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AUTOPEN

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Autopen Adverse Events Reported to the FDA Over Time

How are Autopen adverse event reports trending over time?

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

Most Common Autopen Adverse Events Reported to the FDA

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

Hyperglycaemia
111 (6.25%)
Hypoglycaemia
105 (5.92%)
Blood Glucose Increased
50 (2.82%)
Myocardial Infarction
35 (1.97%)
Blood Glucose Fluctuation
31 (1.75%)
Cerebrovascular Accident
31 (1.75%)
Condition Aggravated
30 (1.69%)
Diabetic Ketoacidosis
30 (1.69%)
Product Quality Issue
28 (1.58%)
Pneumonia
27 (1.52%)
Vomiting
25 (1.41%)
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Weight Decreased
23 (1.3%)
Weight Increased
23 (1.3%)
Fatigue
22 (1.24%)
Injection Site Pain
22 (1.24%)
Cataract
20 (1.13%)
Death
19 (1.07%)
Dizziness
17 (.96%)
Renal Failure
17 (.96%)
Hyperhidrosis
16 (.9%)
Eye Haemorrhage
15 (.85%)
Diabetes Mellitus Inadequate Contro...
14 (.79%)
Feeling Abnormal
14 (.79%)
Ketoacidosis
14 (.79%)
Pain In Extremity
14 (.79%)
Vision Blurred
14 (.79%)
Asthenia
13 (.73%)
Fall
13 (.73%)
Renal Impairment
13 (.73%)
Nausea
12 (.68%)
Drug Ineffective
11 (.62%)
Oedema Peripheral
11 (.62%)
Urinary Tract Infection
11 (.62%)
Wrong Drug Administered
11 (.62%)
Gastrointestinal Carcinoma
10 (.56%)
Hospitalisation
10 (.56%)
Hypoglycaemic Unconsciousness
10 (.56%)
Medication Error
10 (.56%)
Visual Impairment
10 (.56%)
Hypoaesthesia
9 (.51%)
Atrial Fibrillation
8 (.45%)
Cardiac Disorder
8 (.45%)
Dyspnoea
8 (.45%)
Headache
8 (.45%)
Hypertension
8 (.45%)
Malaise
8 (.45%)
Myalgia
8 (.45%)
Renal Disorder
8 (.45%)
Syncope
8 (.45%)
Angina Pectoris
7 (.39%)
Blindness
7 (.39%)
Blood Glucose Decreased
7 (.39%)
Convulsion
7 (.39%)
Coronary Artery Disease
7 (.39%)
Cough
7 (.39%)
Injection Site Haemorrhage
7 (.39%)
Pain
7 (.39%)
Pulmonary Oedema
7 (.39%)
Sepsis
7 (.39%)
Somnolence
7 (.39%)
Tremor
7 (.39%)
Anaemia
6 (.34%)
Cardiac Failure
6 (.34%)
Chest Pain
6 (.34%)
Cold Sweat
6 (.34%)
Coronary Artery Bypass
6 (.34%)
Eye Disorder
6 (.34%)
Infarction
6 (.34%)
Loss Of Consciousness
6 (.34%)
Off Label Use
6 (.34%)
Pyrexia
6 (.34%)
Thrombosis
6 (.34%)
Blindness Unilateral
5 (.28%)
Bronchitis
5 (.28%)
Cardiac Arrest
5 (.28%)
Confusional State
5 (.28%)
Dehydration
5 (.28%)
Depression
5 (.28%)
Heart Rate Increased
5 (.28%)
Hunger
5 (.28%)
Hypoglycaemic Coma
5 (.28%)
Incorrect Dose Administered
5 (.28%)
Muscle Spasms
5 (.28%)
Neoplasm Malignant
5 (.28%)
Nervousness
5 (.28%)
Staphylococcal Infection
5 (.28%)
Abdominal Pain
4 (.23%)
Acidosis
4 (.23%)
Arterial Occlusive Disease
4 (.23%)
Coronary Artery Occlusion
4 (.23%)
Diabetic Coma
4 (.23%)
Diabetic Complication
4 (.23%)
Diabetic Retinopathy
4 (.23%)
Diarrhoea
4 (.23%)
Drug Administration Error
4 (.23%)
Endocarditis
4 (.23%)
Eye Pain
4 (.23%)
Haematoma
4 (.23%)
Injection Site Haematoma
4 (.23%)
Intestinal Polyp
4 (.23%)
Limb Injury
4 (.23%)

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

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

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

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

Device Therapy
69
Type 2 Diabetes Mellitus
2
Diabetes Mellitus
1

Autopen Case Reports

What Autopen 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 Autopen. 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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