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Metformin Side Effects

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Common Metformin Side Effects


The most commonly reported Metformin side effects (click to view or check a box to report):

Lactic Acidosis (2533)
Renal Failure Acute (1526)
Diarrhoea (990)
Vomiting (734)
Blood Glucose Increased (635)
Hypotension (588)
Nausea (587)
Haemodialysis (566)
Hypoglycaemia (554)
Completed Suicide (515)
Metabolic Acidosis (488)
Abdominal Pain (385)
Dehydration (375)
Renal Failure (366)
Cardiac Arrest (346)
Dyspnoea (333)
Malaise (311)
Toxicity To Various Agents (287)
Hyperkalaemia (276)
Dizziness (259)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Metformin Side Effects Reported to FDA



Metformin Side Effect Report#9999324
Hypothyroidism, Condition Aggravated
This is a report of a 71-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: type 2 diabetes mellitus, who was treated with Metformin (dosage: 1.5 Per Day Once Daily, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Hypothyroidism, Condition Aggravated after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Metformin treatment in male patients, resulting in Hypothyroidism side effect.
Metformin Side Effect Report#9999301
Somnolence, Fatigue, Depressed Mood
This report suggests a potential Metformin Somnolence side effect(s) that can have serious consequences. A 17-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: glucose tolerance impaired,insulin resistance,overweight and used Metformin (dosage: 1 Tablet) starting
Jan 11, 2014. After starting Metformin the patient began experiencing various side effects, including: Somnolence, Fatigue, Depressed MoodAdditional drugs used concurrently: NA. Although Metformin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Somnolence, may still occur.
Metformin Side Effect Report#9996512
Abortion Spontaneous, Maternal Exposure During Pregnancy
This Abortion Spontaneous problem was reported by a health professional from US. A 44-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: insulin resistance. On NS this consumer started treatment with Metformin (dosage: 500 Mg, Per Day). The following drugs were being taken at the same time:
  • Aspirin (81 Mg, Per Day)
  • Calcium (1000 Mg, Per Day)
  • Immunoglobulin G Human (400 Mg/kg, Every 3-4 Weeks)
  • Thyroid Hormones
When using Metformin, the patient experienced the following unwanted symptoms/side effects: Abortion Spontaneous, Maternal Exposure During PregnancyAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Abortion Spontaneous, may become evident only after a product is in use by the general population.
Metformin Side Effect Report#9996495
Abortion Spontaneous, Maternal Exposure During Pregnancy
This Abortion Spontaneous side effect was reported by a health professional from US. A 44-year-old female patient (weight:NA) experienced the following symptoms/conditions: insulin resistance.The patient was prescribed Metformin (drug dosage: 500 Mg, Per Day), which was initiated on NS. Concurrently used drugs:
  • Thyroid Hormones
  • Aspirin (81 Mg, Per Day)
  • Calcium (1000 Mg, Per Day)
  • Immunoglobulin G Human (400 Mg/kg, Every 3?4 Weeks)
.After starting to take Metformin the consumer reported adverse symptoms, such as: Abortion Spontaneous, Maternal Exposure During PregnancyThese side effects may potentially be related to Metformin.
Metformin Side Effect Report#9996471
Pulmonary Oedema, Metabolic Acidosis, Vomiting
This is a report of a 67-year-old male patient (weight: NA) from IT, suffering from the following health symptoms/conditions: type 2 diabetes mellitus, who was treated with Metformin (dosage: 1000 Mg, Bid, start time:
Jan 23, 2013), combined with:
  • Diclofenac
and developed a serious reaction and side effect(s): Pulmonary Oedema, Metabolic Acidosis, Vomiting after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Metformin treatment in male patients, resulting in Pulmonary Oedema side effect. The patient was hospitalized.
Metformin Side Effect Report#9996467
Abortion Spontaneous, Maternal Exposure During Pregnancy
This report suggests a potential Metformin Abortion Spontaneous side effect(s) that can have serious consequences. A 44-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: insulin resistance and used Metformin (dosage: 500 Mg, Per Day) starting NS. After starting Metformin the patient began experiencing various side effects, including: Abortion Spontaneous, Maternal Exposure During PregnancyAdditional drugs used concurrently:
  • Calcium (1000 Mg, Per Day)
  • Thyroid Hormones
  • Aspirin (81 Mg, Per Day)
  • Immunoglobulin G Human (400 Mg/kg, Every 3-4 Weeks)
Although Metformin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Abortion Spontaneous, may still occur.
Metformin Side Effect Report#9996461
Abortion Spontaneous, Maternal Exposure During Pregnancy
This Abortion Spontaneous problem was reported by a health professional from US. A 44-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: insulin resistance. On NS this consumer started treatment with Metformin (dosage: 500 Mg, Per Day). The following drugs were being taken at the same time:
  • Calcium (1000 Mg, Per Day)
  • Thyroid Hormones
  • Aspirin (81 Mg, Per Day)
  • Immunoglobulin G Human (400 Mg/kg, Unk)
When using Metformin, the patient experienced the following unwanted symptoms/side effects: Abortion Spontaneous, Maternal Exposure During PregnancyAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Abortion Spontaneous, may become evident only after a product is in use by the general population.
Metformin Side Effect Report#9996440
Abortion Spontaneous, Maternal Exposure During Pregnancy
This Abortion Spontaneous side effect was reported by a health professional from US. A 44-year-old female patient (weight:NA) experienced the following symptoms/conditions: insulin resistance.The patient was prescribed Metformin (drug dosage: 500 Mg, Per Day), which was initiated on NS. Concurrently used drugs:
  • Calcium (1000 Mg, Per Day)
  • Immunoglobulin G Human (400 Mg/kg, Every 3-4 Weeks)
  • Aspirin (81 Mg, Per Day)
  • Thyroid Hormones
.After starting to take Metformin the consumer reported adverse symptoms, such as: Abortion Spontaneous, Maternal Exposure During PregnancyThese side effects may potentially be related to Metformin.
Metformin Side Effect Report#9996439
Abortion Spontaneous, Maternal Exposure During Pregnancy
This is a report of a 44-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: insulin resistance, who was treated with Metformin (dosage: 500 Mg, Per Day, start time: NS), combined with:
  • Thyroid Hormones
  • Aspirin (81 Mg, Per Day)
  • Calcium (1000 Mg, Per Day)
  • Immunoglobulin G Human (400 Mg/kg, Repeated Every 3-4 Weeks)
and developed a serious reaction and side effect(s): Abortion Spontaneous, Maternal Exposure During Pregnancy after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Metformin treatment in female patients, resulting in Abortion Spontaneous side effect.
Metformin Side Effect Report#9995548
Abdominal Pain, Hypothermia, Tachycardia, Hypotension, Lactic Acidosis, Haemodialysis, Haemodynamic Instability, Metabolic Acidosis, Infection
This report suggests a potential Metformin Abdominal Pain side effect(s) that can have serious consequences. A 63-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus and used Metformin (dosage: NA) starting NS. After starting Metformin the patient began experiencing various side effects, including: Abdominal Pain, Hypothermia, Tachycardia, Hypotension, Lactic Acidosis, Haemodialysis, Haemodynamic Instability, Metabolic Acidosis, InfectionAdditional drugs used concurrently: NA.The patient was hospitalized. Although Metformin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Abdominal Pain, may still occur.
Metformin Side Effect Report#9991552
Metabolic Acidosis, Pulmonary Oedema, Vomiting, Blood Creatinine Increased
This Metabolic Acidosis problem was reported by a health professional from IT. A 67-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus. On
Jan 23, 2013 this consumer started treatment with Metformin (dosage: 2000 Mg Daily). The following drugs were being taken at the same time:
  • Voltaren
When using Metformin, the patient experienced the following unwanted symptoms/side effects: Metabolic Acidosis, Pulmonary Oedema, Vomiting, Blood Creatinine IncreasedThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Metabolic Acidosis, may become evident only after a product is in use by the general population.
Metformin Side Effect Report#9981420
Subdural Haematoma
This Subdural Haematoma side effect was reported by a physician from US. A 82-year-old male patient (weight:NA) experienced the following symptoms/conditions: type 2 diabetes mellitus.The patient was prescribed Metformin (drug dosage: NA), which was initiated on
Jul 25, 2012. Concurrently used drugs:
  • Isosorbide Mononitrate
  • Nicorandil
.After starting to take Metformin the consumer reported adverse symptoms, such as: Subdural HaematomaThese side effects may potentially be related to Metformin. The patient was hospitalized.
Metformin Side Effect Report#9981225
Lactic Acidosis, Toxicity To Various Agents, Metabolic Acidosis, Abdominal Pain, Wheezing, Blood Pressure Increased, Respiratory Distress, Cardiovascular Disorder, Depressed Level Of Consciousness
This is a report of a 56-year-old male patient (weight: NA) from SE, suffering from the following health symptoms/conditions: type 2 diabetes mellitus,gout, who was treated with Metformin (metformin) (dosage: NA, start time: NS), combined with:
  • Allopurinol
  • Warfarin
and developed a serious reaction and side effect(s): Lactic Acidosis, Toxicity To Various Agents, Metabolic Acidosis, Abdominal Pain, Wheezing, Blood Pressure Increased, Respiratory Distress, Cardiovascular Disorder, Depressed Level Of Consciousness after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Metformin (metformin) treatment in male patients, resulting in Lactic Acidosis side effect. The patient was hospitalized.
Metformin Side Effect Report#9981217
Rosacea, Pruritus, Rash Papular, Telangiectasia, Lupus-like Syndrome
This report suggests a potential Metformin (metformin) Rosacea side effect(s) that can have serious consequences. A 29-year-old female patient (weight: NA) from IT was diagnosed with the following symptoms/conditions: glucose tolerance impaired and used Metformin (metformin) (dosage: NA) starting NS. After starting Metformin (metformin) the patient began experiencing various side effects, including: Rosacea, Pruritus, Rash Papular, Telangiectasia, Lupus-like SyndromeAdditional drugs used concurrently: NA. Although Metformin (metformin) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Rosacea, may still occur.
Metformin Side Effect Report#9981214
Rosacea, Rash, Pruritus, Burning Sensation, Erythema, Rash Papular, Off Label Use, Lupus-like Syndrome, Toxic Skin Eruption
This Rosacea problem was reported by a health professional from IT. A 29-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: glucose tolerance impaired. On NS this consumer started treatment with Metformin Hydrochloride (metformin Hydrochloride) (dosage: NA). The following drugs were being taken at the same time:
  • Levothyroxine (levothyroxine)
When using Metformin Hydrochloride (metformin Hydrochloride), the patient experienced the following unwanted symptoms/side effects: Rosacea, Rash, Pruritus, Burning Sensation, Erythema, Rash Papular, Off Label Use, Lupus-like Syndrome, Toxic Skin EruptionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Rosacea, may become evident only after a product is in use by the general population.
Metformin Side Effect Report#9981201
Lactic Acidosis, Toxicity To Various Agents, Metabolic Acidosis, Blood Pressure Increased, Nausea, Vomiting, Abdominal Pain, Wheezing, Respiratory Distress
This Lactic Acidosis side effect was reported by a health professional from SE. A 66-year-old male patient (weight:NA) experienced the following symptoms/conditions: type 2 diabetes mellitus,gout.The patient was prescribed Metformin Hydrochloride (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Allopurinol
  • Warfarin(warfarin)
.After starting to take Metformin Hydrochloride the consumer reported adverse symptoms, such as: Lactic Acidosis, Toxicity To Various Agents, Metabolic Acidosis, Blood Pressure Increased, Nausea, Vomiting, Abdominal Pain, Wheezing, Respiratory DistressThese side effects may potentially be related to Metformin Hydrochloride. The patient was hospitalized.
Metformin Side Effect Report#9981115
Vomiting, Renal Failure Acute, Lactic Acidosis, Respiratory Distress, Decreased Appetite, Nervous System Disorder
This is a report of a 70-year-old male patient (weight: NA) from FR, suffering from the following health symptoms/conditions: diabetes mellitus, who was treated with Metformin (metformin) (dosage: 1 D, start time:
Dec 15, 2013), combined with:
  • Aldactone (spironolactone) (1 Dosage Forms, 1 In 1 D)
  • Eucreas (2 Dosage Forms, 1 In 1 D)
  • Xeloda (capecitabine) (4 Dosage Forms, 1 In 1 D)
  • Zolpidem (zolpidem)
  • Ixprim
and developed a serious reaction and side effect(s): Vomiting, Renal Failure Acute, Lactic Acidosis, Respiratory Distress, Decreased Appetite, Nervous System Disorder after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Metformin (metformin) treatment in male patients, resulting in Vomiting side effect. The patient was hospitalized.
Metformin Side Effect Report#9980302
Hypoglycaemic Coma, Tongue Biting, Metabolic Encephalopathy, Apallic Syndrome, Urinary Incontinence, Agitation, Accidental Overdose, Encephalitis
This report suggests a potential Metformin (metformin) Hypoglycaemic Coma side effect(s) that can have serious consequences. A 63-year-old male patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus and used Metformin (metformin) (dosage: 1500 Mg (500 Mg, 3 In 1 D)) starting
Nov 15, 2013. After starting Metformin (metformin) the patient began experiencing various side effects, including: Hypoglycaemic Coma, Tongue Biting, Metabolic Encephalopathy, Apallic Syndrome, Urinary Incontinence, Agitation, Accidental Overdose, EncephalitisAdditional drugs used concurrently:
  • Atenolol (atenolol) (100 Mg, 1 D)
  • Amarel (glimepiride) (4 Mg, 1 D)
  • Onglyza (saxagliptin Hydrochloride) (5 Mg, 1 D)
  • Oflocet (ofloxacin) (400 Mg (200 Mg, 2 In 1 D))
  • Inexium (esomeprazole Magnesium) (esomeprazole Magnesium)
  • Lipanthyl (fenofibrate)
The patient was hospitalized. Although Metformin (metformin) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hypoglycaemic Coma, may still occur.
Metformin Side Effect Report#9979820
Suicide Attempt, Hypoglycaemia, Bradycardia, Lactic Acidosis, Renal Failure Acute, Shock, Intentional Overdose
This Suicide Attempt problem was reported by a health professional from US. A 59-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Metformin (dosage: Approximately Ingested?60 Metformin 500-mg Tablets (30 G)). The following drugs were being taken at the same time:
  • Amlodipine (Approximately Ingested?30 Amlodipine 10-mg Tablets (300 Mg))
  • Lisinopril (Approximately Ingested?30 Lisinopril 10-mg Tablets (300 Mg))
  • Simvastatin
When using Metformin, the patient experienced the following unwanted symptoms/side effects: Suicide Attempt, Hypoglycaemia, Bradycardia, Lactic Acidosis, Renal Failure Acute, Shock, Intentional OverdoseThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Suicide Attempt, may become evident only after a product is in use by the general population.
Metformin Side Effect Report#9976065
Metabolic Acidosis, Discomfort, Intentional Overdose
This Metabolic Acidosis side effect was reported by a health professional from US. A 60-year-old male patient (weight:NA) experienced the following symptoms/conditions: type 2 diabetes mellitus.The patient was prescribed Metformin (drug dosage: 10 U, Unk), which was initiated on NS. Concurrently used drugs:
  • Insulin
  • Protamine
.After starting to take Metformin the consumer reported adverse symptoms, such as: Metabolic Acidosis, Discomfort, Intentional OverdoseThese side effects may potentially be related to Metformin. The patient was hospitalized.
Metformin Side Effect Report#9976049
Renal Failure Acute, Respiratory Failure, Renal Impairment, Lactic Acidosis, Metabolic Acidosis, Mental Status Changes
This is a report of a 56-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: type 2 diabetes mellitus, who was treated with Metformin (dosage: 500 Mg, Bid, start time: NS), combined with:
  • Lisinopril
  • Diuretics
and developed a serious reaction and side effect(s): Renal Failure Acute, Respiratory Failure, Renal Impairment, Lactic Acidosis, Metabolic Acidosis, Mental Status Changes after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Metformin treatment in male patients, resulting in Renal Failure Acute side effect. The patient was hospitalized.
Metformin Side Effect Report#9976045
Metabolic Acidosis, Congestive Cardiomyopathy, Renal Failure Chronic, Chest Pain, Dyspnoea, Renal Failure Acute, Ejection Fraction Decreased, Kussmaul Respiration
This report suggests a potential Metformin Metabolic Acidosis side effect(s) that can have serious consequences. A 70-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus and used Metformin (dosage: 500 Mg, Bid) starting NS. After starting Metformin the patient began experiencing various side effects, including: Metabolic Acidosis, Congestive Cardiomyopathy, Renal Failure Chronic, Chest Pain, Dyspnoea, Renal Failure Acute, Ejection Fraction Decreased, Kussmaul RespirationAdditional drugs used concurrently: NA.The patient was hospitalized. Although Metformin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Metabolic Acidosis, may still occur.
Metformin Side Effect Report#9974336
Myocardial Ischaemia
This Myocardial Ischaemia problem was reported by a physician from IL. A 64-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus. On
Sep 06, 2009 this consumer started treatment with Metformin (dosage: 2550 Milligram Daily;). The following drugs were being taken at the same time:
  • Bezafibrate (400 Milligram Daily;)
  • Tritace (5 Milligram Daily;)
  • Simovil (20 Milligram Daily;)
  • Cartia (100 Milligram Daily;)
When using Metformin, the patient experienced the following unwanted symptoms/side effects: Myocardial IschaemiaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Myocardial Ischaemia, may become evident only after a product is in use by the general population.
Metformin Side Effect Report#9974255
Erythema Multiforme
This Erythema Multiforme side effect was reported by a pharmacist from GB. A 73-year-old male patient (weight:NA) experienced the following symptoms/conditions: type 2 diabetes mellitus,urinary tract disorder,cardiac disorder,hypercholesterolaemia,hypertension.The patient was prescribed Metformin (drug dosage: 1000 Milligram Daily;), which was initiated on
Jan 20, 2014. Concurrently used drugs:
  • Tamsulosin
  • Bisoprolol
  • Simvastatin
  • Ramipril
  • Aspirin
.After starting to take Metformin the consumer reported adverse symptoms, such as: Erythema MultiformeThese side effects may potentially be related to Metformin. The patient was hospitalized.
Metformin Side Effect Report#9970198
Jaundice Hepatocellular, Hypertension
This is a report of a 52-year-old female patient (weight: NA) from IN, suffering from the following health symptoms/conditions: NA, who was treated with Metformin (metformin)(metformin) (dosage: For Last 7 Years, start time: NS), combined with:
  • Levothyroxine (levothyroxine)(levothyroxine Sodium) (For Last 10 Years)
  • Calcium (calcium)(calcium) (Last 5 Years)
  • Atenolol (atenolol) (tablet) (atenolol) (For Last 3 Weeks -)
and developed a serious reaction and side effect(s): Jaundice Hepatocellular, Hypertension after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Metformin (metformin)(metformin) treatment in female patients, resulting in Jaundice Hepatocellular side effect.


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The appearance of Metformin on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Metformin Side Effects for Women?

Women Side EffectsReports
Lactic Acidosis 1504
Renal Failure Acute 912
Diarrhoea 631
Vomiting 456
Nausea 395
Hypotension 353
Haemodialysis 346
Blood Glucose Increased 320
Hypoglycaemia 310
Metabolic Acidosis 309

What are common Metformin Side Effects for Men?

Men Side EffectsReports
Lactic Acidosis 1015
Renal Failure Acute 610
Diarrhoea 354
Blood Glucose Increased 311
Vomiting 277
Completed Suicide 267
Hypoglycaemia 243
Hypotension 233
Haemodialysis 215
Nausea 191

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Metformin reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

    Discuss Metformin Side Effects

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    How Effective is Metformin for You?

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    Metformin Safety Alerts, Active Ingredients, Usage Information

    NDC0093-1048
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameMetformin Hydrochloride
    NameMetformin Hydrochloride
    Dosage FormTABLET, FILM COATED
    RouteORAL
    On market since20020128
    LabelerTeva Pharmaceuticals USA Inc
    Active Ingredient(s)METFORMIN HYDROCHLORIDE
    Strength(s)500
    Unit(s)mg/1
    Pharma ClassBiguanide [EPC],Biguanides [Chemical/Ingredient]

    More About Metformin

    Side Effects reported to FDA: 10583

    Metformin safety alerts: 2007 2006 2005

    Reported deaths: 878

    Reported hospitalizations: 2864

    ACTOplus met (pioglitazone and metformin hydrochloride)

    Audience: Endocrinologists, other healthcare professionals, consumers

    [Posted 03/09/2007] Takeda and FDA notified healthcare professionals of recent safety data concerning pioglitazone-containing products. The results of an analysis of the manufacturer's clinical trial database of pioglitazone showed more reports of fractures in female patients taking pioglitazone than those taking a comparator (either placebo or active). The majority of fractures observed in female patients were in the distal upper limb (forearm, hand and wrist) or distal lower limb (foot, ankle, fibula and tibia). There were more than 8100 patients in the pioglitazone-treated groups and over 7400 patients in the comparator-treated groups. The duration of pioglitazone treatment was up to 3.5 years. Healthcare professionals should consider the risk of fracture when initiating or treating female patients with type 2 diabetes mellitus with pioglitazone-containing products.

    [March 2007 - Letter - Takeda Pharmaceuticals North America, Inc.]

    Latest Metformin clinical trials