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INSULIN GLARGINE

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Insulin Glargine Adverse Events Reported to the FDA Over Time

How are Insulin Glargine adverse event reports trending over time?

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

Most Common Insulin Glargine Adverse Events Reported to the FDA

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

Hypoglycaemia
148 (5.58%)
Blood Glucose Increased
75 (2.83%)
Hyperglycaemia
69 (2.6%)
Drug Exposure During Pregnancy
51 (1.92%)
Renal Failure Acute
50 (1.89%)
Blood Glucose Decreased
47 (1.77%)
Death
40 (1.51%)
Dizziness
38 (1.43%)
Hyperhidrosis
36 (1.36%)
Myocardial Infarction
36 (1.36%)
Diabetic Ketoacidosis
35 (1.32%)
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Dyspnoea
30 (1.13%)
Nausea
29 (1.09%)
Diabetes Mellitus Inadequate Contro...
26 (.98%)
Dehydration
25 (.94%)
Malaise
25 (.94%)
Renal Failure
21 (.79%)
Vomiting
21 (.79%)
Asthenia
19 (.72%)
Chest Pain
19 (.72%)
Drug Ineffective
18 (.68%)
Tremor
18 (.68%)
Fatigue
17 (.64%)
Fall
16 (.6%)
Gastrointestinal Disorder
15 (.57%)
Weight Increased
15 (.57%)
Abortion Spontaneous
14 (.53%)
Drug Interaction
14 (.53%)
Pulmonary Oedema
14 (.53%)
Suicide Attempt
14 (.53%)
Blood Glucose Fluctuation
13 (.49%)
Coma
13 (.49%)
Diabetic Complication
13 (.49%)
Ketoacidosis
13 (.49%)
Overdose
13 (.49%)
Abdominal Pain
12 (.45%)
Intentional Overdose
12 (.45%)
Loss Of Consciousness
12 (.45%)
Pancreatic Carcinoma
12 (.45%)
Pneumonia
12 (.45%)
Pruritus
12 (.45%)
Pyrexia
12 (.45%)
Syncope
12 (.45%)
Body Mass Index Decreased
11 (.41%)
Diarrhoea
11 (.41%)
Hypertension
11 (.41%)
Mental Status Changes
11 (.41%)
Somnolence
11 (.41%)
Urinary Tract Infection
11 (.41%)
Vision Blurred
11 (.41%)
Weight Decreased
11 (.41%)
Cerebrovascular Accident
10 (.38%)
Gait Disturbance
10 (.38%)
Gastroenteritis
10 (.38%)
Pain
10 (.38%)
Skin Ulcer
10 (.38%)
Arthralgia
9 (.34%)
Blood Creatinine Increased
9 (.34%)
Cardiac Failure
9 (.34%)
Confusional State
9 (.34%)
Convulsion
9 (.34%)
Diabetes Mellitus
9 (.34%)
Foetal Distress Syndrome
9 (.34%)
Hypotension
9 (.34%)
Lethargy
9 (.34%)
Rash
9 (.34%)
Road Traffic Accident
9 (.34%)
Anaemia
8 (.3%)
Back Pain
8 (.3%)
Hepatic Neoplasm Malignant
8 (.3%)
Oedema Peripheral
8 (.3%)
Pain In Extremity
8 (.3%)
Swelling
8 (.3%)
Vaginal Haemorrhage
8 (.3%)
Acute Myocardial Infarction
7 (.26%)
Blindness
7 (.26%)
Blood Pressure Increased
7 (.26%)
Blood Urea Increased
7 (.26%)
Caesarean Section
7 (.26%)
Cardiac Failure Congestive
7 (.26%)
Cellulitis
7 (.26%)
Cerebral Thrombosis
7 (.26%)
Condition Aggravated
7 (.26%)
Depressed Level Of Consciousness
7 (.26%)
Feeling Abnormal
7 (.26%)
Glycosylated Haemoglobin Increased
7 (.26%)
Headache
7 (.26%)
Hypoglycaemic Coma
7 (.26%)
International Normalised Ratio Incr...
7 (.26%)
Treatment Noncompliance
7 (.26%)
Abortion Induced
6 (.23%)
Atrial Fibrillation
6 (.23%)
Breast Cancer
6 (.23%)
Decreased Appetite
6 (.23%)
Depression
6 (.23%)
Diabetic Foetopathy
6 (.23%)
Dyspepsia
6 (.23%)
Grand Mal Convulsion
6 (.23%)
Haematuria
6 (.23%)
Hospitalisation
6 (.23%)
Incoherent
6 (.23%)

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

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

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

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

Diabetes Mellitus
508
Type 2 Diabetes Mellitus
300
Type 1 Diabetes Mellitus
126
Drug Use For Unknown Indication
119
Product Used For Unknown Indication
74
Diabetes Mellitus Insulin-dependent
40
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Diabetes Mellitus Non-insulin-depen...
22
Insulin-requiring Type 2 Diabetes M...
13
Diabetic Relative
6
Insulin-requiring Type Ii Diabetes ...
3
Suicide Attempt
3
Blood Glucose Abnormal
3
Ill-defined Disorder
3
Metabolic Disorder
2
Blood Glucose Increased
2
Hyperglycaemia
1
Maternal Exposure During Pregnancy
1
Diabetic Ketoacidosis
1
Diabetes Mellitus Inadequate Contro...
1

Drug Labels

LabelLabelerEffective
LantusPhysicians Total Care, Inc.05-JAN-10
Lantussanofi-aventis U.S. LLC05-AUG-10
LantusDispensing Solutions, Inc.20-SEP-11

Insulin Glargine Case Reports

What Insulin Glargine 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 Insulin Glargine. 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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