INSULIN

Insulin Adverse Events Reported to the FDA Over Time

How are Insulin adverse event reports trending over time?

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

Most Common Insulin Adverse Events Reported to the FDA

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

Hypoglycaemia	1306 (5.26%)
Blood Glucose Increased	967 (3.9%)
Blood Glucose Decreased	524 (2.11%)
Hyperglycaemia	465 (1.87%)
Loss Of Consciousness	258 (1.04%)
Drug Exposure During Pregnancy	237 (.95%)
Fall	228 (.92%)
Dizziness	221 (.89%)
Diabetes Mellitus Inadequate Contro...	203 (.82%)
Diabetic Ketoacidosis	199 (.8%)
Device Malfunction	197 (.79%)
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Nausea	191 (.77%)
Hyperhidrosis	189 (.76%)
Vomiting	188 (.76%)
Dyspnoea	184 (.74%)
Renal Failure Acute	184 (.74%)
Convulsion	183 (.74%)
Myocardial Infarction	180 (.73%)
Drug Ineffective	169 (.68%)
Dehydration	165 (.66%)
Malaise	164 (.66%)
Death	158 (.64%)
Drug Interaction	157 (.63%)
Blood Glucose Fluctuation	154 (.62%)
Confusional State	153 (.62%)
Asthenia	151 (.61%)
Pneumonia	150 (.6%)
Cerebrovascular Accident	149 (.6%)
Weight Increased	142 (.57%)
Medication Error	141 (.57%)
Overdose	134 (.54%)
Glycosylated Haemoglobin Increased	126 (.51%)
Syncope	125 (.5%)
Condition Aggravated	123 (.5%)
Cataract	122 (.49%)
Renal Failure	122 (.49%)
Cardiac Arrest	117 (.47%)
Weight Decreased	116 (.47%)
Incorrect Dose Administered	113 (.46%)
Completed Suicide	111 (.45%)
Ketoacidosis	111 (.45%)
Diarrhoea	109 (.44%)
Hypotension	109 (.44%)
Hypertension	104 (.42%)
Device Failure	103 (.42%)
Somnolence	103 (.42%)
Coma	101 (.41%)
Oedema Peripheral	101 (.41%)
Fatigue	100 (.4%)
No Adverse Event	99 (.4%)
Tremor	99 (.4%)
Depressed Level Of Consciousness	91 (.37%)
Feeling Abnormal	90 (.36%)
Hypoglycaemic Coma	89 (.36%)
Chest Pain	87 (.35%)
Blindness	85 (.34%)
Pyrexia	84 (.34%)
Blood Pressure Increased	83 (.33%)
Pain In Extremity	79 (.32%)
Headache	78 (.31%)
Mental Status Changes	78 (.31%)
Product Quality Issue	78 (.31%)
Treatment Noncompliance	78 (.31%)
Wrong Drug Administered	78 (.31%)
Caesarean Section	77 (.31%)
Cardiogenic Shock	75 (.3%)
Diabetes Mellitus	74 (.3%)
Vision Blurred	74 (.3%)
Hypoglycaemic Unconsciousness	73 (.29%)
Visual Impairment	73 (.29%)
Pain	72 (.29%)
Cardiac Failure Congestive	70 (.28%)
Urinary Tract Infection	70 (.28%)
Diabetic Retinopathy	69 (.28%)
Hypoglycaemia Neonatal	66 (.27%)
Injection Site Pain	66 (.27%)
Anaemia	65 (.26%)
Atrial Fibrillation	65 (.26%)
Visual Acuity Reduced	65 (.26%)
Hypokalaemia	63 (.25%)
Suicide Attempt	62 (.25%)
Aspartate Aminotransferase Increase...	61 (.25%)
Road Traffic Accident	61 (.25%)
Abdominal Pain	60 (.24%)
Alanine Aminotransferase Increased	60 (.24%)
Anorexia	60 (.24%)
Hospitalisation	60 (.24%)
Hepatic Function Abnormal	58 (.23%)
Medical Device Complication	58 (.23%)
Pruritus	57 (.23%)
Cardiac Disorder	56 (.23%)
Cellulitis	56 (.23%)
Pulmonary Oedema	56 (.23%)
Cardiac Failure	55 (.22%)
Depression	53 (.21%)
Erythema	53 (.21%)
Intentional Overdose	53 (.21%)
Decreased Appetite	52 (.21%)
Intra-uterine Death	51 (.21%)
Premature Baby	51 (.21%)
Angina Pectoris	50 (.2%)

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

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

Glucose Metabolism Disorders	2341 (9.43%)
Metabolic, Nutritional And Blood Ga...	1873 (7.55%)
Neurological	1415 (5.7%)
Medication Errors	817 (3.29%)
Infections - Pathogen Unspecified	632 (2.55%)
Gastrointestinal Signs	566 (2.28%)
Epidermal And Dermal Conditions	475 (1.91%)
Procedural And Device Related Injur...	471 (1.9%)
Renal Disorders	442 (1.78%)
Respiratory	440 (1.77%)
Cardiac Arrhythmias	439 (1.77%)
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Injuries	429 (1.73%)
Therapeutic And Nontherapeutic Effe...	403 (1.62%)
Vision	354 (1.43%)
Coronary Artery	346 (1.39%)
Electrolyte And Fluid Balance Condi...	345 (1.39%)
Physical Examination Topics	334 (1.35%)
Chemical Injury And Poisoning	328 (1.32%)
Administration Site Reactions	311 (1.25%)
Central Nervous System Vascular	281 (1.13%)
Hepatic And Hepatobiliary	281 (1.13%)
Cardiac And Vascular Investigations	262 (1.06%)
Diabetic Complications	249 (1%)
Skin Appendage Conditions	246 (.99%)
Seizures	241 (.97%)
Heart Failures	215 (.87%)
Hepatobiliary	197 (.79%)
Suicidal And Self-injurious Behavio...	197 (.79%)
Appetite And General Nutritional	195 (.79%)
Fatal Outcomes	195 (.79%)
Deliria	194 (.78%)
Muscle	192 (.77%)
Gastrointestinal Motility And Defec...	187 (.75%)
Acid-base	183 (.74%)
Bacterial Infectious	183 (.74%)
Bone And Joint Injuries	182 (.73%)
Musculoskeletal And Connective Tiss...	175 (.71%)
Retina, Choroid And Vitreous Hemorr...	171 (.69%)
Movement Disorders	164 (.66%)
Decreased And Nonspecific Blood Pre...	144 (.58%)
Hematology Investigations	142 (.57%)
Renal And Urinary Tract Investigati...	134 (.54%)
Lifestyle Issues	132 (.53%)
Anterior Eye Structural Change, Dep...	129 (.52%)
Anxiety Disorders	127 (.51%)
Urinary Tract Signs	117 (.47%)
Psychiatric	116 (.47%)
Therapeutic Procedures And Supporti...	116 (.47%)
Allergic Conditions	112 (.45%)
Lower Respiratory Tract Disorders	111 (.45%)
Vascular Hypertensive	108 (.44%)
Cardiac Disorder Signs	103 (.42%)
Abortions And Stillbirth	100 (.4%)
Neonatal And Perinatal Conditions	100 (.4%)
Body Temperature Conditions	99 (.4%)
Mental Impairment	99 (.4%)
Viral Infectious	99 (.4%)
Joint	94 (.38%)
Product Quality Issues	93 (.37%)
Water, Electrolyte And Mineral	93 (.37%)
Obstetric And Gynecological Therape...	91 (.37%)
Anemias Nonhemolytic And Marrow Dep...	87 (.35%)
Exocrine Pancreas Conditions	86 (.35%)
Gastrointestinal Neoplasms Malignan...	85 (.34%)
Headaches	83 (.33%)
Peripheral Neuropathies	83 (.33%)
Ocular Structural Change, Deposit A...	79 (.32%)
Myocardial	74 (.3%)
Depressed Mood Disorders	72 (.29%)
Enzyme	71 (.29%)
Arteriosclerosis, Stenosis, Vascula...	69 (.28%)
Lipid Analyses	67 (.27%)
Bone And Joint Therapeutic Procedur...	66 (.27%)
Vascular	66 (.27%)
Bronchial Disorders	64 (.26%)
Cardiac Valve	61 (.25%)
Fetal Complications	60 (.24%)
Eye	54 (.22%)
Placental, Amniotic And Cavity Diso...	54 (.22%)
Skin And Subcutaneous Tissue	51 (.21%)
Gastrointestinal Inflammatory Condi...	50 (.2%)
Gastrointestinal Conditions	47 (.19%)
Sleep Disorders	47 (.19%)
Pleural	46 (.19%)
Gastrointestinal Hemorrhages	45 (.18%)
Vascular Hemorrhagic	45 (.18%)
Ocular Hemorrhages And Vascular	44 (.18%)
Pregnancy, Labour, Delivery And Pos...	44 (.18%)
Fungal Infectious	41 (.17%)
Respiratory And Mediastinal Neoplas...	41 (.17%)
Eye Therapeutic Procedures	40 (.16%)
Maternal Complications Of Labour An...	40 (.16%)
Oral Soft Tissue Conditions	40 (.16%)
Tissue	40 (.16%)
White Blood Cell	40 (.16%)
Endocrine Investigations	39 (.16%)
Platelet	39 (.16%)
Hematological And Lymphoid Tissue T...	36 (.15%)
Immunology And Allergy	36 (.15%)
Disturbances In Thinking	35 (.14%)
Miscellaneous And Site Unspecified ...	35 (.14%)

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