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HUMULIN

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Humulin Adverse Events Reported to the FDA Over Time

How are Humulin adverse event reports trending over time?

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

Most Common Humulin Adverse Events Reported to the FDA

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

Blood Glucose Increased
2409 (6.7%)
Blood Glucose Decreased
1156 (3.21%)
Drug Ineffective
770 (2.14%)
Drug Exposure During Pregnancy
732 (2.04%)
Hypoglycaemia
501 (1.39%)
Loss Of Consciousness
434 (1.21%)
Cerebrovascular Accident
400 (1.11%)
Visual Acuity Reduced
400 (1.11%)
Myocardial Infarction
398 (1.11%)
Blood Glucose Fluctuation
363 (1.01%)
Fall
362 (1.01%)
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Feeling Abnormal
323 (.9%)
Malaise
317 (.88%)
Blindness
310 (.86%)
Diabetes Mellitus Inadequate Contro...
301 (.84%)
Hospitalisation
298 (.83%)
Dyspnoea
278 (.77%)
Cardiac Disorder
261 (.73%)
Cataract
231 (.64%)
Hyperglycaemia
226 (.63%)
Renal Failure
225 (.63%)
Incorrect Dose Administered
224 (.62%)
Dizziness
221 (.61%)
Weight Decreased
214 (.59%)
Asthenia
211 (.59%)
Hypertension
194 (.54%)
Vomiting
193 (.54%)
Cardiac Failure Congestive
190 (.53%)
Memory Impairment
187 (.52%)
Eye Haemorrhage
178 (.49%)
Tremor
178 (.49%)
Weight Increased
178 (.49%)
Death
175 (.49%)
Fatigue
170 (.47%)
Headache
170 (.47%)
Medication Error
169 (.47%)
Oedema Peripheral
163 (.45%)
Pain
163 (.45%)
Convulsion
161 (.45%)
Pneumonia
159 (.44%)
Premature Baby
159 (.44%)
Pain In Extremity
157 (.44%)
Hyperhidrosis
148 (.41%)
Vision Blurred
147 (.41%)
Blindness Unilateral
146 (.41%)
Nausea
144 (.4%)
Visual Impairment
139 (.39%)
Arthralgia
136 (.38%)
Glycosylated Haemoglobin Increased
136 (.38%)
Renal Disorder
130 (.36%)
Arthritis
128 (.36%)
Drug Dose Omission
127 (.35%)
Gait Disturbance
127 (.35%)
Chest Pain
124 (.34%)
Diabetic Retinopathy
116 (.32%)
Injection Site Pain
116 (.32%)
Abortion Spontaneous
115 (.32%)
Diarrhoea
114 (.32%)
Drug Hypersensitivity
114 (.32%)
Confusional State
113 (.31%)
Hypersensitivity
107 (.3%)
Road Traffic Accident
106 (.29%)
Diabetic Ketoacidosis
104 (.29%)
Wrong Drug Administered
102 (.28%)
Hypoaesthesia
99 (.28%)
Infection
99 (.28%)
Poor Quality Drug Administered
97 (.27%)
Depression
95 (.26%)
Neuropathy Peripheral
94 (.26%)
Coma
93 (.26%)
Drug Dispensing Error
93 (.26%)
Pruritus
93 (.26%)
Pyrexia
93 (.26%)
Syncope
93 (.26%)
Amnesia
92 (.26%)
Chronic Obstructive Pulmonary Disea...
90 (.25%)
Stress
88 (.24%)
Anxiety
84 (.23%)
Blood Pressure Increased
84 (.23%)
Hypoglycaemic Unconsciousness
84 (.23%)
Insomnia
84 (.23%)
Blood Glucose Abnormal
83 (.23%)
Glaucoma
81 (.23%)
Mobility Decreased
81 (.23%)
Treatment Noncompliance
81 (.23%)
Cardiac Failure
80 (.22%)
Depressed Level Of Consciousness
79 (.22%)
Hypoacusis
79 (.22%)
Eye Disorder
78 (.22%)
Blood Pressure Decreased
77 (.21%)
Dehydration
77 (.21%)
Expired Drug Administered
77 (.21%)
Limb Injury
77 (.21%)
Toe Amputation
77 (.21%)
Macular Degeneration
76 (.21%)
Dialysis
75 (.21%)
Hypoglycaemia Unawareness
75 (.21%)
Hip Fracture
73 (.2%)
Diabetic Neuropathy
72 (.2%)
Urinary Tract Infection
71 (.2%)
Localised Infection
70 (.19%)

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

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

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

Common Uses of Humulin According to Those Reporting Adverse Events

Why are people taking Humulin, according to those reporting adverse events to the FDA?

Diabetes Mellitus
6570
Type 2 Diabetes Mellitus
828
Type 1 Diabetes Mellitus
380
Diabetes Mellitus Insulin-dependent
375
Gestational Diabetes
300
Diabetes Mellitus Non-insulin-depen...
292
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Drug Use For Unknown Indication
227
Product Used For Unknown Indication
226
Hyperglycaemia
79
Blood Glucose Increased
65
Insulin-requiring Type Ii Diabetes ...
18
Blood Glucose Abnormal
14
Blood Glucose
14
Prophylaxis
13
Blood Glucose Fluctuation
10
Pancreatic Disorder
8
Diabetic Ketoacidosis
7
Hypoglycaemia
7
Diabetes Mellitus Inadequate Contro...
6
Blood Insulin
5
Insulin-requiring Type 2 Diabetes M...
4
Glucose Tolerance Impaired
3
Diabetic Hyperosmolar Coma
3
Post Herpetic Neuralgia
3
Hepatic Function Abnormal
2
Renal Failure Chronic
2
Off Label Use
2
Parenteral Nutrition
2
Cystic Fibrosis
2
Angiopathy
2
Diabetic Coma
2
Metabolic Disorder
2
Allergenic Desensitisation Procedur...
1
Jaundice
1
Depression
1
Asthenia
1
Dementia
1
Abortion Threatened
1
Chronic Myeloid Leukaemia
1
Ill-defined Disorder
1
Cardiac Arrest
1
Suicide Attempt
1
Insulin Resistance
1
Pancreatogenous Diabetes
1
Overweight
1
Hyperlipidaemia
1
Pancreatic Carcinoma Stage Iv
1
Surgery
1
Hyperkalaemia
1
Renal Failure Acute
1

Drug Labels

LabelLabelerEffective
Humulin R Physicians Total Care, Inc.08-NOV-10
Humulin NPhysicians Total Care, Inc.08-NOV-10
Humulin NEli Lilly and Company09-NOV-11
Humulin 70/30Eli Lilly and Company09-NOV-11
Humulin R Eli Lilly and Company12-FEB-13
Humulin R Eli Lilly and Company 09-MAR-13
Humulin 70/30Eli Lilly and Company09-MAR-13
Sterile DiluentEli Lilly and Company09-MAR-13
Humulin NEli Lilly and Company09-MAR-13

Humulin Case Reports

What Humulin safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Humulin. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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