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Lantus Adverse Events Reported to the FDA Over Time

How are Lantus adverse event reports trending over time?

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

Most Common Lantus Adverse Events Reported to the FDA

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

Device Malfunction
3834 (6.74%)
Blood Glucose Increased
3392 (5.96%)
Hypoglycaemia
2057 (3.61%)
Hyperglycaemia
1746 (3.07%)
Product Quality Issue
1618 (2.84%)
Blood Glucose Decreased
1098 (1.93%)
Fall
673 (1.18%)
Drug Ineffective
652 (1.15%)
Cerebrovascular Accident
525 (.92%)
Myocardial Infarction
495 (.87%)
Dizziness
490 (.86%)
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Loss Of Consciousness
483 (.85%)
Malaise
439 (.77%)
Hyperhidrosis
433 (.76%)
Death
426 (.75%)
Weight Increased
424 (.75%)
Asthenia
419 (.74%)
Drug Exposure During Pregnancy
406 (.71%)
Dyspnoea
404 (.71%)
Cataract
399 (.7%)
Visual Impairment
398 (.7%)
Weight Decreased
397 (.7%)
Pneumonia
386 (.68%)
Diabetic Ketoacidosis
372 (.65%)
Vomiting
369 (.65%)
Diabetes Mellitus Inadequate Contro...
367 (.64%)
Glycosylated Haemoglobin Increased
357 (.63%)
Blood Glucose Fluctuation
347 (.61%)
Renal Failure
331 (.58%)
Nausea
311 (.55%)
Tremor
310 (.54%)
Condition Aggravated
307 (.54%)
Injection Site Pain
295 (.52%)
Vision Blurred
284 (.5%)
Medication Error
282 (.5%)
Fatigue
280 (.49%)
Blindness
278 (.49%)
Feeling Abnormal
275 (.48%)
Hospitalisation
273 (.48%)
Hypoglycaemic Unconsciousness
271 (.48%)
Convulsion
263 (.46%)
Visual Acuity Reduced
255 (.45%)
Headache
242 (.43%)
Pain In Extremity
234 (.41%)
Wrong Drug Administered
233 (.41%)
Cardiac Failure Congestive
229 (.4%)
Hypertension
229 (.4%)
Hypoglycaemic Coma
217 (.38%)
Eye Haemorrhage
206 (.36%)
Oedema Peripheral
205 (.36%)
Pain
203 (.36%)
Confusional State
201 (.35%)
Injection Site Haemorrhage
199 (.35%)
Syncope
192 (.34%)
Chest Pain
190 (.33%)
Somnolence
182 (.32%)
Device Breakage
181 (.32%)
Dehydration
175 (.31%)
Diarrhoea
174 (.31%)
Ketoacidosis
173 (.3%)
Injection Site Haematoma
171 (.3%)
Pyrexia
170 (.3%)
Diabetic Retinopathy
166 (.29%)
Drug Interaction
159 (.28%)
Gait Disturbance
156 (.27%)
Pruritus
156 (.27%)
Macular Degeneration
149 (.26%)
Cardiac Disorder
147 (.26%)
Breast Cancer
146 (.26%)
Decreased Appetite
140 (.25%)
Overdose
136 (.24%)
Urinary Tract Infection
136 (.24%)
Drug Administration Error
135 (.24%)
Hypoglycaemic Seizure
132 (.23%)
Road Traffic Accident
130 (.23%)
Atrial Fibrillation
128 (.22%)
Intentional Overdose
128 (.22%)
Abdominal Pain
126 (.22%)
Suicide Attempt
125 (.22%)
Cardiac Failure
124 (.22%)
Renal Failure Acute
124 (.22%)
Back Pain
123 (.22%)
Glaucoma
120 (.21%)
Incorrect Dose Administered
119 (.21%)
Nervousness
118 (.21%)
Renal Disorder
117 (.21%)
Blood Pressure Increased
115 (.2%)
Arthralgia
111 (.2%)
Anaemia
110 (.19%)
Cold Sweat
107 (.19%)
Hypoaesthesia
106 (.19%)
Amnesia
103 (.18%)
Device Failure
103 (.18%)
Myalgia
103 (.18%)
Hepatic Function Abnormal
102 (.18%)
Depression
100 (.18%)
Coma
97 (.17%)
Rash
97 (.17%)
Abortion Spontaneous
95 (.17%)
Swelling
95 (.17%)
Depressed Level Of Consciousness
94 (.17%)

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

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

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

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

Diabetes Mellitus
5227
Type 2 Diabetes Mellitus
4555
Product Used For Unknown Indication
1626
Type 1 Diabetes Mellitus
1043
Drug Use For Unknown Indication
805
Diabetes Mellitus Non-insulin-depen...
793
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Diabetes Mellitus Insulin-dependent
669
Insulin-requiring Type 2 Diabetes M...
237
Insulin-requiring Type Ii Diabetes ...
67
Blood Glucose Increased
49
Hyperglycaemia
37
Suicide Attempt
30
Blood Glucose Abnormal
26
Gestational Diabetes
20
Diabetic Relative
18
Diabetes Mellitus Inadequate Contro...
14
Blood Glucose
14
Blood Insulin
14
Hypertension
9
Ill-defined Disorder
7
Cardiac Failure
6
Febrile Neutropenia
6
Unevaluable Event
6
Latent Autoimmune Diabetes In Adult...
6
Cystic Fibrosis Related Diabetes
5
Diabetes Mellitus Malnutrition-rela...
4
Diabetes Mellitus Management
4
Glucose Tolerance Impaired
3
Glucose Tolerance Test Abnormal
3
Pancreatogenous Diabetes
3
Depression
3
Ketoacidosis
3
Device Therapy
3
Renal Failure Chronic
2
Weight Control
2
Renal Disorder
2
Diabetes Prophylaxis
2
Diabetic Ketoacidosis
2
Pain In Extremity
2
Insulin Resistance
2
Diabetic Nephropathy
2
Anxiety
2
Cystic Fibrosis
2
Intentional Overdose
2
Pancreaticoduodenectomy
2
Neuropathy
2
Blood Glucose Fluctuation
2
Hypoglycaemia
2
Crohns Disease
1
Neonatal Diabetes Mellitus
1
Pancreatectomy
1

Drug Labels

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

Lantus Case Reports

What Lantus 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 Lantus. 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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