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Pletal Adverse Events Reported to the FDA Over Time

How are Pletal adverse event reports trending over time?

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

Most Common Pletal Adverse Events Reported to the FDA

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

Cardiac Failure
105 (1.76%)
Anaemia
91 (1.53%)
Cerebral Infarction
86 (1.44%)
Interstitial Lung Disease
73 (1.23%)
Condition Aggravated
71 (1.19%)
Pyrexia
64 (1.07%)
Pneumonia
60 (1.01%)
Fall
59 (.99%)
Tachycardia
50 (.84%)
Malaise
44 (.74%)
Dyspnoea
43 (.72%)
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Renal Impairment
40 (.67%)
Aspartate Aminotransferase Increase...
38 (.64%)
Gastric Ulcer Haemorrhage
38 (.64%)
Loss Of Consciousness
38 (.64%)
Alanine Aminotransferase Increased
37 (.62%)
Gastrointestinal Haemorrhage
37 (.62%)
Haemoglobin Decreased
37 (.62%)
Blood Pressure Decreased
36 (.6%)
Nausea
36 (.6%)
Headache
35 (.59%)
Oedema Peripheral
35 (.59%)
Cerebral Haemorrhage
34 (.57%)
Diarrhoea
34 (.57%)
Hepatic Function Abnormal
34 (.57%)
White Blood Cell Count Decreased
34 (.57%)
Dizziness
33 (.55%)
Platelet Count Decreased
33 (.55%)
Pleural Effusion
31 (.52%)
Renal Failure Acute
31 (.52%)
Acute Myocardial Infarction
29 (.49%)
Atrial Fibrillation
29 (.49%)
Blood Urea Increased
29 (.49%)
Dehydration
29 (.49%)
Liver Disorder
29 (.49%)
Palpitations
29 (.49%)
Cardio-respiratory Arrest
26 (.44%)
Death
26 (.44%)
Decreased Appetite
26 (.44%)
Hypotension
26 (.44%)
Thrombocytopenia
26 (.44%)
Agranulocytosis
25 (.42%)
Blood Alkaline Phosphatase Increase...
23 (.39%)
Blood Glucose Increased
23 (.39%)
Blood Lactate Dehydrogenase Increas...
23 (.39%)
Chest Pain
23 (.39%)
Drug Ineffective
23 (.39%)
Myocardial Infarction
23 (.39%)
Vomiting
23 (.39%)
Haematemesis
22 (.37%)
Gamma-glutamyltransferase Increased
21 (.35%)
Rash
21 (.35%)
Altered State Of Consciousness
20 (.34%)
Blood Creatinine Increased
20 (.34%)
Diabetes Mellitus
20 (.34%)
Gastric Ulcer
20 (.34%)
Pain In Extremity
20 (.34%)
Blood Creatine Phosphokinase Increa...
18 (.3%)
Blood Pressure Increased
18 (.3%)
Convulsion
18 (.3%)
Gait Disturbance
18 (.3%)
Haematocrit Decreased
18 (.3%)
Haemorrhage
18 (.3%)
Haemorrhagic Diathesis
18 (.3%)
Heart Rate Increased
18 (.3%)
Drug Interaction
17 (.29%)
Infection
17 (.29%)
Pneumonia Aspiration
17 (.29%)
Pulmonary Oedema
17 (.29%)
Shock Haemorrhagic
17 (.29%)
Depressed Level Of Consciousness
16 (.27%)
Disseminated Intravascular Coagulat...
16 (.27%)
Sepsis
16 (.27%)
White Blood Cell Count Increased
16 (.27%)
Cardiac Arrest
15 (.25%)
Cardiac Failure Acute
15 (.25%)
Eosinophil Count Increased
15 (.25%)
Respiratory Failure
15 (.25%)
Transient Ischaemic Attack
15 (.25%)
Asthenia
14 (.24%)
Chest Discomfort
14 (.24%)
Contusion
14 (.24%)
Diabetes Mellitus Inadequate Contro...
14 (.24%)
Hypertension
14 (.24%)
Hypoglycaemia
14 (.24%)
International Normalised Ratio Incr...
14 (.24%)
Subarachnoid Haemorrhage
14 (.24%)
Urine Output Decreased
14 (.24%)
Ventricular Fibrillation
14 (.24%)
Cerebrovascular Accident
13 (.22%)
Disease Recurrence
13 (.22%)
Duodenal Ulcer
13 (.22%)
Granulocyte Count Decreased
13 (.22%)
Jaundice
13 (.22%)
Melaena
13 (.22%)
Renal Failure
13 (.22%)
Sudden Death
13 (.22%)
Arrhythmia
12 (.2%)
Blood Cholesterol Increased
12 (.2%)
Blood Potassium Increased
12 (.2%)
Blood Triglycerides Increased
12 (.2%)

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

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

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

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

Cerebral Infarction
515
Arteriosclerosis Obliterans
196
Peripheral Arterial Occlusive Disea...
124
Intermittent Claudication
118
Drug Use For Unknown Indication
72
Product Used For Unknown Indication
71
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Lacunar Infarction
50
Thrombosis Prophylaxis
49
Prophylaxis
45
Angina Pectoris
43
Arterial Occlusive Disease
40
Myocardial Infarction
28
Peripheral Vascular Disorder
21
Arteriosclerosis
15
Hypertension
15
Carotid Artery Stenosis
14
Antiplatelet Therapy
14
Transient Ischaemic Attack
14
Cerebral Artery Stenosis
13
Acute Myocardial Infarction
12
Cerebrovascular Accident Prophylaxi...
12
Anticoagulant Therapy
11
Poor Peripheral Circulation
11
Cerebrovascular Accident
11
Thrombotic Cerebral Infarction
11
Stent Placement
10
Bradycardia
8
Brain Stem Infarction
7
Percutaneous Coronary Intervention
7
Atherosclerosis Obliterans
7
Atrial Fibrillation
6
Coronary Arterial Stent Insertion
6
Myocardial Ischaemia
6
Angiopathy
6
Pain In Extremity
6
Cardiovascular Disorder
5
Thrombosis In Device
5
Arterial Stenosis
5
Peripheral Ischaemia
5
Subclavian Vein Thrombosis
5
Cerebrovascular Spasm
5
Shunt Occlusion
4
Hyperlipidaemia
4
Cerebrovascular Disorder
4
Thrombosis
4
Streptococcal Identification Test
4
Moyamoya Disease
4
Ill-defined Disorder
4
Cerebral Artery Embolism
4
Promotion Of Peripheral Circulation
3
Muscle Spasms
3

Drug Labels

LabelLabelerEffective
PletalOtsuka America Pharmaceutical, Inc.13-NOV-07

Pletal Case Reports

What Pletal 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 Pletal. 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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