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GLUCOPHAGE

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Glucophage Adverse Events Reported to the FDA Over Time

How are Glucophage adverse event reports trending over time?

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

Most Common Glucophage Adverse Events Reported to the FDA

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

Lactic Acidosis
3465 (4.8%)
Renal Failure Acute
2847 (3.94%)
Diarrhoea
1958 (2.71%)
Blood Glucose Increased
1505 (2.08%)
Vomiting
1366 (1.89%)
Hypoglycaemia
1242 (1.72%)
Nausea
1170 (1.62%)
Hypotension
824 (1.14%)
Metabolic Acidosis
794 (1.1%)
Haemodialysis
758 (1.05%)
Renal Failure
753 (1.04%)
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Completed Suicide
723 (1%)
Dehydration
718 (.99%)
Hyperkalaemia
686 (.95%)
Drug Ineffective
649 (.9%)
Malaise
590 (.82%)
Drug Interaction
558 (.77%)
Dyspnoea
545 (.75%)
Abdominal Pain
517 (.72%)
Weight Decreased
489 (.68%)
Overdose
485 (.67%)
Asthenia
483 (.67%)
Dizziness
456 (.63%)
Cardiac Arrest
444 (.61%)
Blood Creatinine Increased
434 (.6%)
Fatigue
425 (.59%)
Renal Impairment
397 (.55%)
Blood Glucose Decreased
371 (.51%)
Death
361 (.5%)
Somnolence
359 (.5%)
Confusional State
358 (.5%)
Diabetes Mellitus Inadequate Contro...
353 (.49%)
Weight Increased
337 (.47%)
Fall
322 (.45%)
Pancreatitis Acute
311 (.43%)
Abdominal Pain Upper
307 (.43%)
Headache
296 (.41%)
Suicide Attempt
289 (.4%)
Loss Of Consciousness
271 (.38%)
Decreased Appetite
265 (.37%)
Intentional Overdose
262 (.36%)
Myocardial Infarction
257 (.36%)
Oedema Peripheral
255 (.35%)
Hypertension
253 (.35%)
Hypothermia
251 (.35%)
Shock
247 (.34%)
Abdominal Discomfort
246 (.34%)
Pneumonia
238 (.33%)
Anaemia
235 (.33%)
Drug Exposure During Pregnancy
233 (.32%)
Glycosylated Haemoglobin Increased
227 (.31%)
Agitation
224 (.31%)
General Physical Health Deteriorati...
222 (.31%)
Drug Toxicity
220 (.3%)
Coma
219 (.3%)
Pancreatitis
210 (.29%)
Chest Pain
207 (.29%)
Pyrexia
205 (.28%)
Alanine Aminotransferase Increased
199 (.28%)
Sepsis
196 (.27%)
Multi-organ Failure
193 (.27%)
Bradycardia
192 (.27%)
Constipation
189 (.26%)
Myalgia
188 (.26%)
Continuous Haemodiafiltration
185 (.26%)
Depressed Level Of Consciousness
182 (.25%)
Hyperglycaemia
181 (.25%)
Diabetes Mellitus
180 (.25%)
Pruritus
180 (.25%)
White Blood Cell Count Increased
177 (.25%)
Tachypnoea
175 (.24%)
Rash
174 (.24%)
Respiratory Failure
173 (.24%)
Rhabdomyolysis
173 (.24%)
Dialysis
172 (.24%)
Blood Glucose Fluctuation
171 (.24%)
Muscle Spasms
171 (.24%)
Condition Aggravated
170 (.24%)
Blood Pressure Decreased
168 (.23%)
Pain In Extremity
165 (.23%)
Blood Potassium Increased
164 (.23%)
Blood Pressure Increased
163 (.23%)
Acidosis
162 (.22%)
Anuria
162 (.22%)
Aspartate Aminotransferase Increase...
161 (.22%)
Medication Error
155 (.21%)
Back Pain
154 (.21%)
Cardio-respiratory Arrest
154 (.21%)
Blood Lactic Acid Increased
152 (.21%)
Gastrointestinal Disorder
150 (.21%)
Poisoning
150 (.21%)
Tremor
149 (.21%)
Cerebrovascular Accident
148 (.2%)
Heart Rate Increased
147 (.2%)
Thrombocytopenia
146 (.2%)
Haemoglobin Decreased
145 (.2%)
Hyperhidrosis
145 (.2%)
Abdominal Distension
142 (.2%)
Syncope
142 (.2%)
Lethargy
141 (.2%)
Feeling Abnormal
140 (.19%)

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

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

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

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

Diabetes Mellitus
17617
Type 2 Diabetes Mellitus
8812
Product Used For Unknown Indication
4465
Drug Use For Unknown Indication
3528
Diabetes Mellitus Non-insulin-depen...
1682
Polycystic Ovaries
575
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Glucose Tolerance Impaired
295
Blood Glucose Increased
199
Insulin Resistance
167
Hyperglycaemia
157
Blood Glucose Abnormal
156
Ill-defined Disorder
108
Type 1 Diabetes Mellitus
102
Gestational Diabetes
102
Suicide Attempt
77
Blood Glucose
72
Insulin-requiring Type 2 Diabetes M...
69
Diabetes Mellitus Management
67
Insulin-requiring Type Ii Diabetes ...
57
Weight Decreased
47
Hypertension
43
Diabetes Mellitus Inadequate Contro...
41
Metabolic Syndrome
40
Diabetes Mellitus Insulin-dependent
38
Intentional Overdose
34
Weight Control
33
Obesity
33
Infertility
24
Completed Suicide
21
Hyperinsulinaemia
21
Diabetes Prophylaxis
18
Prophylaxis
18
Drug Exposure During Pregnancy
18
Blood Testosterone Abnormal
17
Unevaluable Event
13
Cardiac Disorder
13
Blood Cholesterol Increased
12
Blood Triglycerides Increased
10
Hepatic Steatosis
10
Ovarian Cyst
10
Incorrect Dose Administered
9
Blood Insulin Increased
9
Metabolic Disorder
9
Insulin Resistant Diabetes
9
Blood Cholesterol
9
Hyperlipidaemia
8
Hypoglycaemia
8
Weight Increased
8
Foetal Exposure During Pregnancy
8
Overdose
7
Accidental Exposure
7

Drug Labels

LabelLabelerEffective
GlucophagePD-Rx Pharmaceuticals, Inc.27-FEB-09
GlucophageBristol-Myers Squibb Company01-APR-13
Glucophage XrBristol-Myers Squibb Company01-APR-13

Glucophage Case Reports

What Glucophage 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 Glucophage. 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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