GLIBENCLAMIDE

Glibenclamide Adverse Events Reported to the FDA Over Time

How are Glibenclamide adverse event reports trending over time?

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

Most Common Glibenclamide Adverse Events Reported to the FDA

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

Hypoglycaemia	138 (7.22%)
Renal Failure Acute	57 (2.98%)
Drug Interaction	49 (2.56%)
Blood Glucose Increased	32 (1.67%)
Lactic Acidosis	31 (1.62%)
Metabolic Acidosis	28 (1.46%)
Overdose	26 (1.36%)
Completed Suicide	25 (1.31%)
Cardiac Arrest	24 (1.26%)
Sudden Death	23 (1.2%)
Confusional State	22 (1.15%)
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Drug Ineffective	22 (1.15%)
Myocardial Infarction	21 (1.1%)
Death	20 (1.05%)
Depressed Level Of Consciousness	18 (.94%)
Drug Toxicity	18 (.94%)
Fall	16 (.84%)
Hypotension	16 (.84%)
Loss Of Consciousness	16 (.84%)
Renal Failure	15 (.78%)
Dehydration	14 (.73%)
Diarrhoea	14 (.73%)
Cerebrovascular Accident	13 (.68%)
Coma	13 (.68%)
Blood Glucose Decreased	12 (.63%)
Hypoglycaemic Coma	12 (.63%)
Weight Decreased	12 (.63%)
Somnolence	11 (.58%)
Suicide Attempt	11 (.58%)
Decreased Appetite	10 (.52%)
Haemodialysis	10 (.52%)
Haemoglobin Decreased	10 (.52%)
Hyperkalaemia	10 (.52%)
Hypertension	10 (.52%)
Renal Impairment	10 (.52%)
Toxic Epidermal Necrolysis	10 (.52%)
Vomiting	10 (.52%)
Accidental Exposure	9 (.47%)
Asthenia	9 (.47%)
Blood Creatinine Increased	9 (.47%)
Condition Aggravated	9 (.47%)
Glycosylated Haemoglobin Increased	9 (.47%)
Granulomatous Liver Disease	9 (.47%)
Intentional Overdose	9 (.47%)
Vitamin B12 Deficiency	9 (.47%)
Convulsion	8 (.42%)
Dizziness	8 (.42%)
General Physical Health Deteriorati...	8 (.42%)
Hepatitis Toxic	8 (.42%)
Pancreatitis Acute	8 (.42%)
Pneumonia	8 (.42%)
Alanine Aminotransferase Increased	7 (.37%)
Anaemia	7 (.37%)
Erythema	7 (.37%)
Heart Rate Decreased	7 (.37%)
Hyperventilation	7 (.37%)
Malaise	7 (.37%)
Multi-organ Failure	7 (.37%)
Stevens-johnson Syndrome	7 (.37%)
Thrombocytopenia	7 (.37%)
Unresponsive To Stimuli	7 (.37%)
Wheezing	7 (.37%)
Acute Myocardial Infarction	6 (.31%)
Apnoea	6 (.31%)
Hyperhidrosis	6 (.31%)
Intentional Drug Misuse	6 (.31%)
Mental Status Changes	6 (.31%)
Myelopathy	6 (.31%)
Nausea	6 (.31%)
Poisoning	6 (.31%)
Pyrexia	6 (.31%)
Rash	6 (.31%)
Transaminases Increased	6 (.31%)
Tremor	6 (.31%)
Weight Increased	6 (.31%)
White Blood Cell Count Increased	6 (.31%)
Blood Pressure Increased	5 (.26%)
Cardiac Disorder	5 (.26%)
Clonus	5 (.26%)
Diabetes Mellitus	5 (.26%)
Dyspnoea	5 (.26%)
Hyponatraemia	5 (.26%)
Paraparesis	5 (.26%)
Respiratory Failure	5 (.26%)
Subarachnoid Haemorrhage	5 (.26%)
Tachypnoea	5 (.26%)
Abdominal Pain	4 (.21%)
Acute Respiratory Distress Syndrome	4 (.21%)
Anuria	4 (.21%)
Bacterial Infection	4 (.21%)
Blood Creatine Phosphokinase Increa...	4 (.21%)
Body Height Decreased	4 (.21%)
Bradycardia	4 (.21%)
Cardiac Failure	4 (.21%)
Circulatory Collapse	4 (.21%)
Cytomegalovirus Enteritis	4 (.21%)
Drug Eruption	4 (.21%)
Drug Exposure During Pregnancy	4 (.21%)
Dry Mouth	4 (.21%)
Extensor Plantar Response	4 (.21%)
Fatigue	4 (.21%)

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

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

Glucose Metabolism Disorders	157 (8.21%)
Neurological	118 (6.17%)
Renal Disorders	91 (4.76%)
Therapeutic And Nontherapeutic Effe...	80 (4.18%)
Epidermal And Dermal Conditions	63 (3.29%)
Medication Errors	62 (3.24%)
Metabolic, Nutritional And Blood Ga...	61 (3.19%)
Acid-base	60 (3.14%)
Cardiac Arrhythmias	48 (2.51%)
Fatal Outcomes	45 (2.35%)
Respiratory	40 (2.09%)
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Hepatic And Hepatobiliary	38 (1.99%)
Suicidal And Self-injurious Behavio...	36 (1.88%)
Electrolyte And Fluid Balance Condi...	35 (1.83%)
Coronary Artery	34 (1.78%)
Central Nervous System Vascular	29 (1.52%)
Chemical Injury And Poisoning	29 (1.52%)
Gastrointestinal Signs	29 (1.52%)
Injuries	28 (1.46%)
Physical Examination Topics	28 (1.46%)
Hematology Investigations	26 (1.36%)
Infections - Pathogen Unspecified	26 (1.36%)
Deliria	23 (1.2%)
Cardiac And Vascular Investigations	22 (1.15%)
Decreased And Nonspecific Blood Pre...	21 (1.1%)
Renal And Urinary Tract Investigati...	20 (1.05%)
Bacterial Infectious	19 (.99%)
Hepatobiliary	18 (.94%)
Appetite And General Nutritional	17 (.89%)
Gastrointestinal Motility And Defec...	17 (.89%)
Psychiatric	17 (.89%)
Movement Disorders	16 (.84%)
Bone And Joint Injuries	15 (.78%)
Seizures	15 (.78%)
Urinary Tract Signs	15 (.78%)
Muscle	14 (.73%)
Exocrine Pancreas Conditions	13 (.68%)
Hematological And Lymphoid Tissue T...	13 (.68%)
Lower Respiratory Tract Disorders	12 (.63%)
Anemias Nonhemolytic And Marrow Dep...	11 (.58%)
Heart Failures	11 (.58%)
Vascular Hypertensive	10 (.52%)
Vision	10 (.52%)
Body Temperature Conditions	9 (.47%)
Cardiac Disorder Signs	9 (.47%)
Skin Appendage Conditions	9 (.47%)
Spinal Cord And Nerve Root	9 (.47%)
Vitamin Related	9 (.47%)
Bronchial Disorders	8 (.42%)
Allergic Conditions	7 (.37%)
Nephropathies	7 (.37%)
Platelet	7 (.37%)
Anxiety Disorders	6 (.31%)
Eye	6 (.31%)
Gallbladder	6 (.31%)
Lipid Analyses	6 (.31%)
Mental Impairment	6 (.31%)
Salivary Gland Conditions	6 (.31%)
Tissue	6 (.31%)
Water, Electrolyte And Mineral	6 (.31%)
Depressed Mood Disorders	5 (.26%)
Fungal Infectious	5 (.26%)
Procedural And Device Related Injur...	5 (.26%)
Skin Vascular Abnormalities	5 (.26%)
White Blood Cell	5 (.26%)
Enzyme	4 (.21%)
Gastrointestinal Neoplasms Benign	4 (.21%)
Headaches	4 (.21%)
Hearing	4 (.21%)
Joint	4 (.21%)
Mood Disorders	4 (.21%)
Musculoskeletal And Connective Tiss...	4 (.21%)
Mycobacterial Infectious	4 (.21%)
Neonatal And Perinatal Conditions	4 (.21%)
Therapeutic Procedures And Supporti...	4 (.21%)
Vascular	4 (.21%)
Viral Infectious	4 (.21%)
Abdominal Hernias And Other Abdomin...	3 (.16%)
Anterior Eye Structural Change, Dep...	3 (.16%)
Arteriosclerosis, Stenosis, Vascula...	3 (.16%)
Bone And Joint Therapeutic Procedur...	3 (.16%)
Changes In Physical Activity	3 (.16%)
Disturbances In Thinking	3 (.16%)
Endocrine Investigations	3 (.16%)
Eye Therapeutic Procedures	3 (.16%)
Gastrointestinal Hemorrhages	3 (.16%)
Gastrointestinal Inflammatory Condi...	3 (.16%)
Leukemias	3 (.16%)
Neurological, Special Senses And Ps...	3 (.16%)
Ocular Hemorrhages And Vascular	3 (.16%)
Oral Soft Tissue Conditions	3 (.16%)
Sleep Disorders	3 (.16%)
Upper Respiratory Tract Disorders	3 (.16%)
Abortions And Stillbirth	2 (.1%)
Administration Site Reactions	2 (.1%)
Aneurysms And Artery Dissections	2 (.1%)
Angiedema And Urticaria	2 (.1%)
Breast Neoplasms Malignant And Unsp...	2 (.1%)
Central Nervous System Infections A...	2 (.1%)
Coagulopathies And Bleeding Diathes...	2 (.1%)
Encephalopathies	2 (.1%)

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