Metformin
Metformin is an oral diabetes medicine used alongside diet and exercise to improve blood sugar control in adults and children (age 10 and older) with type 2 diabetes mellitus.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 346 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Metformin is the usual first choice for type 2 diabetes, lowering blood sugar by cutting the liver’s glucose output and helping insulin work better; on the market since the mid-1990s and available as a generic, it is among the most prescribed diabetes medicines. Most people tolerate it well, though diarrhea, nausea and gas are common early, so the dose starts low and rises slowly. Its boxed warning is for lactic acidosis, a rare but potentially fatal acid buildup, so get emergency care for unexplained muscle aches, trouble breathing, stomach pain or unusual sleepiness. Avoid heavy drinking, and expect regular kidney checks, because weaker kidneys raise that risk.
Clinical pearls
- Take it with food; extended-release tablets go with the evening meal and must be swallowed whole, never crushed, cut or chewed.
- Before a CT scan with IV contrast dye or surgery, tell the team you take metformin, since it may be paused.
- Over years it can lower vitamin B12, so ask for periodic B12 checks, especially if numbness or unusual tiredness appears.
- It can restart ovulation in women who have not been ovulating, so use contraception if pregnancy is not the plan.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Metformin carries a boxed warning — the FDA's most serious safety alert — for a condition called lactic acidosis (a dangerous buildup of lactic acid in the blood). This has caused deaths in some cases. The warning signs can be easy to miss at first: general tiredness, muscle aches, stomach pain, difficulty breathing, or unusual drowsiness. In severe cases, it can also cause dangerously low blood pressure and abnormal heart rhythms.
The risk is highest in people with kidney problems, liver disease, heart failure, low-oxygen states, those who drink heavily, people age 65 or older, those taking certain interacting drugs, and anyone having surgery or an imaging procedure with IV contrast dye. If you think you or someone you know may be experiencing lactic acidosis, stop metformin and go to an emergency room immediately — prompt treatment including dialysis may be needed.
Patient information guide A plain-language walkthrough of Metformin, written from its FDA label.
What Metformin is used for
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Metformin is an oral antidiabetic medicine approved to help control blood sugar in people with type 2 diabetes mellitus, always used alongside diet and exercise.
- Metformin hydrochloride tablets and the oral solution (including Riomet) are approved for adults and children age 10 and older with type 2 diabetes.
- Metformin hydrochloride extended-release tablets — including Fortamet, Glumetza, and Metformin Hydrochloride Extended Release — are approved for adults only with type 2 diabetes.
How Metformin works
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Metformin lowers blood sugar through three actions: it tells the liver to release less glucose into the bloodstream, slows the absorption of sugar from food in the gut, and makes the body's cells more sensitive to insulin so they take in glucose more efficiently. Because it works on these pathways rather than directly stimulating the pancreas, it does not cause blood sugar to drop too low when used on its own.
Metformin dosage
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Metformin is taken by mouth, and the right dose is individualized — there is no single fixed amount that works for everyone. Tablets and oral solution are taken in divided doses with meals during the day. Extended-release tablets are generally taken once daily with the evening meal, and must always be swallowed whole — never crushed, cut, or chewed. Dosing is always started low and increased gradually to minimize stomach upset. Follow your prescriber's schedule closely, and never adjust your dose without guidance.
Dosing details from the FDA-approved label
From the Metformin prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Adults - metformin hydrochloride extended-release tablets (type 2 diabetes)
- Usual starting dose 500 mg once daily with the evening meal
- Dosage increases in increments of 500 mg weekly
- If glycemic control is not achieved on 2000 mg once daily, a trial of 1000 mg twice daily should be considered
- Maximum: 2000 mg once daily with the evening meal
- Swallow whole, never crushed or chewed
- Patients switched from metformin hydrochloride tablets to extended-release tablets
- May be switched to extended-release tablets once daily at the same total daily dose, up to 2000 mg once daily
- Maximum: 2000 mg once daily
- Monitor glycemic control closely and adjust dosage accordingly
- Pediatrics - metformin hydrochloride extended-release tablets
- Safety and effectiveness have not been established
- Not recommended in pediatric patients (below the age of 17 years)
- Transfer from chlorpropamide
- No transition period generally necessary when transferring from other standard oral hypoglycemic agents
- When transferring from chlorpropamide, care should be exercised during the first two weeks
- Prolonged retention of chlorpropamide may cause overlapping drug effects and possible hypoglycemia
- Concomitant extended-release tablets and oral sulfonylurea in adults
- If no response to four weeks of maximum dose monotherapy, consider gradual addition of an oral sulfonylurea while continuing metformin extended-release at the maximum dose
- Risk of hypoglycemia from sulfonylurea continues and may be increased
- Concomitant extended-release tablets and insulin in adults
- Continue current insulin dose
- Start extended-release tablets at 500 mg once daily
- Increase by 500 mg after approximately 1 week and by 500 mg every week thereafter until adequate glycemic control is achieved
- Maximum: 2000 mg daily
- Decrease insulin dose by 10% to 25% when fasting plasma glucose decreases to less than 120 mg/dL
- Pregnancy
- Metformin hydrochloride extended-release tablets are not recommended for use in pregnancy
- Adults - metformin hydrochloride tablets (film coated)
- Usual starting dose 500 mg twice a day or 850 mg once a day, given with meals
- Increase by 500 mg weekly or 850 mg every 2 weeks, up to a total of 2000 mg per day in divided doses
- May be titrated from 500 mg twice a day to 850 mg twice a day after 2 weeks
- Maximum: 2550 mg per day; doses above 2000 mg may be better tolerated given 3 times a day with meals
- Given with meals
- Pediatrics (10 to 16 years of age) - metformin hydrochloride tablets
- Usual starting dose 500 mg twice a day, given with meals
- Maximum: 2000 mg per day
- Given with meals
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION 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 30-45 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 ) Discontinuation for Iodinated Contrast Imaging Procedures: Metformin Hydrochloride Tablets may need to be discontinued at time of, or prior to, iodinated contrast imaging procedures ( 2.4 ) 2.1 Adult Dosage Metformin Hydrochloride Tablets The recommended starting dose of Metformin Hydrochloride Tablets is 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 .
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Metformin side effects
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The most common side effects of metformin are digestive in nature and tend to be most noticeable when first starting or increasing the dose:
Common side effects
- Diarrhea
- Nausea or vomiting
- Gas (flatulence)
- Upset stomach or indigestion
- Abdominal discomfort
- Weakness or fatigue (asthenia)
- Headache
- Abnormal or unpleasant taste in the mouth
- Gas and bloating
When to get medical help
- Seek emergency care immediately if you notice muscle pain or weakness, trouble breathing, stomach pain, unusual sleepiness, feeling cold, or dizziness — these can be signs of lactic acidosis, a rare but life-threatening buildup of lactic acid in the blood.
- Call your doctor if you develop signs of low blood sugar (shakiness, sweating, confusion) — risk is higher when metformin is combined with insulin or a sulfonylurea.
- Tell your doctor about any signs of vitamin B12 deficiency, such as unusual tiredness, pale skin, or numbness — your doctor should check your B12 levels periodically.
- Stop metformin and contact your doctor if you have a serious illness, major surgery, or a procedure requiring IV contrast dye — your doctor needs to decide when it is safe to restart.
- Seek medical help for signs of liver injury — yellowing of the skin or eyes, dark urine, or severe nausea — which have been reported rarely after metformin use.
These usually improve as your body adjusts. However, seek care right away for symptoms of lactic acidosis (muscle pain, difficulty breathing, unusual sleepiness, stomach pain, or feeling cold) or signs of low blood sugar if you also take insulin or a sulfonylurea.
Metformin warnings and precautions
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- Lactic acidosis (rare but life-threatening): Metformin can cause a dangerous buildup of lactic acid in the blood. Early signs include tiredness, muscle aches, stomach pain, trouble breathing, and unusual drowsiness. Stop metformin and seek emergency care immediately if these occur. Risk is highest in people with kidney disease, liver disease, heart failure, low-oxygen conditions, those who drink heavily, and adults 65 or older.
- Kidney function: Metformin is cleared by the kidneys — if kidneys are not working well, the drug can build up to dangerous levels. Your doctor will check kidney function before starting and at least yearly while you take it.
- Vitamin B12 levels: Long-term metformin use can lower vitamin B12, potentially causing anemia or nerve symptoms. Blood checks every 2–3 years are recommended.
- Low blood sugar (hypoglycemia): Metformin alone rarely causes hypoglycemia, but the risk rises when it is combined with insulin or sulfonylureas. Symptoms include shakiness, sweating, and confusion.
- Before procedures: Tell your care team you take metformin before any surgery, significant procedure, or imaging with IV contrast dye — it may need to be temporarily stopped.
- Alcohol: Avoid heavy drinking — alcohol increases the risk of lactic acidosis with metformin.
Metformin interactions
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Several medications and substances can interact with metformin in clinically important ways:
- Carbonic anhydrase inhibitors (topiramate, zonisamide, acetazolamide, dichlorphenamide) — can cause metabolic acidosis and raise lactic acidosis risk when combined with metformin.
- Drugs that reduce metformin's kidney clearance (cimetidine, ranolazine, vandetanib, dolutegravir) — cause metformin to build up in the body, increasing lactic acidosis risk.
- Insulin or sulfonylureas (e.g., glipizide, glyburide) — combining with metformin raises hypoglycemia (low blood sugar) risk; lower doses of insulin or the sulfonylurea may be needed.
- Alcohol — amplifies metformin's effect on lactic acid; heavy drinking should be avoided.
- Iodinated IV contrast agents (used in CT scans and some imaging) — can impair kidney function acutely, causing metformin to accumulate; metformin may need to be paused before and after the procedure.
- Blood sugar-raising drugs (corticosteroids, thiazide diuretics, estrogens, oral contraceptives, phenytoin, thyroid products, sympathomimetics, calcium channel blockers, nicotinic acid, phenothiazines, isoniazid) — may reduce blood sugar control; monitor glucose closely if these are started or stopped.
Interactions listed in the FDA-approved label
From the Metformin prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Carbonic anhydrase inhibitors (topiramate, zonisamide, acetazolamide, dichlorphenamide): Frequently cause a decrease in serum bicarbonate and non-anion gap, hyperchloremic metabolic acidosis; concomitant use may increase the risk for lactic acidosis. Consider more frequent monitoring of these patients.
- Drugs that reduce metformin clearance (ranolazine, vandetanib, dolutegravir, cimetidine): Drugs interfering with renal tubular transport (e.g., OCT2/MATE inhibitors) could increase systemic exposure to metformin and may increase the risk for lactic acidosis. Consider the benefits and risks of concomitant use.
- Alcohol: Alcohol is known to potentiate the effect of metformin on lactate metabolism. Warn patients against excessive alcohol intake.
- Insulin secretagogues (e.g., sulfonylurea) or insulin: Coadministration may increase the risk of hypoglycemia. Patients may require lower doses of the insulin secretagogue or insulin.
- Drugs affecting glycemic control (thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blockers, isoniazid): Certain drugs tend to produce hyperglycemia and may lead to loss of glycemic control. Observe closely for loss of blood glucose control when such drugs are given, and for hypoglycemia when they are withdrawn.
- Glyburide: Metformin AUC ratio 0.91; glyburide AUC ratio 0.78 with metformin. No dosing adjustments required.
- Furosemide: Metformin AUC ratio 1.09; furosemide AUC ratio 0.87 with metformin. No dosing adjustments required.
- Nifedipine: Metformin AUC ratio 1.16; nifedipine AUC ratio 1.10 with metformin. No dosing adjustments required.
- Propranolol: Metformin AUC ratio 0.90; propranolol AUC ratio 1.01 with metformin. No dosing adjustments required.
- Ibuprofen: Metformin AUC ratio 1.05; ibuprofen AUC ratio 0.97 with metformin. No dosing adjustments required.
Read the label’s full interactions text
7 DRUG INTERACTIONS Table 2 presents clinically significant drug interactions with metformin hydrochloride extended-release tablets. Table 2: Clinically Significant Drug Interactions with Metformin Hydrochloride Extended-Release 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 extended-release 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 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 extended-release 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 extended-release tablets. Insulin Secretagogues or Insulin Clinical Impact: Coadministration of metformin hydrochloride extended-release 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.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Metformin
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- Kidney disease: Metformin is contraindicated if your eGFR (kidney filtration rate) is below 30 mL/min/1.73 m². Starting metformin is not recommended if eGFR is 30–45. Kidney function should be checked before starting and regularly while taking it.
- Liver disease: Avoid metformin if you have significant liver problems — it raises lactic acidosis risk.
- Metabolic acidosis or diabetic ketoacidosis: Metformin is contraindicated in these conditions.
- Allergy: Do not take metformin if you have had a hypersensitivity (allergic) reaction to it.
- Age 65 or older: More careful monitoring of kidney function is needed; start at the lowest effective dose.
- Pregnancy: Poorly controlled diabetes in pregnancy is risky for mother and baby; talk to your doctor about whether to continue metformin — available data have not confirmed a clear risk of birth defects, but evidence is limited.
- Breastfeeding: Metformin passes into breast milk. Discuss benefits and risks with your doctor before continuing while nursing.
- Premenopausal women not currently ovulating: Metformin may trigger ovulation; discuss contraception with your doctor if pregnancy is not desired.
- Children under 10: Safety and effectiveness of metformin have not been established in children younger than 10. Extended-release tablets are for adults only.
- Upcoming surgery or procedures: Tell your care team you take metformin — it may need to be temporarily stopped if you will be fasting or receiving IV contrast dye.
Metformin overdose
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Taking too much metformin can lead to lactic acidosis (dangerous acid buildup in the blood) in a significant number of overdose cases. Low blood sugar has also been reported, though metformin's direct role is uncertain. If an overdose is suspected, seek emergency medical care immediately — hemodialysis (a kidney-filtering machine) can be used to remove metformin from the body and may help reverse symptoms.
What Metformin does in the body
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Metformin reduces blood sugar by decreasing the liver's output of glucose, slowing glucose absorption from the intestines, and improving the body's sensitivity to insulin — leading to better uptake and use of glucose by muscle and other tissues. It lowers both fasting blood sugar (before meals) and postprandial blood sugar (after meals). Importantly, metformin does not stimulate insulin secretion, so insulin levels may actually decrease over time while blood sugar control improves.
How your body processes Metformin
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When taken by mouth as a standard tablet under fasting conditions, roughly 50–60% of metformin is absorbed. Steady blood levels are typically reached within 24–48 hours of regular dosing. Metformin is not broken down by the liver and is excreted essentially unchanged by the kidneys, primarily through active secretion in the kidney tubules. The plasma half-life is approximately 6 hours, though the drug's half-life in red blood cells is considerably longer (around 17–18 hours), suggesting the cells act as a secondary storage compartment. In people with reduced kidney function, metformin clears more slowly and can accumulate — which is why kidney function is monitored carefully throughout treatment. Food slightly increases and delays the absorption of Riomet (oral solution).
How to store Metformin
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Store at 20°to 25° C (68°to 77° F); excursions permitted to 15° to 30° C (59° to 86° F).
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Metformin
258 supplements and herbal products have documented interactions with Metformin in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 2
- Moderate · 217
- Minor · 39
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Nutrient depletion considerations
Metformin has been associated with lower levels of 4 nutrients in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.
- Higher significance · 1
- Moderate · 2
- Unrated · 1
Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.
Metformin: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Metformin — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is metformin doing for my diabetes?
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My stomach has been a mess since I started metformin. Is that normal? Will it get better?
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I've heard something about a dangerous buildup of acid. Should I be worried?
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Do I need to stop metformin before surgery or a CT scan?
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Can I drink alcohol while taking metformin?
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I'm a woman and my doctor mentioned metformin might affect my ability to get pregnant. What does that mean?
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Is Metformin available over the counter?
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When was Metformin first available?
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Who makes Metformin?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Metformin on HelloPharmacist
Metformin forms and strengths (how it comes)
Metformin is available in 3 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Approved to improve blood sugar control in adults and children age 10 and older with type 2 diabetes mellitus, alongside diet and exercise.
- Take with meals, in divided doses throughout the day.
- Start at a low dose; your prescriber will increase it gradually to reduce stomach side effects.
- Follow your prescriber's specific dosing schedule — there is no single fixed dose that fits everyone.
Extended-release tablet
How this form is used
- Approved to improve blood sugar control in adults with type 2 diabetes mellitus, alongside diet and exercise.
- Extended-release tablets are approved for adults only — not for children.
- Swallow extended-release tablets whole — never crush, cut, or chew them.
- Generally taken once daily with the evening meal.
- Start at a low dose; the dose is increased slowly over weeks to minimize stomach side effects.
- If you are switching from regular metformin tablets, your doctor may transition you to extended-release tablets at the same total daily dose.
Oral solution
How this form is used
- Riomet is approved to improve blood sugar control in adults and children age 10 and older with type 2 diabetes mellitus, alongside diet and exercise.
- Metformin Hydrochloride Oral Solution is approved for adults and children age 10 and older with type 2 diabetes mellitus, alongside diet and exercise.
- Take with meals, in divided doses throughout the day.
- Start at a low dose; increase gradually as directed by your prescriber to reduce stomach side effects.
- Measure each dose carefully using the measuring device provided — do not estimate with a kitchen spoon.
Metformin on the U.S. market: products, makers and brands
How Metformin appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
75 companies list 451 Metformin product records with the FDA, mostly as tablet, extended-release tablet, oral solution; the earliest marketing or approval year on record is 2000. Brand names on the directory include Fortamet, Glucophage, Glumetza and 1 more; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (39) · Granule (5) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Metformin is used (Medicaid data)
A general measure of how commonly Metformin is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Metformin is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Metformin prescribed? Of the 1,601 medications we measure, Metformin ranks #11 by Medicaid prescriptions — more than 99% of them.
Utilization by Metformin product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
metformin hydrochloride 500 MG Oral Tablet Most dispensed
Summed across the 48 of 487 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 861007
metformin hydrochloride 1000 MG Oral Tablet
Summed across the 48 of 541 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 861004
24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet
Summed across the 32 of 401 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 860975
metformin hydrochloride 850 MG Oral Tablet
Summed across the 33 of 351 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 861010
24 HR metformin hydrochloride 750 MG Extended Release Oral Tablet
Summed across the 15 of 166 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 860981
Osmotic 24 HR metformin hydrochloride 1000 MG Extended Release Oral Tablet
Summed across the 6 of 39 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1807894
Modified 24 HR metformin hydrochloride 1000 MG Extended Release Oral Tablet
Summed across the 7 of 34 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1807888
metformin hydrochloride 625 MG Oral Tablet
Summed across the 2 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 861021
Modified 24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet
Summed across the 8 of 29 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1807915
metformin hydrochloride 100 MG/ML Oral Solution
Summed across the 5 of 15 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 861025
Osmotic 24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet
Summed across the 5 of 34 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1807917
metformin hydrochloride 750 MG Oral Tablet
Summed across the 2 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2703582
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Metformin, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 211 of 2,108 listed Metformin NDCs with Medicaid activity.
Compare Metformin products
A representative set of FDA-listed product records for Metformin — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Oral solution | ||||
| 500 mg/5 mL | Oral | Bionpharma Inc., | ANDA | View NDC → |
| 500 mg/5 mL | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 500 mg/5 mL | Oral | Micro Labs Limited | ANDA | View NDC → |
| 500 mg/5 mL | Oral | Saptalis Pharmaceuticals, LLC. | ANDA | View NDC → |
| 500 mg/5 mL | Oral | Sun Pharmaceutical Industries, Inc. × 2 listings | NDA | View NDC → |
| 500 mg/5 mL | Oral | Trupharma, Llc × 2 listings | ANDA | View NDC → |
| 500 mg/5 mL | Oral | VistaPharm, LLC | ANDA | View NDC → |
| 💊Tablet | ||||
| 500 mg | Oral | A-S Medication Solutions × 9 listings | ANDA | View NDC → |
| 850 mg | Oral | A-S Medication Solutions × 4 listings | ANDA | View NDC → |
| 1000 mg | Oral | A-S Medication Solutions × 8 listings | ANDA | View NDC → |
| 500 mg | Oral | ACI Healthcare USA, Inc. | ANDA | View NDC → |
| 850 mg | Oral | ACI Healthcare USA, Inc. | ANDA | View NDC → |
| 1000 mg | Oral | ACI Healthcare USA, Inc. | ANDA | View NDC → |
| 1000 mg | Oral | Advanced Rx of Tennessee, LLC | ANDA | View NDC → |
| 500 mg | Oral | Amneal Pharmaceuticals of New York LLC | ANDA | View NDC → |
| 850 mg | Oral | Amneal Pharmaceuticals of New York LLC | ANDA | View NDC → |
| 1000 mg | Oral | Amneal Pharmaceuticals of New York LLC | ANDA | View NDC → |
| 500 mg | Oral | Aphena Pharma Solutions - Tennessee, LLC × 3 listings | ANDA | View NDC → |
| 850 mg | Oral | Aphena Pharma Solutions - Tennessee, LLC × 2 listings | ANDA | View NDC → |
| 1000 mg | Oral | Aphena Pharma Solutions - Tennessee, LLC × 4 listings | ANDA | View NDC → |
| 500 mg | Oral | Ascend Laboratories, LLC | ANDA | View NDC → |
| 850 mg | Oral | Ascend Laboratories, LLC | ANDA | View NDC → |
| 1000 mg | Oral | Ascend Laboratories, LLC | ANDA | View NDC → |
| 500 mg | Oral | Bryant Ranch Prepack × 6 listings | ANDA | View NDC → |
| 850 mg | Oral | Bryant Ranch Prepack × 4 listings | ANDA | View NDC → |
| 1000 mg | Oral | Bryant Ranch Prepack × 4 listings | ANDA | View NDC → |
| 500 mg | Oral | Cardinal Health 107, LLC | ANDA | View NDC → |
| 500 mg | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| 625 mg | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| 750 mg | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| 850 mg | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| 1000 mg | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| 500 mg | Oral | Coupler LLC | ANDA | View NDC → |
| 850 mg | Oral | Coupler LLC | ANDA | View NDC → |
| 1000 mg | Oral | Coupler LLC | ANDA | View NDC → |
| 500 mg | Oral | direct rx | ANDA | View NDC → |
| 850 mg | Oral | direct rx | ANDA | View NDC → |
| 1000 mg | Oral | direct rx | ANDA | View NDC → |
| 500 mg | Oral | Direct_Rx | ANDA | View NDC → |
| 1000 mg | Oral | Direct_Rx | ANDA | View NDC → |
| 500 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 850 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 1000 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 500 mg | Oral | Granules India Ltd × 2 listings | ANDA | View NDC → |
| 750 mg | Oral | Granules India Ltd | ANDA | View NDC → |
| 850 mg | Oral | Granules India Ltd | ANDA | View NDC → |
| 1000 mg | Oral | Granules India Ltd | ANDA | View NDC → |
| 500 mg | Oral | Granules Pharmaceuticals Inc. × 2 listings | ANDA | View NDC → |
| 750 mg | Oral | Granules Pharmaceuticals Inc. | ANDA | View NDC → |
| 850 mg | Oral | Granules Pharmaceuticals Inc. | ANDA | View NDC → |
| 1000 mg | Oral | Granules Pharmaceuticals Inc. | ANDA | View NDC → |
| 500 mg | Oral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | View NDC → |
| 850 mg | Oral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | View NDC → |
| 1000 mg | Oral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | View NDC → |
| 500 mg | Oral | Legacy Pharmaceutical Packaging, LLC × 2 listings | ANDA | View NDC → |
| 850 mg | Oral | Legacy Pharmaceutical Packaging, LLC | ANDA | View NDC → |
| 1000 mg | Oral | Legacy Pharmaceutical Packaging, LLC | ANDA | View NDC → |
| 625 mg | Oral | Lifsa Drugs, LLC | ANDA | View NDC → |
| 750 mg | Oral | Lifsa Drugs, LLC | ANDA | View NDC → |
| 500 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| 850 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
Showing 101 of 451 products — FDA National Drug Code Directory. See every product, package size and price: browse all 451 Metformin NDCs →
Metformin side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Metformin — a signal of what to watch for, not proof the drug caused it.
The effects most often named in FDA reports that mention Metformin are nausea, diarrhoea, blood glucose increased; about 67% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Metformin in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Metformin FDA approval history
How Metformin went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Metformin was first approved by the FDA in 1995 (Brand: GLUCOPHAGE · Emd Serono Inc); the first generic version was approved in 2002. It remains available in U.S. pharmacies today.
Source: Drugs@FDA.
Metformin recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list 4 Metformin recalls since July 2021. Two of them are still ongoing or began in the last six months and are listed first. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.
- Metformin Hydrochloride Extended-Release Tablets 1000mg, 90-count bottle. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharma… Lots: Lot # 17232088, exp. date Sep-25 17232093, exp. date Sep-25 FDA record D-0328-2025 →
- METFORMIN HYDROCHLORIDE EXTENDED- RELEASE 500MG, 180 TABLETS, Packaged BY: A-S Medication Solutions, Libertyville, IL 60048 NDC 50090-1494-3. Lots: Lot# 4260340; Exp.12/31/2025. FDA record D-0292-2025 →
- Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules India Limited, Hyderabad- 500 081, India, Manufactured for: Quallent Pharmaceutic… Lots: Lot #: 4911311A, Exp. Date: 11/2025 FDA record D-0192-2025 →
- Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01 Lots: M008130 06/2022, M008131 06/2022, M008132 06/2022, M008133 06/2022, M010080 07/2022, M010081 07/2022, M011029 08/2022, M011030 08/2022, M011031 08/2022, M011032 08/2022, M011304 08/2022, M013394 09/2022, M013395 09/2022, M013396 09/2022, M… FDA record D-0392-2022 →
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 6809 3 dose forms · 12 strengths
-
Dose form (SCDF) Extended Release Oral Tablet RxCUI 372804In current FDA listingsClinical drug / strength (SCD) Modified 24 HR metformin hydrochloride 1000 MGRxCUI 1807888Modified 24 HR metformin hydrochloride 500 MGRxCUI 1807915Osmotic 24 HR metformin hydrochloride 1000 MGRxCUI 1807894Osmotic 24 HR metformin hydrochloride 500 MGRxCUI 180791724 HR metformin hydrochloride 500 MGRxCUI 86097524 HR metformin hydrochloride 750 MGRxCUI 860981 -
Dose form (SCDF) Oral Solution RxCUI 406082In current FDA listingsClinical drug / strength (SCD) hydrochloride 100 MG/MLRxCUI 861025 -
Dose form (SCDF) Oral Tablet RxCUI 372803In current FDA listingsClinical drug / strength (SCD) hydrochloride 1000 MGRxCUI 861004hydrochloride 500 MGRxCUI 861007hydrochloride 625 MGRxCUI 861021hydrochloride 750 MGRxCUI 2703582hydrochloride 850 MGRxCUI 861010
Look up RxCUI 6809 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Metformin supply and shortage status
Whether Metformin is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Metformin brand names
Metformin is sold under 4 brand names in the FDA directory — Fortamet, Glucophage, Glumetza, Riomet. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Metformin: manufacturers and labelers
75 companies list Metformin products with the FDA. By number of product records, the largest are A-S Medication Solutions, Bryant Ranch Prepack, Aphena Pharma Solutions - Tennessee, LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
…and 51 more on the FDA NDC directory.
Metformin drug class (RxNorm)
Metformin belongs to the Biguanide class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Metformin page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Mylan Pharmaceuticals Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →