COZAAR

Adverse Events

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Cozaar Adverse Events Reported to the FDA Over Time

How are Cozaar adverse event reports trending over time?

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

Most Common Cozaar Adverse Events Reported to the FDA

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

Renal Failure Acute	353 (1.68%)
Dizziness	327 (1.56%)
Blood Pressure Increased	312 (1.49%)
Hypotension	270 (1.29%)
Headache	224 (1.07%)
Dyspnoea	216 (1.03%)
Hypertension	214 (1.02%)
Hyperkalaemia	204 (.97%)
Diarrhoea	202 (.96%)
Drug Interaction	195 (.93%)
Malaise	193 (.92%)
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Drug Ineffective	192 (.92%)
Fatigue	178 (.85%)
Nausea	173 (.83%)
Asthenia	172 (.82%)
Cough	164 (.78%)
Renal Failure	146 (.7%)
Loss Of Consciousness	141 (.67%)
Rhabdomyolysis	141 (.67%)
Product Substitution Issue	139 (.66%)
Blood Creatinine Increased	138 (.66%)
Oedema Peripheral	134 (.64%)
Dehydration	133 (.63%)
Fall	130 (.62%)
Palpitations	126 (.6%)
Hyponatraemia	123 (.59%)
Vomiting	119 (.57%)
Arthralgia	117 (.56%)
Overdose	113 (.54%)
Pruritus	109 (.52%)
Rash	109 (.52%)
Angioedema	107 (.51%)
Feeling Abnormal	105 (.5%)
Myalgia	105 (.5%)
Pneumonia	104 (.5%)
Renal Impairment	104 (.5%)
Syncope	103 (.49%)
Confusional State	101 (.48%)
Abdominal Pain	99 (.47%)
Anaemia	98 (.47%)
Blood Urea Increased	95 (.45%)
Chest Pain	93 (.44%)
Cardiac Failure	91 (.43%)
Lactic Acidosis	91 (.43%)
Completed Suicide	90 (.43%)
Condition Aggravated	90 (.43%)
Heart Rate Increased	89 (.42%)
Pain In Extremity	89 (.42%)
Blood Pressure Decreased	87 (.42%)
Back Pain	86 (.41%)
Muscle Spasms	84 (.4%)
Hypoglycaemia	83 (.4%)
Blood Creatine Phosphokinase Increa...	82 (.39%)
Cardiac Arrest	82 (.39%)
Abdominal Pain Upper	80 (.38%)
Atrial Fibrillation	79 (.38%)
Blood Pressure Inadequately Control...	79 (.38%)
Alanine Aminotransferase Increased	78 (.37%)
Myocardial Infarction	78 (.37%)
Pain	78 (.37%)
Bradycardia	76 (.36%)
Somnolence	75 (.36%)
Aspartate Aminotransferase Increase...	73 (.35%)
Cerebrovascular Accident	73 (.35%)
Convulsion	72 (.34%)
Insomnia	72 (.34%)
Platelet Count Decreased	70 (.33%)
Pyrexia	70 (.33%)
Metabolic Acidosis	68 (.32%)
Weight Decreased	65 (.31%)
Pulmonary Oedema	64 (.31%)
Adverse Event	63 (.3%)
Death	63 (.3%)
Decreased Appetite	63 (.3%)
Hypokalaemia	61 (.29%)
Blood Potassium Increased	60 (.29%)
Abdominal Discomfort	57 (.27%)
Weight Increased	57 (.27%)
Blood Glucose Increased	55 (.26%)
Chest Discomfort	54 (.26%)
Dysphagia	53 (.25%)
Gait Disturbance	53 (.25%)
Wrong Technique In Drug Usage Proce...	53 (.25%)
Drug Exposure During Pregnancy	52 (.25%)
Constipation	51 (.24%)
Pancytopenia	51 (.24%)
Anuria	50 (.24%)
Drug Hypersensitivity	50 (.24%)
Tachycardia	50 (.24%)
Cardiac Failure Congestive	49 (.23%)
Hyperhidrosis	49 (.23%)
Swollen Tongue	49 (.23%)
Hypoaesthesia	47 (.22%)
Thrombocytopenia	47 (.22%)
Anxiety	46 (.22%)
Gamma-glutamyltransferase Increased	46 (.22%)
Haemodialysis	46 (.22%)
Haemoglobin Decreased	46 (.22%)
Medication Error	46 (.22%)
Atrioventricular Block First Degree	45 (.21%)
Blood Alkaline Phosphatase Increase...	45 (.21%)

Share/Embed Graph Export Data

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

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

Neurological	1147 (5.47%)
Renal Disorders	811 (3.87%)
Respiratory	791 (3.78%)
Epidermal And Dermal Conditions	780 (3.72%)
Cardiac And Vascular Investigations	751 (3.58%)
Gastrointestinal Signs	720 (3.44%)
Cardiac Arrhythmias	597 (2.85%)
Electrolyte And Fluid Balance Condi...	587 (2.8%)
Therapeutic And Nontherapeutic Effe...	543 (2.59%)
Decreased And Nonspecific Blood Pre...	496 (2.37%)
Muscle	432 (2.06%)
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Hematology Investigations	397 (1.89%)
Infections - Pathogen Unspecified	393 (1.88%)
Medication Errors	364 (1.74%)
Renal And Urinary Tract Investigati...	337 (1.61%)
Hepatobiliary	302 (1.44%)
Gastrointestinal Motility And Defec...	301 (1.44%)
Hepatic And Hepatobiliary	294 (1.4%)
Musculoskeletal And Connective Tiss...	283 (1.35%)
Vascular Hypertensive	249 (1.19%)
Headaches	245 (1.17%)
Joint	235 (1.12%)
Central Nervous System Vascular	219 (1.05%)
Injuries	209 (1%)
Coronary Artery	203 (.97%)
Product Quality Issues	197 (.94%)
Anemias Nonhemolytic And Marrow Dep...	194 (.93%)
Cardiac Disorder Signs	184 (.88%)
Urinary Tract Signs	183 (.87%)
Enzyme	180 (.86%)
Heart Failures	177 (.84%)
Water, Electrolyte And Mineral	173 (.83%)
Acid-base	171 (.82%)
Physical Examination Topics	171 (.82%)
Anxiety Disorders	170 (.81%)
Angiedema And Urticaria	168 (.8%)
Lower Respiratory Tract Disorders	168 (.8%)
Glucose Metabolism Disorders	165 (.79%)
Metabolic, Nutritional And Blood Ga...	152 (.73%)
Skin Appendage Conditions	142 (.68%)
Allergic Conditions	140 (.67%)
Bone And Joint Injuries	122 (.58%)
Deliria	121 (.58%)
Appetite And General Nutritional	117 (.56%)
Sleep Disorders	116 (.55%)
Oral Soft Tissue Conditions	115 (.55%)
Movement Disorders	113 (.54%)
Suicidal And Self-injurious Behavio...	113 (.54%)
Vision	110 (.53%)
Fatal Outcomes	105 (.5%)
Chemical Injury And Poisoning	97 (.46%)
Body Temperature Conditions	91 (.43%)
Eye	90 (.43%)
Seizures	89 (.42%)
Bronchial Disorders	87 (.42%)
Upper Respiratory Tract Disorders	87 (.42%)
White Blood Cell	87 (.42%)
Myocardial	85 (.41%)
Mental Impairment	81 (.39%)
Lifestyle Issues	79 (.38%)
Nephropathies	76 (.36%)
Arteriosclerosis, Stenosis, Vascula...	72 (.34%)
Hematological And Lymphoid Tissue T...	68 (.32%)
Skin Vascular Abnormalities	62 (.3%)
Cardiac Valve	61 (.29%)
Gallbladder	59 (.28%)
Tongue Conditions	58 (.28%)
Exocrine Pancreas Conditions	57 (.27%)
Bacterial Infectious	56 (.27%)
Salivary Gland Conditions	54 (.26%)
Viral Infectious	54 (.26%)
Depressed Mood Disorders	53 (.25%)
Inner Ear And Viiith Cranial Nerve	53 (.25%)
Platelet	52 (.25%)
Gastrointestinal Hemorrhages	49 (.23%)
Vascular	47 (.22%)
Gastrointestinal Inflammatory Condi...	46 (.22%)
Lipid Analyses	45 (.21%)
Gastrointestinal Ulceration And Per...	44 (.21%)
Disturbances In Thinking	43 (.21%)
Placental, Amniotic And Cavity Diso...	42 (.2%)
Protein And Chemistry Analyses	41 (.2%)
Ocular Infections, Irritations And ...	39 (.19%)
Gastrointestinal Conditions	36 (.17%)
Gastrointestinal Neoplasms Malignan...	36 (.17%)
Urolithiases	35 (.17%)
Encephalopathies	34 (.16%)
Pulmonary Vascular	34 (.16%)
Bone And Joint Therapeutic Procedur...	33 (.16%)
Peripheral Neuropathies	33 (.16%)
Psychiatric	33 (.16%)
Coagulopathies And Bleeding Diathes...	31 (.15%)
Pleural	31 (.15%)
Leukemias	29 (.14%)
Spleen, Lymphatic And Reticulendoth...	27 (.13%)
Therapeutic Procedures And Supporti...	27 (.13%)
Vascular Hemorrhagic	26 (.12%)
Procedural And Device Related Injur...	25 (.12%)
Embolism And Thrombosis	24 (.11%)
Endocrine Investigations	24 (.11%)
Toxicology And Therapeutic Drug Mon...	24 (.11%)

Share/Embed Graph Export Data

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

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

Hypertension	7452
Product Used For Unknown Indication	1305
Drug Use For Unknown Indication	1084
Blood Pressure	597
Essential Hypertension	179
Cardiac Disorder	175
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Cardiac Failure Congestive	161
Cardiac Failure	156
Blood Pressure Increased	139
Blood Pressure Abnormal	124
Diabetes Mellitus	46
Proteinuria	41
Prophylaxis	41
Ill-defined Disorder	37
Renal Disorder	35
Blood Pressure Management	30
Diabetic Nephropathy	25
Coronary Artery Disease	24
Myocardial Ischaemia	24
Atrial Fibrillation	20
Aortic Valve Replacement	18
Swelling	18
Renal Failure	17
Blood Cholesterol Increased	14
Cerebrovascular Disorder	14
Myocardial Infarction	13
Blood Cholesterol	12
Acute Myocardial Infarction	12
Cardiomyopathy	11
Nephropathy	10
Pulmonary Hypertension	9
Nephrotic Syndrome	9
Cardiac Failure Chronic	9
Drug Therapy	9
Cardiomegaly	9
Hypertonia	8
Cardiac Murmur	8
Systemic Sclerosis	7
Lupus Nephritis	7
Congestive Cardiomyopathy	6
Cardiac Valve Disease	6
Aortic Stenosis	6
Hypotension	6
Pain	6
Portal Hypertension	5
Prophylaxis Against Transplant Reje...	5
Cardiac Hypertrophy	5
Anticoagulant Therapy	5
Marfans Syndrome	5
Protein Urine Present	4
Mucopolysaccharidosis Ii	4

Drug Labels

Label	Labeler	Effective
Cozaar	REMEDYREPACK INC.	07-APR-11
Cozaar	REMEDYREPACK INC.	22-APR-11
Cozaar	REMEDYREPACK INC.	19-MAY-11
Cozaar	PD-Rx Pharmaceuticals, Inc.	21-NOV-11
Cozaar	Cardinal Health	24-APR-12
Cozaar	Physicians Total Care, Inc.	01-OCT-12
Cozaar	Merck Sharp & Dohme Corp.	19-NOV-12
Cozaar	Bryant Ranch Prepack	18-JAN-13
Cozaar	Bryant Ranch Prepack	18-JAN-13

Cozaar Case Reports

What Cozaar safety concerns are being reported by doctors and researchers in the medical literature?

About Results

This report contains aggregated drug side effects and adverse events for Cozaar. 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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