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Review Isovue Safety Reports submitted to FDA

Total Isovue reports: 208.
Isovue FDA safety alerts: No.
Reported deaths: 22    Reported hospitalizations: 69.
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FDA Reported Isovue Side Effects: hypersensitivity, urticaria, pruritus, dyspnoea, vomiting, anaphylactoid reaction, nausea, convulsion, contrast media reaction, extravasation, swelling face.
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< Previous  Showing 201-208 of 208

Isovue Side Effects Report #5329486-5
Health Professional from UNITED STATES reported ISOVUE problem on Apr 13, 2006. Female patient, 45 years of age, was diagnosed with aneurysm, computerised tomogram head and was treated with ISOVUE. After drug was administered, patient experienced the following problems/side effects: hypersensitivity. ISOVUE dosage: 100 ML ONCE IV. Patient recovered.

Isovue Side Effects Report #5329489-0
ISOVUE problem was reported by a Health Professional from UNITED STATES on Mar 29, 2006. Female patient, 38 years of age, was diagnosed with computerised tomogram, hernia and was treated with ISOVUE. After drug was administered, patient experienced the following problems/side effects: hypersensitivity. ISOVUE dosage: 150 ML ONCE IV. Patient recovered.

Isovue Side Effects Report #5329490-7
Health Professional from UNITED STATES reported ISOVUE problem on Mar 30, 2006. Female patient, 51 years of age, was diagnosed with computerised tomogram and was treated with ISOVUE. After drug was administered, patient experienced the following problems/side effects: hypersensitivity. ISOVUE dosage: 100 ML ONCE IV. Patient recovered.

Isovue Side Effects Report #5329491-9
ISOVUE problem was reported by a Health Professional from UNITED STATES on Mar 24, 2006. Female patient, 38 years of age, weighting 115.2 lb, was diagnosed with abdominal pain, computerised tomogram and was treated with ISOVUE. After drug was administered, patient experienced the following problems/side effects: anaphylactoid reaction. ISOVUE dosage: 100 ML ONCE IV. Patient recovered.

Isovue Side Effects Report #5329492-0
Health Professional from UNITED STATES reported ISOVUE problem on Mar 22, 2006. Male patient was diagnosed with abdominal pain, computerised tomogram abdomen and was treated with ISOVUE. After drug was administered, patient experienced the following problems/side effects: contrast media reaction, dysphonia, wheezing. ISOVUE dosage: 120 ML ONCE IV. During the same period patient was treated with GLUCOPHAGE. Patient recovered.

Isovue Side Effects Report #5232480-6
ISOVUE problem was reported by a Health Professional from UNITED STATES on July 27, 2006. Male patient, 60 years of age, was diagnosed with computerised tomogram head, hemiparesis and was treated with ISOVUE. After drug was administered, patient experienced the following problems/side effects: anaphylactoid reaction. ISOVUE dosage: 80 ML ONCE IV. Patient recovered.

Isovue Side Effects Report #5232481-8
Physician from UNITED STATES reported ISOVUE problem on Nov 28, 2005. Male patient, 71 years of age, was diagnosed with computerised tomogram and was treated with ISOVUE. After drug was administered, patient experienced the following problems/side effects: convulsion. ISOVUE dosage: 125 ML ONCE IV. During the same period patient was treated with PREDNISOLONE, BENADRYL. Patient was hospitalized. Patient recovered.

Isovue Side Effects Report #5283563-6
ISOVUE problem was reported by a Pharmacist from UNITED STATES on Mar 29, 2007. Female patient, 52 years of age, weighting 195.0 lb, was diagnosed with computerised tomogram and was treated with ISOVUE. After drug was administered, patient experienced the following problems/side effects: eye pruritus, rash pruritic, vision blurred. ISOVUE dosage: 80 ML ONCE IV. Patient recovered.

< Previous  Showing 201-208 of 208


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hypersensitivity, hypersensitivity, hypersensitivity, anaphylactoid reaction, contrast media reaction, dysphonia, wheezing, , was diagnosed with aneurysm, computerised tomogram head and was diagnosed with computerised tomogram, hernia and