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Metformin (Metformin) - Side Effect Reports to FDA

 
 



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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