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Definity Adverse Events Reported to the FDA Over Time

How are Definity adverse event reports trending over time?

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

Most Common Definity Adverse Events Reported to the FDA

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

Back Pain
902 (24.84%)
Urticaria
150 (4.13%)
Dyspnoea
149 (4.1%)
Flushing
117 (3.22%)
Chest Pain
104 (2.86%)
Headache
96 (2.64%)
Pruritus
81 (2.23%)
Pain In Extremity
73 (2.01%)
Muscle Spasms
72 (1.98%)
Dizziness
69 (1.9%)
Nausea
66 (1.82%)
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Arthralgia
59 (1.62%)
Hypotension
51 (1.4%)
Rash
47 (1.29%)
Cardiac Arrest
45 (1.24%)
Chest Discomfort
42 (1.16%)
Hyperhidrosis
39 (1.07%)
Blood Pressure Increased
35 (.96%)
Feeling Hot
35 (.96%)
Erythema
31 (.85%)
Neck Pain
31 (.85%)
Hypersensitivity
29 (.8%)
Loss Of Consciousness
29 (.8%)
Pain
29 (.8%)
Throat Tightness
28 (.77%)
Blood Pressure Decreased
26 (.72%)
Flank Pain
26 (.72%)
Heart Rate Increased
25 (.69%)
Respiratory Arrest
25 (.69%)
Convulsion
23 (.63%)
Vomiting
23 (.63%)
Death
22 (.61%)
Syncope
21 (.58%)
Bradycardia
19 (.52%)
Paraesthesia
19 (.52%)
Musculoskeletal Pain
18 (.5%)
Wheezing
18 (.5%)
Anaphylactic Reaction
17 (.47%)
Tachycardia
17 (.47%)
Renal Pain
16 (.44%)
Ventricular Tachycardia
16 (.44%)
Coma
15 (.41%)
Asthenia
14 (.39%)
Atrial Fibrillation
14 (.39%)
Hypoaesthesia
14 (.39%)
Respiratory Distress
14 (.39%)
Abdominal Pain
13 (.36%)
Anxiety
13 (.36%)
Feeling Abnormal
13 (.36%)
Tremor
13 (.36%)
Fatigue
12 (.33%)
Lip Swelling
12 (.33%)
Malaise
12 (.33%)
Musculoskeletal Discomfort
12 (.33%)
Cough
11 (.3%)
Hypertension
11 (.3%)
Oxygen Saturation Decreased
11 (.3%)
Swelling Face
11 (.3%)
Swollen Tongue
11 (.3%)
Burning Sensation
10 (.28%)
Hot Flush
10 (.28%)
Hypoxia
10 (.28%)
Pharyngeal Oedema
10 (.28%)
Dysgeusia
9 (.25%)
Rash Generalised
9 (.25%)
Abdominal Discomfort
8 (.22%)
Cardio-respiratory Arrest
8 (.22%)
Pulmonary Oedema
8 (.22%)
Supraventricular Tachycardia
8 (.22%)
Ventricular Extrasystoles
8 (.22%)
Ventricular Fibrillation
8 (.22%)
Agitation
7 (.19%)
Contrast Media Reaction
7 (.19%)
Groin Pain
7 (.19%)
Myalgia
7 (.19%)
Pallor
7 (.19%)
Sinus Tachycardia
7 (.19%)
Unresponsive To Stimuli
7 (.19%)
Abdominal Pain Upper
6 (.17%)
Anaphylactic Shock
6 (.17%)
Chills
6 (.17%)
Infusion Related Reaction
6 (.17%)
Pulmonary Embolism
6 (.17%)
Shock
6 (.17%)
Throat Irritation
6 (.17%)
Vision Blurred
6 (.17%)
Bronchospasm
5 (.14%)
Cardiac Failure
5 (.14%)
Cardiomegaly
5 (.14%)
Cyanosis
5 (.14%)
Depressed Level Of Consciousness
5 (.14%)
Drug Hypersensitivity
5 (.14%)
Eye Swelling
5 (.14%)
Heart Rate Decreased
5 (.14%)
Hypoaesthesia Oral
5 (.14%)
Ocular Hyperaemia
5 (.14%)
Palpitations
5 (.14%)
Pulse Absent
5 (.14%)
Resuscitation
5 (.14%)
Retching
5 (.14%)
Anaphylactoid Reaction
4 (.11%)

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

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

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

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

Echocardiogram
602
Stress Echocardiogram
293
Cardiac Stress Test
68
Chest Pain
40
Ultrasound Scan
34
Diagnostic Procedure
14
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Dyspnoea
13
Coronary Artery Disease
12
Cardiovascular Evaluation
10
Cardiac Failure Congestive
9
Scan With Contrast
8
Cardiac Imaging Procedure
7
Cardiac Pharmacologic Stress Test
7
Liver Transplant
6
Exercise Test
6
Ultrasound Doppler
6
Preoperative Care
5
Atrial Fibrillation
4
Shock
4
Cardiac Function Test
3
Syncope
3
Cardiac Ventricular Disorder
3
Transient Ischaemic Attack
3
Angina Pectoris
3
Left Ventricular Failure
3
Cerebrovascular Accident
2
Thrombosis
2
Imaging Procedure
2
Electrocardiogram
2
Ischaemic Cardiomyopathy
2
Cardiomyopathy
2
Congestive Cardiomyopathy
2
Endocardial Disease
2
Product Used For Unknown Indication
2
Palpitations
2
Ejection Fraction
2
Cardiac Murmur
2
Mitral Valve Stenosis
2
Mitral Valve Incompetence
2
Cardiac Tamponade
1
Pulmonary Hypertension
1
Aortic Valve Stenosis
1
Arterial Therapeutic Procedure
1
Surgery
1
Ejection Fraction Decreased
1
Intracardiac Thrombus
1
Arrhythmia
1
Laboratory Test Interference
1
Obesity
1
Familial Risk Factor
1
Diabetes Mellitus
1

Drug Labels

LabelLabelerEffective
DefinityLantheus Medical Imaging, Inc.21-FEB-13

Definity Case Reports

What Definity 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 Definity. 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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