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CLOPIDOGREL

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Clopidogrel Adverse Events Reported to the FDA Over Time

How are Clopidogrel adverse event reports trending over time?

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

Most Common Clopidogrel Adverse Events Reported to the FDA

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

Death
1043 (1.49%)
Anaemia
1033 (1.48%)
Gastrointestinal Haemorrhage
947 (1.36%)
Myocardial Infarction
920 (1.32%)
Contusion
747 (1.07%)
Dyspnoea
735 (1.05%)
Haemorrhage
733 (1.05%)
Asthenia
667 (.95%)
Dizziness
639 (.91%)
Haemoglobin Decreased
633 (.91%)
Drug Interaction
606 (.87%)
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Cerebrovascular Accident
567 (.81%)
Chest Pain
562 (.8%)
Nausea
554 (.79%)
Drug Ineffective
539 (.77%)
Fall
524 (.75%)
Fatigue
503 (.72%)
Pyrexia
498 (.71%)
Hypotension
484 (.69%)
Epistaxis
468 (.67%)
Diarrhoea
447 (.64%)
Melaena
430 (.62%)
Vomiting
427 (.61%)
Headache
417 (.6%)
Thrombocytopenia
414 (.59%)
Thrombosis In Device
387 (.55%)
Rectal Haemorrhage
366 (.52%)
Renal Failure Acute
365 (.52%)
Pneumonia
361 (.52%)
Loss Of Consciousness
360 (.52%)
Thrombosis
347 (.5%)
Renal Failure
338 (.48%)
Weight Decreased
336 (.48%)
International Normalised Ratio Incr...
335 (.48%)
Cerebral Haemorrhage
333 (.48%)
Haematemesis
333 (.48%)
Rash
323 (.46%)
Malaise
321 (.46%)
Transient Ischaemic Attack
315 (.45%)
Coronary Artery Occlusion
310 (.44%)
Haematoma
310 (.44%)
Condition Aggravated
295 (.42%)
Pruritus
295 (.42%)
Abdominal Pain
285 (.41%)
Confusional State
284 (.41%)
Acute Myocardial Infarction
283 (.4%)
Pain In Extremity
280 (.4%)
Overdose
269 (.38%)
Cardiac Arrest
268 (.38%)
Abdominal Pain Upper
266 (.38%)
Atrial Fibrillation
265 (.38%)
Oedema Peripheral
259 (.37%)
Angina Pectoris
251 (.36%)
Platelet Count Decreased
246 (.35%)
Cardiac Failure Congestive
243 (.35%)
Pain
234 (.33%)
Arthralgia
229 (.33%)
Haematocrit Decreased
223 (.32%)
Syncope
222 (.32%)
Haematuria
218 (.31%)
Hypertension
216 (.31%)
Cardiac Failure
214 (.31%)
Gastric Ulcer
213 (.3%)
Back Pain
212 (.3%)
Gait Disturbance
212 (.3%)
Off Label Use
212 (.3%)
Gastritis
211 (.3%)
Myalgia
205 (.29%)
Upper Gastrointestinal Haemorrhage
200 (.29%)
Post Procedural Haemorrhage
197 (.28%)
Decreased Appetite
196 (.28%)
Blood Pressure Increased
191 (.27%)
Jaundice
191 (.27%)
Constipation
190 (.27%)
Cough
190 (.27%)
Gastric Haemorrhage
188 (.27%)
Interstitial Lung Disease
187 (.27%)
Dehydration
177 (.25%)
Pulmonary Embolism
176 (.25%)
Haemorrhage Intracranial
172 (.25%)
Subdural Haematoma
172 (.25%)
Sepsis
171 (.24%)
In-stent Coronary Artery Restenosis
167 (.24%)
Hypoaesthesia
166 (.24%)
Thrombotic Thrombocytopenic Purpura
165 (.24%)
Vascular Pseudoaneurysm
165 (.24%)
Completed Suicide
162 (.23%)
Faeces Discoloured
162 (.23%)
Haematochezia
162 (.23%)
Hepatic Function Abnormal
162 (.23%)
Muscular Weakness
156 (.22%)
Cardiac Disorder
155 (.22%)
Deep Vein Thrombosis
155 (.22%)
Rhabdomyolysis
155 (.22%)
Alanine Aminotransferase Increased
153 (.22%)
Respiratory Failure
150 (.21%)
Blood Creatine Phosphokinase Increa...
147 (.21%)
Blood Creatinine Increased
146 (.21%)
Haemoptysis
145 (.21%)
Liver Disorder
145 (.21%)
Renal Impairment
143 (.2%)

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

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

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

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

Drug Use For Unknown Indication
4683
Product Used For Unknown Indication
3732
Stent Placement
2295
Myocardial Infarction
1430
Coronary Artery Disease
1273
Anticoagulant Therapy
1138
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Cardiac Disorder
1033
Cerebrovascular Accident
991
Acute Coronary Syndrome
935
Thrombosis Prophylaxis
869
Prophylaxis
821
Coronary Arterial Stent Insertion
702
Antiplatelet Therapy
627
Transient Ischaemic Attack
619
Acute Myocardial Infarction
451
Cerebrovascular Accident Prophylaxi...
451
Cerebral Infarction
409
Angina Pectoris
315
Atrial Fibrillation
312
Percutaneous Coronary Intervention
299
Myocardial Ischaemia
255
Ill-defined Disorder
221
Thrombosis
217
Angioplasty
210
Hypertension
199
Cardiovascular Event Prophylaxis
193
Coronary Angioplasty
186
Angina Unstable
169
Peripheral Arterial Occlusive Disea...
158
Cardiovascular Disorder
144
Peripheral Vascular Disorder
141
Coronary Artery Bypass
139
Arteriosclerosis
106
Blood Cholesterol Increased
99
Lacunar Infarction
92
Ischaemic Stroke
89
Coronary Artery Occlusion
85
Arterial Disorder
83
Ischaemic Heart Disease Prophylaxis
82
Arterial Occlusive Disease
82
Ischaemic Cardiomyopathy
78
Cardiac Operation
76
Arteritis
76
Chest Pain
72
Coagulopathy
69
Carotid Artery Stenosis
68
Cerebrovascular Disorder
64
Platelet Aggregation Inhibition
64
Carotid Artery Occlusion
63
Angiopathy
52
Vascular Graft
48

Drug Labels

LabelLabelerEffective
PlavixState of Florida DOH Central Pharmacy07-JUN-10
PlavixContract Pharmacy Services-PA19-AUG-10
PlavixRebel Distributors Corp28-DEC-10
PlavixPD-Rx Pharmaceuticals, Inc.10-MAY-11
PlavixCardinal Health07-JUN-11
PlavixLake Erie Medical & Surgical Supply DBA Quality Care Products LLC13-DEC-11
PlavixBristol-Myers Squibb/Sanofi Pharmaceuticals Partnership31-DEC-11
Clopidogrel BisulfateGolden State Medical Supply, Inc.09-JAN-12
PlavixPhysicians Total Care, Inc.12-JAN-12
Clopidogrel BisulfateMylan Pharmaceuticals Inc.09-MAR-12
Clopidogrel BisulfateDr.Reddy's Laboratories Limited22-MAR-12
Clopidogrel BisulfateMylan Institutional Inc.06-APR-12
ClopidogrelGreenstone LLC03-MAY-12
Clopidogrel BisulfateTorrent Pharmaceuticals Limited15-MAY-12
Clopidogrel BisulfatePD-Rx Pharmaceuticals, Inc.15-MAY-12
ClopidogrelTeva Pharmaceuticals USA Inc17-MAY-12
ClopidogrelAurobindo Pharma Limited17-MAY-12
Clopidogrel Unit Dose Services17-MAY-12
Clopidogrel BisulfateDr.Reddy's Laboratories Limited17-MAY-12
Clopidogrel BisulfateSun Pharma Global FZE18-MAY-12
ClopidogrelApotex Corp.31-MAY-12
ClopidogrelAmerican Health Packaging19-JUN-12
Clopidogrel BisulfatePhysicians Total Care, Inc.27-JUN-12
Clopidogrel BisulfateMajor Pharmaceuticals18-JUL-12
Clopidogrel BisulfatePreferred Pharmaceuticals, Inc.25-JUL-12
ClopidogrelLegacy Pharmaceutical Packaging05-OCT-12
ClopidogrelLegacy Pharmaceutical Packaging09-OCT-12
PlavixBryant Ranch Prepack12-OCT-12
ClopidogrelWockhardt Limited13-NOV-12
ClopidogrelWockhardt USA LLC.13-NOV-12
ClopidogrelAmerican Health Packaging28-NOV-12
ClopidogrelBryant Ranch Prepack21-JAN-13
Clopidogrel BisulfateREMEDYREPACK INC. 18-FEB-13
Clopidogrel BisulfateREMEDYREPACK INC. 20-FEB-13
Clopidogrel BisulfateREMEDYREPACK INC. 01-MAR-13
Clopidogrel BisulfateCardinal Health05-MAR-13
Clopidogrel BisulfateCardinal Health08-MAR-13
Clopidogrel BisulfateCardinal Health08-MAR-13
PlavixREMEDYREPACK INC. 19-MAR-13
Clopidogrel BisulfateREMEDYREPACK INC. 26-MAR-13
Clopidogrel BisulfateCardinal Health27-MAR-13
ClopidogrelREMEDYREPACK INC. 06-MAY-13
ClopidogrelREMEDYREPACK INC. 06-MAY-13

Clopidogrel Case Reports

What Clopidogrel 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 Clopidogrel. 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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