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Glucovance Adverse Events Reported to the FDA Over Time

How are Glucovance adverse event reports trending over time?

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

Most Common Glucovance Adverse Events Reported to the FDA

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

Lactic Acidosis
3028 (4.91%)
Renal Failure Acute
2396 (3.88%)
Diarrhoea
1489 (2.41%)
Blood Glucose Increased
1231 (2%)
Vomiting
1139 (1.85%)
Hypoglycaemia
1094 (1.77%)
Nausea
964 (1.56%)
Hypotension
785 (1.27%)
Haemodialysis
728 (1.18%)
Completed Suicide
713 (1.16%)
Metabolic Acidosis
696 (1.13%)
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Dehydration
595 (.96%)
Renal Failure
590 (.96%)
Drug Ineffective
535 (.87%)
Malaise
519 (.84%)
Hyperkalaemia
518 (.84%)
Dyspnoea
489 (.79%)
Drug Interaction
466 (.76%)
Abdominal Pain
463 (.75%)
Overdose
439 (.71%)
Cardiac Arrest
416 (.67%)
Weight Decreased
395 (.64%)
Dizziness
389 (.63%)
Asthenia
383 (.62%)
Blood Creatinine Increased
376 (.61%)
Renal Impairment
365 (.59%)
Fatigue
338 (.55%)
Blood Glucose Decreased
322 (.52%)
Somnolence
316 (.51%)
Diabetes Mellitus Inadequate Contro...
309 (.5%)
Confusional State
303 (.49%)
Pancreatitis Acute
288 (.47%)
Weight Increased
288 (.47%)
Suicide Attempt
257 (.42%)
Fall
253 (.41%)
Headache
243 (.39%)
Abdominal Pain Upper
240 (.39%)
Intentional Overdose
238 (.39%)
Loss Of Consciousness
238 (.39%)
Hypertension
236 (.38%)
Hypothermia
236 (.38%)
Decreased Appetite
232 (.38%)
Death
226 (.37%)
Oedema Peripheral
221 (.36%)
Agitation
219 (.35%)
Drug Exposure During Pregnancy
213 (.35%)
Drug Toxicity
211 (.34%)
Shock
211 (.34%)
Abdominal Discomfort
204 (.33%)
Pneumonia
193 (.31%)
Pancreatitis
191 (.31%)
Myocardial Infarction
189 (.31%)
Coma
186 (.3%)
Glycosylated Haemoglobin Increased
186 (.3%)
Continuous Haemodiafiltration
184 (.3%)
Chest Pain
177 (.29%)
Pyrexia
177 (.29%)
White Blood Cell Count Increased
172 (.28%)
Bradycardia
171 (.28%)
Alanine Aminotransferase Increased
170 (.28%)
Sepsis
168 (.27%)
Diabetes Mellitus
165 (.27%)
General Physical Health Deteriorati...
165 (.27%)
Hyperglycaemia
165 (.27%)
Rhabdomyolysis
162 (.26%)
Blood Pressure Decreased
161 (.26%)
Tachypnoea
161 (.26%)
Anaemia
160 (.26%)
Depressed Level Of Consciousness
157 (.25%)
Multi-organ Failure
156 (.25%)
Respiratory Failure
155 (.25%)
Myalgia
153 (.25%)
Poisoning
153 (.25%)
Constipation
151 (.24%)
Dialysis
151 (.24%)
Acidosis
148 (.24%)
Blood Pressure Increased
146 (.24%)
Blood Potassium Increased
145 (.24%)
Muscle Spasms
144 (.23%)
Heart Rate Increased
143 (.23%)
Condition Aggravated
142 (.23%)
Aspartate Aminotransferase Increase...
140 (.23%)
Pain In Extremity
140 (.23%)
Lethargy
138 (.22%)
Anuria
136 (.22%)
Rash
135 (.22%)
Syncope
135 (.22%)
Gastrointestinal Disorder
134 (.22%)
Haemoglobin Decreased
133 (.22%)
Hyperhidrosis
130 (.21%)
Blood Lactic Acid Increased
128 (.21%)
Multiple Drug Overdose
128 (.21%)
Pruritus
128 (.21%)
Intentional Drug Misuse
124 (.2%)
Insomnia
123 (.2%)
Atrial Fibrillation
120 (.19%)
Back Pain
119 (.19%)
Blood Creatine Phosphokinase Increa...
119 (.19%)
Blood Glucose Fluctuation
119 (.19%)
Cerebrovascular Accident
119 (.19%)
Disorientation
119 (.19%)

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

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

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

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

Diabetes Mellitus
15018
Type 2 Diabetes Mellitus
7680
Product Used For Unknown Indication
4127
Drug Use For Unknown Indication
3103
Diabetes Mellitus Non-insulin-depen...
1259
Polycystic Ovaries
472
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Glucose Tolerance Impaired
257
Blood Glucose Increased
178
Hyperglycaemia
147
Blood Glucose Abnormal
142
Insulin Resistance
114
Gestational Diabetes
97
Ill-defined Disorder
86
Type 1 Diabetes Mellitus
82
Suicide Attempt
77
Blood Glucose
63
Diabetes Mellitus Management
58
Insulin-requiring Type 2 Diabetes M...
50
Hypertension
40
Weight Decreased
37
Insulin-requiring Type Ii Diabetes ...
36
Diabetes Mellitus Inadequate Contro...
35
Obesity
30
Weight Control
30
Metabolic Syndrome
30
Intentional Overdose
27
Diabetes Mellitus Insulin-dependent
21
Completed Suicide
21
Infertility
20
Drug Exposure During Pregnancy
18
Blood Testosterone Abnormal
17
Diabetes Prophylaxis
17
Hyperinsulinaemia
17
Prophylaxis
13
Cardiac Disorder
13
Blood Cholesterol Increased
11
Blood Cholesterol
9
Unevaluable Event
9
Incorrect Dose Administered
9
Blood Triglycerides Increased
9
Hyperlipidaemia
8
Foetal Exposure During Pregnancy
8
Weight Increased
8
Diabetes Mellitus Malnutrition-rela...
7
Hepatic Steatosis
7
Abortion Spontaneous
7
Hypoglycaemia
7
Accidental Exposure
7
Metabolic Disorder
7
Cushings Syndrome
6
Blood Insulin Increased
6

Drug Labels

LabelLabelerEffective
GlucovancePhysicians Total Care, Inc.23-APR-12
GlucovanceBristol-Myers Squibb Company01-APR-13

Glucovance Case Reports

What Glucovance 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 Glucovance. 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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