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LISPRO

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Lispro Adverse Events Reported to the FDA Over Time

How are Lispro adverse event reports trending over time?

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

Most Common Lispro Adverse Events Reported to the FDA

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

Hypoglycaemia
53 (4.03%)
Blood Glucose Increased
31 (2.36%)
Diabetes Mellitus Inadequate Contro...
26 (1.98%)
Renal Failure Acute
24 (1.82%)
Diabetic Ketoacidosis
23 (1.75%)
Hyperglycaemia
19 (1.44%)
Abdominal Pain
18 (1.37%)
Blood Glucose Decreased
18 (1.37%)
Chest Pain
18 (1.37%)
Diabetic Complication
17 (1.29%)
Drug Exposure During Pregnancy
17 (1.29%)
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Fall
17 (1.29%)
Anaemia
16 (1.22%)
Dyspnoea
16 (1.22%)
Death
14 (1.06%)
Nausea
14 (1.06%)
Cerebrovascular Accident
13 (.99%)
Loss Of Consciousness
13 (.99%)
Pulmonary Oedema
13 (.99%)
Non-cardiac Chest Pain
12 (.91%)
Suicide Attempt
12 (.91%)
Atrial Fibrillation
11 (.84%)
Hyperhidrosis
11 (.84%)
Asthma
10 (.76%)
Drug Ineffective
10 (.76%)
Intentional Overdose
10 (.76%)
Suicidal Ideation
10 (.76%)
Dizziness
9 (.68%)
Drug Interaction
9 (.68%)
Incorrect Dose Administered
9 (.68%)
Pneumonia
9 (.68%)
Road Traffic Accident
9 (.68%)
Depression
8 (.61%)
Dyspnoea Exertional
8 (.61%)
Glycosylated Haemoglobin Increased
8 (.61%)
Medication Error
8 (.61%)
Wrong Drug Administered
8 (.61%)
Anaphylactic Reaction
7 (.53%)
Cardiac Failure
7 (.53%)
Cellulitis
7 (.53%)
Dehydration
7 (.53%)
Hypertension
7 (.53%)
Hypoglycaemic Unconsciousness
7 (.53%)
Pregnancy
7 (.53%)
Reflux Gastritis
7 (.53%)
Rhabdomyolysis
7 (.53%)
Syncope
7 (.53%)
Abortion Spontaneous
6 (.46%)
Cardio-respiratory Arrest
6 (.46%)
Coma
6 (.46%)
Diabetic Foot
6 (.46%)
Injection Site Pain
6 (.46%)
International Normalised Ratio Incr...
6 (.46%)
Malaise
6 (.46%)
Radius Fracture
6 (.46%)
Urticaria
6 (.46%)
Weight Increased
6 (.46%)
Asthenia
5 (.38%)
Brain Stem Infarction
5 (.38%)
Diarrhoea
5 (.38%)
Foetal Growth Retardation
5 (.38%)
Gangrene
5 (.38%)
Gastritis
5 (.38%)
Hypersensitivity
5 (.38%)
Intraventricular Haemorrhage
5 (.38%)
Ketoacidosis
5 (.38%)
Neonatal Respiratory Distress Syndr...
5 (.38%)
Pneumothorax
5 (.38%)
Pre-eclampsia
5 (.38%)
Pulmonary Hypoplasia
5 (.38%)
Respiratory Failure
5 (.38%)
Skin Ulcer
5 (.38%)
Small For Dates Baby
5 (.38%)
Vaginal Haemorrhage
5 (.38%)
Vomiting
5 (.38%)
Abdominal Distension
4 (.3%)
Abdominal Neoplasm
4 (.3%)
Ascites
4 (.3%)
Caesarean Section
4 (.3%)
Cardiac Disorder
4 (.3%)
Cardiac Failure Congestive
4 (.3%)
Cardiomegaly
4 (.3%)
Cerebrovascular Disorder
4 (.3%)
Coma Hepatic
4 (.3%)
Condition Aggravated
4 (.3%)
Coronary Artery Disease
4 (.3%)
Drug Dispensing Error
4 (.3%)
Epistaxis
4 (.3%)
Femoral Arterial Stenosis
4 (.3%)
Gastric Cancer
4 (.3%)
Gastrointestinal Haemorrhage
4 (.3%)
Hepatitis C
4 (.3%)
Hypothermia
4 (.3%)
Hypothyroidism
4 (.3%)
Injection Site Abscess
4 (.3%)
Injection Site Erythema
4 (.3%)
Lichen Planus
4 (.3%)
Limb Injury
4 (.3%)
Oedema
4 (.3%)
Oedema Peripheral
4 (.3%)
Oligohydramnios
4 (.3%)

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

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

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This graph shows the top categories of adverse events submitted to the FDA for Lispro, 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 Lispro 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 Lispro According to Those Reporting Adverse Events

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

Diabetes Mellitus
223
Type 2 Diabetes Mellitus
134
Type 1 Diabetes Mellitus
80
Drug Use For Unknown Indication
64
Diabetes Mellitus Non-insulin-depen...
41
Product Used For Unknown Indication
33
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Diabetes Mellitus Insulin-dependent
20
Drug Exposure During Pregnancy
3
Suicide Attempt
3
Blood Glucose Abnormal
3
Diabetes Mellitus Inadequate Contro...
3
Gestational Diabetes
2
Hyperglycaemia
2
Insulin-requiring Type 2 Diabetes M...
2
Dementia
1
Blood Glucose Decreased
1
Blood Glucose Increased
1
Insulin-requiring Type Ii Diabetes ...
1
Cystitis
1

Drug Labels

LabelLabelerEffective
Humalogmix75/25Physicians Total Care, Inc.20-DEC-11
HumalogcartridgePhysicians Total Care, Inc.22-MAY-12
HumalogpenPhysicians Total Care, Inc.22-MAY-12
HumalogPhysicians Total Care, Inc.22-MAY-12
HumalogDispensing Solutions, Inc.27-SEP-12
HumalogEli Lilly and Company11-MAR-13
HumalogpenEli Lilly and Company11-MAR-13
HumalogkwikpenEli Lilly and Company11-MAR-13
Humalog Mix50/50 Pen Eli Lilly and Company11-MAR-13
Humalog Mix50/50 Kwikpen Eli Lilly and Company11-MAR-13
Humalog Mix50/50 Eli Lilly and Company11-MAR-13
Humalog Mix75/25 Kwikpen Eli Lilly and Company 11-MAR-13
Humalog Mix75/25 Eli Lilly and Company 11-MAR-13
Humalog Mix75/25 Pen Eli Lilly and Company 11-MAR-13

Lispro Case Reports

What Lispro 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 Lispro. 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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