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OMNIPAQUE

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Omnipaque Adverse Events Reported to the FDA Over Time

How are Omnipaque adverse event reports trending over time?

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

Most Common Omnipaque Adverse Events Reported to the FDA

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

Dyspnoea
131 (2.64%)
Contrast Media Reaction
88 (1.78%)
Anaphylactoid Reaction
83 (1.67%)
Urticaria
82 (1.65%)
Nausea
78 (1.57%)
Pruritus
68 (1.37%)
Pyrexia
65 (1.31%)
Vomiting
64 (1.29%)
Renal Failure Acute
63 (1.27%)
Loss Of Consciousness
57 (1.15%)
Headache
56 (1.13%)
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Chills
54 (1.09%)
Hypotension
47 (.95%)
Cardio-respiratory Arrest
45 (.91%)
Erythema
44 (.89%)
Blood Pressure Decreased
43 (.87%)
Post Procedural Complication
42 (.85%)
Chest Pain
41 (.83%)
Anaphylactoid Shock
40 (.81%)
Hypersensitivity
40 (.81%)
Convulsion
34 (.69%)
Dizziness
34 (.69%)
Depressed Level Of Consciousness
33 (.67%)
Shock
33 (.67%)
Cardiac Arrest
32 (.65%)
Rash
30 (.61%)
Respiratory Arrest
30 (.61%)
Staphylococcal Infection
30 (.61%)
Extravasation
29 (.59%)
Injection Site Extravasation
29 (.59%)
Anaphylactic Reaction
26 (.52%)
Chest Discomfort
26 (.52%)
Cough
25 (.5%)
Hypoaesthesia
25 (.5%)
Blood Creatinine Increased
24 (.48%)
Procedural Complication
24 (.48%)
Pulmonary Oedema
24 (.48%)
Anaphylactic Shock
23 (.46%)
Confusional State
23 (.46%)
Blood Pressure Increased
22 (.44%)
Injection Site Pain
22 (.44%)
Renal Failure
22 (.44%)
Flushing
21 (.42%)
Pain
21 (.42%)
Oedema Peripheral
20 (.4%)
Throat Tightness
20 (.4%)
Coma
19 (.38%)
Disorientation
19 (.38%)
Hyperhidrosis
19 (.38%)
Malaise
19 (.38%)
Multi-organ Failure
19 (.38%)
Condition Aggravated
18 (.36%)
Disseminated Intravascular Coagulat...
18 (.36%)
Musculoskeletal Stiffness
18 (.36%)
Off Label Use
18 (.36%)
Unresponsive To Stimuli
18 (.36%)
Heart Rate Increased
17 (.34%)
Oedema
17 (.34%)
Pain In Extremity
17 (.34%)
Sneezing
17 (.34%)
Asthenia
16 (.32%)
Back Pain
16 (.32%)
Discomfort
16 (.32%)
Myocardial Infarction
16 (.32%)
Tachycardia
16 (.32%)
Aphasia
15 (.3%)
Bradycardia
15 (.3%)
Compartment Syndrome
15 (.3%)
Cyanosis
15 (.3%)
Fatigue
15 (.3%)
Oxygen Saturation Decreased
15 (.3%)
Wheezing
15 (.3%)
Dehydration
14 (.28%)
Feeling Hot
14 (.28%)
Haemodialysis
14 (.28%)
Hemiparesis
14 (.28%)
Hepatic Function Abnormal
14 (.28%)
Infusion Site Extravasation
14 (.28%)
Thrombocytopenia
14 (.28%)
Tremor
14 (.28%)
Death
13 (.26%)
Drug Hypersensitivity
13 (.26%)
Erythema Multiforme
13 (.26%)
Grand Mal Convulsion
13 (.26%)
Nephrogenic Systemic Fibrosis
13 (.26%)
Rash Papular
13 (.26%)
Bacteraemia
12 (.24%)
Blood Urea Increased
12 (.24%)
Burning Sensation
12 (.24%)
Dialysis
12 (.24%)
Feeling Abnormal
12 (.24%)
Infusion Related Reaction
12 (.24%)
Injection Site Swelling
12 (.24%)
Muscular Weakness
12 (.24%)
Platelet Count Decreased
12 (.24%)
Rash Erythematous
12 (.24%)
Blister
11 (.22%)
Cholecystitis Acute
11 (.22%)
General Physical Health Deteriorati...
11 (.22%)
Hypoxia
11 (.22%)
Meningitis Bacterial
11 (.22%)

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This graph shows the top adverse events submitted to the FDA for Omnipaque, 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 Omnipaque 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 Omnipaque

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

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This graph shows the top categories of adverse events submitted to the FDA for Omnipaque, 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 Omnipaque 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 Omnipaque According to Those Reporting Adverse Events

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

Drug Use For Unknown Indication
157
Product Used For Unknown Indication
132
Computerised Tomogram
107
Catheterisation Cardiac
98
Diagnostic Procedure
46
Scan With Contrast
45
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Back Pain
36
Angiogram
35
Abdominal Pain
34
Computerised Tomogram Abdomen
30
Chest Pain
19
Aortic Aneurysm
17
Arteriogram Coronary
17
Pulmonary Embolism
15
Angina Pectoris
15
Therapeutic Embolisation
14
Coronary Artery Disease
14
Haematuria
13
Abdominal Pain Lower
11
Spinal Myelogram
10
Headache
10
Computerised Tomogram Thorax
10
Appendicitis
9
Catheter Placement
9
Venogram
9
Abdomen Scan
9
Intracranial Aneurysm
8
Deep Vein Thrombosis
8
Central Venous Catheterisation
8
Coronary Angioplasty
7
Dyspnoea
7
Rectal Cancer
7
Fistulogram
7
Myocardial Infarction
7
Coronary Artery Stenosis
6
Aneurysm
6
Colon Cancer
6
Bile Duct Cancer
6
Acute Myocardial Infarction
5
Heart Disease Congenital
5
Bladder Cancer
5
Pain
5
Abdominal Mass
5
Coronary Arterial Stent Insertion
5
Calculus Ureteric
5
Hepatic Neoplasm
5
Intervertebral Disc Protrusion
5
Sciatica
5
Carotid Artery Stenosis
4
Intra-aortic Balloon Placement
4
Metastasis
4

Drug Labels

LabelLabelerEffective
OmnipaqueGE Healthcare Inc.22-SEP-10
OmnipaqueGE Healthcare Inc.18-OCT-10
OmnipaqueGE Healthcare Inc.23-JAN-13

Omnipaque Case Reports

What Omnipaque 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 Omnipaque. 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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