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Isovue Adverse Events Reported to the FDA Over Time

How are Isovue adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Isovue, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Isovue is flagged as the suspect drug causing the adverse event.

Most Common Isovue Adverse Events Reported to the FDA

What are the most common Isovue adverse events reported to the FDA?

Hypersensitivity
112 (3.84%)
Dyspnoea
111 (3.81%)
Urticaria
96 (3.29%)
Pruritus
70 (2.4%)
Anaphylactic Reaction
64 (2.19%)
Contrast Media Reaction
63 (2.16%)
Anaphylactoid Reaction
54 (1.85%)
Vomiting
54 (1.85%)
Nausea
51 (1.75%)
Anaphylactic Shock
47 (1.61%)
Convulsion
40 (1.37%)
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Nephropathy Toxic
40 (1.37%)
Cardio-respiratory Arrest
39 (1.34%)
Loss Of Consciousness
37 (1.27%)
Headache
33 (1.13%)
Throat Tightness
32 (1.1%)
Erythema
30 (1.03%)
Extravasation
29 (.99%)
Flushing
29 (.99%)
Depressed Level Of Consciousness
28 (.96%)
Sneezing
28 (.96%)
Chest Pain
27 (.93%)
Hypotension
27 (.93%)
Cardiac Arrest
25 (.86%)
Cough
25 (.86%)
Brain Oedema
23 (.79%)
Cyanosis
23 (.79%)
Respiratory Arrest
23 (.79%)
Chest Discomfort
21 (.72%)
Feeling Abnormal
21 (.72%)
Blood Pressure Decreased
20 (.69%)
Oxygen Saturation Decreased
19 (.65%)
Swelling Face
19 (.65%)
Tachycardia
19 (.65%)
Dizziness
18 (.62%)
Hypoaesthesia
18 (.62%)
Post Procedural Complication
18 (.62%)
Pulse Absent
18 (.62%)
Renal Failure Acute
18 (.62%)
Respiratory Distress
18 (.62%)
Hypertension
17 (.58%)
Procedural Complication
17 (.58%)
Chills
16 (.55%)
Electrocardiogram St Segment Elevat...
16 (.55%)
Hyperhidrosis
16 (.55%)
Pharyngeal Oedema
16 (.55%)
Drug Administration Error
15 (.51%)
Dysphagia
15 (.51%)
Feeling Hot
15 (.51%)
Heart Rate Decreased
15 (.51%)
Rash
15 (.51%)
Throat Irritation
15 (.51%)
Cerebrovascular Accident
14 (.48%)
Pain In Extremity
14 (.48%)
Asthenia
13 (.45%)
Heart Rate Increased
13 (.45%)
Pain
13 (.45%)
Rhabdomyolysis
13 (.45%)
Blood Pressure Increased
12 (.41%)
Compartment Syndrome
12 (.41%)
Confusional State
12 (.41%)
Oedema Peripheral
12 (.41%)
Renal Failure
12 (.41%)
Unresponsive To Stimuli
12 (.41%)
Abdominal Pain
11 (.38%)
Bradycardia
11 (.38%)
Hypotonia
11 (.38%)
Pyrexia
11 (.38%)
Respiratory Depression
11 (.38%)
Tremor
11 (.38%)
Wheezing
11 (.38%)
Back Pain
10 (.34%)
Bronchospasm
10 (.34%)
Hepatitis
10 (.34%)
Blister
9 (.31%)
Contrast Media Allergy
9 (.31%)
Dehydration
9 (.31%)
Eye Pruritus
9 (.31%)
Skin Discolouration
9 (.31%)
Cardiac Disorder
8 (.27%)
Dialysis
8 (.27%)
Disseminated Intravascular Coagulat...
8 (.27%)
Grand Mal Convulsion
8 (.27%)
Muscle Spasms
8 (.27%)
Musculoskeletal Pain
8 (.27%)
Oral Pruritus
8 (.27%)
Paraesthesia
8 (.27%)
Swelling
8 (.27%)
Ventricular Fibrillation
8 (.27%)
Ventricular Tachycardia
8 (.27%)
Agitation
7 (.24%)
Arthralgia
7 (.24%)
Disorientation
7 (.24%)
Drug Hypersensitivity
7 (.24%)
Eye Swelling
7 (.24%)
Lacrimation Increased
7 (.24%)
Mental Status Changes
7 (.24%)
Mydriasis
7 (.24%)
Pulmonary Embolism
7 (.24%)
Pupil Fixed
7 (.24%)
Respiratory Rate Increased
7 (.24%)

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This graph shows the top adverse events submitted to the FDA for Isovue, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Isovue is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Isovue

What are the most common Isovue adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Isovue, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Isovue is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Isovue According to Those Reporting Adverse Events

Why are people taking Isovue, according to those reporting adverse events to the FDA?

Computerised Tomogram
300
Catheterisation Cardiac
103
Computerised Tomogram Abdomen
73
Angiogram
62
Abdominal Pain
48
Spinal Myelogram
47
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Scan With Contrast
43
Chest Pain
31
Diagnostic Procedure
24
Angiogram Cerebral
24
Back Pain
23
Arteriogram Coronary
23
Computerised Tomogram Thorax
20
Pain
17
Dyspnoea
16
Neck Pain
14
Arteriogram Carotid
13
Abdominal Pain Upper
12
Pain In Extremity
12
Carotid Artery Stent Insertion
12
Abdomen Scan
11
Urogram
10
Angioplasty
10
Chest X-ray Abnormal
10
Computerised Tomogram Head
9
Product Used For Unknown Indication
9
Haematuria
9
Abdominal Pain Lower
8
Scan Brain
8
Arteriogram
8
Abdominal Mass
7
Pulmonary Embolism
7
Coronary Artery Disease
7
Peripheral Vascular Disorder
7
Troponin Increased
6
Headache
6
Weight Decreased
6
Angina Pectoris
5
Fistulogram
5
Pain Management
5
Cardiac Stress Test Abnormal
5
Acute Myocardial Infarction
5
Vomiting
5
Nodule
5
Arthralgia
5
Aneurysm
5
Ovarian Cancer
4
Breast Cancer
4
Lung Neoplasm Malignant
4
Pulmonary Mass
4
Neoplasm Malignant
4

Drug Labels

LabelLabelerEffective
Isovue250Bracco Diagnostics Inc23-JAN-12
Isovue-mBracco Diagnostics Inc23-JAN-12
Isovue300Bracco Diagnostics Inc23-JAN-12
Isovue370Bracco Diagnostics Inc23-JAN-12
Isovue200Bracco Diagnostics Inc23-JAN-12
Isovue250Bracco Diagnostics Inc26-JAN-12
Isovue300Bracco Diagnostics Inc26-JAN-12
Isovue370Bracco Diagnostics Inc26-JAN-12
Isovue-m 200General Injectables & Vaccines, Inc.19-APR-12

Isovue Case Reports

What Isovue safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Isovue. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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