IRBESARTAN AND HYDROCHLOROTHIAZIDE

Irbesartan And Hydrochlorothiazide Adverse Events Reported to the FDA Over Time

How are Irbesartan And Hydrochlorothiazide adverse event reports trending over time?

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

Most Common Irbesartan And Hydrochlorothiazide Adverse Events Reported to the FDA

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

Renal Failure Acute	74 (3.93%)
Hyponatraemia	60 (3.19%)
Hypotension	35 (1.86%)
Fall	33 (1.75%)
Hyperkalaemia	32 (1.7%)
Lactic Acidosis	27 (1.43%)
Renal Failure	26 (1.38%)
Drug Interaction	24 (1.28%)
Vomiting	24 (1.28%)
Asthenia	23 (1.22%)
Confusional State	23 (1.22%)
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Diarrhoea	22 (1.17%)
Dizziness	21 (1.12%)
Dehydration	19 (1.01%)
General Physical Health Deteriorati...	18 (.96%)
Hypertension	17 (.9%)
Hypokalaemia	16 (.85%)
Syncope	16 (.85%)
Nausea	15 (.8%)
Bradycardia	14 (.74%)
Dyspnoea	14 (.74%)
Pain In Extremity	14 (.74%)
Blood Pressure Decreased	12 (.64%)
Malaise	12 (.64%)
Overdose	12 (.64%)
Cerebrovascular Accident	11 (.58%)
Chest Pain	11 (.58%)
Rhabdomyolysis	11 (.58%)
Arthralgia	10 (.53%)
Fatigue	10 (.53%)
Renal Impairment	10 (.53%)
Eosinophilia	9 (.48%)
Hyperglycaemia	9 (.48%)
Insomnia	9 (.48%)
Depressed Level Of Consciousness	8 (.43%)
Drug Ineffective	8 (.43%)
Headache	8 (.43%)
Inappropriate Antidiuretic Hormone ...	8 (.43%)
Medication Error	8 (.43%)
Oedema Peripheral	8 (.43%)
Weight Decreased	8 (.43%)
Acidosis	7 (.37%)
Anaemia	7 (.37%)
Breast Cancer	7 (.37%)
Completed Suicide	7 (.37%)
Diabetes Mellitus	7 (.37%)
Hypovolaemic Shock	7 (.37%)
Pancreatic Carcinoma	7 (.37%)
Toxic Skin Eruption	7 (.37%)
Urinary Tract Infection	7 (.37%)
Vertigo	7 (.37%)
Abdominal Pain Upper	6 (.32%)
Balance Disorder	6 (.32%)
Blood Creatinine Increased	6 (.32%)
Cardio-respiratory Arrest	6 (.32%)
Cholestasis	6 (.32%)
Colitis Microscopic	6 (.32%)
Condition Aggravated	6 (.32%)
Decreased Appetite	6 (.32%)
Diabetic Nephropathy	6 (.32%)
Escherichia Urinary Tract Infection	6 (.32%)
Hepatic Cirrhosis	6 (.32%)
Hepatitis Fulminant	6 (.32%)
Hyperhidrosis	6 (.32%)
Inflammation	6 (.32%)
Loss Of Consciousness	6 (.32%)
Metabolic Acidosis	6 (.32%)
Oedema	6 (.32%)
Orthostatic Hypotension	6 (.32%)
Osteoarthritis	6 (.32%)
Pneumonia Aspiration	6 (.32%)
Rash	6 (.32%)
Renal Failure Chronic	6 (.32%)
Respiratory Distress	6 (.32%)
Type 2 Diabetes Mellitus	6 (.32%)
Altered State Of Consciousness	5 (.27%)
Anaphylactic Shock	5 (.27%)
Asthma	5 (.27%)
Atrioventricular Block Complete	5 (.27%)
Blood Creatine Phosphokinase Increa...	5 (.27%)
Blood Potassium Increased	5 (.27%)
Blood Pressure Increased	5 (.27%)
Blood Sodium Decreased	5 (.27%)
Cataract	5 (.27%)
Convulsion	5 (.27%)
Depression	5 (.27%)
Disorientation	5 (.27%)
Dry Mouth	5 (.27%)
Dysgeusia	5 (.27%)
Glaucoma	5 (.27%)
Hypertensive Crisis	5 (.27%)
Interstitial Lung Disease	5 (.27%)
Myalgia	5 (.27%)
Neuropathy Peripheral	5 (.27%)
Palpitations	5 (.27%)
Pancreatitis	5 (.27%)
Pyrexia	5 (.27%)
Renal Tubular Necrosis	5 (.27%)
Septic Shock	5 (.27%)
Somnolence	5 (.27%)
Tachycardia	5 (.27%)

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

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

Electrolyte And Fluid Balance Condi...	136 (7.23%)
Renal Disorders	132 (7.01%)
Neurological	97 (5.15%)
Cardiac Arrhythmias	70 (3.72%)
Decreased And Nonspecific Blood Pre...	58 (3.08%)
Gastrointestinal Signs	57 (3.03%)
Injuries	51 (2.71%)
Epidermal And Dermal Conditions	49 (2.6%)
Infections - Pathogen Unspecified	43 (2.28%)
Acid-base	42 (2.23%)
Respiratory	40 (2.13%)
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Hepatic And Hepatobiliary	37 (1.97%)
Cardiac And Vascular Investigations	35 (1.86%)
Medication Errors	34 (1.81%)
Therapeutic And Nontherapeutic Effe...	32 (1.7%)
Deliria	28 (1.49%)
Anemias Nonhemolytic And Marrow Dep...	27 (1.43%)
Gastrointestinal Motility And Defec...	26 (1.38%)
Glucose Metabolism Disorders	26 (1.38%)
Musculoskeletal And Connective Tiss...	25 (1.33%)
Muscle	23 (1.22%)
Vascular Hypertensive	22 (1.17%)
Central Nervous System Vascular	18 (.96%)
Hepatobiliary	18 (.96%)
Joint	18 (.96%)
Bone And Joint Injuries	17 (.9%)
Lower Respiratory Tract Disorders	17 (.9%)
Coronary Artery	16 (.85%)
Physical Examination Topics	16 (.85%)
White Blood Cell	16 (.85%)
Allergic Conditions	13 (.69%)
Exocrine Pancreas Conditions	13 (.69%)
Nephropathies	13 (.69%)
Water, Electrolyte And Mineral	13 (.69%)
Gastrointestinal Inflammatory Condi...	12 (.64%)
Renal And Urinary Tract Investigati...	12 (.64%)
Urinary Tract Signs	12 (.64%)
Headaches	11 (.58%)
Seizures	11 (.58%)
Suicidal And Self-injurious Behavio...	11 (.58%)
Enzyme	10 (.53%)
Vision	10 (.53%)
Appetite And General Nutritional	9 (.48%)
Body Temperature Conditions	9 (.48%)
Gastrointestinal Hemorrhages	9 (.48%)
Hypothalamus And Pituitary Gland	9 (.48%)
Sleep Disorders	9 (.48%)
Bacterial Infectious	8 (.43%)
Gastrointestinal Neoplasms Malignan...	8 (.43%)
Hematology Investigations	8 (.43%)
Inner Ear And Viiith Cranial Nerve	8 (.43%)
Anxiety Disorders	7 (.37%)
Breast Neoplasms Malignant And Unsp...	7 (.37%)
Bronchial Disorders	7 (.37%)
Cardiac Disorder Signs	7 (.37%)
Cardiac Valve	7 (.37%)
Connective Tissue Disorders	7 (.37%)
Hematological And Lymphoid Tissue T...	7 (.37%)
Movement Disorders	7 (.37%)
Peripheral Neuropathies	7 (.37%)
Skin Appendage Conditions	7 (.37%)
Anterior Eye Structural Change, Dep...	6 (.32%)
Bone Disorders	6 (.32%)
Bone, Calcium, Magnesium And Phosph...	6 (.32%)
Chemical Injury And Poisoning	6 (.32%)
Heart Failures	6 (.32%)
Mental Impairment	6 (.32%)
Procedural And Device Related Injur...	6 (.32%)
Salivary Gland Conditions	6 (.32%)
Arteriosclerosis, Stenosis, Vascula...	5 (.27%)
Depressed Mood Disorders	5 (.27%)
Fatal Outcomes	5 (.27%)
Gastrointestinal Ulceration And Per...	5 (.27%)
Glaucoma And Ocular Hypertension	5 (.27%)
Ocular Infections, Irritations And ...	5 (.27%)
Thyroid Gland	5 (.27%)
Upper Respiratory Tract Disorders	5 (.27%)
Vascular	5 (.27%)
Abortions And Stillbirth	4 (.21%)
Angiedema And Urticaria	4 (.21%)
Encephalopathies	4 (.21%)
Gallbladder	4 (.21%)
Platelet	4 (.21%)
Product Quality Issues	4 (.21%)
Retina, Choroid And Vitreous Hemorr...	4 (.21%)
Spinal Cord And Nerve Root	4 (.21%)
Toxicology And Therapeutic Drug Mon...	4 (.21%)
Anal And Rectal Conditions	3 (.16%)
Bladder And Bladder Neck Disorders	3 (.16%)
Disturbances In Thinking	3 (.16%)
Metastases	3 (.16%)
Musculoskeletal And Connective Tiss...	3 (.16%)
Neurological, Special Senses And Ps...	3 (.16%)
Purine And Pyrimidine Metabolism	3 (.16%)
Skin Vascular Abnormalities	3 (.16%)
Therapeutic Procedures And Supporti...	3 (.16%)
Tongue Conditions	3 (.16%)
Uterine, Pelvic And Broad Ligament	3 (.16%)
Viral Infectious	3 (.16%)
Vulvovaginal Disorders	3 (.16%)
Abdominal Hernias And Other Abdomin...	2 (.11%)

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