VALSARTAN

Valsartan Adverse Events Reported to the FDA Over Time

How are Valsartan adverse event reports trending over time?

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

Most Common Valsartan Adverse Events Reported to the FDA

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

Renal Failure Acute	238 (1.84%)
Dizziness	153 (1.18%)
Hypotension	151 (1.17%)
Dyspnoea	148 (1.14%)
Hyperkalaemia	148 (1.14%)
Blood Creatinine Increased	138 (1.07%)
Chest Pain	124 (.96%)
Hypertension	120 (.93%)
Fall	118 (.91%)
Renal Failure	114 (.88%)
Asthenia	113 (.87%)
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Blood Pressure Diastolic Decreased	112 (.87%)
Vomiting	110 (.85%)
Syncope	101 (.78%)
Death	97 (.75%)
Atrial Fibrillation	94 (.73%)
Malaise	93 (.72%)
Blood Urea Increased	90 (.7%)
Blood Pressure Increased	85 (.66%)
Nausea	83 (.64%)
Oedema Peripheral	83 (.64%)
Dehydration	80 (.62%)
Hyponatraemia	80 (.62%)
Cardiac Failure	79 (.61%)
Anaemia	78 (.6%)
Diarrhoea	76 (.59%)
Completed Suicide	75 (.58%)
Pruritus	74 (.57%)
Loss Of Consciousness	70 (.54%)
Drug Interaction	68 (.53%)
Pyrexia	64 (.49%)
Angina Pectoris	63 (.49%)
Headache	61 (.47%)
Pneumonia	60 (.46%)
Blood Pressure Decreased	59 (.46%)
Somnolence	57 (.44%)
Disease Progression	56 (.43%)
Fatigue	56 (.43%)
Cough	55 (.42%)
Blood Glucose Increased	54 (.42%)
Concomitant Disease Progression	52 (.4%)
Orthostatic Hypotension	52 (.4%)
Hypokalaemia	51 (.39%)
Myocardial Infarction	51 (.39%)
Alanine Aminotransferase Increased	50 (.39%)
Condition Aggravated	49 (.38%)
Palpitations	49 (.38%)
Drug Exposure During Pregnancy	48 (.37%)
Abdominal Pain	47 (.36%)
General Physical Health Deteriorati...	46 (.36%)
Bradycardia	45 (.35%)
Drug Ineffective	45 (.35%)
Cardiac Arrest	44 (.34%)
Diabetes Mellitus	44 (.34%)
Blood Pressure Inadequately Control...	43 (.33%)
Renal Failure Chronic	43 (.33%)
Cerebrovascular Accident	42 (.32%)
Aspartate Aminotransferase Increase...	41 (.32%)
Pancreatitis Acute	41 (.32%)
Weight Decreased	41 (.32%)
Erythema	40 (.31%)
Tremor	39 (.3%)
Gait Disturbance	38 (.29%)
Gastritis	38 (.29%)
Renal Impairment	38 (.29%)
Confusional State	36 (.28%)
Coronary Artery Disease	36 (.28%)
Decreased Appetite	36 (.28%)
Cerebral Infarction	35 (.27%)
Angioedema	34 (.26%)
Gastrointestinal Haemorrhage	34 (.26%)
Lactic Acidosis	34 (.26%)
Pain	34 (.26%)
Sudden Death	34 (.26%)
Weight Increased	34 (.26%)
Blood Pressure Systolic Increased	33 (.25%)
C-reactive Protein Increased	33 (.25%)
Heart Rate Increased	33 (.25%)
Oedema	33 (.25%)
Acute Coronary Syndrome	31 (.24%)
Acute Myocardial Infarction	31 (.24%)
Asthma	31 (.24%)
Blood Potassium Increased	31 (.24%)
Diabetic Nephropathy	31 (.24%)
Gamma-glutamyltransferase Increased	31 (.24%)
Hypoglycaemia	31 (.24%)
Presyncope	31 (.24%)
Proteinuria	31 (.24%)
Oligohydramnios	30 (.23%)
Rhabdomyolysis	30 (.23%)
Thrombocytopenia	30 (.23%)
Rash	29 (.22%)
Urticaria	29 (.22%)
Anxiety	28 (.22%)
Cardio-respiratory Arrest	28 (.22%)
Dry Mouth	28 (.22%)
Electrocardiogram St Segment Depres...	28 (.22%)
Myalgia	27 (.21%)
Pain In Extremity	27 (.21%)
Arrhythmia	26 (.2%)
Cerebral Haemorrhage	26 (.2%)

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

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

Neurological	600 (4.64%)
Renal Disorders	539 (4.16%)
Cardiac And Vascular Investigations	522 (4.03%)
Cardiac Arrhythmias	468 (3.62%)
Epidermal And Dermal Conditions	454 (3.51%)
Electrolyte And Fluid Balance Condi...	411 (3.18%)
Respiratory	383 (2.96%)
Gastrointestinal Signs	362 (2.8%)
Decreased And Nonspecific Blood Pre...	321 (2.48%)
Renal And Urinary Tract Investigati...	314 (2.43%)
Infections - Pathogen Unspecified	302 (2.33%)
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Coronary Artery	272 (2.1%)
Hepatic And Hepatobiliary	206 (1.59%)
Injuries	203 (1.57%)
Central Nervous System Vascular	191 (1.48%)
Hepatobiliary	176 (1.36%)
Hematology Investigations	153 (1.18%)
Metabolic, Nutritional And Blood Ga...	147 (1.14%)
Heart Failures	146 (1.13%)
Vascular Hypertensive	143 (1.1%)
Fatal Outcomes	136 (1.05%)
Therapeutic And Nontherapeutic Effe...	131 (1.01%)
Muscle	126 (.97%)
Anemias Nonhemolytic And Marrow Dep...	124 (.96%)
Gastrointestinal Motility And Defec...	120 (.93%)
Physical Examination Topics	119 (.92%)
Water, Electrolyte And Mineral	115 (.89%)
Glucose Metabolism Disorders	113 (.87%)
Urinary Tract Signs	110 (.85%)
Suicidal And Self-injurious Behavio...	103 (.8%)
Lower Respiratory Tract Disorders	97 (.75%)
Anxiety Disorders	92 (.71%)
Musculoskeletal And Connective Tiss...	91 (.7%)
Movement Disorders	89 (.69%)
Medication Errors	84 (.65%)
Gastrointestinal Hemorrhages	83 (.64%)
Cardiac Disorder Signs	80 (.62%)
Appetite And General Nutritional	79 (.61%)
Body Temperature Conditions	77 (.59%)
Chemical Injury And Poisoning	77 (.59%)
Enzyme	76 (.59%)
Nephropathies	75 (.58%)
Bone And Joint Injuries	73 (.56%)
Acid-base	72 (.56%)
Gastrointestinal Inflammatory Condi...	72 (.56%)
Vision	71 (.55%)
Bacterial Infectious	68 (.53%)
Headaches	68 (.53%)
Deliria	67 (.52%)
Angiedema And Urticaria	64 (.49%)
Exocrine Pancreas Conditions	64 (.49%)
Joint	63 (.49%)
Pleural	59 (.46%)
Protein And Chemistry Analyses	59 (.46%)
Arteriosclerosis, Stenosis, Vascula...	58 (.45%)
Allergic Conditions	56 (.43%)
Mental Impairment	56 (.43%)
Bronchial Disorders	51 (.39%)
Myocardial	50 (.39%)
White Blood Cell	50 (.39%)
Gastrointestinal Therapeutic Proced...	49 (.38%)
Cardiac And Vascular Disorders Cong...	44 (.34%)
Skin Vascular Abnormalities	44 (.34%)
Upper Respiratory Tract Disorders	44 (.34%)
Vascular	44 (.34%)
Inner Ear And Viiith Cranial Nerve	43 (.33%)
Depressed Mood Disorders	41 (.32%)
Gastrointestinal Neoplasms Malignan...	41 (.32%)
Gastrointestinal Ulceration And Per...	40 (.31%)
Placental, Amniotic And Cavity Diso...	39 (.3%)
Skin Appendage Conditions	39 (.3%)
Sleep Disorders	39 (.3%)
Platelet	38 (.29%)
Vascular Hemorrhagic	37 (.29%)
Hematological And Lymphoid Tissue T...	36 (.28%)
Oral Soft Tissue Conditions	35 (.27%)
Seizures	34 (.26%)
Gastrointestinal Vascular Condition...	33 (.25%)
Lipid Metabolism	33 (.25%)
Respiratory Tract Therapeutic Proce...	32 (.25%)
Salivary Gland Conditions	32 (.25%)
Cardiac Valve	30 (.23%)
Lipid Analyses	29 (.22%)
Endocrine Investigations	28 (.22%)
Pulmonary Vascular	27 (.21%)
Viral Infectious	27 (.21%)
Bone, Calcium, Magnesium And Phosph...	26 (.2%)
Gallbladder	25 (.19%)
Psychiatric	25 (.19%)
Tongue Conditions	25 (.19%)
Eye	24 (.19%)
Ocular Infections, Irritations And ...	24 (.19%)
Respiratory And Mediastinal Neoplas...	24 (.19%)
Hemolyses And Related Conditions	23 (.18%)
Microbiology And Serology	23 (.18%)
Immunology And Allergy	22 (.17%)
Benign Neoplasms Gastrointestinal	21 (.16%)
Procedural And Device Related Injur...	21 (.16%)
Diverticular	20 (.15%)
Respiratory And Pulmonary Investiga...	20 (.15%)
Retina, Choroid And Vitreous Hemorr...	20 (.15%)

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