FDA-filed SPL labeling · retrieved through openFDA

Canagliflozin / Metformin

Canagliflozin/metformin (Invokamet) is a two-in-one oral tablet that helps adults and some children with type 2 diabetes control blood sugar — and may also protect the heart and kidneys.

Brand names InvokametInvokamet Xr
Drug classes ⓘ Biguanides
Rx Forms 2 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 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 1 clinical label set 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 →

At a glance
Linked label effectiveAug 24, 2026
AvailabilityRx
Earliest approval/marketing year ⓘ2014
FDA-listed product records ⓘ41
Boxed warningYes
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 22, 2026
⭐ Canagliflozin / Metformin at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Canagliflozin/metformin is a powerful combination for type 2 diabetes that lowers blood sugar through two different pathways and may also protect your heart and kidneys. The metformin component carries a real but rare risk of lactic acidosis — knowing the warning signs and keeping your kidney function checked regularly is key. Take it with meals, follow your prescriber's guidance closely, and don't hesitate to call your doctor if something feels off.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

This medication carries a serious boxed warning about lactic acidosis — a dangerous buildup of lactic acid in the blood that can be fatal. It is caused by the metformin component. Although rare, real-world cases have resulted in death, dangerously low blood pressure, low body temperature, and irregular heartbeat. The early warning signs are often easy to miss: general tiredness or weakness, muscle aches, stomach pain, trouble breathing, or feeling drowsy. People most at risk are those with kidney or liver problems, those aged 65 or older, heavy alcohol drinkers, people with low-oxygen conditions like heart failure, and anyone having surgery or a contrast imaging procedure. If you experience any of those symptoms, stop the medication and go to the emergency room immediately. Treatment may require hemodialysis (a machine that filters the blood).

Read the full warning on DailyMed →

📖 Canagliflozin / Metformin: Patient Information Guide

A plain-language walkthrough of Canagliflozin / Metformin — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Canagliflozin/metformin is used to improve blood sugar control in people with type 2 diabetes, combined with diet and exercise. The canagliflozin part also offers benefits beyond blood sugar in adults:

  • Type 2 diabetes (ages 10 and up): blood sugar control alongside diet and exercise
  • Established cardiovascular disease: reduces the risk of heart attack, stroke, and cardiovascular death in adults
  • Diabetic kidney disease with significant protein in the urine: reduces the risk of kidney failure, cardiovascular death, and hospitalization for heart failure

Not for use in type 1 diabetes.

⚙️How it works▾

Canagliflozin blocks a kidney protein called SGLT2 (sodium-glucose co-transporter 2) that normally pulls glucose back into the bloodstream. By blocking it, excess sugar is excreted in the urine instead of staying in the blood. It also appears to reduce pressure inside the kidney's tiny filtering units, which may explain its kidney-protective effects. Metformin works on a completely different front — it reduces the amount of sugar the liver releases, slows glucose absorption from food, and makes cells respond better to insulin, all without forcing the pancreas to pump out more insulin on its own.

💊How it's taken▾

Both versions are taken by mouth with meals. The immediate-release tablet (Invokamet) is taken twice daily with food. The extended-release tablet (Invokamet XR) is taken once daily with the morning meal — always swallow it whole; crushing, cutting, or chewing it is not safe.

  • Your doctor will choose your starting dose based on your current medications and kidney function
  • The metformin dose is increased gradually to limit stomach side effects
  • Stop the medication at least 3 days before planned surgery or procedures with prolonged fasting, if possible
  • It may also need to be paused around certain imaging scans that use contrast dye
🤒Side effects — in detail▾

The most common side effects come from the two components separately:

  • Canagliflozin: vaginal yeast infections, urinary tract infections, urinating more often
  • Metformin: diarrhea, nausea, vomiting, gas, stomach discomfort, indigestion, headache, fatigue

Serious reactions to act on right away include signs of lactic acidosis (muscle pain, stomach pain, trouble breathing, unusual cold or tiredness), signs of ketoacidosis (nausea, vomiting, stomach pain even with normal blood sugar), a severe genital infection (pain, redness, swelling near the genitals with fever), or a serious allergic reaction (swelling of the face, lips, or throat). Seek emergency care for any of these.

⚠️Warnings & precautions▾
  • Lactic acidosis (metformin): A rare but potentially fatal buildup of lactic acid. Risk is highest in those with kidney or liver problems, heart failure, older age, heavy alcohol use, or around surgery and imaging procedures. Symptoms can be subtle — act immediately if they appear.
  • Lower limb amputation: A higher rate has been seen with canagliflozin. Check feet and legs regularly for sores, ulcers, or infections.
  • Ketoacidosis: Can occur even without very high blood sugar. Watch for nausea, vomiting, stomach pain, or trouble breathing.
  • Fournier's gangrene: A rare, life-threatening genital/perineal infection. Seek urgent care for pain, redness, or swelling in that area with fever.
  • Dehydration and kidney injury: This medication can cause fluid loss. Stay well-hydrated, and take care if you are older, on diuretics, or have reduced kidney function.
  • Vitamin B12 deficiency: Metformin can gradually lower B12 levels. Your doctor should check your levels every 2–3 years.
  • Bone fractures: Canagliflozin has been associated with increased fracture risk; discuss bone health with your doctor before starting.
🔀What it interacts with▾

Several medications and substances can interact in meaningful ways:

  • Topiramate and similar drugs (carbonic anhydrase inhibitors): Increase lactic acidosis risk with metformin — closer monitoring needed
  • Ranolazine, vandetanib, dolutegravir, cimetidine: Slow the kidney's removal of metformin, raising its blood levels and lactic acidosis risk
  • Alcohol: Disrupts how the body handles lactate — excessive drinking raises lactic acidosis risk significantly
  • Rifampin, phenytoin, phenobarbital, ritonavir (UGT inducers): Speed up the breakdown of canagliflozin, which may weaken blood sugar control — your dose may need adjustment
  • Insulin or insulin secretagogues: Combination raises hypoglycemia (low blood sugar) risk; your prescriber may lower those doses

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Severe kidney impairment (eGFR below 30): Do not use — it is contraindicated
  • Moderate kidney impairment (eGFR below 45): Starting the medication is not recommended
  • Liver disease: Avoid use — increases lactic acidosis risk
  • Metabolic or diabetic ketoacidosis: Do not use — contraindicated
  • Pregnancy (2nd and 3rd trimesters): Not recommended due to potential harm to fetal kidneys
  • Breastfeeding: Not recommended
  • Premenopausal women not using contraception: Be aware of potential pregnancy risk
  • Adults 65 and older: Higher risk of low blood pressure, dehydration, and kidney side effects — more frequent monitoring needed
  • Children under 10: Not approved for this age group
  • Type 1 diabetes: Not recommended
  • Serious allergy to canagliflozin or metformin: Do not use
🚑If you take too much▾

If too much of this medication is taken, the most serious concern is lactic acidosis from the metformin component — reported in roughly 1 in 3 metformin overdose cases. Low blood sugar has also been reported, though less commonly. In case of suspected overdose, call Poison Control at 1-800-222-1222 right away. Hemodialysis (blood-filtering treatment) can help remove metformin from the body and is recommended in serious cases.

📡Pharmacodynamics — effects in the body▾

Canagliflozin lowers the threshold at which the kidneys start spilling glucose into the urine, causing the body to excrete excess sugar rather than keeping it in the bloodstream. It does not appear to affect the heart's electrical activity (no meaningful QTc interval changes were seen even at high doses). Metformin lowers both fasting and after-meal blood glucose levels by reducing the liver's sugar output and improving the body's response to insulin, without directly stimulating the pancreas to produce more insulin.

🔬Pharmacokinetics — how your body processes it▾

Canagliflozin is absorbed fairly well after an oral dose (about 65% bioavailability) and reaches peak blood levels within 1 to 2 hours. It has a half-life of roughly 10 to 13 hours, meaning it stays active in the body through the day with once-daily dosing. Metformin's absorption from the gut is more variable (roughly 50–60% for the immediate-release form) and does not increase proportionally with higher doses. Taking the immediate-release combination with food slightly delays peak metformin levels but doesn't meaningfully change the overall amount absorbed; for the extended-release version, food increases metformin exposure and is therefore required.

📦How to store it▾

Keep out of reach of children. Store at 20 °C to 25 °C (68 °F to 77 °F); excursions permitted between 15 °C to 30°C (59 °F to 86 °F) . Store and dispense in the original container.

📄 Written from Canagliflozin / Metformin’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Canagliflozin / Metformin — the kind of thing our pharmacy team would talk through with you at the counter.

What's the difference between Invokamet and Invokamet XR? ▾
Both contain the same two active ingredients — canagliflozin and metformin — just in different forms. Invokamet is the immediate-release version, taken twice a day with meals. Invokamet XR is extended-release, taken once a day with your morning meal. With the XR version, the metformin is released more slowly throughout the day. A key thing to remember: never cut, crush, or chew the XR tablet — always swallow it whole. Your doctor will decide which form is right for you.
Why does this medication sometimes cause stomach issues, and will it go away? ▾
The metformin component is the main culprit for stomach side effects like nausea, diarrhea, and an upset stomach. This is very common when starting the medication or when the dose is increased. The good news is that your doctor will usually raise the dose gradually to let your body adjust, and taking it with food helps a lot. For most people, the stomach symptoms settle down over a few weeks. If they're still bothering you after that, it's worth mentioning to your prescriber.
What are the warning signs of lactic acidosis, and should I be worried? ▾
Lactic acidosis is a serious but rare risk with the metformin in this medication. The tricky part is that the early symptoms are easy to brush off — unusual muscle aches, stomach pain, feeling more tired than normal, trouble breathing, or feeling cold or dizzy. The risk is higher if you have kidney problems, drink heavily, or are going in for surgery or a contrast scan. If you feel any of those symptoms, don't wait — stop the medication and go to the emergency room. It's always better to get checked and be wrong than to ignore it.
I heard this medication can increase the risk of amputations — is that true? ▾
There is a real warning about this. Studies with canagliflozin showed a higher rate of lower limb amputations, mostly involving the toe or foot. This doesn't mean it will happen to you, but it does mean it's important to take good care of your feet. Check them regularly for sores, cuts, blisters, or signs of infection that aren't healing well. If you notice anything unusual — especially redness, swelling, or a wound that isn't getting better — contact your doctor promptly. People with poor circulation or prior foot problems should discuss this risk carefully with their prescriber.
Can I drink alcohol while taking this medication? ▾
It's best to keep alcohol to a minimum. Alcohol can interfere with how your body handles a substance called lactate, which raises the risk of a dangerous condition called lactic acidosis when you're taking metformin. That doesn't mean one occasional drink will cause harm, but consistently heavy drinking is genuinely risky with this medication. If you're unsure about what's safe for your situation, have an honest conversation with your pharmacist or doctor.
Do I need to stop this medication before a surgery or MRI with contrast dye? ▾
Yes — this is an important one to remember. Before any surgery, procedure involving extended fasting, or imaging scan that uses iodinated contrast dye (a type of dye injected for certain X-rays, CT scans, or similar tests), your doctor will likely want you to pause this medication. The goal is to reduce the risk of lactic acidosis, since your kidneys may be under extra stress during these situations. Always tell your surgical or radiology team that you're taking this medication so they can give you specific guidance on timing.
Is Canagliflozin / Metformin available over the counter? ▾
Canagliflozin / Metformin is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Canagliflozin / Metformin first available? ▾
Canagliflozin / Metformin has been available in the United States since at least 2014, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Canagliflozin / Metformin? ▾
Canagliflozin / Metformin is supplied by 3 manufacturers listed in the FDA NDC Directory, including Janssen Pharmaceuticals, Inc., Janssen Ortho LLC, Bryant Ranch Prepack.

💬 Answers drafted from Canagliflozin / Metformin’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

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💊 How Canagliflozin / Metformin comes

Canagliflozin / Metformin is available in 2 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.

📊 Canagliflozin / Metformin across the U.S. market

How Canagliflozin / 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.

2
Dose forms ⓘ
3
Manufacturers
2
Brand names
41
FDA-listed product records ⓘ
2014
First marketed ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Janssen Pharmaceuticals, Inc.78%
Janssen Ortho LLC20%
Bryant Ranch Prepack2%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Canagliflozin / Metformin is used

A general measure of how commonly Canagliflozin / 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 Canagliflozin / 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.

2,694
Medicaid prescriptions filled (Q1–Q4 2025)
$2.2M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Canagliflozin / Metformin prescribed? Of the 1,596 medications we measure, Canagliflozin / Metformin ranks #1,145 by Medicaid prescriptions — more than 28% of them.

Where Canagliflozin / Metformin ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #1,145 of 1,596
#1,140 Dihydroergotamine Nasa... 2,813 Rx #1,141 Oxymetazoline Topical 2,766 Rx #1,142 Dasiglucagon Injection 2,752 Rx #1,143 Ketorolac / Phenylephr... 2,724 Rx #1,144 Ibrutinib 2,698 Rx #1,145 Canagliflozin / Metfor... 2,694 Rx #1,146 Phenol 2,689 Rx #1,147 Dabrafenib 2,673 Rx #1,148 Prasterone Vaginal 2,624 Rx #1,149 Lanadelumab-flyo injec... 2,602 Rx #1,150 Mifepristone (Mifeprex... 2,590 Rx

Utilization by Canagliflozin / 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 150 mg / 1000 mg oral tablet is the most-dispensed Canagliflozin / Metformin product — about 58% of these Medicaid prescriptions.

canagliflozin 150 MG / metformin hydrochloride 1000 MG Oral Tablet Most dispensed

1,550 Medicaid prescriptions (Q1–Q4 2025) 58% of Canagliflozin / Metformin prescriptions shown $1.2M gross reimbursement (before rebates) ≈ $798 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1545150

canagliflozin 50 MG / metformin hydrochloride 1000 MG Oral Tablet

624 Medicaid prescriptions (Q1–Q4 2025) 23% of Canagliflozin / Metformin prescriptions shown $493,423 gross reimbursement (before rebates) ≈ $791 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1545161

24 HR canagliflozin 150 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet

308 Medicaid prescriptions (Q1–Q4 2025) 11% of Canagliflozin / Metformin prescriptions shown $281,697 gross reimbursement (before rebates) ≈ $915 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1810997

canagliflozin 50 MG / metformin hydrochloride 500 MG Oral Tablet

189 Medicaid prescriptions (Q1–Q4 2025) 7% of Canagliflozin / Metformin prescriptions shown $142,723 gross reimbursement (before rebates) ≈ $755 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1545164

24 HR canagliflozin 50 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet

23 Medicaid prescriptions (Q1–Q4 2025) <1% of Canagliflozin / Metformin prescriptions shown $21,516 gross reimbursement (before rebates) ≈ $935 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1811006

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 Canagliflozin / 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 5 of 5 listed Canagliflozin / Metformin NDCs with Medicaid activity.

🔍 Compare Canagliflozin / Metformin products

A representative set of FDA-listed product records for Canagliflozin / 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 41 of 41 products — FDA National Drug Code Directory. See every product, package size and price: browse all 41 Canagliflozin / Metformin NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one exact multiple-ingredient concept (MIN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). A product with a different ingredient combination belongs on a different page.

Multiple ingredients (MIN) Canagliflozin / Metformin RxCUI 1545149 2 dose forms · 8 strengths

Look up RxCUI 1545149 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.

🏷️ Sold under these brand names

Invokamet Invokamet Xr

🏭 Manufacturers & labelers

Janssen Pharmaceuticals, Inc. 32 Janssen Ortho LLC 8 Bryant Ranch Prepack 1

RxNorm drug class

Canagliflozin / Metformin belongs to the Sodium-Glucose Cotransporter 2 Inhibitor class.

Pharmacologic class Sodium-Glucose Cotransporter 2 Inhibitor
Drug family (ATC) Sodium-glucose co-transporter 2 (SGLT2) inhibitors
How it works P-Glycoprotein Inhibitors, Sodium-Glucose Transporter 2 Inhibitors

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.

🔬 Where this comes from

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 Aug 24, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Canagliflozin / 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 Canagliflozin / Metformin after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
NDC products indexed
41
Distinct labelers/manufacturers represented
3
Linked representative label ⓘ
Janssen Pharmaceuticals, Inc.
Linked label effective
Aug 24, 2026
Composite sections available
24
Linked SPL Set ID
6868666b-c25e-40d1-9d1f-306bbe9390c1
Linked SPL Document ID
95b8c81c-dfe3-4dd4-be06-8dd1d935f07e
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Janssen Pharmaceuticals, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.