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GLUCOPHAGE XR

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Glucophage Xr Adverse Events Reported to the FDA Over Time

How are Glucophage Xr adverse event reports trending over time?

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

Most Common Glucophage Xr Adverse Events Reported to the FDA

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

Diarrhoea
98 (10.96%)
Blood Glucose Increased
80 (8.95%)
Death
32 (3.58%)
Medication Residue
31 (3.47%)
Nausea
27 (3.02%)
Drug Ineffective
25 (2.8%)
Blood Glucose Fluctuation
20 (2.24%)
Weight Decreased
20 (2.24%)
Vomiting
16 (1.79%)
Headache
14 (1.57%)
Flatulence
13 (1.45%)
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Abdominal Distension
12 (1.34%)
Myocardial Infarction
12 (1.34%)
Fatigue
11 (1.23%)
Rash
11 (1.23%)
Abdominal Pain Upper
10 (1.12%)
Dizziness
10 (1.12%)
Abdominal Pain
9 (1.01%)
Asthenia
9 (1.01%)
Dysgeusia
9 (1.01%)
Abdominal Discomfort
8 (.89%)
Dyspnoea
8 (.89%)
Alopecia
7 (.78%)
Cerebrovascular Accident
7 (.78%)
Feeling Abnormal
7 (.78%)
Pollakiuria
7 (.78%)
Weight Increased
7 (.78%)
Blood Glucose Abnormal
6 (.67%)
Confusional State
6 (.67%)
Hypoaesthesia
6 (.67%)
Lactic Acidosis
6 (.67%)
Muscle Spasms
6 (.67%)
Somnolence
6 (.67%)
Tremor
6 (.67%)
Adverse Event
5 (.56%)
Constipation
5 (.56%)
Dyspepsia
5 (.56%)
Myalgia
5 (.56%)
Oedema Peripheral
5 (.56%)
Chest Pain
4 (.45%)
Fall
4 (.45%)
Hyperhidrosis
4 (.45%)
Medication Error
4 (.45%)
Pain
4 (.45%)
Palpitations
4 (.45%)
Paraesthesia
4 (.45%)
Pruritus
4 (.45%)
Upper Respiratory Tract Infection
4 (.45%)
Urticaria
4 (.45%)
Anorexia
3 (.34%)
Anxiety
3 (.34%)
Back Pain
3 (.34%)
Blood Creatinine Increased
3 (.34%)
Blood Glucose Decreased
3 (.34%)
Cardiac Disorder
3 (.34%)
Chest Discomfort
3 (.34%)
Decreased Appetite
3 (.34%)
Diabetes Mellitus Inadequate Contro...
3 (.34%)
Erectile Dysfunction
3 (.34%)
Feeling Cold
3 (.34%)
Gastrointestinal Disorder
3 (.34%)
Glycosylated Haemoglobin Increased
3 (.34%)
Irritability
3 (.34%)
Limb Discomfort
3 (.34%)
Malaise
3 (.34%)
Oesophageal Pain
3 (.34%)
Oral Discomfort
3 (.34%)
Pain In Extremity
3 (.34%)
Pancreatitis Acute
3 (.34%)
Rectal Haemorrhage
3 (.34%)
Rib Fracture
3 (.34%)
Therapeutic Response Unexpected Wit...
3 (.34%)
Throat Irritation
3 (.34%)
Abasia
2 (.22%)
Abnormal Faeces
2 (.22%)
Burning Sensation
2 (.22%)
Cholelithiasis
2 (.22%)
Cold Sweat
2 (.22%)
Convulsion
2 (.22%)
Cough
2 (.22%)
Cystitis
2 (.22%)
Drug Dispensing Error
2 (.22%)
Drug Effect Decreased
2 (.22%)
Drug Interaction
2 (.22%)
Faeces Pale
2 (.22%)
Fluid Retention
2 (.22%)
Gastrooesophageal Reflux Disease
2 (.22%)
Hepatic Enzyme Increased
2 (.22%)
Hyperchlorhydria
2 (.22%)
Hypercholesterolaemia
2 (.22%)
Hypersensitivity
2 (.22%)
Hypoaesthesia Facial
2 (.22%)
Hypoglycaemia
2 (.22%)
Hysterectomy
2 (.22%)
Injection Site Haemorrhage
2 (.22%)
Lethargy
2 (.22%)
Malabsorption
2 (.22%)
Metabolic Acidosis
2 (.22%)
Muscle Twitching
2 (.22%)
Painful Defaecation
2 (.22%)
Peripheral Coldness
2 (.22%)

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

What are the most common Glucophage Xr 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 Xr, 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 Xr 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 Xr According to Those Reporting Adverse Events

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

Diabetes Mellitus
280
Diabetes Mellitus Non-insulin-depen...
64
Type 2 Diabetes Mellitus
52
Polycystic Ovaries
10
Insulin Resistance
10
Diabetes Mellitus Management
7
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Product Used For Unknown Indication
6
Blood Glucose Increased
5
Drug Use For Unknown Indication
5
Metabolic Syndrome
3
Hepatic Steatosis
3
Hypersensitivity
2
Metabolic Disorder
2
Hyperglycaemia
2
Hypoglycaemia
1
Weight Control
1
Hypercholesterolaemia
1
Weight Decreased
1
Insulin Resistance Syndrome
1
Glucose Tolerance Impaired
1
Blood Insulin Increased
1
Diabetes Mellitus Inadequate Contro...
1
Insulin Resistant Diabetes
1

Drug Labels

LabelLabelerEffective
Glucophage XrBristol-Myers Squibb Company01-APR-13

Glucophage Xr Case Reports

What Glucophage Xr 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 Xr. 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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