METFORMIN

Metformin Adverse Events Reported to the FDA Over Time

How are Metformin adverse event reports trending over time?

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

Most Common Metformin Adverse Events Reported to the FDA

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

Lactic Acidosis	3596 (3.43%)
Myocardial Infarction	3087 (2.95%)
Renal Failure Acute	3046 (2.91%)
Diarrhoea	2331 (2.23%)
Blood Glucose Increased	1873 (1.79%)
Cardiac Failure Congestive	1794 (1.71%)
Vomiting	1550 (1.48%)
Nausea	1515 (1.45%)
Hypoglycaemia	1460 (1.39%)
Cerebrovascular Accident	1108 (1.06%)
Coronary Artery Disease	1047 (1%)
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Dyspnoea	1027 (.98%)
Renal Failure	966 (.92%)
Drug Ineffective	909 (.87%)
Hypotension	881 (.84%)
Metabolic Acidosis	845 (.81%)
Haemodialysis	770 (.74%)
Dehydration	767 (.73%)
Cardiac Disorder	752 (.72%)
Malaise	738 (.7%)
Completed Suicide	730 (.7%)
Dizziness	729 (.7%)
Hyperkalaemia	727 (.69%)
Death	723 (.69%)
Fatigue	708 (.68%)
Asthenia	700 (.67%)
Weight Increased	698 (.67%)
Weight Decreased	662 (.63%)
Cardiac Arrest	634 (.61%)
Abdominal Pain	632 (.6%)
Chest Pain	621 (.59%)
Drug Interaction	604 (.58%)
Overdose	560 (.53%)
Oedema Peripheral	540 (.52%)
Hypertension	508 (.49%)
Blood Creatinine Increased	492 (.47%)
Blood Glucose Decreased	484 (.46%)
Cardiovascular Disorder	483 (.46%)
Headache	464 (.44%)
Pancreatitis	449 (.43%)
Diabetes Mellitus Inadequate Contro...	447 (.43%)
Abdominal Pain Upper	443 (.42%)
Myocardial Ischaemia	441 (.42%)
Pain	428 (.41%)
Renal Impairment	427 (.41%)
Somnolence	423 (.4%)
Fall	412 (.39%)
Confusional State	407 (.39%)
Atrial Fibrillation	388 (.37%)
Pancreatitis Acute	386 (.37%)
Anaemia	350 (.33%)
Loss Of Consciousness	349 (.33%)
Cardiac Failure	340 (.32%)
Decreased Appetite	331 (.32%)
Pneumonia	321 (.31%)
Abdominal Discomfort	313 (.3%)
Suicide Attempt	306 (.29%)
Myalgia	295 (.28%)
Glycosylated Haemoglobin Increased	294 (.28%)
Intentional Overdose	275 (.26%)
Rash	275 (.26%)
Drug Exposure During Pregnancy	272 (.26%)
Pain In Extremity	271 (.26%)
Shock	271 (.26%)
Pruritus	270 (.26%)
Pyrexia	261 (.25%)
Acute Myocardial Infarction	256 (.24%)
General Physical Health Deteriorati...	255 (.24%)
Hypothermia	255 (.24%)
Oedema	251 (.24%)
Coma	249 (.24%)
Muscle Spasms	248 (.24%)
Alanine Aminotransferase Increased	246 (.23%)
Condition Aggravated	242 (.23%)
Constipation	240 (.23%)
Depression	237 (.23%)
Respiratory Failure	233 (.22%)
Back Pain	231 (.22%)
Agitation	230 (.22%)
Drug Toxicity	228 (.22%)
Diabetes Mellitus	227 (.22%)
Hyperglycaemia	227 (.22%)
Blood Glucose Fluctuation	226 (.22%)
Bradycardia	224 (.21%)
Sepsis	224 (.21%)
Abdominal Distension	221 (.21%)
Multi-organ Failure	221 (.21%)
Hyperhidrosis	220 (.21%)
Tremor	215 (.21%)
Vision Blurred	214 (.2%)
Cardio-respiratory Arrest	213 (.2%)
Blood Pressure Increased	211 (.2%)
Heart Rate Increased	209 (.2%)
Heart Injury	207 (.2%)
Transient Ischaemic Attack	205 (.2%)
Aspartate Aminotransferase Increase...	200 (.19%)
Gastrointestinal Disorder	198 (.19%)
Rhabdomyolysis	197 (.19%)
Medication Error	194 (.19%)
Depressed Level Of Consciousness	193 (.18%)
Syncope	193 (.18%)

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

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

Coronary Artery	5557 (5.31%)
Gastrointestinal Signs	5457 (5.21%)
Renal Disorders	5118 (4.89%)
Acid-base	4719 (4.51%)
Neurological	3719 (3.55%)
Metabolic, Nutritional And Blood Ga...	3507 (3.35%)
Gastrointestinal Motility And Defec...	2752 (2.63%)
Respiratory	2694 (2.57%)
Cardiac Arrhythmias	2567 (2.45%)
Glucose Metabolism Disorders	2529 (2.42%)
Heart Failures	2303 (2.2%)
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Electrolyte And Fluid Balance Condi...	2135 (2.04%)
Therapeutic And Nontherapeutic Effe...	2100 (2.01%)
Medication Errors	1934 (1.85%)
Hepatic And Hepatobiliary	1880 (1.8%)
Epidermal And Dermal Conditions	1858 (1.77%)
Infections - Pathogen Unspecified	1816 (1.73%)
Central Nervous System Vascular	1778 (1.7%)
Physical Examination Topics	1717 (1.64%)
Cardiac Disorder Signs	1537 (1.47%)
Decreased And Nonspecific Blood Pre...	1453 (1.39%)
Cardiac And Vascular Investigations	1249 (1.19%)
Injuries	1148 (1.1%)
Hematological And Lymphoid Tissue T...	1147 (1.1%)
Suicidal And Self-injurious Behavio...	1118 (1.07%)
Muscle	1071 (1.02%)
Hepatobiliary	1004 (.96%)
Hematology Investigations	1001 (.96%)
Renal And Urinary Tract Investigati...	985 (.94%)
Exocrine Pancreas Conditions	927 (.89%)
Fatal Outcomes	901 (.86%)
Chemical Injury And Poisoning	836 (.8%)
Appetite And General Nutritional	757 (.72%)
Musculoskeletal And Connective Tiss...	741 (.71%)
Myocardial	699 (.67%)
Vision	634 (.61%)
Anemias Nonhemolytic And Marrow Dep...	602 (.57%)
Deliria	590 (.56%)
Water, Electrolyte And Mineral	587 (.56%)
Urinary Tract Signs	586 (.56%)
Lower Respiratory Tract Disorders	577 (.55%)
Vascular Hypertensive	554 (.53%)
Anxiety Disorders	546 (.52%)
Body Temperature Conditions	539 (.51%)
Headaches	510 (.49%)
Skin Appendage Conditions	506 (.48%)
Movement Disorders	490 (.47%)
Arteriosclerosis, Stenosis, Vascula...	481 (.46%)
Product Quality Issues	442 (.42%)
Joint	389 (.37%)
Vascular	371 (.35%)
Bone And Joint Injuries	365 (.35%)
Bacterial Infectious	359 (.34%)
Lifestyle Issues	356 (.34%)
Gastrointestinal Hemorrhages	339 (.32%)
Therapeutic Procedures And Supporti...	336 (.32%)
Psychiatric	331 (.32%)
Mental Impairment	328 (.31%)
Enzyme	324 (.31%)
White Blood Cell	312 (.3%)
Gastrointestinal Conditions	309 (.3%)
Depressed Mood Disorders	305 (.29%)
Allergic Conditions	303 (.29%)
Sleep Disorders	303 (.29%)
Vascular Therapeutic Procedures	285 (.27%)
Seizures	274 (.26%)
Angiedema And Urticaria	273 (.26%)
Lipid Analyses	269 (.26%)
Cardiac Valve	259 (.25%)
Gastrointestinal Inflammatory Condi...	258 (.25%)
Gastrointestinal Ulceration And Per...	236 (.23%)
Platelet	236 (.23%)
Pulmonary Vascular	235 (.22%)
Toxicology And Therapeutic Drug Mon...	229 (.22%)
Nephropathies	225 (.21%)
Abortions And Stillbirth	213 (.2%)
Gastrointestinal Neoplasms Malignan...	209 (.2%)
Renal And Urinary Tract Neoplasms M...	201 (.19%)
Disturbances In Thinking	199 (.19%)
Ocular Infections, Irritations And ...	198 (.19%)
Skin Vascular Abnormalities	194 (.19%)
Bronchial Disorders	193 (.18%)
Pregnancy, Labour, Delivery And Pos...	185 (.18%)
Gallbladder	184 (.18%)
Gastrointestinal	171 (.16%)
Procedural And Device Related Injur...	170 (.16%)
Oral Soft Tissue Conditions	166 (.16%)
Peripheral Neuropathies	164 (.16%)
Viral Infectious	163 (.16%)
Lipid Metabolism	161 (.15%)
Mood Disorders	154 (.15%)
Embolism And Thrombosis	153 (.15%)
Cardiac Therapeutic Procedures	150 (.14%)
Eye	147 (.14%)
Encephalopathies	144 (.14%)
Pleural	142 (.14%)
Musculoskeletal And Connective Tiss...	140 (.13%)
Vitamin Related	138 (.13%)
Bone Disorders	124 (.12%)
Upper Respiratory Tract Disorders	120 (.11%)
Ocular Neuromuscular	117 (.11%)

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