GLYBURIDE

Glyburide Adverse Events Reported to the FDA Over Time

How are Glyburide adverse event reports trending over time?

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

Most Common Glyburide Adverse Events Reported to the FDA

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

Hypoglycaemia	537 (8.88%)
Blood Glucose Increased	160 (2.65%)
Blood Glucose Decreased	107 (1.77%)
Renal Failure Acute	96 (1.59%)
Drug Interaction	85 (1.41%)
Completed Suicide	78 (1.29%)
Diarrhoea	68 (1.12%)
Drug Ineffective	64 (1.06%)
Lactic Acidosis	63 (1.04%)
Confusional State	60 (.99%)
Nausea	58 (.96%)
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Asthenia	54 (.89%)
Dizziness	52 (.86%)
Fall	52 (.86%)
Hypotension	51 (.84%)
Hypoglycaemic Coma	50 (.83%)
Metabolic Acidosis	49 (.81%)
Hyperhidrosis	48 (.79%)
Loss Of Consciousness	46 (.76%)
Vomiting	41 (.68%)
Medication Error	40 (.66%)
Pneumonia	37 (.61%)
Hyperglycaemia	36 (.6%)
Renal Failure	36 (.6%)
Diabetes Mellitus Inadequate Contro...	35 (.58%)
Weight Decreased	35 (.58%)
Intentional Overdose	34 (.56%)
Depressed Level Of Consciousness	32 (.53%)
Overdose	32 (.53%)
Blood Creatinine Increased	31 (.51%)
Mental Status Changes	31 (.51%)
Suicide Attempt	31 (.51%)
Cardiac Arrest	30 (.5%)
Decreased Appetite	30 (.5%)
Dyspnoea	30 (.5%)
Malaise	30 (.5%)
Tremor	30 (.5%)
Drug Toxicity	29 (.48%)
Glycosylated Haemoglobin Increased	28 (.46%)
Weight Increased	28 (.46%)
Syncope	27 (.45%)
Acute Respiratory Distress Syndrome	26 (.43%)
Pyrexia	26 (.43%)
Diabetes Mellitus	25 (.41%)
Haemorrhage Intracranial	25 (.41%)
Respiratory Failure	25 (.41%)
Somnolence	25 (.41%)
Toxic Epidermal Necrolysis	25 (.41%)
Unresponsive To Stimuli	25 (.41%)
Dehydration	24 (.4%)
Lethargy	24 (.4%)
Blood Glucose Fluctuation	23 (.38%)
Deafness Neurosensory	23 (.38%)
Death	23 (.38%)
General Physical Health Deteriorati...	23 (.38%)
Myocardial Infarction	23 (.38%)
Disorientation	22 (.36%)
Thrombocytopenia	22 (.36%)
Anaemia	21 (.35%)
Coma	20 (.33%)
Fatigue	20 (.33%)
Hypertension	20 (.33%)
Insomnia	20 (.33%)
Leukocytosis	20 (.33%)
Rash	20 (.33%)
Headache	19 (.31%)
Hyperkalaemia	19 (.31%)
Cerebrovascular Accident	18 (.3%)
Convulsion	18 (.3%)
Pancreatitis Acute	18 (.3%)
Treatment Noncompliance	18 (.3%)
Multiple Drug Overdose Intentional	17 (.28%)
Oedema Peripheral	17 (.28%)
Abdominal Pain	16 (.26%)
Altered State Of Consciousness	16 (.26%)
Condition Aggravated	16 (.26%)
Drug Administration Error	16 (.26%)
Intentional Drug Misuse	16 (.26%)
Myalgia	16 (.26%)
Respiratory Arrest	16 (.26%)
Alanine Aminotransferase Increased	15 (.25%)
Bradycardia	15 (.25%)
Haemodialysis	15 (.25%)
Pruritus	15 (.25%)
Aspartate Aminotransferase Increase...	14 (.23%)
Bacterial Infection	14 (.23%)
Blood Pressure Increased	14 (.23%)
Constipation	14 (.23%)
Drug Effect Decreased	14 (.23%)
Dyspepsia	14 (.23%)
Gait Disturbance	14 (.23%)
Incorrect Dose Administered	14 (.23%)
Product Quality Issue	14 (.23%)
Blood Iron Decreased	13 (.21%)
Cardiac Failure Congestive	13 (.21%)
Drug Exposure During Pregnancy	13 (.21%)
Feeling Abnormal	13 (.21%)
Heart Rate Increased	13 (.21%)
Hypernatraemia	13 (.21%)
Hypersensitivity	13 (.21%)
Pain	13 (.21%)

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

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

Glucose Metabolism Disorders	655 (10.83%)
Neurological	419 (6.93%)
Metabolic, Nutritional And Blood Ga...	351 (5.8%)
Medication Errors	216 (3.57%)
Therapeutic And Nontherapeutic Effe...	204 (3.37%)
Gastrointestinal Signs	184 (3.04%)
Renal Disorders	165 (2.73%)
Respiratory	138 (2.28%)
Epidermal And Dermal Conditions	133 (2.2%)
Acid-base	126 (2.08%)
Infections - Pathogen Unspecified	121 (2%)
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Cardiac Arrhythmias	115 (1.9%)
Suicidal And Self-injurious Behavio...	111 (1.84%)
Physical Examination Topics	91 (1.5%)
Gastrointestinal Motility And Defec...	86 (1.42%)
Hepatic And Hepatobiliary	84 (1.39%)
Deliria	83 (1.37%)
Decreased And Nonspecific Blood Pre...	77 (1.27%)
Injuries	76 (1.26%)
Cardiac And Vascular Investigations	75 (1.24%)
Electrolyte And Fluid Balance Condi...	74 (1.22%)
Renal And Urinary Tract Investigati...	67 (1.11%)
Central Nervous System Vascular	66 (1.09%)
Chemical Injury And Poisoning	66 (1.09%)
Movement Disorders	58 (.96%)
Skin Appendage Conditions	56 (.93%)
Appetite And General Nutritional	55 (.91%)
Lower Respiratory Tract Disorders	54 (.89%)
Psychiatric	53 (.88%)
Muscle	51 (.84%)
Bacterial Infectious	49 (.81%)
Hematology Investigations	47 (.78%)
Coronary Artery	41 (.68%)
Product Quality Issues	40 (.66%)
Water, Electrolyte And Mineral	40 (.66%)
Exocrine Pancreas Conditions	37 (.61%)
Fatal Outcomes	37 (.61%)
Hearing	36 (.6%)
Sleep Disorders	36 (.6%)
Hepatobiliary	35 (.58%)
Anemias Nonhemolytic And Marrow Dep...	34 (.56%)
Vision	33 (.55%)
Anxiety Disorders	32 (.53%)
Body Temperature Conditions	32 (.53%)
Lifestyle Issues	32 (.53%)
White Blood Cell	31 (.51%)
Hematological And Lymphoid Tissue T...	28 (.46%)
Cardiac Disorder Signs	26 (.43%)
Gastrointestinal Hemorrhages	26 (.43%)
Urinary Tract Signs	26 (.43%)
Allergic Conditions	25 (.41%)
Mental Impairment	25 (.41%)
Musculoskeletal And Connective Tiss...	24 (.4%)
Enzyme	23 (.38%)
Platelet	23 (.38%)
Headaches	22 (.36%)
Vascular Hypertensive	20 (.33%)
Inner Ear And Viiith Cranial Nerve	19 (.31%)
Seizures	19 (.31%)
Gastrointestinal Ulceration And Per...	17 (.28%)
Heart Failures	17 (.28%)
Toxicology And Therapeutic Drug Mon...	17 (.28%)
Bone And Joint Injuries	16 (.26%)
Administration Site Reactions	15 (.25%)
Depressed Mood Disorders	15 (.25%)
Encephalopathies	15 (.25%)
Tissue	15 (.25%)
Leukemias	14 (.23%)
Joint	13 (.21%)
Lipid Analyses	13 (.21%)
Myocardial	13 (.21%)
Upper Respiratory Tract Disorders	13 (.21%)
Hemolyses And Related Conditions	12 (.2%)
Pulmonary Vascular	12 (.2%)
Aural	11 (.18%)
Embolism And Thrombosis	11 (.18%)
Gallbladder	11 (.18%)
Microbiology And Serology	11 (.18%)
Neonatal And Perinatal Conditions	11 (.18%)
Psychiatric And Behavioural Symptom...	11 (.18%)
Abortions And Stillbirth	10 (.17%)
Bronchial Disorders	10 (.17%)
Gastrointestinal Neoplasms Malignan...	10 (.17%)
Middle Ear Disorders	10 (.17%)
Procedural And Device Related Injur...	10 (.17%)
Vascular	10 (.17%)
Viral Infectious	10 (.17%)
Nephropathies	9 (.15%)
Ocular Neuromuscular	9 (.15%)
Spinal Cord And Nerve Root	9 (.15%)
Therapeutic Procedures And Supporti...	9 (.15%)
Cranial Nerve Disorders	8 (.13%)
Disturbances In Thinking	8 (.13%)
Oral Soft Tissue Conditions	8 (.13%)
Pregnancy, Labour, Delivery And Pos...	8 (.13%)
Structural Brain	8 (.13%)
Vitamin Related	8 (.13%)
Communication Disorders	7 (.12%)
Metabolism	7 (.12%)
Angiedema And Urticaria	6 (.1%)
Arteriosclerosis, Stenosis, Vascula...	6 (.1%)

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