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Review Isovue Safety Reports submitted to FDA

Total Isovue reports: 37.
Isovue FDA safety alerts: No.
Reported deaths: 14    Reported hospitalizations: 20.
Take Isovue Side Effects Survey, Discuss Isovue with others
FDA Reported Isovue Side Effects: hypersensitivity, urticaria, pruritus, dyspnoea, vomiting, anaphylactoid reaction, nausea, convulsion, contrast media reaction, extravasation, swelling face.
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Isovue Side Effects Report #5647270-X
Health Professional from UNITED STATES reported ISOVUE problem on Feb 27, 2008. Female patient, 50 years of age, was diagnosed with metastatic neoplasm, computerised tomogram and was treated with ISOVUE. After drug was administered, patient experienced the following problems/side effects: anorexia, anxiety, asthenia, azotaemia, cough, dialysis, diarrhoea, dyspnoea, fatigue. ISOVUE dosage: unknown. During the same period patient was treated with BENADRYL, PREDNISONE, TAPAZOLE, BENZOATE, PEGFILGRASTIM, DEXAMETHASONE, DOCETAXEL. Patient was hospitalized. Patient recovered.

Isovue Side Effects Report #5659639-8
ISOVUE problem was reported by a Pharmacist from UNITED STATES on Mar 10, 2008. Female patient, 21 years of age, was diagnosed with computerised tomogram and was treated with ISOVUE. After drug was administered, patient experienced the following problems/side effects: pruritus, urticaria, vomiting. ISOVUE dosage: 150 ML IV. Patient recovered.

Isovue Side Effects Report #5661942-2
Pharmacist from UNITED STATES reported ISOVUE problem on Mar 10, 2008. Female patient, 43 years of age, was diagnosed with computerised tomogram and was treated with ISOVUE. After drug was administered, patient experienced the following problems/side effects: nausea, urticaria, vomiting. ISOVUE dosage: 144 ML. Patient recovered.

Isovue Side Effects Report #5705349-8
ISOVUE problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 09, 2008. Female patient, 77 years of age, was diagnosed with computerised tomogram and was treated with ISOVUE. After drug was administered, patient experienced the following problems/side effects: cardio-respiratory arrest, hypersensitivity. ISOVUE dosage: unknown. During the same period patient was treated with ZOSYN, VANCOMYCIN, HYDROCORTISONE, DOPAMINE, ATROPINE, ASPIRIN, FLUID. Patient died on 12/22/2006.

Isovue Side Effects Report #5720746-2
Consumer or non-health professional from UNITED STATES reported ISOVUE problem on Apr 22, 2008. Female patient, 66 years of age, was diagnosed with computerised tomogram, ischaemia, computerised tomogram abdomen and was treated with ISOVUE. After drug was administered, patient experienced the following problems/side effects: hypertension, nephropathy toxic. ISOVUE dosage: unknown. During the same period patient was treated with BENADRYL, PREDNISONE, LOPRESSOR. Patient recovered.

Isovue Side Effects Report #5612709-2
ISOVUE problem was reported by a Consumer or non-health professional from UNITED STATES on Jan 28, 2008. Female patient, weighting 138.9 lb, was diagnosed with catheter related complication, angioplasty and was treated with ISOVUE. After drug was administered, patient experienced the following problems/side effects: hypersensitivity. ISOVUE dosage: unknown. During the same period patient was treated with BENADRYL, TOPROL, INSULIN, GLIPIZIDE, HYDRALAZINE, CATAPRES, MINOXIDIL. Patient died on 11/20/2007.

Isovue Side Effects Report #5619975-8
Consumer or non-health professional from UNITED STATES reported ISOVUE problem on Feb 01, 2008. Female patient, weighting 138.9 lb, was diagnosed with catheter related complication, angioplasty and was treated with ISOVUE. After drug was administered, patient experienced the following problems/side effects: hypersensitivity. ISOVUE dosage: unknown. During the same period patient was treated with BENADRYL, TOPROL, INSULIN, GLIPIZIDE, HYDRALAZINE, CATAPRES, MINOXIDIL. Patient died on 11/20/2007.

Isovue Side Effects Report #5625695-6
ISOVUE problem was reported by a Consumer or non-health professional from UNITED STATES on Feb 06, 2008. Female patient, 77 years of age, was diagnosed with computerised tomogram and was treated with ISOVUE. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased, cardiac arrest, confusional state, heart rate decreased. ISOVUE dosage: unknown. During the same period patient was treated with ZOSYN, VANCOMYCIN, HYDROCORTISONE, DOPAMINE, ATROPINE, ASPIRIN, FLUID. Patient died on 12/22/2006.

Isovue Side Effects Report #5636747-9
Consumer or non-health professional from UNITED STATES reported ISOVUE problem on Feb 15, 2008. Female patient, 85 years of age, was diagnosed with arteriogram coronary, arteriogram renal and was treated with ISOVUE. After drug was administered, patient experienced the following problems/side effects: renal failure acute. ISOVUE dosage: unknown. Patient recovered.

Isovue Side Effects Report #5638906-8
ISOVUE problem was reported by a Consumer or non-health professional from UNITED STATES on Feb 25, 2008. Female patient, 47 years of age, weighting 255.0 lb, was diagnosed with computerised tomogram thorax and was treated with ISOVUE. After drug was administered, patient experienced the following problems/side effects: arthralgia, confusional state, dizziness, dysarthria, fatigue, headache, memory impairment, muscular weakness, nausea. ISOVUE dosage: unknown. Patient recovered.

Isovue Side Effects Report #5531697-0
Consumer or non-health professional from UNITED STATES reported ISOVUE problem on Nov 28, 2007. Female patient, 51 years of age, was treated with ISOVUE. After drug was administered, patient experienced the following problems/side effects: blister, extravasation, injection site pain, injection site swelling, musculoskeletal pain, neck pain, oedema peripheral, skin discolouration, vomiting. ISOVUE dosage: 2 ML/SEC. During the same period patient was treated with CHLORIDE. Patient recovered.

Isovue Side Effects Report #5571886-2
ISOVUE problem was reported by a Health Professional from UNITED STATES on Dec 13, 2007. Female patient, 50 years of age, was diagnosed with metastatic neoplasm, computerised tomogram and was treated with ISOVUE. After drug was administered, patient experienced the following problems/side effects: renal tubular necrosis. ISOVUE dosage: unknown. During the same period patient was treated with BENADRYL, PREDNISONE, TATDZOL, BENZOATE, PEGFILGRASTIM, DEXAMETHASONE, DOCETAXEL. Patient was hospitalized. Patient recovered.

Isovue Side Effects Report #5579049-1
Pharmacist from UNITED STATES reported ISOVUE problem on Dec 28, 2007. Female patient, 73 years of age, weighting 114.6 lb, was diagnosed with catheterisation cardiac and was treated with ISOVUE. After drug was administered, patient experienced the following problems/side effects: electrocardiogram st segment elevation, procedural hypotension. ISOVUE dosage: 250 ML ONCE IV. Patient recovered.

Isovue Side Effects Report #5518928-8
ISOVUE problem was reported by a Consumer or non-health professional from UNITED STATES on Nov 14, 2007. Female patient, 65 years of age, weighting 150.0 lb, was diagnosed with computerised tomogram and was treated with ISOVUE. After drug was administered, patient experienced the following problems/side effects: bladder pain, blood urine present, burning sensation, feeling hot, gait disturbance, pain in extremity, paraesthesia, renal pain. ISOVUE dosage: unknown. Patient recovered.

Isovue Side Effects Report #5582401-1
Health Professional from UNITED STATES reported ISOVUE problem on Aug 15, 2007. Female patient was diagnosed with computerised tomogram abdomen, computerised tomogram thorax 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 was hospitalized. Patient recovered.

Isovue Side Effects Report #5582402-3
ISOVUE problem was reported by a Health Professional from UNITED STATES on Nov 01, 2006. Male patient, 54 years of age, was diagnosed with arteriogram coronary and was treated with ISOVUE. After drug was administered, patient experienced the following problems/side effects: anaphylactic shock. ISOVUE dosage: 80 ML ONCE IV. Patient was hospitalized. Patient recovered.

Isovue Side Effects Report #5582403-5
Health Professional from UNITED STATES reported ISOVUE problem on Mar 01, 2007. Female patient, 43 years of age, was diagnosed with abdominal pain, computerised tomogram abdomen, diarrhoea and was treated with ISOVUE. After drug was administered, patient experienced the following problems/side effects: anaphylactoid reaction. ISOVUE dosage: 90 ML ONCE IV. During the same period patient was treated with DOXYCYCLINE, KAY CIEL DURA, ORAL CONTRAST. Patient was hospitalized. Patient recovered.

Isovue Side Effects Report #5582404-7
ISOVUE problem was reported by a Health Professional from UNITED STATES on Mar 01, 2007. Male patient, 41 years of age, was diagnosed with abdominal pain, computerised tomogram abdomen and was treated with ISOVUE. After drug was administered, patient experienced the following problems/side effects: hypersensitivity. ISOVUE dosage: 90 ML ONCE IV. During the same period patient was treated with LISINOPRIL, PRILOSEC. Patient was hospitalized. Patient recovered.

Isovue Side Effects Report #5582405-9
Health Professional from UNITED STATES reported ISOVUE problem on Oct 17, 2006. Female patient, 22 years of age, was diagnosed with computerised tomogram abdomen, pelvic pain and was treated with ISOVUE. After drug was administered, patient experienced the following problems/side effects: anaphylactoid reaction. ISOVUE dosage: 110 ML ONCE IV. Patient was hospitalized. Patient recovered.

Isovue Side Effects Report #5476808-0
ISOVUE problem was reported by a Health Professional from UNITED STATES on Oct 03, 2007. Male patient, 74 years of age, weighting 158.0 lb, was diagnosed with computerised tomogram and was treated with ISOVUE. After drug was administered, patient experienced the following problems/side effects: dyspnoea. ISOVUE dosage: unknown. Patient recovered.

Isovue Side Effects Report #5478464-4
Consumer or non-health professional from UNITED STATES reported ISOVUE problem on Sept 26, 2007. Male patient, 85 years of age, was diagnosed with chest x-ray abnormal and was treated with ISOVUE. After drug was administered, patient experienced the following problems/side effects: blood pressure immeasurable, cough, loss of consciousness. ISOVUE dosage: unknown. Patient died on 09/19/2007.

Isovue Side Effects Report #5481267-8
ISOVUE problem was reported by a Pharmacist from UNITED STATES on Oct 05, 2007. Female patient, weighting 145.0 lb, was diagnosed with spinal myelogram and was treated with ISOVUE. After drug was administered, patient experienced the following problems/side effects: apnoea, dystonia, meningitis, mydriasis, pupil fixed, therapeutic product contamination. ISOVUE dosage: 15 ML ONCE IT. Patient died on 06/01/2007.

Isovue Side Effects Report #5483751-X
Consumer or non-health professional from UNITED STATES reported ISOVUE problem on Oct 05, 2007. Male patient, 46 years of age, was diagnosed with chest pain and was treated with ISOVUE. After drug was administered, patient experienced the following problems/side effects: cerebrovascular accident. ISOVUE dosage: ADMINISTERED A TOTAL OF 310 MILLILITERS. Patient was hospitalized. Patient recovered.

Isovue Side Effects Report #5485760-3
ISOVUE problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 08, 2007. Male patient, 85 years of age, was treated with ISOVUE. After drug was administered, patient experienced the following problems/side effects: blood pressure immeasurable, cough, loss of consciousness. ISOVUE dosage: unknown. Patient died on 09/19/2007.

Isovue Side Effects Report #5447649-5
Pharmacist from UNITED STATES reported ISOVUE problem on Sept 06, 2007. Female patient, 39 years of age, was diagnosed with computerised tomogram and was treated with ISOVUE. After drug was administered, patient experienced the following problems/side effects: post procedural complication, urticaria. ISOVUE dosage: 680ML (120ML) ONE TIME INJECTION. Patient recovered.

Isovue Side Effects Report #5402131-6
ISOVUE problem was reported by a Consumer or non-health professional from UNITED STATES on July 24, 2007. Male patient, 75 years of age, weighting 374.8 lb, was treated with ISOVUE. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction. ISOVUE dosage: unknown. Patient died on 06/26/2007.

Isovue Side Effects Report #5406858-1
Consumer or non-health professional from UNITED STATES reported ISOVUE problem on Aug 01, 2007. Male patient, 75 years of age, weighting 374.8 lb, was treated with ISOVUE. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction. ISOVUE dosage: unknown. Patient died on 06/26/2007.

Isovue Side Effects Report #5407163-X
ISOVUE problem was reported by a Consumer or non-health professional from UNITED STATES on July 26, 2007. Female patient, 51 years of age, was treated with ISOVUE. After drug was administered, patient experienced the following problems/side effects: blister, extravasation, injection site pain, injection site swelling, neck pain, oedema peripheral, pharyngolaryngeal pain, skin discolouration, vomiting. ISOVUE dosage: 2 ML/SEC. During the same period patient was treated with CHLORIDE. Patient recovered.

Isovue Side Effects Report #5412482-7
Consumer or non-health professional from UNITED STATES reported ISOVUE problem on Aug 07, 2007. Female patient, 51 years of age, was treated with ISOVUE. After drug was administered, patient experienced the following problems/side effects: blister, extravasation, injection site pain, injection site swelling, musculoskeletal pain, neck pain, oedema peripheral, skin discolouration, vomiting. ISOVUE dosage: 2 ML/SEC. During the same period patient was treated with CHLORIDE. Patient recovered.

Isovue Side Effects Report #5375808-9
ISOVUE problem was reported by a Consumer or non-health professional from UNITED STATES on June 26, 2007. Male patient, 14 years of age, weighting 280.0 lb, was diagnosed with abdominal pain and was treated with ISOVUE. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction, cerebrovascular accident. ISOVUE dosage: unknown. Patient was hospitalized. Patient recovered.

Isovue Side Effects Report #5395291-7
Consumer or non-health professional from UNITED STATES reported ISOVUE problem on July 16, 2007. Male patient, 75 years of age, weighting 374.8 lb, was treated with ISOVUE. After drug was administered, patient experienced the following problems/side effects: cyanosis, dyspnoea, swelling face, swollen tongue, throat tightness. ISOVUE dosage: unknown. Patient died on 06/26/2007.

Isovue Side Effects Report #5397678-5
ISOVUE problem was reported by a Consumer or non-health professional from UNITED STATES on July 23, 2007. Female patient, weighting 209.4 lb, was treated with ISOVUE. After drug was administered, patient experienced the following problems/side effects: angioedema, blister, cellulitis, extravasation, paraesthesia, tendonitis. ISOVUE dosage: unknown. During the same period patient was treated with LOTREL, PROTONIX. Patient was hospitalized. Patient recovered.

Isovue Side Effects Report #5399978-1
Pharmacist from UNITED STATES reported ISOVUE problem on July 26, 2007. Female patient, 55 years of age, weighting 260.0 lb, was treated with ISOVUE. After drug was administered, patient experienced the following problems/side effects: extravasation. ISOVUE dosage: unknown. During the same period patient was treated with DILAUDID, OXYCONTIN, FENTANYL LOLLIPOPS, NEURONTIN, VALTREX, LIPITOR, LORATADINE, SUDAFED. Patient recovered.

Isovue Side Effects Report #5375808-9
ISOVUE problem was reported by a Consumer or non-health professional from UNITED STATES on June 26, 2007. Male patient, 14 years of age, weighting 280.0 lb, was diagnosed with abdominal pain and was treated with ISOVUE. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction, cerebrovascular accident. ISOVUE dosage: unknown. Patient was hospitalized. Patient recovered.

Isovue Side Effects Report #5395291-7
Consumer or non-health professional from UNITED STATES reported ISOVUE problem on July 16, 2007. Male patient, 75 years of age, weighting 374.8 lb, was treated with ISOVUE. After drug was administered, patient experienced the following problems/side effects: cyanosis, dyspnoea, swelling face, swollen tongue, throat tightness. ISOVUE dosage: unknown. Patient died on 06/26/2007.

Isovue Side Effects Report #5397678-5
ISOVUE problem was reported by a Consumer or non-health professional from UNITED STATES on July 23, 2007. Female patient, weighting 209.4 lb, was treated with ISOVUE. After drug was administered, patient experienced the following problems/side effects: angioedema, blister, cellulitis, extravasation, paraesthesia, tendonitis. ISOVUE dosage: unknown. During the same period patient was treated with LOTREL, PROTONIX. Patient was hospitalized. Patient recovered.

Isovue Side Effects Report #5399978-1
Pharmacist from UNITED STATES reported ISOVUE problem on July 26, 2007. Female patient, 55 years of age, weighting 260.0 lb, was treated with ISOVUE. After drug was administered, patient experienced the following problems/side effects: extravasation. ISOVUE dosage: unknown. During the same period patient was treated with DILAUDID, OXYCONTIN, FENTANYL LOLLIPOPS, NEURONTIN, VALTREX, LIPITOR, LORATADINE, SUDAFED. Patient recovered.


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anorexia, anxiety, asthenia, azotaemia, cough, dialysis, diarrhoea, dyspnoea, fatigue, pruritus, urticaria, vomiting, , was diagnosed with metastatic neoplasm, computerised tomogram and was diagnosed with computerised tomogram and