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Optiray Adverse Events Reported to the FDA Over Time

How are Optiray adverse event reports trending over time?

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

Most Common Optiray Adverse Events Reported to the FDA

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

Dyspnoea
335 (4.81%)
Urticaria
265 (3.81%)
Nephropathy Toxic
217 (3.12%)
Pruritus
205 (2.95%)
Anaphylactic Shock
173 (2.49%)
Rash
158 (2.27%)
Nausea
135 (1.94%)
Sneezing
130 (1.87%)
Throat Irritation
130 (1.87%)
Throat Tightness
108 (1.55%)
Erythema
105 (1.51%)
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Cough
101 (1.45%)
Vomiting
99 (1.42%)
Chest Discomfort
97 (1.39%)
Shock
97 (1.39%)
Hypersensitivity
86 (1.24%)
Loss Of Consciousness
86 (1.24%)
Septic Arthritis Staphylococcal
80 (1.15%)
Anaphylactic Reaction
79 (1.14%)
Blood Pressure Decreased
79 (1.14%)
Cardio-respiratory Arrest
75 (1.08%)
Drug Administration Error
74 (1.06%)
Cardiac Arrest
61 (.88%)
Air Embolism
57 (.82%)
Contrast Media Reaction
56 (.8%)
Laryngeal Oedema
51 (.73%)
Wheezing
51 (.73%)
Convulsion
49 (.7%)
Hypotension
49 (.7%)
Pharyngeal Oedema
49 (.7%)
Chest Pain
48 (.69%)
Nasal Congestion
47 (.68%)
Oxygen Saturation Decreased
45 (.65%)
Respiratory Arrest
43 (.62%)
Wrong Technique In Drug Usage Proce...
43 (.62%)
Eye Pruritus
42 (.6%)
Flushing
42 (.6%)
Dysphagia
41 (.59%)
Bronchospasm
40 (.57%)
Cyanosis
40 (.57%)
Renal Failure
40 (.57%)
Hyperhidrosis
39 (.56%)
Malaise
39 (.56%)
Off Label Use
39 (.56%)
Injection Site Extravasation
38 (.55%)
Dizziness
36 (.52%)
Feeling Hot
36 (.52%)
Swollen Tongue
36 (.52%)
Depressed Level Of Consciousness
35 (.5%)
Ocular Hyperaemia
35 (.5%)
Procedural Complication
35 (.5%)
Eye Swelling
34 (.49%)
Incorrect Route Of Drug Administrat...
34 (.49%)
Headache
33 (.47%)
Tremor
33 (.47%)
Lip Swelling
32 (.46%)
Pallor
32 (.46%)
Swelling Face
32 (.46%)
Pyrexia
30 (.43%)
Pain
29 (.42%)
Renal Failure Acute
29 (.42%)
Hypoaesthesia
28 (.4%)
Rash Generalised
28 (.4%)
Respiratory Distress
28 (.4%)
Unresponsive To Stimuli
28 (.4%)
Face Oedema
27 (.39%)
Anaphylactoid Reaction
26 (.37%)
Angioedema
24 (.34%)
Bradycardia
24 (.34%)
Pneumonia
24 (.34%)
Pulmonary Oedema
24 (.34%)
Respiratory Failure
24 (.34%)
Rash Erythematous
23 (.33%)
Blood Pressure Increased
22 (.32%)
Chills
22 (.32%)
Lacrimation Increased
22 (.32%)
Paraesthesia Oral
22 (.32%)
Post Procedural Complication
22 (.32%)
Hypoaesthesia Oral
21 (.3%)
Injury
21 (.3%)
Asthenia
20 (.29%)
Eyelid Oedema
20 (.29%)
Oral Pruritus
20 (.29%)
Paraesthesia
19 (.27%)
Pulse Absent
19 (.27%)
Emotional Distress
18 (.26%)
Injection Site Pain
18 (.26%)
Oedema Peripheral
18 (.26%)
Pruritus Generalised
18 (.26%)
Ventricular Fibrillation
18 (.26%)
Anxiety
17 (.24%)
Blood Creatinine Increased
17 (.24%)
Feeling Abnormal
17 (.24%)
Hypertension
17 (.24%)
Retching
17 (.24%)
Diarrhoea
16 (.23%)
Injection Site Swelling
16 (.23%)
Burning Sensation
15 (.22%)
Dysphonia
15 (.22%)
Nephropathy
15 (.22%)
Tachycardia
15 (.22%)

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

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

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

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

Computerised Tomogram
1119
Computerised Tomogram Abdomen
192
Percutaneous Coronary Intervention
120
Angiogram
113
Catheterisation Cardiac
99
Computerised Tomogram Thorax
91
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Arteriogram Coronary
86
Urogram
57
X-ray Limb
49
Computerised Tomogram Head
43
X-ray
32
Scan Brain
25
Product Used For Unknown Indication
24
Scan With Contrast
20
Therapeutic Embolisation
17
Diagnostic Procedure
12
Joint Injury
9
Scan
9
Arthrogram
9
Abdomen Scan
9
Imaging Procedure
7
Angiogram Cerebral
7
Arteriogram
7
Urography
6
Angioplasty
5
Haematuria
5
Venogram
5
Abdominal Pain
5
Stent Placement
5
Aortic Aneurysm
4
Aortogram
4
Headache
3
Chest Pain
3
Cardiac Imaging Procedure
3
Coronary Artery Disease
3
Drug Use For Unknown Indication
3
Computerised Tomogram Kidney
3
Mass
2
Aortic Aneurysm Repair
2
Spinal Myelogram
2
Dyspnoea
2
Nuclear Magnetic Resonance Imaging
2
Abdominal Pain Upper
2
Computerised Tomogram Abnormal
2
Hepatic Embolisation
2
Lymphadenopathy
2
Urticaria
2
Fistulogram
2
Investigation
2
Renal Disorder
1
Arthroscopy
1

Drug Labels

LabelLabelerEffective
Optiray Pharmacy Bulk Package - 300Mallinckrodt Inc.14-OCT-11
Optiray Pharmacy Bulk Package - 320Mallinckrodt Inc.14-OCT-11
Optiray Pharmacy Bulk Package - 350Mallinckrodt Inc.14-OCT-11
Optiray 350Mallinckrodt Inc.15-MAR-12
Optiray 300Mallinckrodt Inc.15-MAR-12
Optiray 240Mallinckrodt Inc.15-MAR-12
Optiray 320Mallinckrodt Inc.15-MAR-12

Optiray Case Reports

What Optiray 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 Optiray. 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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