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SOLOSTAR

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Solostar Adverse Events Reported to the FDA Over Time

How are Solostar adverse event reports trending over time?

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

Most Common Solostar Adverse Events Reported to the FDA

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

Device Malfunction
3842 (28.61%)
Product Quality Issue
1362 (10.14%)
Blood Glucose Increased
730 (5.44%)
Hypoglycaemia
261 (1.94%)
Hyperglycaemia
215 (1.6%)
Device Breakage
169 (1.26%)
Blood Glucose Decreased
168 (1.25%)
Wrong Drug Administered
153 (1.14%)
Fall
142 (1.06%)
Visual Impairment
121 (.9%)
Cerebrovascular Accident
88 (.66%)
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Pneumonia
87 (.65%)
Hospitalisation
85 (.63%)
Drug Ineffective
84 (.63%)
Injection Site Pain
81 (.6%)
Hyperhidrosis
80 (.6%)
Dizziness
75 (.56%)
Malaise
75 (.56%)
Cataract
69 (.51%)
Myocardial Infarction
68 (.51%)
Weight Decreased
68 (.51%)
Injection Site Haematoma
67 (.5%)
Injection Site Haemorrhage
66 (.49%)
Feeling Abnormal
65 (.48%)
Visual Acuity Reduced
64 (.48%)
Glycosylated Haemoglobin Increased
60 (.45%)
Tremor
60 (.45%)
Asthenia
59 (.44%)
Diabetic Ketoacidosis
51 (.38%)
Cardiac Failure Congestive
50 (.37%)
Dyspnoea
50 (.37%)
Renal Failure
50 (.37%)
Vision Blurred
50 (.37%)
Headache
49 (.36%)
Blindness
48 (.36%)
Condition Aggravated
45 (.34%)
Loss Of Consciousness
45 (.34%)
Death
44 (.33%)
Weight Increased
44 (.33%)
Pain
42 (.31%)
Road Traffic Accident
42 (.31%)
Blood Glucose Fluctuation
40 (.3%)
Syncope
40 (.3%)
Fatigue
39 (.29%)
Nausea
36 (.27%)
No Adverse Event
36 (.27%)
Vomiting
35 (.26%)
Macular Degeneration
34 (.25%)
Diabetes Mellitus Inadequate Contro...
33 (.25%)
Oedema Peripheral
32 (.24%)
Pain In Extremity
32 (.24%)
Drug Dose Omission
31 (.23%)
Hypoglycaemic Unconsciousness
31 (.23%)
Dehydration
29 (.22%)
Atrial Fibrillation
28 (.21%)
Knee Arthroplasty
28 (.21%)
Cardiac Disorder
27 (.2%)
Convulsion
27 (.2%)
Gait Disturbance
27 (.2%)
Coronary Artery Bypass
25 (.19%)
Eye Haemorrhage
25 (.19%)
Transient Ischaemic Attack
25 (.19%)
Drug Exposure During Pregnancy
23 (.17%)
Medication Error
23 (.17%)
Memory Impairment
23 (.17%)
Confusional State
22 (.16%)
Decreased Appetite
22 (.16%)
Neuropathy Peripheral
22 (.16%)
Unevaluable Event
22 (.16%)
Foot Fracture
21 (.16%)
Ketoacidosis
21 (.16%)
Overdose
21 (.16%)
Pruritus
21 (.16%)
Breast Cancer
20 (.15%)
Cardiac Operation
20 (.15%)
Chest Pain
20 (.15%)
Eye Disorder
20 (.15%)
Glaucoma
20 (.15%)
Renal Disorder
20 (.15%)
Upper Limb Fracture
20 (.15%)
Arthropathy
19 (.14%)
Coronary Artery Occlusion
19 (.14%)
Diarrhoea
19 (.14%)
Heart Rate Increased
19 (.14%)
Hypertension
19 (.14%)
Urinary Tract Infection
19 (.14%)
Wrong Technique In Drug Usage Proce...
19 (.14%)
Hypoaesthesia
18 (.13%)
Surgery
18 (.13%)
Arthritis
17 (.13%)
Bronchitis
17 (.13%)
Cataract Operation
17 (.13%)
Cold Sweat
17 (.13%)
Depressed Level Of Consciousness
17 (.13%)
Expired Drug Administered
17 (.13%)
Haemorrhage
17 (.13%)
Nervousness
17 (.13%)
Pyrexia
17 (.13%)
Somnolence
17 (.13%)
Cellulitis
16 (.12%)
Femur Fracture
16 (.12%)

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

What are the most common 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 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 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 Solostar According to Those Reporting Adverse Events

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

Type 2 Diabetes Mellitus
975
Product Used For Unknown Indication
702
Diabetes Mellitus
192
Device Therapy
176
Type 1 Diabetes Mellitus
134
Insulin-requiring Type 2 Diabetes M...
24
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Drug Use For Unknown Indication
6
Hyperglycaemia
4
Gestational Diabetes
2
Blood Glucose
2
Pancreatectomy
1
Suicide Attempt
1
Blood Glucose Increased
1
Latent Autoimmune Diabetes In Adult...
1

Drug Labels

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

Solostar Case Reports

What 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 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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