Mediclarum
Medicine guide

Metformin Hydrochloride

500 mg · Tablet

  • Prescription only
  • Biguanide
Active substance
Metformin Hydrochloride
Made by
A-S Medication Solutions

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2024-08-21

What it is

Biguanide

Used for
  • Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in
The label’s usual adult dose

1 Adult Dosage Metformin Hydrochloride Tablets The recommended starting dose of metformin hydrochloride tablets are 500 mg orally twice a day or 850 mg once a day, given with meals.

500 mg orally twice a day or 850 mg once a day, with meals ( 2.1 ) Increase the dose in increments of 500 mg weekly or 850 mg every 2 weeks, up to a maximum dose of 2550 mg per day, given in divided doses ( 2.1 ) Doses above 2000 mg may be better tolerated given 3 times a day with meals ( 2.1 ) Pediatric Dosage for metformin hydrochloride tablets:

Full directions ↓
Serious warning

LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias.

All warnings ↓
Good to know
  • Prescription only
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-01
258other products contain Metformin Hydrochloride — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

  • Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in
  • adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.
  • Metformin hydrochloride tablets are biguanide indicated as an adjunct to diet and exercise to improve glycemic control in
  • adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.
  • ( 1 )

From the official label · 2024-08-21 · DailyMed

How it works

From this product’s own US prescribing label.

Metformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes mellitus, lowering both basal and postprandial plasma glucose.

Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.

Half-life6.2 h
Mostly cleared after≈ 31 hfive half-lives — our arithmetic
How it leaves the body

Intravenous single-dose studies in normal subjects demonstrate that metformin is excreted unchanged in the urine and does not undergo hepatic metabolism (no metabolites have been identified in humans) nor biliary excretion.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2024-08-21

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

  • WARNING:
  • LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias.
  • The onset of metformin­ associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain.
  • Metformin­ associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL [see Warnings and Precautions (5.1) ].
  • Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g. carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment.
  • Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided [see Dosage and Administration (2.3), (2.7 ) , C ontraindications (4) , Warnings and Precautions (5.1) ].
  • If metformin-associated lactic acidosis is suspected, immediately discontinue metformin hydrochloride tablets and institute general supportive measures in a hospital setting.
  • Prompt hemodialysis is recommended [ see Warnings and Precautions (5.1 ) ].
  • WARNING: LACTIC ACIDOSIS See full prescribing information for complete boxed warning.
  • Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias.
  • Symptoms included malaise, myalgias, respiratory distress, somnolence, and abdominal pain.
  • Laboratory abnormalities included elevated blood lactate levels, anion gap acidosis, increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL.
  • ( 5.1 ) Risk factors include renal impairment, concomitant use of certain drugs, age >65 years old, radiological studies with contrast, surgery and other procedures, hypoxic states, excessive alcohol intake, and hepatic impairment.
  • Steps to reduce the risk of and manage metformin­ associated lactic acidosis in these high risk groups are provided in the Full Prescribing Information.
  • ( 5.1 ) If lactic acidosis is suspected, discontinue metformin hydrochloride tablets and institute general supportive measures in a hospital setting.
  • Prompt hemodialysis is recommended.
  • ( 5.1 )

Quoted from the official label, section “Boxed Warning”.

Do not take it if

  • Metformin hydrochloride tablets are contraindicated in patients with:
  • Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ) [ see Warnings and Precautions (5.1) ].
  • Hypersensitivity to metformin.
  • Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.
  • Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ) ( 4 , 5.1 ) Hypersensitivity to metformin ( 4 ) Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.
  • ( 4 )

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

  • Adult Dosage for metformin hydrochloride tablets:
  • Starting dose:
  • 500 mg orally twice a day or 850 mg once a day, with meals ( 2.1 ) Increase the dose in increments of 500 mg weekly or 850 mg every 2 weeks, up to a maximum dose of 2550 mg per day, given in divided doses ( 2.1 ) Doses above 2000 mg may be better tolerated given 3 times a day with meals ( 2.1 ) Pediatric Dosage for metformin hydrochloride tablets:
  • Starting dose:
  • 500 mg orally twice a day, with meals ( 2.2 ) Increase dosage in increments of 500 mg weekly up to a maximum of 2000 mg per day, given in divided doses twice daily ( 2.2 ) Renal Impairment:
  • Prior to initiation, assess renal function with estimated glomerular filtration rate (eGFR) ( 2.3 )
  • Do not use in patients with eGFR below 30 mL/minute/1.73 m 2 ( 2.3 ) Initiation is not recommended in patients with eGFR between 30 to 45 mL/minute/1.73 m 2 ( 2.3 ) Assess risk/benefit of continuing if eGFR falls below 45 mL/minute/1.73 m 2 ( 2.3 ) Discontinue if eGFR falls below 30 mL/minute/1.73 m 2 ( 2.3 )
  • 2.1 Adult Dosage Metformin Hydrochloride Tablets The recommended starting dose of metformin hydrochloride tablets are 500 mg orally twice a day or 850 mg once a day, given with meals.
  • Increase the dose in increments of 500 mg weekly or 850 mg every 2 weeks on the basis of glycemic control and tolerability, up to a maximum dose of 2550 mg per day, given in divided doses.
  • Doses above 2000 mg may be better tolerated given 3 times a day with meals.
  • 2.2 Pediatric Dosage for metformin hydrochloride tablets The recommended starting dose of metformin hydrochloride tablets for pediatric patients 10 years of age and older is 500 mg orally twice a day, given with meals.
  • Increase dosage in increments of 500 mg weekly on the basis of glycemic control and tolerability, up to a maximum of 2000 mg per day, given in divided doses twice daily.
  • 2.3 Recommendations for Use in Renal Impairment Assess renal function prior to initiation of metformin hydrochloride tablets and periodically thereafter.
  • Metformin hydrochloride tablets are contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/minute/1.73 m 2 .
  • Initiation of metformin hydrochloride tablets in patients with an eGFR between 30 to 45 mL/minute/1.73 m 2 is not recommended.
  • In patients taking metformin hydrochloride tablets whose eGFR later falls below 45 mL/min/1.73 m 2 , assess the benefit risk of continuing therapy.
  • Discontinue metformin hydrochloride tablets if the patient’s eGFR later falls below 30 mL/minute/1.73 m 2 [ see Warnings and Precautions (5.1) ] .
  • 2.4 Discontinuation for Iodinated Contrast Imaging Procedures Discontinue metformin hydrochloride tablets at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/min/1.73 m 2 ; in patients with a history of liver disease, alcoholism, or heart failure; or in patients who will be administered intra-arterial iodinated contrast.
  • Re-evaluate eGFR 48 hours after the imaging procedure; restart metformin hydrochloride tablets if renal function is stable.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

  • ( 5.1 ) Vitamin B 12 Deficiency: Metformin may lower vitamin B12 levels.
  • Measure hematological parameters annually and vitamin B12 at 2 to 3 year intervals and manage any abnormalities.
  • ( 5.2 ) Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues:
  • Increased risk of hypoglycemia when used in combination with insulin and/or an insulin secretagogue.
  • Lower dose of insulin or insulin secretagogue may be required ( 5.3 )
  • 5.1 Lactic Acidosis There have been postmarketing cases of metformin-associated lactic acidosis, including fatal cases.
  • These cases had a subtle onset and were accompanied by nonspecific symptoms such as malaise, myalgias, abdominal pain, respiratory distress, or increased somnolence; however, hypotension and resistant bradyarrhythmias have occurred with severe acidosis.
  • Metformin­ associated lactic acidosis was characterized by elevated blood lactate concentrations (>5 mmol/L), anion gap acidosis (without evidence of ketonuria or ketonemia), and an increased lactate:
  • pyruvate ratio; metformin plasma levels were generally >5 mcg/mL.
  • Metformin decreases liver uptake of lactate increasing lactate blood levels which may increase the risk of lactic acidosis, especially in patients at risk.
  • If metformin-associated lactic acidosis is suspected, general supportive measures should be instituted promptly in a hospital setting, along with immediate discontinuation of metformin hydrochloride tablets.
  • In metformin hydrochloride tablets treated patients with a diagnosis or strong suspicion of lactic acidosis, prompt hemodialysis is recommended to correct the acidosis and remove accumulated metformin (metformin hydrochloride is dialyzable with a clearance of up to 170 mL/min under good hemodynamic conditions).
  • Hemodialysis has often resulted in reversal of symptoms and recovery.
  • Educate patients and their families about the symptoms of lactic acidosis and, if these symptoms occur, instruct them to discontinue metformin hydrochloride tablet and report these symptoms to their healthcare provider.
  • For each of the known and possible risk factors for metformin-associated lactic acidosis, recommendations to reduce the risk of and manage metformin-associated lactic acidosis are provided below:
  • Renal impairment — The postmarketing metformin-associated lactic acidosis cases primarily occurred in patients with significant renal impairment.
  • The risk of metformin accumulation and metformin-associated lactic acidosis increases with the severity of renal impairment because metformin is substantially excreted by the kidney.
  • Clinical recommendations based upon the patient’s renal function include [ see Dosage and Administration (2.1) , Clinical Pharmacology (12.3) ] :
  • Before initiating metformin hydrochloride tablets, obtain an estimated glomerular filtration rate (eGFR).
  • Metformin hydrochloride tablets are contraindicated in patients with an eGFR less than 30 mL/min/1.73 m 2 [see Contraindications (4) ].
  • Initiation of metformin hydrochloride tablets is not recommended in patients with eGFR between 30 to 45 mL/min/1.73 m 2 .
  • Obtain an eGFR at least annually in all patients taking metformin hydrochloride tablets.
  • In patients at risk for the development of renal impairment (e.g., the elderly), renal function should be assessed more frequently.In patients taking metformin hydrochloride tablets whose eGFR falls below 45 mL/min/1.73 m 2 , assess the benefit and risk of continuing therapy.
  • Drug interactions —The concomitant use of metformin hydrochloride tablets with specific drugs may increase the risk of metformin-associated lactic acidosis:
  • those that impair renal function, result in significant hemodynamic change, interfere with acid-base balance, or increase metformin accumulation.
  • Consider more frequent monitoring of patients.
  • Age 65 or greater —The risk of metformin-associated lactic acidosis increases with the patient’s age because elderly patients have a greater likelihood of having hepatic, renal, or cardiac impairment than younger patients.
  • Radiologic studies with contrast —Administration of intravascular iodinated contrast agents in metformin-treated patients has led to an acute decrease in renal function and the occurrence of lactic acidosis.
  • Stop metformin hydrochloride tablets at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/min/1.73 m 2 ; in patients with a history of hepatic impairment, alcoholism or heart failure; or in patients who will be administered intra-arterial iodinated contrast.
  • Re-evaluate eGFR 48 hours after the imaging procedure, and restart metformin hydrochloride tablets if renal function is stable.
  • Surgery and other procedures —Withholding of food and fluids during surgical or other procedures may increase the risk for volume depletion, hypotension, and renal impairment.
  • Metformin hydrochloride tablets should be temporarily discontinued while patients have restricted food and fluid intake.
  • Hypoxic states —Several of the postmarketing cases of metformin-associated lactic acidosis occurred in the setting of acute congestive heart failure (particularly when accompanied by hypoperfusion and hypoxemia).
  • Cardiovascular collapse (shock), acute myocardial infarction, sepsis, and other conditions associated with hypoxemia have been associated with lactic acidosis and may cause prerenal azotemia.
  • When such an event occurs, discontinue metformin hydrochloride tablets.
  • Excessive alcohol intake —Alcohol potentiates the effect of metformin on lactate metabolism.
  • Patients should be warned against excessive alcohol intake while receiving metformin hydrochloride tablets.
  • Hepatic impairment —Patients with hepatic impairment have developed cases of metformin- associated lactic acidosis.
  • This may be due to impaired lactate clearance resulting in higher lactate blood levels.
  • Therefore,
  • avoid use of metformin hydrochloride tablets in patients with clinical or laboratory evidence of hepatic disease.
  • 5.2 Vitamin B12 Deficiency In metformin hydrochloride tablets clinical trials of 29-week duration, a decrease to subnormal levels of previously normal serum vitamin B 12 levels was observed in approximately 7% of patients.
  • Such decrease, possibly due to interference with B 12 absorption from the B 12 -intrinsic factor complex, may be associated with anemia but appears to be rapidly reversible with discontinuation of metformin hydrochloride tablets or vitamin B 12 supplementation.
  • Certain individuals (those with inadequate vitamin B 12 or calcium intake or absorption) appear to be predisposed to developing subnormal vitamin B 12 levels.
  • Measure hematologic parameters on an annual basis and vitamin B 12 at 2 to 3 year intervals in patients on metformin hydrochloride tablets and manage any abnormalities [see Adverse Reactions (6.1) ].
  • 5.3 Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues Insulin and insulin secretagogues (e.g., sulfonylurea) are known to cause hypoglycemia.
  • Metformin hydrochloride tablets may increase the risk of hypoglycemia when combined with insulin and/or an insulin secretagogue.
  • Therefore, a lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used in combination with metformin hydrochloride tablet [ see Drug Interactions (7) ].
  • 5.4 Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with metformin hydrochloride tablets.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

  • Risk Summary Limited data with metformin hydrochloride tablets in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage.
  • Published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk [see Data ] .
  • There are risks to the mother and fetus associated with poorly controlled diabetes mellitus in pregnancy [see Clinical Considerations ] .
  • No adverse developmental effects were observed when metformin was administered to pregnant Sprague Dawley rats and rabbits during the period of organogenesis at doses up to 2- and 5-times, respectively, a 2550 mg clinical dose, based on body surface area [see Data ] .
  • The estimated background risk of major birth defects is 6 to 10% in women with pre-gestational diabetes mellitus with an HbA1C >7 and has been reported to be as high as 20 to 25% in women with a HbA1C > 10.
  • The estimated background risk of miscarriage for the indicated population is unknown.
  • In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
  • Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Poorly-controlled diabetes mellitus in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth and delivery complications.
  • Poorly controlled diabetes mellitus increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity.
  • Data Human Data Published data from post-marketing studies have not reported a clear association with metformin and major birth defects, miscarriage, or adverse maternal or fetal outcomes when metformin was used during pregnancy.
  • However, these studies cannot definitely establish the absence of any metformin-associated risk because of methodological limitations, including small sample size and inconsistent comparator groups.
  • Animal Data Metformin hydrochloride did not adversely affect development outcomes when administered to pregnant rats and rabbits at doses up to 600 mg/kg/day.
  • This represents an exposure of about 2 and 5 times a 2550 mg clinical dose based on body surface area comparisons for rats and rabbits, respectively.
  • Determination of fetal concentrations demonstrated a partial placental barrier to metformin.
  • IN SPECIFIC POPULATIONS Females and Males of Reproductive Potential:
  • Advise premenopausal females of the potential for an unintended pregnancy.
  • ( 8.3 ) Geriatric Use: Assess renal function more frequently.
  • ( 8.5 ) Hepatic Impairment: Avoid use in patients with hepatic impairment.
  • ( 8.7 )
  • 8.1 Pregnancy Risk Summary Limited data with metformin hydrochloride tablets in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage.
  • Published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk [see Data ] .
  • There are risks to the mother and fetus associated with poorly controlled diabetes mellitus in pregnancy [see Clinical Considerations ] .
  • No adverse developmental effects were observed when metformin was administered to pregnant Sprague Dawley rats and rabbits during the period of organogenesis at doses up to 2- and 5-times, respectively, a 2550 mg clinical dose, based on body surface area [see Data ] .
  • The estimated background risk of major birth defects is 6 to 10% in women with pre-gestational diabetes mellitus with an HbA1C >7 and has been reported to be as high as 20 to 25% in women with a HbA1C > 10.
  • The estimated background risk of miscarriage for the indicated population is unknown.
  • In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
  • Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Poorly-controlled diabetes mellitus in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth and delivery complications.
  • Poorly controlled diabetes mellitus increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity.
  • Data Human Data Published data from post-marketing studies have not reported a clear association with metformin and major birth defects, miscarriage, or adverse maternal or fetal outcomes when metformin was used during pregnancy.
  • However, these studies cannot definitely establish the absence of any metformin-associated risk because of methodological limitations, including small sample size and inconsistent comparator groups.
  • Animal Data Metformin hydrochloride did not adversely affect development outcomes when administered to pregnant rats and rabbits at doses up to 600 mg/kg/day.
  • This represents an exposure of about 2 and 5 times a 2550 mg clinical dose based on body surface area comparisons for rats and rabbits, respectively.
  • Determination of fetal concentrations demonstrated a partial placental barrier to metformin.
  • 8.2 Lactation Risk Summary Limited published studies report that metformin is present in human milk [see Data ] .
  • However, there is insufficient information to determine the effects of metformin on the breastfed infant and no available information on the effects of metformin on milk production.
  • Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for metformin hydrochloride tablets and any potential adverse effects on the breastfed child from metformin hydrochloride tablets or from the underlying maternal condition.
  • Data Published clinical lactation studies report that metformin is present in human milk which resulted in infant doses approximately 0.11 % to 1% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 0.13 and 1.
  • However, the studies were not designed to definitely establish the risk of use of metformin during lactation because of small sample size and limited adverse event data collected in infants.
  • 8.3 Females and Males of Reproductive Potential Discuss the potential for unintended pregnancy with premenopausal women as therapy with metformin hydrochloride tablets may result in ovulation in some anovulatory women.
  • 8.4 Pediatric Use Metformin Hydrochloride Tablets The safety and effectiveness of metformin hydrochloride tablets for the treatment of type 2 diabetes mellitus have been established in pediatric patients 10 to 16 years old.
  • Safety and effectiveness of metformin hydrochloride tablets have not been established in pediatric patients less than 10 years old.
  • Use of metformin hydrochloride tablets in pediatric patients 10 to 16 years old for the treatment of type 2 diabetes mellitus is supported by evidence from adequate and well-controlled studies of metformin hydrochloride tablets in
  • adults with additional data from a controlled clinical study in pediatric patients 10 to 16 years old with type 2 diabetes mellitus, which demonstrated a similar response in glycemic control to that seen in
  • adults [ see Clinical Studies (14.1) ] .
  • In this study, adverse reactions were similar to those described in adults.
  • A maximum daily dose of 2000 mg of metformin hydrochloride tablets is recommended. [ see Dosage and Administration (2.2) . ].
  • 8.5 Geriatric Use Controlled clinical studies of metformin hydrochloride tablets did not include sufficient numbers of elderly patients to determine whether they respond differently from younger patients.
  • In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy and the higher risk of lactic acidosis.
  • Assess renal function more frequently in elderly patients [ see Warnings and Precautions (5.1) .
  • 8.6 Renal Impairment Metformin is substantially excreted by the kidney, and the risk of metformin accumulation and lactic acidosis increases with the degree of renal impairment.
  • Metformin hydrochloride tablets are contraindicated in severe renal impairment, patients with an estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m 2 [ see Dosage and Administration (2.3) , Contraindications (4) , Warnings and Precautions (5.1) , and Clinical Pharmacology (12.3) ] .
  • 8.7 Hepatic Impairment Use of metformin in patients with hepatic impairment has been associated with some cases of lactic acidosis.
  • Metformin hydrochloride tablets are not recommended in patients with hepatic impairment. [ see Warnings and Precautions (5.1) ].

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

  • Table 3 presents clinically significant drug interactions with metformin hydrochloride tablets.
  • Table 3:
  • Clinically Significant Drug Interactions with Metformin Hydrochloride Tablets Carbonic Anhydrase Inhibitors Clinical Impact:
  • Carbonic anhydrase inhibitors frequently cause a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis.
  • Concomitant use of these drugs with metformin hydrochloride tablets may increase the risk for lactic acidosis.
  • Intervention: Consider more frequent monitoring of these patients.
  • Examples: Topiramate, zonisamide, acetazolamide or dichlorphenamide.
  • Drugs that Reduce metformin hydrochloride tablet Clearance Clinical Impact:
  • Concomitant use of drugs that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT2] / multidrug and toxin extrusion [MATE] inhibitors) could increase systemic exposure to metformin and may increase the risk for lactic acidosis [ see Clinical Pharmacology (12.3) ].
  • Intervention:
  • Consider the benefits and risks of concomitant use with metformin hydrochloride tablets.
  • Examples: Ranolazine, vandetanib, dolutegravir, and cimetidine.
  • Alcohol Clinical Impact:
  • Alcohol is known to potentiate the effect of metformin on lactate metabolism.
  • Intervention:
  • Warn patients against excessive alcohol intake while receiving metformin hydrochloride tablets.
  • Insulin Secretagogues or Insulin Clinical Impact:
  • Coadministration of metformin hydrochloride tablets with an insulin secretagogue (e.g., sulfonylurea) or insulin may increase the risk of hypoglycemia.
  • Intervention:
  • Patients receiving an insulin secretagogue or insulin may require lower doses of the insulin secretagogue or insulin.
  • Drugs Affecting Glycemic Control Clinical Impact:
  • Certain drugs tend to produce hyperglycemia and may lead to loss of glycemic control.
  • Intervention:
  • When such drugs are administered to a patient receiving metformin hydrochloride tablets, observe the patient closely for loss of blood glucose control.
  • When such drugs are withdrawn from a patient receiving metformin hydrochloride tablets, observe the patient closely for hypoglycemia.
  • Examples:
  • Thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blockers, and isoniazid.
  • Carbonic anhydrase inhibitors may increase risk of lactic acidosis.
  • Consider more frequent monitoring ( 7 ) Drugs that reduce metformin clearance (such as ranolazine, vandetanib, dolutegravir, and cimetidine) may increase the accumulation of metformin.
  • Consider the benefits and risks of concomitant use ( 7 ) Alcohol can potentiate the effect of metformin on lactate metabolism.
  • Warn patients against excessive alcohol intake ( 7 )

Quoted from the official label, section “Drug Interactions”.

Side effects

  • The following adverse reactions are also discussed elsewhere in the labeling:
  • Lactic Acidosis [ see Boxed Warning and Warnings and Precautions (5.1) ].
  • Vitamin B12 Deficiency [ see Warnings and Precautions (5.2) ].
  • Hypoglycemia [ see Warnings and Precautions (5.3) For metformin hydrochloride tablets, the most common adverse reactions (>5.0%) are diarrhea, nausea/vomiting, flatulence, asthenia, indigestion, abdominal discomfort, and headache.
  • ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Granules Pharmaceuticals Inc at 1-877-770-3183 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
  • 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
  • Metformin Hydrochloride Tablets In a U.S. clinical trial of metformin hydrochloride tablets in patients with type 2 diabetes mellitus, a total of 141 patients received metformin hydrochloride tablets up to 2550 mg per day.
  • Adverse reactions reported in greater than 5% of metformin hydrochloride tablets treated patients and that were more common than in placebo-treated patients, are listed in Table 1.
  • Table 1:
  • Adverse Reactions from a Clinical Trial of Metformin Hydrochloride Tablets Occurring >5% and More Common than Placebo in Patients with Type 2 Diabetes Mellitus Metformin Hydrochloride Tablets (n=141) Placebo (n=145) Diarrhea 53% 12% Nausea/Vomiting 26% 8% Flatulence 12% 6% Asthenia 9% 6% Indigestion 7% 4% Abdominal Discomfort 6% 5% Headache 6% 5% Diarrhea led to discontinuation of metformin hydrochloride tablets in 6% of patients.
  • Additionally, the following adverse reactions were reported in ≥1 % to ≤5% of metformin hydrochloride tablets treated patients and were more commonly reported with metformin hydrochloride tablets than placebo:
  • abnormal stools, hypoglycemia, myalgia, lightheaded, dyspnea, nail disorder, rash, sweating increased, taste disorder, chest discomfort, chills, flu syndrome, flushing, palpitation.
  • In metformin hydrochloride tablets clinical trials of 29-week duration, a decrease to subnormal levels of previously normal serum vitamin B 12 levels was observed in approximately 7% of patients.
  • Pediatric Patients In clinical trials with metformin hydrochloride tablets in pediatric patients with type 2 diabetes mellitus, the profile of adverse reactions was similar to that observed in
  • adults.
  • 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of metformin.
  • Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • Cholestatic, hepatocellular, and mixed hepatocellular liver injury have been reported with postmarketing use of metformin.

Quoted from the official label, section “Adverse Reactions”.

Same active substance, strength and form in other countries

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Details

Made byA-S Medication Solutions
Active substanceMetformin Hydrochloride
Used inDigestion, stomach, diabetes and nutrition
Strength500 mg
FormTablet
RouteOral
Packs60 TABLET in 1 BOTTLE · 100 TABLET in 1 BOTTLE · 100 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK
NDC50090-7010
NDC50090-7011

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

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Same active substance

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Glumetza500 mgPrescription onlyTablet, Film Coated, Extended Release Santarus, Inc. · Metformin HydrochlorideGlumetza1000 mgPrescription onlyTablet, Film Coated, Extended Release Santarus, Inc. · Metformin HydrochlorideMetformin Hydrochloride500 mgPrescription onlyTablet, Film Coated Mylan Pharmaceuticals Inc. · Metformin HydrochlorideMetformin Hydrochloride850 mgPrescription onlyTablet, Film Coated Mylan Pharmaceuticals Inc. · Metformin HydrochlorideMetformin Hydrochloride1000 mgPrescription onlyTablet, Film Coated Mylan Pharmaceuticals Inc. · Metformin HydrochlorideMetformin Hydrochloride500 mgPrescription onlyTablet, Film Coated NCS HealthCare of KY, LLC dba Vangard Labs · Metformin Hydrochloride

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