Skip to the answer

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.

Brand names FortametGlucophageGlumetzaRiomet
Drug class Biguanides
Rx Forms 3
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 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 →

✓No current FDA shortage listed · checked Oct 4, 2026 🚨Recall on record · 2
Metformin at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

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.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asTablet, Extended-release tablet, Oral solution
Earliest FDA record2000
Companies listing it with the FDA75
FDA label last updatedJun 15, 2026
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Metformin, written from its FDA label.

What Metformin is used for

▾

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

▾

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

▾

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

▾

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

▾
  • 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

▾

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

▾
  • 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

▾

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

▾

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

▾

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

▾

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 →

258

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.

Severity mix
  • Major · 2
  • Moderate · 217
  • Minor · 39
Every supplement checked against Metformin — ranked by severity The full interaction hub: 2 major · 217 moderate · 39 minor · every one linked to its full report. Check Metformin against your exact supplements

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.

4

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.

Evidence & significance mix
  • Higher significance · 1
  • Moderate · 2
  • Unrated · 1
See the full Metformin nutrient depletion report

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?

▾
Metformin works in three ways: it lowers the amount of sugar your liver dumps into your bloodstream, slows how much sugar your gut absorbs from food, and helps your body respond to insulin better so your cells can actually use the glucose. The result is better blood sugar control — but it works best as part of a plan that includes eating well and staying active. It's a background player, not a quick fix.

My stomach has been a mess since I started metformin. Is that normal? Will it get better?

▾
Yes, this is very common — diarrhea, nausea, and stomach discomfort are the most frequently reported side effects, and they're often worst when you first start or when your dose goes up. Taking metformin with food helps a lot. Your doctor will usually start you on a low dose and increase it slowly for exactly this reason. For most people, the stomach issues settle down after a few weeks as your body adjusts. If they're severe or not improving, talk to your doctor — there may be options to help.

I've heard something about a dangerous buildup of acid. Should I be worried?

▾
This is called lactic acidosis, and it's a real but rare risk. It means lactic acid builds up in the blood to a dangerous level. Most people taking metformin will never experience this, but you should know the warning signs: muscle aches, unusual tiredness, stomach pain, trouble breathing, or feeling unusually cold or sleepy. Your risk is higher if you have kidney problems, liver disease, drink heavily, or are older than 65. If you ever notice those symptoms, stop metformin and get emergency care right away — don't wait it out.

Do I need to stop metformin before surgery or a CT scan?

▾
Quite possibly yes, and this is important. Before any surgery where you won't be eating or drinking, or before an imaging test that uses IV contrast dye (like a CT scan with contrast), your care team needs to know you're on metformin. The contrast dye can temporarily stress your kidneys, which could cause metformin to build up in your body. Your doctor will tell you exactly when to stop and when it's safe to restart — usually after kidney function is confirmed to be normal. Never skip telling a provider you're on it.

Can I drink alcohol while taking metformin?

▾
Occasional, moderate drinking is generally a conversation to have with your doctor, but heavy or excessive alcohol use while on metformin is something to avoid. Alcohol increases metformin's effect on lactic acid metabolism, which raises the risk of lactic acidosis. So while a glass of wine with dinner isn't the same as binge drinking, it's worth being upfront with your doctor about your alcohol habits so they can advise you appropriately.

I'm a woman and my doctor mentioned metformin might affect my ability to get pregnant. What does that mean?

▾
For women who haven't been ovulating regularly — which can happen with conditions like polycystic ovary syndrome — metformin may actually trigger ovulation, which means you could become fertile even if you weren't before. That's worth knowing if you're not planning a pregnancy. Talk to your doctor about contraception if this applies to you. If you are pregnant or trying to become pregnant, discuss your metformin use with your doctor — they'll help you weigh the benefits and any potential risks and make sure your blood sugar is well controlled throughout.

Is Metformin available over the counter?

▾
No. Metformin is a prescription medicine: every Metformin product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Metformin first available?

▾
The earliest FDA record we hold for Metformin is from 2000: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Metformin was first used.

Who makes Metformin?

▾
75 companies currently list Metformin products in the FDA's NDC Directory, including A-S Medication Solutions, Bryant Ranch Prepack, Aphena Pharma Solutions - Tennessee, LLC. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Metformin on HelloPharmacist

Detailed data & references for Metformin Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

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

By mouth
Brands Metformin Hydrochoride
How this form is used
What it may be used for
  • Approved to improve blood sugar control in adults and children age 10 and older with type 2 diabetes mellitus, alongside diet and exercise.
Important instructions
  • 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.
Available strengths 5 strengths
519 FDA-listed product records ⓘ

Extended-release tablet

By mouth
Brands Glumetza
How this form is used
What it may be used for
  • 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.
Important instructions
  • 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.
Available strengths 3 strengths
365 FDA-listed product records ⓘ

Oral solution

By mouth
Brands Riomet
How this form is used
What it may be used for
  • 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.
Important instructions
  • 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.
Available strengths 1 strength
14 FDA-listed product records ⓘ

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.

3
Dose forms ⓘ
75
Labelers (makers, repackagers, distributors)
11
Brand names
451
FDA-listed product records ⓘ
2000
Earliest FDA record ⓘ

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.

A-S Medication Solutions12%
Bryant Ranch Prepack8%
Aphena Pharma Solutions - Tennessee, LLC5%
Proficient Rx LP4%
PD-Rx Pharmaceuticals, Inc.4%
Remedyrepack Inc.4%
Other makers63%

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.

9,119,008
Medicaid prescriptions filled (Q1–Q4 2025)
$147.4M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Metformin prescribed? Of the 1,601 medications we measure, Metformin ranks #11 by Medicaid prescriptions — more than 99% of them.

Where Metformin ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

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.

The 500 mg oral tablet is the most-dispensed Metformin product — about 37% of these Medicaid prescriptions.

metformin hydrochloride 500 MG Oral Tablet Most dispensed

3,364,484 Medicaid prescriptions (Q1–Q4 2025) 37% of Metformin prescriptions shown $30.3M gross reimbursement (before rebates) ≈ $9.00 per prescription (gross)

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

2,652,025 Medicaid prescriptions (Q1–Q4 2025) 29% of Metformin prescriptions shown $27.7M gross reimbursement (before rebates) ≈ $10 per prescription (gross)

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

2,410,844 Medicaid prescriptions (Q1–Q4 2025) 26% of Metformin prescriptions shown $28.8M gross reimbursement (before rebates) ≈ $12 per prescription (gross)

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

294,759 Medicaid prescriptions (Q1–Q4 2025) 3% of Metformin prescriptions shown $3M gross reimbursement (before rebates) ≈ $10 per prescription (gross)

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

278,234 Medicaid prescriptions (Q1–Q4 2025) 3% of Metformin prescriptions shown $3.2M gross reimbursement (before rebates) ≈ $12 per prescription (gross)

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

36,715 Medicaid prescriptions (Q1–Q4 2025) <1% of Metformin prescriptions shown $1.8M gross reimbursement (before rebates) ≈ $49 per prescription (gross)

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

20,586 Medicaid prescriptions (Q1–Q4 2025) <1% of Metformin prescriptions shown $2.8M gross reimbursement (before rebates) ≈ $135 per prescription (gross)

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

15,127 Medicaid prescriptions (Q1–Q4 2025) <1% of Metformin prescriptions shown $28.3M gross reimbursement (before rebates) ≈ $1,868 per prescription (gross)

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

14,216 Medicaid prescriptions (Q1–Q4 2025) <1% of Metformin prescriptions shown $766,446 gross reimbursement (before rebates) ≈ $54 per prescription (gross)

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

13,468 Medicaid prescriptions (Q1–Q4 2025) <1% of Metformin prescriptions shown $3.6M gross reimbursement (before rebates) ≈ $270 per prescription (gross)

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

11,635 Medicaid prescriptions (Q1–Q4 2025) <1% of Metformin prescriptions shown $340,738 gross reimbursement (before rebates) ≈ $29 per prescription (gross)

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

6,915 Medicaid prescriptions (Q1–Q4 2025) <1% of Metformin prescriptions shown $16.8M gross reimbursement (before rebates) ≈ $2,429 per prescription (gross)

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.)

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.

439,165
Reports mentioning it
67%
Reported as serious
12
Distinct effects shown
Most reported effects
Nausea
30,163
Diarrhoea
28,202
Blood Glucose Increased
27,576
Fatigue
21,488
Vomiting
19,617
Lactic Acidosis
19,398
Acute Kidney Injury
18,251
Weight Decreased
17,509
Dyspnoea
16,729
Dizziness
15,837
Age groups
Adult · 35,954Elderly · 33,842Neonate · 564Adolescent · 337Child · 94Infant · 92

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.

1995
Brand approved
Brand: GLUCOPHAGE · Emd Serono Inc
2002
First generic approved
Lower-cost ANDA competition begins
2026
Available today
Active in U.S. pharmacies

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.

Ongoing Class II Mar 13, 2025 · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
  • 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 →
Ongoing Class II Feb 25, 2025 · A-S Medication Solutions LLC
Presence of Foreign Tablets/Capsules.
  • 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 →
Class II Dec 30, 2024 · Terminated · Granules Pharmaceuticals Inc.
Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.
  • 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 →
Class II Dec 27, 2021 · Terminated · VIONA PHARMACEUTICALS INC
CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
  • 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.

Ingredient (IN) Metformin RxCUI 6809 3 dose forms · 12 strengths
  1. Dose form (SCDF) Oral Solution RxCUI 406082 In current FDA listings
    Clinical drug / strength (SCD) hydrochloride 100 MG/ML RxCUI 861025

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 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.

Fortamet Glucophage Glumetza Riomet

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.

A-S Medication Solutions 55 Bryant Ranch Prepack 34 Aphena Pharma Solutions - Tennessee, LLC 24 Proficient Rx LP 20 PD-Rx Pharmaceuticals, Inc. 18 Remedyrepack Inc. 18 Preferred Pharmaceuticals Inc. 16 NuCare Pharmaceuticals, Inc. 15 Ascend Laboratories, LLC 12 Aurobindo Pharma Limited 10 Northwind Health Company, LLC 10 Coupler LLC 9 ScieGen Pharmaceuticals Inc 9 Quallent Pharmaceuticals Health LLC 8 Westminster Pharmaceuticals, LLC 8 direct rx 8 Epic Pharma, LLC 7 Granules India Ltd 7 Granules Pharmaceuticals Inc. 7 Macleods Pharmaceuticals Limited 6 Chartwell RX, LLC 5 Laurus Labs Limited 5 Marksans Pharma Limited 5 Mylan Pharmaceuticals Inc. 5

…and 51 more on the FDA NDC directory.

Metformin drug class (RxNorm)

Metformin belongs to the Biguanide class.

Pharmacologic class Biguanide
Drug family (ATC) Biguanides

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.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jun 15, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Metformin.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Metformin after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
346
Finished products in the current FDA directory
451
Companies listing them (makers, repackagers, distributors)
75
FDA labeler codes behind them ⓘ
84
Linked representative label ⓘ
Mylan Pharmaceuticals Inc.
Linked label effective
Jun 15, 2026
Composite sections available
22
Linked SPL Set ID
7e41818c-60e9-4bcf-9586-7bb8d33d5e89
Linked SPL Document ID
2a0bac1b-3575-4b62-a74b-07f54ba064af
Open the linked representative label on DailyMed ↗

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 →