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Optipen Adverse Events Reported to the FDA Over Time

How are Optipen adverse event reports trending over time?

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

Most Common Optipen Adverse Events Reported to the FDA

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

Hyperglycaemia
160 (6.24%)
Hypoglycaemia
133 (5.19%)
Blood Glucose Increased
58 (2.26%)
Dizziness
42 (1.64%)
Ketoacidosis
42 (1.64%)
Vomiting
41 (1.6%)
Hyperhidrosis
37 (1.44%)
Condition Aggravated
36 (1.4%)
Diabetic Retinopathy
28 (1.09%)
Drug Exposure During Pregnancy
25 (.98%)
Diabetic Ketoacidosis
24 (.94%)
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Weight Increased
24 (.94%)
Blood Glucose Fluctuation
23 (.9%)
Loss Of Consciousness
23 (.9%)
Product Quality Issue
23 (.9%)
Syncope
23 (.9%)
Somnolence
22 (.86%)
Hepatic Function Abnormal
21 (.82%)
Medication Error
21 (.82%)
Fatigue
20 (.78%)
Feeling Abnormal
20 (.78%)
Nausea
20 (.78%)
Asthenia
19 (.74%)
Convulsion
19 (.74%)
Renal Failure
19 (.74%)
Vision Blurred
19 (.74%)
Weight Decreased
19 (.74%)
Myocardial Infarction
18 (.7%)
Blindness
17 (.66%)
Diabetes Mellitus Inadequate Contro...
17 (.66%)
Hypoglycaemic Unconsciousness
17 (.66%)
Pain In Extremity
17 (.66%)
Pyrexia
17 (.66%)
Tremor
17 (.66%)
Alanine Aminotransferase Increased
16 (.62%)
Aspartate Aminotransferase Increase...
16 (.62%)
Fall
16 (.62%)
Hypoglycaemic Coma
16 (.62%)
Pneumonia
16 (.62%)
Dyspnoea
15 (.59%)
Malaise
15 (.59%)
Visual Impairment
15 (.59%)
Cerebrovascular Accident
13 (.51%)
Diarrhoea
13 (.51%)
Speech Disorder
13 (.51%)
Cataract
12 (.47%)
Eye Haemorrhage
12 (.47%)
Headache
12 (.47%)
Amnesia
11 (.43%)
Cardiac Arrest
11 (.43%)
Coma
11 (.43%)
Gait Disturbance
11 (.43%)
Hypoglycaemic Seizure
11 (.43%)
Overdose
11 (.43%)
Pain
11 (.43%)
Blood Alkaline Phosphatase Increase...
10 (.39%)
Blood Pressure Increased
10 (.39%)
Cardiac Failure
10 (.39%)
Glycosylated Haemoglobin Increased
10 (.39%)
Hypertension
10 (.39%)
Urinary Tract Infection
10 (.39%)
Back Pain
9 (.35%)
Breast Cancer
9 (.35%)
Death
9 (.35%)
Hypoaesthesia
9 (.35%)
Off Label Use
9 (.35%)
Suicide Attempt
9 (.35%)
Blood Lactate Dehydrogenase Increas...
8 (.31%)
Coronary Artery Occlusion
8 (.31%)
Depressed Level Of Consciousness
8 (.31%)
Drug Administration Error
8 (.31%)
Infarction
8 (.31%)
Paraesthesia
8 (.31%)
Thirst
8 (.31%)
Vitreous Haemorrhage
8 (.31%)
Abdominal Pain Upper
7 (.27%)
Blood Glucose Decreased
7 (.27%)
Chest Pain
7 (.27%)
Cold Sweat
7 (.27%)
Drug Ineffective
7 (.27%)
Grand Mal Convulsion
7 (.27%)
Haematuria
7 (.27%)
Hunger
7 (.27%)
Injection Site Pain
7 (.27%)
Nasopharyngitis
7 (.27%)
Pancreatic Carcinoma
7 (.27%)
Renal Disorder
7 (.27%)
Renal Failure Chronic
7 (.27%)
Retinopathy
7 (.27%)
Abdominal Pain
6 (.23%)
Benign Prostatic Hyperplasia
6 (.23%)
Depression
6 (.23%)
Device Failure
6 (.23%)
Erythema Multiforme
6 (.23%)
Gamma-glutamyltransferase Increased
6 (.23%)
Hospitalisation
6 (.23%)
Liver Disorder
6 (.23%)
Muscular Weakness
6 (.23%)
Oedema Peripheral
6 (.23%)
Prostate Cancer
6 (.23%)
Wrong Drug Administered
6 (.23%)

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

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

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

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

Diabetes Mellitus
93
Diabetes Mellitus Insulin-dependent
15
Device Therapy
12
Type 2 Diabetes Mellitus
4
Type 1 Diabetes Mellitus
3
Premature Labour
1
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Optipen Case Reports

What Optipen 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 Optipen. 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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