This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Metformin and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (22)
Death (5)
Life Threatening Events (2)
Disability (1)
Reports by Reaction Type
Renal Failure Acute (5),
Hypotension (4),
Lactic Acidosis (3),
Suicide Attempt (3),
Intentional Overdose (2),
Hypoglycaemia (2),
Completed Suicide (2),
Blood Creatinine Increased (2),
Dyspnoea (2),
Diarrhoea (2),
Rhabdomyolysis (1),
Culture Urine Positive (1)
Possible Metformin side effects in female
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-23
Patient: female, weighing 3.0 kg (6.6 pounds)
Reactions: Hypoplastic Left Heart Syndrome, Turner's Syndrome
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Metformin
Other drugs received by patient: Cetirizine HCL; Albuterol; Progesterone; Folic Acid; Levothyroxine Sodium; Emser Nasenspray; Ebenol; Kadefungin 3 Kombi-Packung
Possible Metformin side effects in male
Reported by a physician from United States on 2012-08-22
Patient: male, weighing 78.0 kg (171.6 pounds)
Reactions: Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Spironolactone
Dosage: 25 mg, qd
Start date: 2011-08-01
End date: 2012-03-29
Ibuprofen
Victoza
Dosage: unk
Indication: Type 2 Diabetes Mellitus
Start date: 2012-02-14
End date: 2012-03-24
Metformin
Dosage: 1000 mg, bid
Start date: 2011-09-01
End date: 2012-03-29
Omeprazole
Dosage: 20 mg, qd
Indication: Gastrooesophageal Reflux Disease
Start date: 2011-09-01
End date: 2012-03-29
Losartan Potassium
Dosage: 25 mg, bid
Start date: 2011-12-01
End date: 2012-03-29
Lasix
Dosage: 40 mg, qd
Start date: 2011-08-01
End date: 2012-03-29
Placebo
Dosage: code not broken
Indication: Cardiovascular Event Prophylaxis
Start date: 2011-09-29
End date: 2012-06-29
Ilaris
Dosage: code not broken
Indication: Cardiovascular Event Prophylaxis
Start date: 2011-09-29
End date: 2012-06-29
Blinded NO Treatment Received
Dosage: code not broken
Indication: Cardiovascular Event Prophylaxis
Start date: 2011-09-29
End date: 2012-06-29
Other drugs received by patient: Aspirin; Carvedilol; Multi-Vitamins; Potassium; Crestor
Possible Metformin side effects in 55 year old male
Reported by a physician from United States on 2012-08-20
Patient: 55 year old male
Reactions: Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Metformin
Dosage: 2000 mg
Indication: Type 2 Diabetes Mellitus
Placebo
Dosage: unk
Indication: Type 2 Diabetes Mellitus
Start date: 2011-04-26
Ramipril
Dosage: unk
Saxagliptin
Dosage: unk
Indication: Type 2 Diabetes Mellitus
Start date: 2011-04-26
Actos
Dosage: 15 mg, unk
Indication: Type 2 Diabetes Mellitus
Other drugs received by patient: Acetylsalicylic Acid
Possible Metformin side effects in 90 year old female
Reported by a individual with unspecified qualification from Japan on 2012-06-20
Patient: 90 year old female
Reactions: Hypoglycaemic Unconsciousness, Hypoglycaemia
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Actos
Dosage: 30 mg/daily/po
Administration route: Oral
Indication: Type 2 Diabetes Mellitus
End date: 2010-09-28
Metformin
Dosage: 25c mg/daily/po
Administration route: Oral
Indication: Type 2 Diabetes Mellitus
End date: 2010-09-28
TAB Januvia (Silagliptin Phosphate)
Dosage: 50 mg/daily/po
Administration route: Oral
Indication: Type 2 Diabetes Mellitus
Start date: 2010-09-17
End date: 2010-09-28
Amaryl
Dosage: 3 mg/daily/po
Administration route: Oral
Indication: Type 2 Diabetes Mellitus
End date: 2010-09-28
Other drugs received by patient: Lasix; Baymycard; Lipitor; EC Doparl
Possible Metformin side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-18
Patient: female
Reactions: Drug Hypersensitivity
Drug(s) suspected as cause:
Oxycodone HCL
Dosage: unk
Metformin
Dosage: unk
Mirtazapine
Dosage: unk
Hydrocodone
Dosage: unk
Penicillin G Potassium
Dosage: unk
Possible Metformin side effects in 66 year old female
Reported by a physician from United States on 2012-06-11
Patient: 66 year old female
Reactions: Completed Suicide
Adverse event resulted in: death
Drug(s) suspected as cause:
Septra
Dosage: unk
Administration route: Oral
Indication: Completed Suicide
Clonazepam
Dosage: unk
Administration route: Oral
Indication: Completed Suicide
Pioglitazone
Dosage: unk
Administration route: Oral
Indication: Completed Suicide
Metformin
Dosage: unk
Administration route: Oral
Indication: Completed Suicide
Quetiapine
Dosage: unk
Administration route: Oral
Indication: Completed Suicide
Venlafaxine HCL
Dosage: unk
Administration route: Oral
Indication: Completed Suicide
Possible Metformin side effects in 52 year old female
Reported by a physician from United States on 2012-04-26
Patient: 52 year old female, weighing 97.0 kg (213.4 pounds)
Reactions: Urinary Tract Infection, Hyponatraemia, Pancreatitis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Metformin
Janumet
Administration route: Oral
Indication: Diabetes Mellitus
Start date: 2009-01-01
End date: 2012-01-29
Januvia
Administration route: Oral
Indication: Diabetes Mellitus
Start date: 2012-01-30
Other drugs received by patient: Ranitidine; Hydrochlorothiazide and Lisinopril; Celexa; Nexium; Glucotrol XL; Dicyclomine Hydrochloride; Hydrochlorothiazide and Lisinopril
Possible Metformin side effects in 78 year old female
Reported by a health professional (non-physician/pharmacist) from Spain on 2012-04-25
Patient: 78 year old female
Reactions: Meningitis Pneumococcal, Vomiting, Hypotension, Coma, General Physical Health Deterioration, Lactic Acidosis, Poor Peripheral Circulation, Depressed Level of Consciousness, Blood Creatinine Increased, Blood Glucose Increased
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Metformin
Other drugs received by patient: Glipizide; Lisinopril; Hydrochlorothiazide; Ibuprofen; Lercanidipine; Acenocoumarol
Possible Metformin side effects in 62 year old female
Reported by a health professional (non-physician/pharmacist) from Sweden on 2012-04-23
Patient: 62 year old female, weighing 83.0 kg (182.6 pounds)
Reactions: Abdominal Pain, Fatigue, Pruritus, Dyspnoea, Nausea, Diarrhoea
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Metformin
Administration route: Oral
Indication: Type 2 Diabetes Mellitus
Start date: 2012-02-09
End date: 2012-02-11
Januvia
Administration route: Oral
Indication: Type 2 Diabetes Mellitus
Start date: 2012-02-01
End date: 2012-02-01
Insulatard NPH Human
Indication: Type 2 Diabetes Mellitus
Start date: 2012-02-01
End date: 2012-02-01
Other drugs received by patient: Doxyferm
Possible Metformin side effects in male
Reported by a physician from Germany on 2012-03-14
Patient: male, weighing 95.0 kg (209.0 pounds)
Reactions: Blood Pressure Increased, Left Ventricular Dysfunction, Dyspnoea, Angina Pectoris, Atrioventricular Block, Bundle Branch Block Left, Congestive Cardiomyopathy, Obstructive Airways Disorder
Drug(s) suspected as cause:
Torsemide
Dosage: 20 meq/kg, qd
Administration route: Oral
Start date: 2011-10-31
Bisoprolol Fumarate
Dosage: 2.5 mg, qd
Administration route: Oral
Start date: 2011-10-31
Spironolactone
Dosage: 25 mg, qd
Administration route: Oral
Start date: 2011-10-31
Omeprazole
Dosage: 20 mg, qd
Administration route: Oral
Start date: 2011-10-31
Metformin
Dosage: 2000 mg, qd
Administration route: Oral
Start date: 2011-10-31
Rasilez
Dosage: 300 mg, qd
Administration route: Oral
Other drugs received by patient: Oral Antidiabetics
Possible Metformin side effects in
Reported by a health professional (non-physician/pharmacist) from France on 2012-03-13
Patient:
Reactions: Congenital Great Vessel Anomaly, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Januvia
Indication: Type 2 Diabetes Mellitus
End date: 2011-04-01
Metformin
Administration route: Oral
Indication: Type 2 Diabetes Mellitus
End date: 2011-04-01
Possible Metformin side effects in male
Reported by a consumer/non-health professional from United States on 2012-03-05
Patient: male
Reactions: Weight Increased
Drug(s) suspected as cause:
Metformin
Dosage: unk
Actos
Dosage: unk
Glipizide
Dosage: unk
Possible Metformin side effects in 49 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-23
Patient: 49 year old male, weighing 74.0 kg (162.8 pounds)
Reactions: Tinnitus, Tympanic Membrane Disorder, Anion GAP Increased, Necrosis, Unresponsive To Stimuli, Hypoglycaemia, Continuous Haemodiafiltration, Lactic Acidosis, Hypernatraemia, Culture Urine Positive, Cerebral Ischaemia, Overdose, Blood Culture Positive, Thrombocytopenia, Renal Failure Acute, Hyperglycaemia, Hypotension, Deafness Neurosensory, Otitis Externa, Streptococcus Test Positive, Respiratory Distress, Respiratory Failure, Diarrhoea, Suicide Attempt, Vertigo, Middle Ear Disorder, Ear Pain, Leukocytosis, Staphylococcus Test Positive, Adrenal Disorder
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Metformin
Dosage: (df oral)
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Glyburide
Dosage: (df)
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Vardenafil Hydrochloride (Levitra); Lisinopril; Gemfibrozil
Possible Metformin side effects in 38 year old female
Reported by a physician from Germany on 2012-02-10
Patient: 38 year old female
Reactions: Intentional Overdose, Hypotension, Suicide Attempt, Somnolence
Drug(s) suspected as cause:
Pipamperone Hydrochloride
Dosage: 100 mg, single
Administration route: Oral
Start date: 2009-12-10
End date: 2009-12-10
Metformin
Dosage: 5 df, single
Administration route: Oral
Start date: 2009-12-10
End date: 2009-12-10
Lorazepam
Dosage: 30 mg, single
Administration route: Oral
Start date: 2009-12-10
End date: 2009-12-10
Altace
Dosage: 25 mg, single
Administration route: Oral
Start date: 2009-12-10
End date: 2009-12-10
Levoxyl
Dosage: 5 df, single
Administration route: Oral
Start date: 2009-12-10
End date: 2009-12-10
Escitalopram Oxalate
Dosage: 50 mg, single
Administration route: Oral
Start date: 2009-12-10
End date: 2009-12-10
Abilify
Dosage: 25 mg, single
Administration route: Oral
Start date: 2009-12-10
End date: 2009-12-10
Possible Metformin side effects in 53 year old male
Reported by a consumer/non-health professional from United States on 2012-01-30
Patient: 53 year old male
Reactions: Staphylococcal Infection, Myocardial Infarction, Blood Creatinine Increased, Kidney Infection, Diabetes Mellitus Inadequate Control
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Januvia
Administration route: Oral
Start date: 2011-07-01
Metformin
Januvia
Administration route: Oral
Indication: Type 2 Diabetes Mellitus
Amaryl
Administration route: Oral
Start date: 2011-08-01
Amaryl
Administration route: Oral
Indication: Type 2 Diabetes Mellitus
Possible Metformin side effects in 56 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-01-18
Patient: 56 year old female
Reactions: Rhabdomyolysis, Pain in Extremity, Diabetic Nephropathy, Acidosis, Altered State of Consciousness, Renal Failure Acute
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Altace
Dosage: 10 mg, 1x/day
Administration route: Oral
End date: 2011-04-23
Metformin
Dosage: 1000 mg, 3x/day
Administration route: Oral
End date: 2011-04-23
Lyrica
Dosage: 200 mg, 2x/day
Administration route: Oral
Indication: Myalgia
End date: 2011-04-23
Irbesartan and Hydrochlorothiazide
Dosage: 300 mg/12.5, qd
Administration route: Oral
End date: 2011-04-23
Crestor
Dosage: 20 mg, 2x/day
Administration route: Oral
End date: 2011-04-23
Ezetimibe
Dosage: 10 mg, 1x/day
Administration route: Oral
End date: 2011-04-23
Possible Metformin side effects in 62 year old female
Reported by a physician from United States on 2011-12-22
Patient: 62 year old female
Reactions: Completed Suicide
Adverse event resulted in: death
Drug(s) suspected as cause:
Phenothiazine
Administration route: Oral
Metformin
Administration route: Oral
Thiothixene HCL
Administration route: Oral
Possible Metformin side effects in 75 year old male
Reported by a physician from Argentina on 2011-11-23
Patient: 75 year old male
Reactions: Hepatitis Cholestatic, Jaundice, Liver Function Test Abnormal, Peripheral Ischaemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Metformin
Indication: Type 2 Diabetes Mellitus
Ketoconazole
Indication: Infected Skin Ulcer
Rifampicin
Indication: Infected Skin Ulcer
Blinded Therapy
Indication: Type 2 Diabetes Mellitus
Start date: 2010-09-23
End date: 2011-09-07
Blinded Therapy
Other drugs received by patient: ACE Inhibitor NOS; HMG COA Reductase Inhibitors; Diuretics; Insulin; Acetylsalicylic Acid SRT
Possible Metformin side effects in 82 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2011-11-21
Patient: 82 year old female
Reactions: Cholelithiasis, Cytolytic Hepatitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Metformin
Administration route: Oral
End date: 2011-08-08
Furosemide
Administration route: Oral
End date: 2011-08-08
Januvia
Administration route: Oral
End date: 2011-08-08
Aricept
Administration route: Oral
Start date: 2010-02-01
End date: 2011-08-23
Stablon
Administration route: Oral
Start date: 2011-06-01
End date: 2011-08-29
Nexium
Administration route: Oral
End date: 2011-08-29
Other drugs received by patient: Irbesartan; Warfarin Sodium; Insulin Glargine; Sotalol Hydrochloride; Ferrous Sulfate; Domperidone; Rosuvastatin Calcium
Possible Metformin side effects in 66 year old male
Reported by a physician from Germany on 2011-11-08
Patient: 66 year old male, weighing 160.0 kg (352.0 pounds)
Reactions: Bile Duct Cancer
Adverse event resulted in: death
Drug(s) suspected as cause:
Januvia
Administration route: Oral
Indication: Type 2 Diabetes Mellitus
Start date: 2010-10-01
End date: 2011-09-01
Metformin
Administration route: Oral
Indication: Type 2 Diabetes Mellitus
Start date: 2009-05-01
End date: 2011-09-01
Possible Metformin side effects in 50 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-28
Patient: 50 year old male
Reactions: Drug Level Increased, Intentional Overdose, Urine Output Decreased, Hypotension, Mental Status Changes, Lactic Acidosis, Toxicity To Various Agents, Suicide Attempt, Anuria, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Metformin HCL
Dosage: 500 mg, bid
Indication: Type 2 Diabetes Mellitus
Metformin
Dosage: 52 g, unk
Possible Metformin side effects in 69 year old male
Reported by a physician from United Kingdom on 2011-10-27
Patient: 69 year old male
Reactions: Skin Discolouration, Skin Lesion, Rash Erythematous, Rash Macular, Naevus Flammeus
Drug(s) suspected as cause:
Metformin
Indication: Type 2 Diabetes Mellitus
Ramipril
Indication: Type 2 Diabetes Mellitus
Zocor
Administration route: Oral
Indication: Hypercholesterolaemia
Aspirin
Indication: Type 2 Diabetes Mellitus
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