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BRILINTA

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Brilinta Adverse Events Reported to the FDA Over Time

How are Brilinta adverse event reports trending over time?

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

Most Common Brilinta Adverse Events Reported to the FDA

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

Dyspnoea
151 (7.78%)
Myocardial Infarction
72 (3.71%)
Off Label Use
53 (2.73%)
Rash
38 (1.96%)
Chest Pain
35 (1.8%)
Death
35 (1.8%)
Fatigue
33 (1.7%)
Coronary Artery Occlusion
31 (1.6%)
Thrombosis In Device
29 (1.49%)
Haemorrhage
28 (1.44%)
Malaise
28 (1.44%)
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Intentional Drug Misuse
25 (1.29%)
Cerebrovascular Accident
22 (1.13%)
Dizziness
22 (1.13%)
Nausea
20 (1.03%)
Drug Dose Omission
19 (.98%)
Cardiac Disorder
17 (.88%)
Gastrointestinal Haemorrhage
17 (.88%)
Arterial Occlusive Disease
16 (.82%)
Bradycardia
16 (.82%)
Cough
16 (.82%)
Drug Hypersensitivity
15 (.77%)
Epistaxis
15 (.77%)
Pneumonia
15 (.77%)
Cardiac Arrest
14 (.72%)
Drug Interaction
14 (.72%)
Myalgia
14 (.72%)
Angina Pectoris
12 (.62%)
Haemoglobin Decreased
12 (.62%)
Anxiety
11 (.57%)
Anaemia
10 (.52%)
Atrial Fibrillation
10 (.52%)
Atrioventricular Block
10 (.52%)
Chronic Obstructive Pulmonary Disea...
10 (.52%)
Diabetes Mellitus
10 (.52%)
Headache
10 (.52%)
Liver Function Test Abnormal
10 (.52%)
Pericardial Effusion
10 (.52%)
Pruritus
10 (.52%)
Weight Decreased
10 (.52%)
Acute Myocardial Infarction
9 (.46%)
Adverse Event
9 (.46%)
Asthenia
9 (.46%)
Contusion
9 (.46%)
Diarrhoea
9 (.46%)
Pain
9 (.46%)
Suffocation Feeling
9 (.46%)
Atrioventricular Block Complete
8 (.41%)
Cardiac Failure
8 (.41%)
Chest Discomfort
8 (.41%)
Gastric Ulcer Haemorrhage
8 (.41%)
Haematoma
8 (.41%)
Haemorrhagic Stroke
8 (.41%)
Heart Rate Increased
8 (.41%)
Palpitations
8 (.41%)
Platelet Count Decreased
8 (.41%)
Pyrexia
8 (.41%)
Renal Impairment
8 (.41%)
Stomatitis
8 (.41%)
Thrombocytopenia
8 (.41%)
Urticaria
8 (.41%)
Decreased Appetite
7 (.36%)
Dyspepsia
7 (.36%)
Dysphagia
7 (.36%)
In-stent Coronary Artery Restenosis
7 (.36%)
Myocardial Ischaemia
7 (.36%)
Skin Exfoliation
7 (.36%)
Abdominal Pain
6 (.31%)
Angioedema
6 (.31%)
Eye Haemorrhage
6 (.31%)
Gout
6 (.31%)
Haematocrit Decreased
6 (.31%)
Haematuria
6 (.31%)
Hyperlipidaemia
6 (.31%)
Hypertension
6 (.31%)
Hypotension
6 (.31%)
Mallory-weiss Syndrome
6 (.31%)
Pulmonary Haemorrhage
6 (.31%)
Rash Generalised
6 (.31%)
Rash Pruritic
6 (.31%)
Syncope
6 (.31%)
Acute Coronary Syndrome
5 (.26%)
Arterial Restenosis
5 (.26%)
Cardiogenic Shock
5 (.26%)
Cerebral Haemorrhage
5 (.26%)
Device Occlusion
5 (.26%)
Fall
5 (.26%)
Infarction
5 (.26%)
Influenza
5 (.26%)
Lung Neoplasm Malignant
5 (.26%)
Muscular Weakness
5 (.26%)
Pain In Extremity
5 (.26%)
Post Procedural Haemorrhage
5 (.26%)
Rhabdomyolysis
5 (.26%)
Thrombosis
5 (.26%)
Vomiting
5 (.26%)
Abdominal Discomfort
4 (.21%)
Abdominal Pain Upper
4 (.21%)
Arterial Injury
4 (.21%)
Blood Glucose Increased
4 (.21%)
Cardio-respiratory Arrest
4 (.21%)

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

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

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

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

Acute Coronary Syndrome
85
Acute Myocardial Infarction
32
Stent Placement
29
Coronary Artery Disease
28
Myocardial Infarction
23
Coronary Arterial Stent Insertion
13
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Thrombosis Prophylaxis
13
Cardiovascular Event Prophylaxis
12
Anticoagulant Therapy
9
Coronary Artery Occlusion
9
Angioplasty
9
Infarction
8
Arterial Occlusive Disease
8
Catheterisation Cardiac
6
Ischaemic Heart Disease Prophylaxis
5
Cardiovascular Disorder
5
Angina Pectoris
4
Coronary Angioplasty
4
Cerebrovascular Accident
3
Thrombosis In Device
3
Arterial Stent Insertion
3
Product Used For Unknown Indication
3
Cardiac Disorder
3
Device Occlusion
2
Coronary Artery Bypass
2
Vascular Stenosis
2
Antiplatelet Therapy
2
Coronary Artery Insufficiency
2
Peripheral Arterial Occlusive Disea...
2
Vascular Stent Insertion
2
Percutaneous Coronary Intervention
2
Renal Embolism
2
Preoperative Care
2
Angina Unstable
2
Brain Neoplasm
2
Intestinal Obstruction
1
Postoperative Care
1
Anti-platelet Antibody
1
Cerebral Ischaemia
1
Cardiac Infection
1
Cardiac Operation
1
Drug Therapy
1
Stent Embolisation
1
Hypertonia
1
Venous Occlusion
1
Intracranial Aneurysm
1
Carotid Artery Occlusion
1
Platelet Aggregation Inhibition
1
Vascular Graft Occlusion
1
Gastrointestinal Haemorrhage
1
Chest Pain
1

Drug Labels

LabelLabelerEffective
BrilintaAstraZeneca LP29-MAR-13

Brilinta Case Reports

What Brilinta 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 Brilinta. 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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