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METFORMIN HYDROCHLORIDE

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Metformin Hydrochloride Adverse Events Reported to the FDA Over Time

How are Metformin Hydrochloride adverse event reports trending over time?

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

Most Common Metformin Hydrochloride Adverse Events Reported to the FDA

What are the most common Metformin Hydrochloride adverse events reported to the FDA?

Lactic Acidosis
3596 (3.43%)
Myocardial Infarction
3087 (2.95%)
Renal Failure Acute
3046 (2.91%)
Diarrhoea
2331 (2.23%)
Blood Glucose Increased
1873 (1.79%)
Cardiac Failure Congestive
1794 (1.71%)
Vomiting
1550 (1.48%)
Nausea
1515 (1.45%)
Hypoglycaemia
1460 (1.39%)
Cerebrovascular Accident
1108 (1.06%)
Coronary Artery Disease
1047 (1%)
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Dyspnoea
1027 (.98%)
Renal Failure
966 (.92%)
Drug Ineffective
909 (.87%)
Hypotension
881 (.84%)
Metabolic Acidosis
845 (.81%)
Haemodialysis
770 (.74%)
Dehydration
767 (.73%)
Cardiac Disorder
752 (.72%)
Malaise
738 (.7%)
Completed Suicide
730 (.7%)
Dizziness
729 (.7%)
Hyperkalaemia
727 (.69%)
Death
723 (.69%)
Fatigue
708 (.68%)
Asthenia
700 (.67%)
Weight Increased
698 (.67%)
Weight Decreased
662 (.63%)
Cardiac Arrest
634 (.61%)
Abdominal Pain
632 (.6%)
Chest Pain
621 (.59%)
Drug Interaction
604 (.58%)
Overdose
560 (.53%)
Oedema Peripheral
540 (.52%)
Hypertension
508 (.49%)
Blood Creatinine Increased
492 (.47%)
Blood Glucose Decreased
484 (.46%)
Cardiovascular Disorder
483 (.46%)
Headache
464 (.44%)
Pancreatitis
449 (.43%)
Diabetes Mellitus Inadequate Contro...
447 (.43%)
Abdominal Pain Upper
443 (.42%)
Myocardial Ischaemia
441 (.42%)
Pain
428 (.41%)
Renal Impairment
427 (.41%)
Somnolence
423 (.4%)
Fall
412 (.39%)
Confusional State
407 (.39%)
Atrial Fibrillation
388 (.37%)
Pancreatitis Acute
386 (.37%)
Anaemia
350 (.33%)
Loss Of Consciousness
349 (.33%)
Cardiac Failure
340 (.32%)
Decreased Appetite
331 (.32%)
Pneumonia
321 (.31%)
Abdominal Discomfort
313 (.3%)
Suicide Attempt
306 (.29%)
Myalgia
295 (.28%)
Glycosylated Haemoglobin Increased
294 (.28%)
Intentional Overdose
275 (.26%)
Rash
275 (.26%)
Drug Exposure During Pregnancy
272 (.26%)
Pain In Extremity
271 (.26%)
Shock
271 (.26%)
Pruritus
270 (.26%)
Pyrexia
261 (.25%)
Acute Myocardial Infarction
256 (.24%)
General Physical Health Deteriorati...
255 (.24%)
Hypothermia
255 (.24%)
Oedema
251 (.24%)
Coma
249 (.24%)
Muscle Spasms
248 (.24%)
Alanine Aminotransferase Increased
246 (.23%)
Condition Aggravated
242 (.23%)
Constipation
240 (.23%)
Depression
237 (.23%)
Respiratory Failure
233 (.22%)
Back Pain
231 (.22%)
Agitation
230 (.22%)
Drug Toxicity
228 (.22%)
Diabetes Mellitus
227 (.22%)
Hyperglycaemia
227 (.22%)
Blood Glucose Fluctuation
226 (.22%)
Bradycardia
224 (.21%)
Sepsis
224 (.21%)
Abdominal Distension
221 (.21%)
Multi-organ Failure
221 (.21%)
Hyperhidrosis
220 (.21%)
Tremor
215 (.21%)
Vision Blurred
214 (.2%)
Cardio-respiratory Arrest
213 (.2%)
Blood Pressure Increased
211 (.2%)
Heart Rate Increased
209 (.2%)
Heart Injury
207 (.2%)
Transient Ischaemic Attack
205 (.2%)
Aspartate Aminotransferase Increase...
200 (.19%)
Gastrointestinal Disorder
198 (.19%)
Rhabdomyolysis
197 (.19%)
Medication Error
194 (.19%)
Depressed Level Of Consciousness
193 (.18%)
Syncope
193 (.18%)

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

What are the most common Metformin Hydrochloride adverse events reported to the FDA?

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

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

Diabetes Mellitus
22289
Type 2 Diabetes Mellitus
10576
Product Used For Unknown Indication
4865
Drug Use For Unknown Indication
4221
Diabetes Mellitus Non-insulin-depen...
1993
Polycystic Ovaries
587
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Glucose Tolerance Impaired
306
Blood Glucose Increased
237
Insulin Resistance
178
Hyperglycaemia
170
Blood Glucose Abnormal
168
Ill-defined Disorder
163
Type 1 Diabetes Mellitus
118
Blood Glucose
111
Gestational Diabetes
103
Insulin-requiring Type 2 Diabetes M...
83
Diabetes Mellitus Management
79
Suicide Attempt
78
Insulin-requiring Type Ii Diabetes ...
58
Diabetes Mellitus Inadequate Contro...
51
Hypertension
49
Weight Decreased
48
Metabolic Syndrome
40
Diabetes Mellitus Insulin-dependent
39
Weight Control
36
Intentional Overdose
34
Obesity
33
Infertility
24
Hyperinsulinaemia
22
Completed Suicide
21
Drug Exposure During Pregnancy
19
Diabetes Prophylaxis
18
Prophylaxis
18
Blood Testosterone Abnormal
17
Glycosylated Haemoglobin Increased
13
Cardiac Disorder
13
Unevaluable Event
13
Blood Cholesterol Increased
12
Ovarian Cyst
10
Blood Triglycerides Increased
10
Hepatic Steatosis
10
Metabolic Disorder
9
Incorrect Dose Administered
9
Insulin Resistant Diabetes
9
Hypoglycaemia
9
Accidental Exposure
9
Hyperlipidaemia
9
Blood Cholesterol
9
Blood Insulin Increased
9
Foetal Exposure During Pregnancy
8
Weight Increased
8

Drug Labels

LabelLabelerEffective
GlucophagePD-Rx Pharmaceuticals, Inc.27-FEB-09
Glyburide And Metformin HydrochlorideDr. Reddy's Laboratories Limited23-JUN-09
Metformin Hydrochloride Extended ReleaseMajor Pharmaceuticals25-SEP-09
Metformin HydrochlorideSun Pharmaceutical Industries Limited01-OCT-09
Metformin Hydrochloride PD-Rx Pharmaceuticals, Inc.01-OCT-09
Metformin HydrochloridePhysicians Total Care, Inc.01-OCT-09
Actoplus MetPhysicians Total Care, Inc.24-FEB-10
Metformin HydrochlorideState of Florida DOH Central Pharmacy04-MAR-10
Glipizide And Metformin HydrochloridePhysicians Total Care, Inc.12-MAR-10
Metformin Hydrochloride Cadila Healthcare Limited18-MAR-10
Glyburide (micronized) And Metformin HydrochlorideActavis Pharma Manufacturing Pvt. Ltd.24-MAR-10
Metformin HydrochlorideCaraco Pharmaceutical Laboratories, Ltd30-MAR-10
Metformin Hydrochloride PD-Rx Pharmaceuticals, Inc.30-MAR-10
Glyburide And Metformin HydrochlorideActavis Elizabeth LLC30-MAR-10
Glyburide And Metformin HydrochloridePreferred Pharmaceuticals, Inc30-MAR-10
Metformin HydrochlorideMed-Health Pharma, LLC30-MAR-10
Metformin HydrochlorideMylan Pharmaceuticals Inc.31-MAR-10
Metformin HydrochlorideContract Pharmacy Services-PA09-APR-10
Metformin HydrochlorideState of Florida DOH Central Pharmacy07-JUN-10
Metformin HydrochlorideState of Florida DOH Central Pharmacy07-JUN-10
Metformin HydrochlorideMedVantx, Inc.11-JUN-10
Metformin HydrochlorideTorrent Pharmaceuticals Limited23-JUN-10
Metformin HydrochlorideTorrent Pharmaceuticals Limited23-JUN-10
Metformin Hydrochloride AvPAK23-JUL-10
Metformin HydrochloridePD-Rx Pharmaceuticals, Inc.27-JUL-10
Metformin HydrochlorideMedVantx, Inc.27-JUL-10
Metformin HydrochloridePD-Rx Pharmaceuticals, Inc.27-JUL-10
Metformin HydrochlorideState of Florida DOH Central Pharmacy09-AUG-10
Glyburide (micronized) And Metformin HydrochlorideActavis Inc.08-SEP-10
Metformin Hydrochloride AvKARE, Inc.21-SEP-10
Metformin HydrochlorideRebel Distributors Corp.04-OCT-10
Metformin HydrochlorideUDL Laboratories, Inc.08-OCT-10
Metformin HydrochlorideGreenstone LLC25-NOV-10
Metformin HydrochlorideAurobindo Pharma Limited02-DEC-10
Glyburide And MetforminRebel Distributors Corp28-DEC-10
Glyburide And MetforminUnit Dose Services02-JAN-11
Glyburide And MetforminPD-Rx Pharmaceuticals, Inc.02-JAN-11
Metformin HydrochloridePreferred Pharmaceuticals, Inc12-JAN-11
Metformin HydrochlorideGlenmark Generics Inc., USA27-JAN-11
Metformin HydrochlorideRebel Distributors Corp13-APR-11
Glipizide And Metformin HydrochlorideRebel Distributors Corp13-APR-11
Metformin Hydrochloride Extended ReleaseREMEDYREPACK INC. 21-APR-11
Metformin HydrochlorideREMEDYREPACK INC. 29-APR-11
GlumetzaDepomed, Inc.30-APR-11
Metformin HydrochlorideZydus Pharmaceuticals (USA) Inc.04-MAY-11
Metformin HydrochlorideApotex Corp.05-MAY-11
Metformin Hydrochloride REMEDYREPACK INC. 12-MAY-11
Metformin Hydrochloride REMEDYREPACK INC. 16-MAY-11
Metformin HydrochlorideGolden State Medical Supply, Inc.19-MAY-11
Metformin HydrochlorideCardinal Health09-JUN-11
Metformin HydrochlorideCardinal Health10-JUN-11
Metformin HydrochlorideNCS HealthCare of KY, Inc dba Vangard Labs14-JUN-11
Glyburide And Metformin HydrochlorideAurobindo Pharma Limited29-JUN-11
Metformin HydrochlorideQualitest Pharmaceuticals29-JUN-11
Metformin HydrochlorideREMEDYREPACK INC. 21-JUL-11
Metformin HydrochlorideLUPIN PHARMACEUTICALS INC28-JUL-11
Metformin HydrochlorideREMEDYREPACK INC. 10-AUG-11
Metformin Hydrochloride Unit Dose Services17-AUG-11
Metformin Hydrochloride Unit Dose Services17-AUG-11
Metformin HydrochloridePreferred Pharmaceuticals, Inc17-AUG-11
Metformin HydrochlorideREMEDYREPACK INC. 08-SEP-11
Metformin Hydrochloride St Marys Medical Park Pharmacy08-SEP-11
Metformin HydrochlorideEon Labs, Inc.21-SEP-11
Metformin HydrochlorideZydus Pharmaceuticals (USA) Inc.07-NOV-11
Metformin HydrochlorideCadila Healthcare Limited12-NOV-11
Metformin HydrochlorideREMEDYREPACK INC. 14-NOV-11
Metformin Hydrochloride Lake Erie Medical DBA Quality Care Products LLC01-DEC-11
Metformin HydrochlorideREMEDYREPACK INC. 02-DEC-11
Glyburide And MetforminPhysicians Total Care, Inc.20-DEC-11
Glyburide And MetforminRebel Distributors Corp20-DEC-11
Metformin HydrochlorideNostrum Laboratories Inc.20-DEC-11
Metformin HydrochlorideInventia Healthcare Private Limited30-JAN-12
JentaduetoBoehringer Ingelheim Pharmaceuticals, Inc.31-JAN-12
Metformin HydrochlorideMylan Pharmaceuticals Inc.01-FEB-12
Metformin HydrochlorideMcKesson Contract Packaging08-FEB-12
Glyburide And Metformin HydrochlorideCorePharma, LLC09-FEB-12
Metformin HydrochlorideLegacy Pharmaceutical Packaging14-FEB-12
Metformin HydrochlorideLegacy Pharmaceutical Packaging14-FEB-12
Metformin HydrochlorideNCS HealthCare of KY, Inc dba Vangard Labs21-FEB-12
Metformin Hydrochloride Life Line Home Care Services, Inc.22-FEB-12
Metformin HydrochlorideAmerican Health Packaging26-MAR-12
AvandametGlaxoSmithKline LLC03-APR-12
Glipizide And Metformin HydrochlorideMylan Pharmaceuticals Inc.09-APR-12
Metformin HydrochlorideWatson Laboratories, Inc.26-APR-12
Metformin HydrochlorideCardinal Health01-MAY-12
Metformin HydrochlorideCardinal Health01-MAY-12
Metformin HydrochlorideSandoz Inc08-MAY-12
Metformin HydrochlorideMajor Pharmaceuticals22-MAY-12
Metformin HydrochlorideHeritage Pharmaceuticals Inc.23-MAY-12
Pioglitazone Hydrochloride And Metformin HydrochlorideMylan Pharmaceuticals Inc.31-MAY-12
Metformin Hydrochloride AvKARE, Inc.26-JUN-12
Metformin HydrochlorideAmerican Health Packaging26-JUN-12
Metformin HydrochlorideWatson Pharma, Inc.09-JUL-12
Metformin HydrochloridePD-Rx Pharmaceuticals, Inc.09-JUL-12
Metformin HydrochlorideAphena Pharma Solutions - Tennessee, Inc.09-JUL-12
Metformin HydrochlorideREMEDYREPACK INC. 10-JUL-12
Glyburide And Metformin HydrochlorideGreenstone LLC16-JUL-12
Glyburide And Metformin HydrochlorideAphena Pharma Solutions - Tennessee, Inc.19-JUL-12
Metformin HydrochlorideAurobindo Pharma Limited23-JUL-12
Glyburide And MetforminTeva Pharmaceuticals USA Inc23-JUL-12
Metformin HydrochlorideAscend Laboratories, LLC24-JUL-12
Metformin HydrochlorideTeva Pharmaceuticals USA Inc25-JUL-12
Actoplus MetCardinal Health16-AUG-12
Metformin HydrochlorideREMEDYREPACK INC. 27-AUG-12
Metformin HydrochlorideREMEDYREPACK INC. 27-AUG-12
Metformin HydrochlorideTeva Pharmaceuticals USA Inc29-AUG-12
Avandamet Physicians Total Care, Inc.30-AUG-12
Metformin Hydrochloride PD-Rx Pharmaceuticals, Inc.06-SEP-12
Metformin HydrochlorideAmneal Pharmaceuticals06-SEP-12
Metformin HydrochlorideAmneal Pharmaceuticals07-SEP-12
Metformin Hydrochloride PD-Rx Pharmaceuticals, Inc.07-SEP-12
Metformin Hydrochloride PD-Rx Pharmaceuticals, Inc.11-SEP-12
Metformin HydrochlorideAmneal Pharmaceuticals11-SEP-12
Metformin Hydrochloride PD-Rx Pharmaceuticals, Inc.11-SEP-12
Metformin HydrochloridePhysicians Total Care, Inc.13-SEP-12
Metformin HydrochlorideEon Labs, Inc.19-SEP-12
Actoplus MetTakeda Pharmaceuticals America, Inc.30-SEP-12
Metformin Hydrochloride STAT Rx USA LLC04-OCT-12
Metformin HydrochlorideMajor Pharmaceuticals09-OCT-12
Metformin Hydrochloride Bryant Ranch Prepack12-OCT-12
Metformin HydrochlorideBryant Ranch Prepack12-OCT-12
Metformin HydrochlorideMylan Institutional Inc.12-OCT-12
Metformin HydrochlorideBryant Ranch Prepack12-OCT-12
Glyburide-metformin HydrochlorideHeritage Pharmaceuticals Inc.22-OCT-12
Metformin HydrochlorideAidarex Pharmaceuticals LLC26-OCT-12
Metformin HydrochlorideAidarex Pharmaceuticals LLC26-OCT-12
Metformin HydrochlorideMajor Pharmaceuticals31-OCT-12
Actoplus MetxrTakeda Pharmaceuticals America, Inc.31-OCT-12
Pioglitazone And Metformin HydrocholrideTeva Pharmaceuticals USA30-NOV-12
Metformin HydrochlorideSolco healthcare U.S., LLC01-DEC-12
Metformin Hydrochloride Solco healthcare U.S., LLC01-JAN-13
GlumetzaSantarus, Inc.01-JAN-13
Metformin HydrochlorideAscend Laboratories, LLC14-JAN-13
Glyburide And Metformin HydrochloridePreferred Pharmaceuticals, Inc.14-JAN-13
Glyburide And MetforminBryant Ranch Prepack17-JAN-13
Glyburide And MetforminBryant Ranch Prepack17-JAN-13
Glyburide And MetforminBryant Ranch Prepack18-JAN-13
Metformin Hydrochloride Bryant Ranch Prepack21-JAN-13
FortametShionogi Inc.07-FEB-13
Glipizide And Metformin HydrochlorideTeva Pharmaceuticals USA Inc08-FEB-13
Metformin HydrochlorideREMEDYREPACK INC. 09-FEB-13
Glipizide And Metformin HydrochlorideWatson Laboratories, Inc.12-FEB-13
Pioglitazone Hydrochloride And Metformin HydrochlorideAurobindo Pharma Limited13-FEB-13
Pioglitazone Hcl And Metformin HclTorrent Pharmaceuticals Limited13-FEB-13
Metformin HydrochlorideREMEDYREPACK INC. 01-MAR-13
Metformin HydrochlorideBryant Ranch Prepack06-MAR-13
Metformin HydrochlorideREMEDYREPACK INC. 14-MAR-13
Metformin HydrochlorideNCS HealthCare of KY, Inc dba Vangard Labs15-MAR-13
Metformin HydrochlorideREMEDYREPACK INC. 19-MAR-13
Metformin HydrochlorideREMEDYREPACK INC. 29-MAR-13
Glucophage XrBristol-Myers Squibb Company01-APR-13
GlucophageBristol-Myers Squibb Company01-APR-13
Metformin HydrochlorideSolco healthcare U.S., LLC01-APR-13
Metformin HydrochlorideREMEDYREPACK INC. 08-APR-13
Metformin HydrochlorideREMEDYREPACK INC. 09-APR-13
Metformin HydrochlorideMARKSANS PHARMA LIMITED15-APR-13
Pioglitazone And MetforminSandoz Inc17-APR-13
Metformin HydrochlorideCardinal Health22-APR-13
Metformin HydrochlorideREMEDYREPACK INC. 07-MAY-13
Metformin HydrochlorideREMEDYREPACK INC. 07-MAY-13

Metformin Hydrochloride Case Reports

What Metformin Hydrochloride 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 Metformin Hydrochloride. 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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