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Starlix Adverse Events Reported to the FDA Over Time

How are Starlix adverse event reports trending over time?

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

Most Common Starlix Adverse Events Reported to the FDA

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

Blood Glucose Increased
38 (1.96%)
Dizziness
37 (1.9%)
Disease Progression
36 (1.85%)
Dyspnoea
36 (1.85%)
Anaemia
29 (1.49%)
Chest Pain
28 (1.44%)
Vomiting
25 (1.29%)
Asthenia
24 (1.24%)
Nausea
24 (1.24%)
Abdominal Pain
22 (1.13%)
Arrhythmia
22 (1.13%)
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Pyrexia
21 (1.08%)
Hypoglycaemia
18 (.93%)
Concomitant Disease Progression
17 (.87%)
Loss Of Consciousness
17 (.87%)
Gastritis
16 (.82%)
Multi-organ Failure
16 (.82%)
Acute Myeloid Leukaemia
15 (.77%)
Fall
15 (.77%)
Hypertension
15 (.77%)
Renal Failure Acute
15 (.77%)
Weight Decreased
15 (.77%)
Angina Pectoris
14 (.72%)
Blood Glucose Decreased
14 (.72%)
Colectomy
14 (.72%)
Pneumonia
14 (.72%)
Tinnitus
14 (.72%)
Ventricular Fibrillation
13 (.67%)
Ventricular Tachycardia
13 (.67%)
Alanine Aminotransferase Increased
12 (.62%)
Aspartate Aminotransferase Increase...
12 (.62%)
Death
12 (.62%)
Syncope
12 (.62%)
Thrombocytopenia
12 (.62%)
Acute Coronary Syndrome
11 (.57%)
Carotid Artery Disease
11 (.57%)
Decreased Appetite
11 (.57%)
Diabetes Mellitus Inadequate Contro...
11 (.57%)
Drug Ineffective
11 (.57%)
Haemoglobin Decreased
11 (.57%)
Malaise
11 (.57%)
Abdominal Pain Upper
10 (.51%)
Atrial Fibrillation
10 (.51%)
Blood Creatinine Increased
10 (.51%)
Cholelithiasis
10 (.51%)
Electrocardiogram St Segment Depres...
10 (.51%)
Gastrointestinal Angiodysplasia
10 (.51%)
Haemorrhoids
10 (.51%)
Intermittent Claudication
10 (.51%)
Intestinal Resection
10 (.51%)
Proteinuria
10 (.51%)
Tremor
10 (.51%)
Anorexia
9 (.46%)
Coronary Artery Disease
9 (.46%)
Diverticulum Intestinal
9 (.46%)
Electrocardiogram Qt Prolonged
9 (.46%)
Pancreatitis
9 (.46%)
Rash
9 (.46%)
Renal Disorder
9 (.46%)
Urinary Tract Infection
9 (.46%)
Abscess Drainage
8 (.41%)
Atrioventricular Block
8 (.41%)
Fatigue
8 (.41%)
Gastritis Erosive
8 (.41%)
Gastroenteritis
8 (.41%)
Glycosylated Haemoglobin Increased
8 (.41%)
Hyperkalaemia
8 (.41%)
Pleural Effusion
8 (.41%)
Small Intestinal Haemorrhage
8 (.41%)
Spirometry Abnormal
8 (.41%)
Vertigo
8 (.41%)
Acute Myocardial Infarction
7 (.36%)
Balance Disorder
7 (.36%)
Cerebrovascular Accident
7 (.36%)
Chills
7 (.36%)
Convulsion
7 (.36%)
Diabetes Mellitus
7 (.36%)
Hypoglycaemic Coma
7 (.36%)
Pancreatitis Acute
7 (.36%)
Sudden Death
7 (.36%)
Surgery
7 (.36%)
Weight Increased
7 (.36%)
Abdominal Distension
6 (.31%)
Acute Abdomen
6 (.31%)
Anastomotic Leak
6 (.31%)
Angiodysplasia
6 (.31%)
Arteriovenous Malformation
6 (.31%)
Brain Neoplasm
6 (.31%)
Chest Tube Insertion
6 (.31%)
Colon Cancer Stage Ii
6 (.31%)
Colonic Polyp
6 (.31%)
Coronary Artery Stenosis
6 (.31%)
Diarrhoea
6 (.31%)
Drug Interaction
6 (.31%)
Electrocardiogram St Segment Elevat...
6 (.31%)
Electrocardiogram T Wave Inversion
6 (.31%)
Empyema
6 (.31%)
Epididymitis
6 (.31%)
Epistaxis
6 (.31%)
Erythema
6 (.31%)
Faeces Discoloured
6 (.31%)

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

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

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ExportShare/Embed Graph Export Export Data

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

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

Diabetes Mellitus
214
Glucose Tolerance Impaired
87
Type 2 Diabetes Mellitus
49
Drug Use For Unknown Indication
44
Product Used For Unknown Indication
30
Diabetes Mellitus Non-insulin-depen...
28
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Blood Glucose Increased
7
Hyperglycaemia
4
Blood Glucose Abnormal
3
Ill-defined Disorder
3
Cerebral Infarction
2
Blood Glucose
2
Diabetes Mellitus Inadequate Contro...
1
Blood Glucose Decreased
1

Drug Labels

LabelLabelerEffective
StarlixNovartis Pharmaceuticals Corporation31-JAN-13

Starlix Case Reports

What Starlix 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 Starlix. 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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