GLIMEPIRIDE

Glimepiride Adverse Events Reported to the FDA Over Time

How are Glimepiride adverse event reports trending over time?

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

Most Common Glimepiride Adverse Events Reported to the FDA

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

Hypoglycaemia	171 (4.42%)
Blood Glucose Increased	99 (2.56%)
Renal Failure Acute	66 (1.71%)
Blood Glucose Decreased	50 (1.29%)
Nausea	47 (1.21%)
Dizziness	44 (1.14%)
Loss Of Consciousness	38 (.98%)
Drug Interaction	37 (.96%)
Dyspnoea	34 (.88%)
Lactic Acidosis	34 (.88%)
Vomiting	34 (.88%)
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Abdominal Pain	33 (.85%)
Diarrhoea	33 (.85%)
Malaise	33 (.85%)
Chest Pain	32 (.83%)
Fatigue	29 (.75%)
Hypotension	29 (.75%)
Drug Ineffective	28 (.72%)
Completed Suicide	26 (.67%)
Hypoglycaemic Coma	26 (.67%)
Tachycardia	26 (.67%)
Weight Decreased	26 (.67%)
Overdose	25 (.65%)
Renal Failure	24 (.62%)
Fall	23 (.59%)
Diabetes Mellitus Inadequate Contro...	22 (.57%)
Haemoglobin Decreased	22 (.57%)
Headache	22 (.57%)
Weight Increased	22 (.57%)
Hyperkalaemia	21 (.54%)
Pancreatitis Acute	21 (.54%)
Abdominal Pain Upper	20 (.52%)
Ventricular Fibrillation	20 (.52%)
Asthenia	19 (.49%)
Oedema Peripheral	19 (.49%)
Pruritus	19 (.49%)
Coma	18 (.47%)
Confusional State	18 (.47%)
Somnolence	18 (.47%)
Hypertension	17 (.44%)
Pain In Extremity	17 (.44%)
Pneumonia	17 (.44%)
Anaemia	15 (.39%)
Atrial Fibrillation	15 (.39%)
Hyperglycaemia	15 (.39%)
Pancreatitis	15 (.39%)
Pyrexia	15 (.39%)
Amnesia	14 (.36%)
Circulatory Collapse	14 (.36%)
Depressed Level Of Consciousness	14 (.36%)
Glycosylated Haemoglobin Increased	14 (.36%)
Hyperventilation	14 (.36%)
Musculoskeletal Pain	14 (.36%)
Rash	14 (.36%)
Acute Myocardial Infarction	13 (.34%)
Alanine Aminotransferase Increased	13 (.34%)
Decreased Appetite	13 (.34%)
Hepatic Enzyme Increased	13 (.34%)
Muscle Spasms	13 (.34%)
Road Traffic Accident	13 (.34%)
Suicide Attempt	13 (.34%)
Angina Pectoris	12 (.31%)
Blood Creatinine Increased	12 (.31%)
Bradycardia	12 (.31%)
Cardiac Arrest	12 (.31%)
Cerebrovascular Accident	12 (.31%)
Dehydration	12 (.31%)
Gastroenteritis	12 (.31%)
Intentional Overdose	12 (.31%)
Multi-organ Failure	12 (.31%)
Sciatica	12 (.31%)
Sepsis	12 (.31%)
Vision Blurred	12 (.31%)
Arrhythmia	11 (.28%)
Bladder Cancer	11 (.28%)
Blood Pressure Increased	11 (.28%)
Death	11 (.28%)
Hyperhidrosis	11 (.28%)
Hypoglycaemic Encephalopathy	11 (.28%)
Hyponatraemia	11 (.28%)
Rectal Haemorrhage	11 (.28%)
Respiratory Failure	11 (.28%)
Blood Potassium Increased	10 (.26%)
Chest Discomfort	10 (.26%)
Circumstance Or Information Capable...	10 (.26%)
Cold Sweat	10 (.26%)
Cough	10 (.26%)
Disorientation	10 (.26%)
Hepatic Steatosis	10 (.26%)
Hypoglycaemic Unconsciousness	10 (.26%)
Medication Error	10 (.26%)
Muscular Weakness	10 (.26%)
Renal Impairment	10 (.26%)
Speech Disorder	10 (.26%)
Aspartate Aminotransferase Increase...	9 (.23%)
Back Pain	9 (.23%)
Blood Glucose Fluctuation	9 (.23%)
Cardiac Failure	9 (.23%)
Cardiac Failure Congestive	9 (.23%)
Cholestasis	9 (.23%)
Convulsion	9 (.23%)

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

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

Glucose Metabolism Disorders	236 (6.1%)
Neurological	232 (5.99%)
Metabolic, Nutritional And Blood Ga...	187 (4.83%)
Gastrointestinal Signs	160 (4.13%)
Cardiac Arrhythmias	120 (3.1%)
Respiratory	120 (3.1%)
Renal Disorders	114 (2.95%)
Medication Errors	113 (2.92%)
Epidermal And Dermal Conditions	104 (2.69%)
Infections - Pathogen Unspecified	90 (2.33%)
Injuries	90 (2.33%)
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Therapeutic And Nontherapeutic Effe...	84 (2.17%)
Hepatic And Hepatobiliary	73 (1.89%)
Coronary Artery	57 (1.47%)
Electrolyte And Fluid Balance Condi...	56 (1.45%)
Hematology Investigations	56 (1.45%)
Physical Examination Topics	56 (1.45%)
Decreased And Nonspecific Blood Pre...	52 (1.34%)
Hepatobiliary	51 (1.32%)
Acid-base	49 (1.27%)
Exocrine Pancreas Conditions	49 (1.27%)
Musculoskeletal And Connective Tiss...	47 (1.21%)
Gastrointestinal Motility And Defec...	44 (1.14%)
Cardiac And Vascular Investigations	43 (1.11%)
Central Nervous System Vascular	43 (1.11%)
Suicidal And Self-injurious Behavio...	40 (1.03%)
Muscle	37 (.96%)
Gastrointestinal Hemorrhages	35 (.9%)
Movement Disorders	35 (.9%)
Deliria	31 (.8%)
Renal And Urinary Tract Investigati...	28 (.72%)
Skin Appendage Conditions	26 (.67%)
Appetite And General Nutritional	25 (.65%)
Body Temperature Conditions	25 (.65%)
Bone And Joint Injuries	25 (.65%)
Vision	25 (.65%)
White Blood Cell	25 (.65%)
Anemias Nonhemolytic And Marrow Dep...	24 (.62%)
Water, Electrolyte And Mineral	24 (.62%)
Mental Impairment	23 (.59%)
Headaches	22 (.57%)
Heart Failures	22 (.57%)
Lower Respiratory Tract Disorders	22 (.57%)
Vascular Hypertensive	22 (.57%)
Renal And Urinary Tract Neoplasms M...	21 (.54%)
Bacterial Infectious	20 (.52%)
Encephalopathies	19 (.49%)
Product Quality Issues	17 (.44%)
Fatal Outcomes	16 (.41%)
Lifestyle Issues	16 (.41%)
Myocardial	16 (.41%)
Pleural	16 (.41%)
Seizures	16 (.41%)
Gastrointestinal Neoplasms Malignan...	15 (.39%)
Immunology And Allergy	14 (.36%)
Psychiatric	14 (.36%)
Respiratory And Mediastinal Neoplas...	14 (.36%)
Sleep Disorders	14 (.36%)
Urinary Tract Signs	13 (.34%)
Anxiety Disorders	12 (.31%)
Spinal Cord And Nerve Root	12 (.31%)
Allergic Conditions	11 (.28%)
Cardiac Disorder Signs	11 (.28%)
Enzyme	11 (.28%)
Hematological And Lymphoid Tissue T...	11 (.28%)
Lipid Analyses	11 (.28%)
Arteriosclerosis, Stenosis, Vascula...	10 (.26%)
Bronchial Disorders	10 (.26%)
Chemical Injury And Poisoning	10 (.26%)
Depressed Mood Disorders	10 (.26%)
Gastrointestinal Ulceration And Per...	10 (.26%)
Joint	10 (.26%)
Metastases	10 (.26%)
Nephropathies	10 (.26%)
Bone Disorders	9 (.23%)
Gallbladder	9 (.23%)
Mood Disorders	9 (.23%)
Oral Soft Tissue Conditions	9 (.23%)
Platelet	9 (.23%)
Viral Infectious	9 (.23%)
Vulvovaginal Disorders	9 (.23%)
Angiedema And Urticaria	8 (.21%)
Cornification And Dystrophic Skin	8 (.21%)
Reproductive Neoplasms Male Maligna...	8 (.21%)
Skin Vascular Abnormalities	8 (.21%)
Vascular	8 (.21%)
Bile Duct	7 (.18%)
Gastrointestinal Inflammatory Condi...	7 (.18%)
Salivary Gland Conditions	7 (.18%)
Therapeutic Procedures And Supporti...	7 (.18%)
Upper Respiratory Tract Disorders	7 (.18%)
Abortions And Stillbirth	6 (.16%)
Aneurysms And Artery Dissections	6 (.16%)
Coagulopathies And Bleeding Diathes...	6 (.16%)
Gastrointestinal	6 (.16%)
Inner Ear And Viiith Cranial Nerve	6 (.16%)
Ocular Infections, Irritations And ...	6 (.16%)
Tissue	6 (.16%)
Administration Site Reactions	5 (.13%)
Anterior Eye Structural Change, Dep...	5 (.13%)
Breast Neoplasms Malignant And Unsp...	5 (.13%)

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