Side Effects Report #5652458-8
IODIXANOL problem was reported by a Pharmacist from UNITED STATES on Mar 05, 2008. Male patient, 45 years of age, weighting 245.8 lb, was diagnosed with catheterisation cardiac and was treated with IODIXANOL. After drug was administered, patient experienced the following problems/side effects: contrast media reaction, rash pruritic. IODIXANOL dosage: 150ML ONCE IV. Patient recovered.

Iodixanol Side Effects Report #5514056-6
Pharmacist from UNITED STATES reported IODIXANOL problem on Nov 09, 2007. Male patient, 70 years of age, was diagnosed with aortic aneurysm and was treated with IODIXANOL. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased, fat embolism, haematuria, nephropathy, oliguria, post procedural complication, renal failure acute, renal tubular necrosis, renal vessel disorder. IODIXANOL dosage: 150ML ONCE IV BOLUS. During the same period patient was treated with ERYTHROPOETIN ALFA, FERRLICIT, NS PLUS D, BICARBONATE, ADVAIR DISKUS, PROPOFOL, ASPIRIN, CLOPIDOGREL. Patient was hospitalized. Patient recovered.

Iodixanol Side Effects Report #5520707-2
IODIXANOL problem was reported by a Health Professional from UNITED STATES on Nov 15, 2007. Male patient, 60 years of age, was diagnosed with coronary arterial stent insertion and was treated with IODIXANOL. After drug was administered, patient experienced the following problems/side effects: muscle spasms, pruritus, rash, throat irritation. IODIXANOL dosage: unknown. Patient was hospitalized. Patient recovered.

Iodixanol Side Effects Report #5485734-2
Pharmacist from UNITED STATES reported IODIXANOL problem on Oct 11, 2007. Male patient, 49 years of age, was diagnosed with cardiac imaging procedure, scan with contrast and was treated with IODIXANOL. After drug was administered, patient experienced the following problems/side effects: pruritus, sneezing. IODIXANOL dosage: 90ML ONE TIME IV BOLUS. Patient recovered.

Iodixanol Side Effects Report #5489523-4
IODIXANOL problem was reported by a Pharmacist from UNITED STATES on Oct 16, 2007. Female patient, 87 years of age, weighting 176.4 lb, was diagnosed with angiogram pulmonary, dyspnoea and was treated with IODIXANOL. After drug was administered, patient experienced the following problems/side effects: nephropathy toxic, renal failure acute. IODIXANOL dosage: 150ML ONCE IV BOLUS. During the same period patient was treated with FUROSEMIDE, HEPARIN, METOPROLOL TARTRATE, ACETYLCYSTEINE, CEFTRIAXONE, AZITHROMYCIN, ESOMEPRAZOLE. Patient was hospitalized. Patient recovered.

Iodixanol Side Effects Report #5444526-0
Pharmacist from UNITED STATES reported IODIXANOL problem on Sept 04, 2007. Male patient, 65 years of age, weighting 195.0 lb, was diagnosed with angioplasty, gout and was treated with IODIXANOL. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, contrast media reaction, renal failure acute. IODIXANOL dosage: 150ML ONCE IV. During the same period patient was treated with INDOMETHACIN, ALLOPURINOL, FEXOFENADINE, WARFARIN, TRIAMTERENE, DIGOXIN, NADOLOL, ATORVASTATIN. Patient was hospitalized. Patient recovered.


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atrial fibrillation, dyspnoea, lip oedema, stridor, tongue oedema, contrast media reaction, rash pruritic, , was diagnosed with fistulogram and was diagnosed with catheterisation cardiac and was diagnosed with aortic aneurysm and