IRBESARTAN

Irbesartan Adverse Events Reported to the FDA Over Time

How are Irbesartan adverse event reports trending over time?

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

Most Common Irbesartan Adverse Events Reported to the FDA

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

Renal Failure Acute	306 (3.9%)
Dehydration	141 (1.8%)
Hypotension	123 (1.57%)
Renal Failure	122 (1.55%)
Hyperkalaemia	115 (1.47%)
Hyponatraemia	108 (1.38%)
Hypertension	102 (1.3%)
Drug Interaction	101 (1.29%)
Fall	95 (1.21%)
Vomiting	93 (1.19%)
Pyrexia	85 (1.08%)
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Nausea	83 (1.06%)
Lactic Acidosis	82 (1.04%)
Atrial Fibrillation	69 (.88%)
Diarrhoea	69 (.88%)
Dyspnoea	66 (.84%)
Blood Creatinine Increased	65 (.83%)
Weight Increased	65 (.83%)
Dizziness	64 (.82%)
Anaemia	61 (.78%)
Oliguria	60 (.76%)
Oedema	59 (.75%)
Back Pain	51 (.65%)
Bradycardia	51 (.65%)
Confusional State	49 (.62%)
Asthenia	48 (.61%)
Fear Of Eating	48 (.61%)
Gastrooesophageal Reflux Disease	47 (.6%)
Malaise	47 (.6%)
Renal Impairment	46 (.59%)
Constipation	43 (.55%)
Dyspepsia	42 (.54%)
Headache	42 (.54%)
Rectal Haemorrhage	42 (.54%)
Syncope	40 (.51%)
Completed Suicide	37 (.47%)
Rhabdomyolysis	37 (.47%)
General Physical Health Deteriorati...	36 (.46%)
Loss Of Consciousness	35 (.45%)
Overdose	35 (.45%)
Pneumonia	34 (.43%)
Renal Pain	34 (.43%)
Hypoglycaemia	33 (.42%)
Weight Decreased	33 (.42%)
Cholestasis	32 (.41%)
Cytolytic Hepatitis	32 (.41%)
Fatigue	32 (.41%)
Metabolic Acidosis	32 (.41%)
Myocardial Infarction	32 (.41%)
Hypokalaemia	31 (.4%)
Aspartate Aminotransferase Increase...	30 (.38%)
Blood Pressure Decreased	30 (.38%)
Chest Pain	30 (.38%)
Somnolence	27 (.34%)
Cardiac Failure	26 (.33%)
Alanine Aminotransferase Increased	25 (.32%)
Blood Sodium Decreased	25 (.32%)
Cardio-respiratory Arrest	25 (.32%)
Gastrointestinal Haemorrhage	25 (.32%)
Angioedema	24 (.31%)
Thrombocytopenia	24 (.31%)
Cerebrovascular Accident	23 (.29%)
Lethargy	23 (.29%)
Orthostatic Hypotension	23 (.29%)
Urinary Tract Infection	23 (.29%)
Blood Potassium Increased	22 (.28%)
Cardiac Arrest	22 (.28%)
Oedema Peripheral	22 (.28%)
Rash	22 (.28%)
Therapeutic Agent Toxicity	22 (.28%)
Drug Ineffective	21 (.27%)
Haemoglobin Decreased	21 (.27%)
International Normalised Ratio Incr...	21 (.27%)
Lung Disorder	21 (.27%)
Pain In Extremity	21 (.27%)
Swollen Tongue	21 (.27%)
White Blood Cell Count Increased	21 (.27%)
Haemorrhoids	20 (.25%)
Anal Haemorrhage	19 (.24%)
Arthralgia	19 (.24%)
Blood Potassium Decreased	19 (.24%)
Dysarthria	19 (.24%)
Sinus Bradycardia	19 (.24%)
Blood Pressure Increased	18 (.23%)
Hyperglycaemia	18 (.23%)
Hyperhidrosis	18 (.23%)
Pregnancy	18 (.23%)
Pulmonary Oedema	18 (.23%)
Respiratory Distress	18 (.23%)
Tachycardia	18 (.23%)
Vertigo	18 (.23%)
Cataract	17 (.22%)
Death	17 (.22%)
Disorientation	17 (.22%)
Gamma-glutamyltransferase Increased	17 (.22%)
Hypersensitivity	17 (.22%)
Pulmonary Arterial Hypertension	17 (.22%)
Renal Failure Chronic	17 (.22%)
Sepsis	17 (.22%)
Abdominal Pain	16 (.2%)
Anuria	16 (.2%)

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

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

Renal Disorders	607 (7.74%)
Electrolyte And Fluid Balance Condi...	425 (5.42%)
Neurological	351 (4.47%)
Cardiac Arrhythmias	311 (3.96%)
Gastrointestinal Signs	281 (3.58%)
Respiratory	222 (2.83%)
Decreased And Nonspecific Blood Pre...	202 (2.57%)
Infections - Pathogen Unspecified	198 (2.52%)
Gastrointestinal Motility And Defec...	159 (2.03%)
Epidermal And Dermal Conditions	156 (1.99%)
Hepatic And Hepatobiliary	150 (1.91%)
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Injuries	150 (1.91%)
Acid-base	136 (1.73%)
Therapeutic And Nontherapeutic Effe...	131 (1.67%)
Hematology Investigations	125 (1.59%)
Physical Examination Topics	118 (1.5%)
Cardiac And Vascular Investigations	116 (1.48%)
Vascular Hypertensive	115 (1.47%)
Body Temperature Conditions	109 (1.39%)
Gastrointestinal Hemorrhages	107 (1.36%)
Anemias Nonhemolytic And Marrow Dep...	105 (1.34%)
Renal And Urinary Tract Investigati...	105 (1.34%)
Hepatobiliary	100 (1.27%)
Central Nervous System Vascular	99 (1.26%)
Musculoskeletal And Connective Tiss...	96 (1.22%)
Medication Errors	89 (1.13%)
Coronary Artery	87 (1.11%)
Urinary Tract Signs	81 (1.03%)
Water, Electrolyte And Mineral	81 (1.03%)
Anxiety Disorders	78 (.99%)
Glucose Metabolism Disorders	74 (.94%)
Muscle	69 (.88%)
Deliria	68 (.87%)
Suicidal And Self-injurious Behavio...	65 (.83%)
Lower Respiratory Tract Disorders	63 (.8%)
Chemical Injury And Poisoning	58 (.74%)
Bone And Joint Injuries	53 (.68%)
Metabolic, Nutritional And Blood Ga...	49 (.62%)
Headaches	45 (.57%)
Movement Disorders	45 (.57%)
Gastrointestinal Ulceration And Per...	44 (.56%)
Heart Failures	44 (.56%)
White Blood Cell	44 (.56%)
Cardiac Valve	43 (.55%)
Bacterial Infectious	38 (.48%)
Angiedema And Urticaria	34 (.43%)
Bronchial Disorders	34 (.43%)
Enzyme	34 (.43%)
Nephropathies	33 (.42%)
Allergic Conditions	32 (.41%)
Platelet	32 (.41%)
Skin Vascular Abnormalities	31 (.4%)
Joint	30 (.38%)
Cardiac Disorder Signs	29 (.37%)
Gastrointestinal Inflammatory Condi...	29 (.37%)
Fatal Outcomes	26 (.33%)
Myocardial	26 (.33%)
Exocrine Pancreas Conditions	25 (.32%)
Hematological And Lymphoid Tissue T...	25 (.32%)
Pulmonary Vascular	25 (.32%)
Tongue Conditions	25 (.32%)
Skin Appendage Conditions	24 (.31%)
Appetite And General Nutritional	23 (.29%)
Gastrointestinal Vascular Condition...	23 (.29%)
Pregnancy, Labour, Delivery And Pos...	22 (.28%)
Vascular Hemorrhagic	22 (.28%)
Vision	21 (.27%)
Inner Ear And Viiith Cranial Nerve	19 (.24%)
Peritoneal And Retroperitoneal Cond...	19 (.24%)
Procedural And Device Related Injur...	19 (.24%)
Anterior Eye Structural Change, Dep...	18 (.23%)
Gastrointestinal Neoplasms Malignan...	18 (.23%)
Neurological, Special Senses And Ps...	18 (.23%)
Ocular Infections, Irritations And ...	17 (.22%)
Upper Respiratory Tract Disorders	17 (.22%)
Lifestyle Issues	16 (.2%)
Thyroid Gland	16 (.2%)
Vascular	16 (.2%)
Viral Infectious	16 (.2%)
Obstetric And Gynecological Therape...	15 (.19%)
Protein And Chemistry Analyses	15 (.19%)
Seizures	15 (.19%)
Mood Disorders	14 (.18%)
Peripheral Neuropathies	14 (.18%)
Arteriosclerosis, Stenosis, Vascula...	13 (.17%)
Connective Tissue Disorders	13 (.17%)
Depressed Mood Disorders	13 (.17%)
Mental Impairment	13 (.17%)
Psychiatric	13 (.17%)
Bone, Calcium, Magnesium And Phosph...	12 (.15%)
Pleural	12 (.15%)
Product Quality Issues	12 (.15%)
Therapeutic Procedures And Supporti...	12 (.15%)
Gastrointestinal	11 (.14%)
Gastrointestinal Conditions	11 (.14%)
Hypothalamus And Pituitary Gland	11 (.14%)
Personality Disorders	11 (.14%)
Vascular Therapeutic Procedures	11 (.14%)
Encephalopathies	10 (.13%)
Gallbladder	10 (.13%)
Gastrointestinal Stenosis And Obstr...	10 (.13%)

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