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GLICLAZIDE

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Gliclazide Adverse Events Reported to the FDA Over Time

How are Gliclazide adverse event reports trending over time?

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

Most Common Gliclazide Adverse Events Reported to the FDA

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

Hypoglycaemia
119 (5.12%)
Renal Failure Acute
92 (3.96%)
Lactic Acidosis
58 (2.5%)
Drug Interaction
45 (1.94%)
Diabetes Mellitus Inadequate Contro...
24 (1.03%)
Dehydration
23 (.99%)
Hyperkalaemia
23 (.99%)
Jaundice
23 (.99%)
Malaise
22 (.95%)
Diarrhoea
21 (.9%)
Blood Glucose Increased
18 (.77%)
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Gastrointestinal Disorder
18 (.77%)
Nausea
18 (.77%)
Pancreatitis
18 (.77%)
Abdominal Pain Upper
17 (.73%)
Condition Aggravated
16 (.69%)
Fall
16 (.69%)
Obesity
16 (.69%)
Drug Exposure During Pregnancy
15 (.65%)
Hypotension
15 (.65%)
Liver Function Test Abnormal
15 (.65%)
Vomiting
15 (.65%)
Body Mass Index Decreased
14 (.6%)
Coma
14 (.6%)
Pancytopenia
14 (.6%)
Renal Impairment
14 (.6%)
Urinary Incontinence
14 (.6%)
Pancreatic Carcinoma
13 (.56%)
Treatment Noncompliance
13 (.56%)
Weight Decreased
13 (.56%)
Hypertension
12 (.52%)
Hyponatraemia
12 (.52%)
Mental Disorder
12 (.52%)
Pulmonary Fibrosis
12 (.52%)
Anuria
11 (.47%)
Cardio-respiratory Arrest
11 (.47%)
Dyspepsia
11 (.47%)
Hypothermia
11 (.47%)
Oedema Peripheral
11 (.47%)
Pyrexia
11 (.47%)
Shock
11 (.47%)
Sleep Terror
11 (.47%)
Thrombocytopenia
11 (.47%)
Type 2 Diabetes Mellitus
11 (.47%)
Asthenia
10 (.43%)
Cerebrovascular Accident
10 (.43%)
Circulatory Collapse
10 (.43%)
Cytolytic Hepatitis
10 (.43%)
Dizziness
10 (.43%)
Loss Of Consciousness
10 (.43%)
Aspartate Aminotransferase Increase...
9 (.39%)
Cholelithiasis
9 (.39%)
Dermatitis Exfoliative
9 (.39%)
Haemolytic Anaemia
9 (.39%)
Lower Respiratory Tract Infection
9 (.39%)
Blood Cholesterol Increased
8 (.34%)
Breast Enlargement
8 (.34%)
Breast Pain
8 (.34%)
Gastroenteritis
8 (.34%)
General Physical Health Deteriorati...
8 (.34%)
Interstitial Lung Disease
8 (.34%)
Jealous Delusion
8 (.34%)
Liver Disorder
8 (.34%)
Metabolic Disorder
8 (.34%)
Myocardial Infarction
8 (.34%)
Pneumonia
8 (.34%)
Weight Fluctuation
8 (.34%)
White Blood Cell Count Increased
8 (.34%)
Abortion Spontaneous
7 (.3%)
Bladder Cancer
7 (.3%)
Blood Bilirubin Increased
7 (.3%)
Blood Creatinine Increased
7 (.3%)
Blood Pressure Decreased
7 (.3%)
Bronchiectasis
7 (.3%)
Dyspnoea
7 (.3%)
Erythema
7 (.3%)
Fatigue
7 (.3%)
Hepatitis
7 (.3%)
Hypokalaemia
7 (.3%)
Metabolic Acidosis
7 (.3%)
Overdose
7 (.3%)
Pancreatitis Acute
7 (.3%)
Rash
7 (.3%)
Renal Failure
7 (.3%)
Respiratory Failure
7 (.3%)
Rhabdomyolysis
7 (.3%)
Septic Shock
7 (.3%)
Acute Myeloid Leukaemia
6 (.26%)
Alanine Aminotransferase Increased
6 (.26%)
Alcohol Use
6 (.26%)
Anaemia
6 (.26%)
Arthritis
6 (.26%)
Blood Alkaline Phosphatase Increase...
6 (.26%)
Confusional State
6 (.26%)
Diabetes Mellitus
6 (.26%)
Drug Ineffective
6 (.26%)
Face Oedema
6 (.26%)
Gynaecomastia
6 (.26%)
Headache
6 (.26%)
Hepatitis Cholestatic
6 (.26%)
Hypoglycaemic Coma
6 (.26%)

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

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

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

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

Diabetes Mellitus
845
Type 2 Diabetes Mellitus
414
Drug Use For Unknown Indication
295
Product Used For Unknown Indication
202
Diabetes Mellitus Non-insulin-depen...
93
Ill-defined Disorder
33
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Hyperglycaemia
14
Hypertension
9
Hypersensitivity
9
Diabetes Mellitus Insulin-dependent
5
Type 1 Diabetes Mellitus
5
Blood Glucose Increased
5
Insulin-requiring Type 2 Diabetes M...
5
Seasonal Allergy
4
Blood Glucose Abnormal
4
Unevaluable Event
3
Allergic Sinusitis
3
Foetal Exposure During Pregnancy
3
Insulin Resistant Diabetes
2
Urinary Tract Infection
2
Menieres Disease
2
Asthma
2
Diabetes Mellitus Management
1
Diuretic Therapy
1
Lymphocyte Count Abnormal
1
Insulin Resistance
1
Dyspnoea
1
Urticaria
1
Metabolic Disorder
1
Blood Cholesterol Increased
1
Prophylaxis
1
Cardiac Disorder
1
Swelling
1
Blood Pressure
1

Gliclazide Case Reports

What Gliclazide 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 Gliclazide. 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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