CLOPIDOGREL BISULFATE

Clopidogrel Bisulfate Adverse Events Reported to the FDA Over Time

How are Clopidogrel Bisulfate adverse event reports trending over time?

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

Most Common Clopidogrel Bisulfate Adverse Events Reported to the FDA

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

Death	985 (1.69%)
Anaemia	867 (1.48%)
Myocardial Infarction	824 (1.41%)
Gastrointestinal Haemorrhage	759 (1.3%)
Contusion	711 (1.22%)
Dyspnoea	634 (1.09%)
Asthenia	607 (1.04%)
Haemorrhage	581 (1%)
Dizziness	551 (.94%)
Cerebrovascular Accident	519 (.89%)
Haemoglobin Decreased	486 (.83%)
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Drug Ineffective	481 (.82%)
Nausea	458 (.78%)
Fatigue	453 (.78%)
Drug Interaction	445 (.76%)
Chest Pain	443 (.76%)
Fall	443 (.76%)
Pyrexia	439 (.75%)
Epistaxis	407 (.7%)
Diarrhoea	389 (.67%)
Hypotension	370 (.63%)
Melaena	354 (.61%)
Vomiting	350 (.6%)
Headache	345 (.59%)
Thrombocytopenia	339 (.58%)
Loss Of Consciousness	328 (.56%)
Weight Decreased	311 (.53%)
Pneumonia	306 (.52%)
Thrombosis	304 (.52%)
Rectal Haemorrhage	303 (.52%)
Rash	294 (.5%)
Malaise	289 (.49%)
Transient Ischaemic Attack	286 (.49%)
Coronary Artery Occlusion	277 (.47%)
Renal Failure	276 (.47%)
International Normalised Ratio Incr...	269 (.46%)
Renal Failure Acute	266 (.46%)
Pain In Extremity	265 (.45%)
Pruritus	264 (.45%)
Cerebral Haemorrhage	257 (.44%)
Confusional State	257 (.44%)
Haematoma	256 (.44%)
Condition Aggravated	254 (.44%)
Thrombosis In Device	254 (.44%)
Overdose	251 (.43%)
Haematemesis	247 (.42%)
Abdominal Pain	245 (.42%)
Oedema Peripheral	233 (.4%)
Abdominal Pain Upper	228 (.39%)
Atrial Fibrillation	227 (.39%)
Platelet Count Decreased	217 (.37%)
Cardiac Failure Congestive	214 (.37%)
Off Label Use	208 (.36%)
Pain	206 (.35%)
Arthralgia	202 (.35%)
Angina Pectoris	201 (.34%)
Cardiac Failure	198 (.34%)
Gait Disturbance	197 (.34%)
Back Pain	192 (.33%)
Myalgia	191 (.33%)
Cardiac Arrest	190 (.33%)
Acute Myocardial Infarction	184 (.32%)
Hypertension	184 (.32%)
Syncope	184 (.32%)
Interstitial Lung Disease	180 (.31%)
Constipation	178 (.3%)
Jaundice	172 (.29%)
Decreased Appetite	170 (.29%)
Gastritis	169 (.29%)
Blood Pressure Increased	166 (.28%)
Gastric Ulcer	163 (.28%)
Haematuria	162 (.28%)
Post Procedural Haemorrhage	162 (.28%)
Cough	159 (.27%)
In-stent Coronary Artery Restenosis	156 (.27%)
Haematocrit Decreased	155 (.27%)
Dehydration	150 (.26%)
Hypoaesthesia	150 (.26%)
Hepatic Function Abnormal	146 (.25%)
Deep Vein Thrombosis	145 (.25%)
Pulmonary Embolism	145 (.25%)
Thrombotic Thrombocytopenic Purpura	143 (.24%)
Liver Disorder	141 (.24%)
Upper Gastrointestinal Haemorrhage	141 (.24%)
Cardiac Disorder	138 (.24%)
Blood Creatine Phosphokinase Increa...	137 (.23%)
Alanine Aminotransferase Increased	135 (.23%)
Haematochezia	134 (.23%)
Subdural Haematoma	133 (.23%)
Haemorrhage Intracranial	132 (.23%)
Sepsis	132 (.23%)
Rhabdomyolysis	131 (.22%)
Agranulocytosis	130 (.22%)
Muscular Weakness	128 (.22%)
Haemoptysis	125 (.21%)
Blood Creatinine Increased	123 (.21%)
Blood Glucose Increased	123 (.21%)
Faeces Discoloured	123 (.21%)
Feeling Abnormal	123 (.21%)
Urticaria	123 (.21%)
Aspartate Aminotransferase Increase...	121 (.21%)

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

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

Neurological	2424 (4.15%)
Gastrointestinal Hemorrhages	2255 (3.86%)
Central Nervous System Vascular	2032 (3.48%)
Epidermal And Dermal Conditions	1945 (3.33%)
Gastrointestinal Signs	1879 (3.22%)
Coronary Artery	1878 (3.22%)
Injuries	1873 (3.21%)
Hematology Investigations	1817 (3.11%)
Respiratory	1663 (2.85%)
Anemias Nonhemolytic And Marrow Dep...	1221 (2.09%)
Procedural And Device Related Injur...	1194 (2.04%)
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Infections - Pathogen Unspecified	1155 (1.98%)
Cardiac Arrhythmias	1151 (1.97%)
Hepatic And Hepatobiliary	1145 (1.96%)
Fatal Outcomes	1138 (1.95%)
Therapeutic And Nontherapeutic Effe...	1132 (1.94%)
Renal Disorders	893 (1.53%)
Vascular Hemorrhagic	870 (1.49%)
Gastrointestinal Ulceration And Per...	737 (1.26%)
Gastrointestinal Motility And Defec...	724 (1.24%)
Muscle	722 (1.24%)
Musculoskeletal And Connective Tiss...	683 (1.17%)
Lower Respiratory Tract Disorders	636 (1.09%)
Decreased And Nonspecific Blood Pre...	615 (1.05%)
Medication Errors	613 (1.05%)
Cardiac And Vascular Investigations	611 (1.05%)
Hepatobiliary	606 (1.04%)
Platelet	588 (1.01%)
Heart Failures	555 (.95%)
Embolism And Thrombosis	542 (.93%)
Upper Respiratory Tract Disorders	489 (.84%)
White Blood Cell	470 (.8%)
Physical Examination Topics	459 (.79%)
Body Temperature Conditions	451 (.77%)
Gastrointestinal Inflammatory Condi...	450 (.77%)
Joint	441 (.76%)
Urinary Tract Signs	440 (.75%)
Arteriosclerosis, Stenosis, Vascula...	424 (.73%)
Vision	417 (.71%)
Skin Vascular Abnormalities	399 (.68%)
Electrolyte And Fluid Balance Condi...	389 (.67%)
Renal And Urinary Tract Investigati...	384 (.66%)
Headaches	381 (.65%)
Deliria	371 (.64%)
Bacterial Infectious	353 (.6%)
Therapeutic Procedures And Supporti...	321 (.55%)
Enzyme	310 (.53%)
Appetite And General Nutritional	303 (.52%)
Movement Disorders	302 (.52%)
Cardiac Disorder Signs	301 (.52%)
Allergic Conditions	288 (.49%)
Metabolic, Nutritional And Blood Ga...	255 (.44%)
Bone And Joint Injuries	251 (.43%)
Mental Impairment	238 (.41%)
Coagulopathies And Bleeding Diathes...	233 (.4%)
Vascular	226 (.39%)
Tissue	215 (.37%)
Skin Appendage Conditions	211 (.36%)
Vascular Hypertensive	208 (.36%)
Glucose Metabolism Disorders	207 (.35%)
Sleep Disorders	199 (.34%)
Oral Soft Tissue Conditions	188 (.32%)
Administration Site Reactions	185 (.32%)
Pulmonary Vascular	183 (.31%)
Peritoneal And Retroperitoneal Cond...	181 (.31%)
Ocular Hemorrhages And Vascular	173 (.3%)
Angiedema And Urticaria	168 (.29%)
Water, Electrolyte And Mineral	167 (.29%)
Pleural	163 (.28%)
Anxiety Disorders	160 (.27%)
Gastrointestinal Neoplasms Malignan...	160 (.27%)
Product Quality Issues	151 (.26%)
Bronchial Disorders	148 (.25%)
Psychiatric	126 (.22%)
Gastrointestinal Conditions	125 (.21%)
Dental And Gingival Conditions	124 (.21%)
Ocular Structural Change, Deposit A...	124 (.21%)
Seizures	122 (.21%)
Gastrointestinal Vascular Condition...	121 (.21%)
Viral Infectious	121 (.21%)
Respiratory And Mediastinal Neoplas...	120 (.21%)
Lifestyle Issues	118 (.2%)
Depressed Mood Disorders	113 (.19%)
Retina, Choroid And Vitreous Hemorr...	113 (.19%)
Eye	110 (.19%)
Gallbladder	108 (.18%)
Pericardial	107 (.18%)
Exocrine Pancreas Conditions	106 (.18%)
Nephropathies	101 (.17%)
Myocardial	99 (.17%)
Protein And Chemistry Analyses	99 (.17%)
Hemolyses And Related Conditions	98 (.17%)
Abdominal Hernias And Other Abdomin...	96 (.16%)
Leukemias	96 (.16%)
Vascular Therapeutic Procedures	92 (.16%)
Chemical Injury And Poisoning	91 (.16%)
Peripheral Neuropathies	91 (.16%)
Disturbances In Thinking	90 (.15%)
Tongue Conditions	90 (.15%)
Aneurysms And Artery Dissections	88 (.15%)
Ocular Infections, Irritations And ...	86 (.15%)

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This graph shows the top categories of adverse events submitted to the FDA for Clopidogrel Bisulfate, 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 Bisulfate 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.