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PRASUGREL

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Prasugrel Adverse Events Reported to the FDA Over Time

How are Prasugrel adverse event reports trending over time?

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

Most Common Prasugrel Adverse Events Reported to the FDA

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

Thrombosis In Device
300 (4.09%)
Chest Pain
185 (2.52%)
Angina Pectoris
146 (1.99%)
Death
136 (1.85%)
Acute Myocardial Infarction
135 (1.84%)
In-stent Coronary Artery Restenosis
110 (1.5%)
Haemorrhage
109 (1.49%)
Myocardial Infarction
107 (1.46%)
Gastrointestinal Haemorrhage
94 (1.28%)
Hospitalisation
87 (1.19%)
Off Label Use
84 (1.15%)
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Cerebrovascular Accident
82 (1.12%)
Drug Dose Omission
79 (1.08%)
Dyspnoea
76 (1.04%)
Haemorrhage Intracranial
76 (1.04%)
Anaemia
65 (.89%)
Drug Ineffective
65 (.89%)
Coronary Artery Restenosis
55 (.75%)
Fall
53 (.72%)
Angina Unstable
51 (.7%)
Thrombosis
50 (.68%)
Contusion
47 (.64%)
Dizziness
47 (.64%)
Epistaxis
47 (.64%)
Abdominal Pain
42 (.57%)
Device Occlusion
42 (.57%)
Haematoma
42 (.57%)
Syncope
42 (.57%)
Rectal Haemorrhage
40 (.55%)
Cardiac Arrest
39 (.53%)
Haemoglobin Decreased
39 (.53%)
Headache
39 (.53%)
Myocardial Ischaemia
39 (.53%)
Cardiac Failure Congestive
38 (.52%)
Cardiac Tamponade
37 (.5%)
Cardiogenic Shock
37 (.5%)
Cardiac Failure
36 (.49%)
Coronary Artery Occlusion
36 (.49%)
Fatigue
36 (.49%)
Overdose
36 (.49%)
Nausea
35 (.48%)
Asthenia
33 (.45%)
Deep Vein Thrombosis
33 (.45%)
Rash
33 (.45%)
Subdural Haematoma
33 (.45%)
Chest Discomfort
32 (.44%)
Transient Ischaemic Attack
32 (.44%)
Gastric Ulcer
31 (.42%)
Hypersensitivity
31 (.42%)
Stent Placement
31 (.42%)
Cardio-respiratory Arrest
30 (.41%)
Coronary Artery Disease
30 (.41%)
Pneumonia
30 (.41%)
Pulmonary Embolism
30 (.41%)
Pericardial Effusion
29 (.4%)
Vascular Pseudoaneurysm
29 (.4%)
Cerebral Haemorrhage
28 (.38%)
Vomiting
27 (.37%)
Non-cardiac Chest Pain
26 (.35%)
Hypotension
25 (.34%)
In-stent Arterial Restenosis
25 (.34%)
Intracardiac Thrombus
25 (.34%)
Malaise
25 (.34%)
Renal Failure Acute
25 (.34%)
Upper Gastrointestinal Haemorrhage
25 (.34%)
Colon Cancer
24 (.33%)
Coronary Artery Stenosis
24 (.33%)
Gastritis
24 (.33%)
Pulmonary Oedema
24 (.33%)
Renal Failure
24 (.33%)
Ventricular Tachycardia
23 (.31%)
Abdominal Pain Upper
22 (.3%)
Atrial Fibrillation
22 (.3%)
Coronary Artery Thrombosis
22 (.3%)
Melaena
22 (.3%)
Coronary Arterial Stent Insertion
21 (.29%)
Coronary Artery Bypass
21 (.29%)
Head Injury
21 (.29%)
Loss Of Consciousness
21 (.29%)
Urticaria
21 (.29%)
Ventricular Fibrillation
21 (.29%)
Coagulopathy
20 (.27%)
Haematuria
20 (.27%)
Shock Haemorrhagic
20 (.27%)
Acute Coronary Syndrome
19 (.26%)
Diarrhoea
19 (.26%)
Pain
19 (.26%)
Pain In Extremity
19 (.26%)
Palpitations
19 (.26%)
Platelet Count Decreased
19 (.26%)
Pruritus
19 (.26%)
Retroperitoneal Haemorrhage
19 (.26%)
Surgery
19 (.26%)
Thrombocytopenia
19 (.26%)
Pyrexia
18 (.25%)
Anxiety
17 (.23%)
Gastric Ulcer Haemorrhage
17 (.23%)
Muscular Weakness
17 (.23%)
Pericardial Haemorrhage
17 (.23%)
Peripheral Arterial Occlusive Disea...
17 (.23%)
Thrombotic Thrombocytopenic Purpura
17 (.23%)

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

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

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

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

Acute Coronary Syndrome
542
Stent Placement
507
Percutaneous Coronary Intervention
238
Acute Myocardial Infarction
169
Product Used For Unknown Indication
169
Myocardial Infarction
63
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Coronary Artery Disease
60
Coronary Arterial Stent Insertion
57
Anticoagulant Therapy
37
Antiplatelet Therapy
33
Angina Pectoris
29
Angioplasty
26
Thrombosis Prophylaxis
25
Thrombosis In Device
24
Cardiac Disorder
21
Prophylaxis
13
Angina Unstable
12
Cardiovascular Event Prophylaxis
9
Coronary Artery Occlusion
8
Intermittent Claudication
8
Thrombosis
7
Drug Use For Unknown Indication
7
Ischaemic Heart Disease Prophylaxis
6
Coronary Angioplasty
5
Peripheral Arterial Occlusive Disea...
5
Hiv Infection
5
In-stent Arterial Restenosis
4
Aortic Valve Replacement
4
Catheterisation Cardiac
4
Ischaemia
4
Atrial Fibrillation
4
Blood Disorder
3
Arterial Stent Insertion
3
Platelet Aggregation
3
Heart Rate Irregular
3
Device Occlusion
3
Platelet Disorder
3
Myocardial Ischaemia
3
Ischaemic Stroke
3
Platelet Aggregation Inhibition
2
Blood Phosphorus
2
In-stent Coronary Artery Restenosis
2
Angiopathy
2
Arteriosclerosis Coronary Artery
2
Angiogram Abnormal
2
Deep Vein Thrombosis
2
Carotid Artery Stenosis
2
Arterial Catheterisation
2
Peripheral Vascular Disorder
2
Ill-defined Disorder
2
Congestive Cardiomyopathy
2

Drug Labels

LabelLabelerEffective
EffientPhysicians Total Care, Inc.14-JAN-11
EffientEli Lilly and Company 30-NOV-12

Prasugrel Case Reports

What Prasugrel 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 Prasugrel. 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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