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CILOSTAZOL

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Cilostazol Adverse Events Reported to the FDA Over Time

How are Cilostazol adverse event reports trending over time?

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

Most Common Cilostazol Adverse Events Reported to the FDA

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

Fall
46 (1.37%)
Anaemia
40 (1.19%)
Cardiac Failure
40 (1.19%)
Cerebral Infarction
39 (1.16%)
Drug Interaction
36 (1.07%)
Blood Pressure Decreased
34 (1.01%)
Nausea
33 (.98%)
Cerebral Haemorrhage
32 (.95%)
Platelet Count Decreased
32 (.95%)
Hepatic Function Abnormal
31 (.92%)
Condition Aggravated
30 (.89%)
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Tachycardia
29 (.86%)
Vomiting
27 (.8%)
Haemoglobin Decreased
25 (.74%)
Palpitations
25 (.74%)
Diarrhoea
22 (.65%)
Heart Rate Increased
22 (.65%)
Loss Of Consciousness
22 (.65%)
Pneumonia
21 (.63%)
Disease Recurrence
20 (.6%)
Dyspnoea
20 (.6%)
Hypotension
20 (.6%)
Pyrexia
20 (.6%)
Renal Impairment
20 (.6%)
Thrombosis In Device
20 (.6%)
Ventricular Tachycardia
20 (.6%)
White Blood Cell Count Decreased
19 (.57%)
Dizziness
18 (.54%)
Gastrointestinal Haemorrhage
18 (.54%)
Headache
18 (.54%)
Liver Disorder
18 (.54%)
Myocardial Infarction
18 (.54%)
Oedema Peripheral
18 (.54%)
Ventricular Extrasystoles
18 (.54%)
Acute Myocardial Infarction
17 (.51%)
Alanine Aminotransferase Increased
17 (.51%)
Blood Pressure Increased
17 (.51%)
Disseminated Intravascular Coagulat...
17 (.51%)
Gastric Ulcer Haemorrhage
17 (.51%)
Haemorrhage
17 (.51%)
Pain In Extremity
17 (.51%)
Arrhythmia
16 (.48%)
Renal Failure Acute
16 (.48%)
Shock
16 (.48%)
Anorexia
15 (.45%)
Aspartate Aminotransferase Increase...
15 (.45%)
Chest Pain
15 (.45%)
Dehydration
15 (.45%)
Hypertension
15 (.45%)
Malaise
15 (.45%)
Muscle Haemorrhage
15 (.45%)
Pleural Effusion
15 (.45%)
Atrial Fibrillation
14 (.42%)
Decreased Appetite
14 (.42%)
Bradycardia
13 (.39%)
Depressed Level Of Consciousness
13 (.39%)
Haematocrit Decreased
13 (.39%)
Interstitial Lung Disease
13 (.39%)
Pain
13 (.39%)
Subdural Haematoma
13 (.39%)
Activated Partial Thromboplastin Ti...
12 (.36%)
Electrocardiogram Qt Prolonged
12 (.36%)
Rash
12 (.36%)
Toxic Epidermal Necrolysis
12 (.36%)
Back Pain
11 (.33%)
Blood Creatinine Increased
11 (.33%)
Blood Lactate Dehydrogenase Increas...
11 (.33%)
C-reactive Protein Increased
11 (.33%)
Jaundice
11 (.33%)
Prothrombin Time Prolonged
11 (.33%)
Pruritus
11 (.33%)
Syncope
11 (.33%)
Asthenia
10 (.3%)
Blood Urea Increased
10 (.3%)
Cardiac Disorder
10 (.3%)
Granulocytopenia
10 (.3%)
Renal Failure
10 (.3%)
Upper Gastrointestinal Haemorrhage
10 (.3%)
Abdominal Pain
9 (.27%)
Blood Glucose Increased
9 (.27%)
Blood Pressure Systolic Increased
9 (.27%)
Cardio-respiratory Arrest
9 (.27%)
Cerebellar Haemorrhage
9 (.27%)
Convulsion
9 (.27%)
Disease Progression
9 (.27%)
Feeling Abnormal
9 (.27%)
Intraventricular Haemorrhage
9 (.27%)
Rhabdomyolysis
9 (.27%)
Septic Shock
9 (.27%)
Somnolence
9 (.27%)
Torsade De Pointes
9 (.27%)
White Blood Cell Count Increased
9 (.27%)
Cardiac Failure Congestive
8 (.24%)
Constipation
8 (.24%)
Generalised Oedema
8 (.24%)
Haemorrhagic Diathesis
8 (.24%)
Hypokalaemia
8 (.24%)
Inflammation
8 (.24%)
Lymphocyte Stimulation Test Positiv...
8 (.24%)
Melaena
8 (.24%)
Pneumonia Aspiration
8 (.24%)

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

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

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

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

Cerebral Infarction
231
Intermittent Claudication
95
Product Used For Unknown Indication
61
Arteriosclerosis Obliterans
50
Drug Use For Unknown Indication
48
Peripheral Vascular Disorder
46
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Antiplatelet Therapy
41
Peripheral Arterial Occlusive Disea...
37
Lacunar Infarction
37
Thrombosis Prophylaxis
28
Cardiovascular Disorder
24
Prophylaxis
21
Arteriosclerosis
20
Poor Peripheral Circulation
19
Arterial Occlusive Disease
18
Angiopathy
18
Angina Pectoris
13
Atherosclerosis Obliterans
13
Myocardial Infarction
12
Carotid Artery Stenosis
11
Peripheral Circulatory Failure
9
Anticoagulant Therapy
9
Transient Ischaemic Attack
8
Cerebrovascular Accident
7
Hypertension
7
Thrombosis
7
Pain In Extremity
6
Bradycardia
6
Protein S Deficiency
6
Cerebrovascular Spasm
5
Cardiovascular Event Prophylaxis
5
Vasodilation Procedure
5
Cerebral Artery Stenosis
5
Thrombotic Cerebral Infarction
4
Off Label Use
4
Ischaemic Stroke
4
Ventricular Fibrillation
4
Pain
4
Peripheral Ischaemia
4
Diabetic Vascular Disorder
3
Atherosclerosis
3
Atrioventricular Block Complete
3
Shunt Occlusion
3
Cerebral Artery Embolism
3
Skin Ulcer
3
Cerebrovascular Accident Prophylaxi...
3
Platelet Aggregation Inhibition
3
Arterial Stenosis
3
Cardiac Disorder
3
Vasodilatation
3
Coronary Arterial Stent Insertion
3

Drug Labels

LabelLabelerEffective
PletalOtsuka America Pharmaceutical, Inc.13-NOV-07
CilostazolBreckenridge Pharmaceutical, Inc.20-OCT-09
CilostazolSTAT RX USA LLC12-MAR-10
CilostazolUDL Laboratories, Inc.10-SEP-10
CilostazolPhysicians Total Care, Inc.15-NOV-10
CilostazolMylan Pharmaceuticals Inc.07-APR-11
CilostazolGolden State Medical Supply, Inc.01-JUL-11
CilostazolApotex Corp.18-OCT-11
CilostazolCorepharma LLC.28-NOV-11
CilostazolCardinal Health02-FEB-12
CilostazolRoxane Laboratories, Inc31-MAY-12
CilostazolNCS HealthCare of KY, Inc dba Vangard Labs21-JUN-12
CilostazolTeva Pharmaceuticals USA Inc27-JUL-12
CilostazolGolden State Medical Supply, Inc.15-OCT-12
CilostazolNCS HealthCare of KY, Inc dba Vangard Labs06-DEC-12
CilostazolBryant Ranch Prepack21-JAN-13
CilostazolTeva Pharmaceuticals USA Inc07-FEB-13
CilostazolEon Labs, Inc.31-MAR-13

Cilostazol Case Reports

What Cilostazol 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 Cilostazol. 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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