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APIDRA SOLOSTAR

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Apidra Solostar Adverse Events Reported to the FDA Over Time

How are Apidra Solostar adverse event reports trending over time?

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

Most Common Apidra Solostar Adverse Events Reported to the FDA

What are the most common Apidra Solostar adverse events reported to the FDA?

Device Malfunction
105 (17.5%)
Wrong Drug Administered
66 (11%)
Product Quality Issue
51 (8.5%)
Hypoglycaemia
38 (6.33%)
Hyperglycaemia
24 (4%)
Asthenia
10 (1.67%)
Dizziness
10 (1.67%)
Blood Glucose Increased
9 (1.5%)
Drug Exposure During Pregnancy
9 (1.5%)
Depressed Level Of Consciousness
8 (1.33%)
Feeling Abnormal
8 (1.33%)
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Headache
8 (1.33%)
Cold Sweat
7 (1.17%)
Blood Glucose Decreased
6 (1%)
Blood Glucose Fluctuation
6 (1%)
Diabetic Ketoacidosis
6 (1%)
Premature Baby
6 (1%)
Ketoacidosis
5 (.83%)
Musculoskeletal Pain
5 (.83%)
Vomiting
5 (.83%)
Colorectal Cancer
4 (.67%)
Confusional State
4 (.67%)
Device Breakage
4 (.67%)
Dyspnoea
4 (.67%)
Expired Drug Administered
4 (.67%)
Hospitalisation
4 (.67%)
Hyperhidrosis
4 (.67%)
Hypoglycaemic Unconsciousness
4 (.67%)
Ketonuria
4 (.67%)
Loss Of Consciousness
4 (.67%)
Malaise
4 (.67%)
Metabolic Acidosis
4 (.67%)
Neck Pain
4 (.67%)
Road Traffic Accident
4 (.67%)
Tremor
4 (.67%)
Vision Blurred
4 (.67%)
Visual Impairment
4 (.67%)
Convulsion
3 (.5%)
Drug Ineffective
3 (.5%)
Feeling Hot
3 (.5%)
Injection Site Pain
3 (.5%)
Nausea
3 (.5%)
No Adverse Event
3 (.5%)
Pyrexia
3 (.5%)
Unevaluable Event
3 (.5%)
Abdominal Discomfort
2 (.33%)
Abdominal Pain
2 (.33%)
Alanine Aminotransferase Increased
2 (.33%)
Altered State Of Consciousness
2 (.33%)
Anaemia
2 (.33%)
Arterial Occlusive Disease
2 (.33%)
Aspartate Aminotransferase Increase...
2 (.33%)
Chest Discomfort
2 (.33%)
Coronary Artery Occlusion
2 (.33%)
Drug Dose Omission
2 (.33%)
Fall
2 (.33%)
Feeling Cold
2 (.33%)
Glycosylated Haemoglobin Increased
2 (.33%)
Hepatic Function Abnormal
2 (.33%)
Inappropriate Affect
2 (.33%)
Jaundice
2 (.33%)
Large For Dates Baby
2 (.33%)
Localised Infection
2 (.33%)
Mental Disorder
2 (.33%)
Monoplegia
2 (.33%)
Muscle Spasms
2 (.33%)
Pain In Extremity
2 (.33%)
Respiratory Tract Infection
2 (.33%)
Syncope
2 (.33%)
Thrombocytopenia
2 (.33%)
Tonsillitis
2 (.33%)
White Blood Cell Count Increased
2 (.33%)
Abdominal Pain Upper
1 (.17%)
Accidental Overdose
1 (.17%)
Adverse Event
1 (.17%)
Anxiety
1 (.17%)
Aphonia
1 (.17%)
Arrhythmia
1 (.17%)
Asthma
1 (.17%)
Bone Disorder
1 (.17%)
Cardiac Failure
1 (.17%)
Carotid Artery Disease
1 (.17%)
Cerebrovascular Accident
1 (.17%)
Chest Pain
1 (.17%)
Coeliac Disease
1 (.17%)
Cough
1 (.17%)
Cyanosis
1 (.17%)
Death
1 (.17%)
Deep Vein Thrombosis
1 (.17%)
Dehydration
1 (.17%)
Dengue Fever
1 (.17%)
Diabetes Mellitus Inadequate Contro...
1 (.17%)
Diarrhoea
1 (.17%)
Disorientation
1 (.17%)
Drug Administration Error
1 (.17%)
Drug Interaction
1 (.17%)
Drug Label Confusion
1 (.17%)
Dysentery
1 (.17%)
Gait Disturbance
1 (.17%)
Haematoma
1 (.17%)
Hypoglycaemic Seizure
1 (.17%)

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

What are the most common Apidra Solostar adverse events reported to the FDA?

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

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

Type 2 Diabetes Mellitus
36
Diabetes Mellitus
31
Product Used For Unknown Indication
20
Type 1 Diabetes Mellitus
18
Gestational Diabetes
2
Drug Use For Unknown Indication
2
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Drug Labels

LabelLabelerEffective
ApidraSanofi-Aventis U.S. LLC19-APR-12
Apidra SolostarSanofi-Aventis U.S. LLC19-APR-12

Apidra Solostar Case Reports

What Apidra Solostar 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 Apidra Solostar. 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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