Prescription medicine
Canagliflozin and metformin Brand names: Invokamet
Canagliflozin and metformin (Invokamet) is a prescription medicine with an FDA approval on record since 2014. No generic is listed; pharmacies paid $9.58 per Invokamet 150-1,000 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the canagliflozin and metformin FDA label on DailyMed (effective August 24, 2026, Janssen Pharmaceuticals, Inc.); the NDA 204353 record on Drugs@FDA; every canagliflozin and metformin label on DailyMed.
Highlights of the record
FDA label of August 24, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
LACTIC ACIDOSIS.
Post-marketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (> 5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL [see Warnings and Precautions (5.1) ]. Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, hepatic impairment, and mitochondrial diseases [see Warnings and Precautions (5.1) ]. […]
Used for
From the label: indications and usageINVOKAMET INVOKAMET is a combination of canagliflozin and metformin HCl immediate-release indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus.
Forms and strengths
- 50 mg / 1000 mg
- 50 mg / 500 mg
- 150 mg / 500 mg
- 150 mg / 1000 mg
Film-coated tablet; film-coated extended-release tablet.
On the market
- Earliest approval on file
- August 8, 2014 Invokamet, Janssen Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- July 6, 2030 Invokamet tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $9.58 per tablet Invokamet 150-1,000 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2016 0 Class I among all firms' recalls; latest October 19, 2016
- FAERS reports
- 1,810 through July 30, 2026
What is canagliflozin and metformin used for?
From the label: indications and usageINVOKAMET INVOKAMET is a combination of canagliflozin and metformin HCl immediate-release indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. INVOKAMET XR INVOKAMET XR is a combination of canagliflozin and metformin HCl extended-release indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. […]
Conditions named in the indications of canagliflozin and metformin's FDA labels, with every medicine labeled for each:
From other canagliflozin and metformin labelsHeart attack and coronary artery disease: Major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD).
FDA pharmacologic class: Biguanide and Sodium-Glucose Cotransporter 2 Inhibitor.
Source: FDA drug label (INVOKAMET), Janssen Pharmaceuticals, Inc., effective August 24, 2026 (SPL set 6868666b-c25e-40d1-9d1f-306bbe9390c1), via openFDA; the full label on DailyMed
What does the patient leaflet for canagliflozin and metformin say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about INVOKAMET or INVOKAMET XR?INVOKAMET and INVOKAMET XR can cause serious side effects, including: Lactic Acidosis. Metformin, one of the medicines in INVOKAMET and INVOKAMET XR, can cause a rare but serious condition called lactic acidosis (a build-up of lactic acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital. Stop taking INVOKAMET or INVOKAMET XR and call your healthcare provider right away if you have any of the following symptoms of lactic acidosis: feel cold in your hands or feet feel very weak or tired have trouble breathing have stomach pains, nausea, or vomiting have a slow or irregular heartbeat have unusual (not normal) muscle pain have unusual sleepiness or sleep longer than usual feel dizzy or lightheaded Most people who have had lactic acidosis had other conditions that, in combination with metformin use, led to the lactic acidosis. […] Seek medical attention immediately if you have a fever or you are feeling very weak, tired or uncomfortable (malaise), and you develop any of the following symptoms in the area between and around your anus and genitals: pain or tenderness swelling redness of skin (erythema) Also tell your healthcare provider if you have any of these signs or symptoms of urinary tract infections or yeast infections: Urinary tract infection: burning feeling when you urinate need to urinate often or right away pain in the lower part of your stomach (pelvis) blood in your urine You may also have a fever, back pain, nausea, or vomiting. […]
From the patient leaflet: What should I avoid while taking INVOKAMET or INVOKAMET XR?Avoid drinking alcohol very often or drinking a lot of alcohol in a short period of time ("binge" drinking). It can increase your chances of getting serious side effects.
From the patient leaflet: How should I store INVOKAMET or INVOKAMET XR?Store INVOKAMET or INVOKAMET XR at room temperature between 68 °F to 77 °F (20 °C to 25 °C). Store INVOKAMET or INVOKAMET XR in the original container to protect from moisture. Storage in a pill box or pill organizer is allowed for up to 30 days. Keep INVOKAMET and INVOKAMET XR and all medicines out of the reach of children.
Source: FDA drug label (INVOKAMET), Janssen Pharmaceuticals, Inc., effective August 24, 2026 (SPL set 6868666b-c25e-40d1-9d1f-306bbe9390c1), via openFDA; the full label on DailyMed
Is there a generic for canagliflozin and metformin (Invokamet)?
No generic canagliflozin and metformin is approved (Drugs@FDA, October 8, 2026). Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 4 patents for Invokamet tablets: the compound patent runs to February 26, 2029 (pediatric exclusivity to August 26, 2029), and the last listed entry to July 6, 2030. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2014 earliest approval on file
- 2030 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for canagliflozin and metformin (Invokamet)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $9.58 per Invokamet 150-1,000 mg tablet, about the same as a year earlier. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Invokamet XR 150-1,000 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Invokamet 150-1,000 mg tablet | Brand | $9.58 per tablet | $287.26 | -0.1% |
| Invokamet 150-500 mg tablet | Brand | $9.61 per tablet | $288.27 | +0.8% |
| Invokamet 50-1,000 mg tablet | Brand | $9.54 per tablet | $286.15 | -0.3% |
| Invokamet 50-500 mg tablet | Brand | $9.56 per tablet | $286.91 | -0.1% |
| Invokamet XR 150-1,000 mg tablet | Brand | $9.54 per tablet | $286.07 | -0.2% |
| Invokamet XR 150-500 mg tablet | Brand | $9.56 per tablet | $286.84 | no change |
| Invokamet XR 50-1,000 mg tablet | Brand | $9.69 per tablet | $290.63 | +1% |
| Invokamet XR 50-500 mg tablet | Brand | $9.68 per tablet | $290.33 | +0.1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has canagliflozin and metformin been recalled?
The FDA's Enforcement Report lists 1 recall naming canagliflozin and metformin since 2016: 0 Class I (the most serious), 0 Class II, 1 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| October 19, 2016 | Class III | Janssen Ortho L.L.C. | Labeling: Incorrect or Missing Package Insert - Xarelto prescribing information outserts may be affixed to the exterior of Invokamet bottles in place of the … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the canagliflozin and metformin label say about other medicines?
The canagliflozin and metformin label names 15 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acetazolamide | drug interactions | 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 INVOKAMET or INVOKAMET XR may increase the risk for lactic … Intervention: Consider more frequent monitoring of these patients. Examples: Topiramate or other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide or dichlorphenamide) |
| Cimetidine | drug interactions | 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 (…) could increase systemic exposure to metformin and may increase the risk for lactic acidosis. Intervention: Consider the benefits and risks of concomitant use. Examples: Ranolazine, vandetanib, dolutegravir, and cimetidine |
| Dichlorphenamide | drug interactions | 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 INVOKAMET or INVOKAMET XR may increase the risk for lactic … Intervention: Consider more frequent monitoring of these patients. Examples: Topiramate or other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide or dichlorphenamide) |
| Digoxin | drug interactions | Digoxin Clinical Impact: Canagliflozin increases digoxin exposure. Intervention: Monitor patients taking INVOKAMET or INVOKAMET XR with concomitant digoxin for a need to adjust the dosage of digoxin. |
| Dolutegravir | drug interactions | 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 (…) could increase systemic exposure to metformin and may increase the risk for lactic acidosis. Intervention: Consider the benefits and risks of concomitant use. Examples: Ranolazine, vandetanib, dolutegravir, and cimetidine |
| Isoniazid | drug interactions | Clinical Impact: Certain drugs tend to produce hyperglycemia and may lead to loss of glycemic control. … phenytoin, nicotinic acid, sympathomimetics, calcium channel blockers, and isoniazid. |
| Lithium | drug interactions | Clinical Impact: Concomitant use of an SGLT2 inhibitor with lithium may decrease serum lithium concentrations. Intervention: Monitor serum lithium concentration more frequently during INVOKAMET or INVOKAMET XR initiation and dosage changes. Drug/Laboratory Test Interference Positive Urine Glucose Test |
| Phenobarbital | drug interactions | UGT Enzyme Inducers Clinical Impact: UGT enzyme inducers decrease canagliflozin exposure which may reduce the effectiveness of INVOKAMET or INVOKAMET XR. … tolerating canagliflozin 100 mg [see and ]. Examples: Rifampin, phenytoin, phenobarbital, ritonavir |
| Phenytoin | drug interactions | UGT Enzyme Inducers Clinical Impact: UGT enzyme inducers decrease canagliflozin exposure which may reduce the effectiveness of INVOKAMET or INVOKAMET XR. … currently tolerating canagliflozin 100 mg [see and ]. Examples: Rifampin, phenytoin, phenobarbital, ritonavir |
| Ranolazine | drug interactions | 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 (…) could increase systemic exposure to metformin and may increase the risk for lactic acidosis. Intervention: Consider the benefits and risks of concomitant use. Examples: Ranolazine, vandetanib, dolutegravir, and cimetidine |
| Rifampin | drug interactions | UGT Enzyme Inducers Clinical Impact: UGT enzyme inducers decrease canagliflozin exposure which may reduce the effectiveness of INVOKAMET or INVOKAMET XR. … patients currently tolerating canagliflozin 100 mg [see and ]. Examples: Rifampin, phenytoin, phenobarbital, ritonavir |
| Ritonavir | drug interactions | UGT Enzyme Inducers Clinical Impact: UGT enzyme inducers decrease canagliflozin exposure which may reduce the effectiveness of INVOKAMET or INVOKAMET XR. … canagliflozin 100 mg [see and ]. Examples: Rifampin, phenytoin, phenobarbital, ritonavir |
| Topiramate | boxed warning | Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart … |
| Vandetanib | drug interactions | 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 (…) could increase systemic exposure to metformin and may increase the risk for lactic acidosis. Intervention: Consider the benefits and risks of concomitant use. Examples: Ranolazine, vandetanib, dolutegravir, and cimetidine |
Every other medicine the canagliflozin and metformin label names
| Medicine named | Section | What the label says |
|---|---|---|
| Zonisamide | drug interactions | 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 INVOKAMET or INVOKAMET XR may increase the risk for lactic … Intervention: Consider more frequent monitoring of these patients. Examples: Topiramate or other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide or dichlorphenamide) |
Source: FDA drug label (INVOKAMET), Janssen Pharmaceuticals, Inc., effective August 24, 2026 (SPL set 6868666b-c25e-40d1-9d1f-306bbe9390c1), via openFDA; the full label on DailyMed
What do FAERS reports show for canagliflozin and metformin?
The FDA Adverse Event Reporting System holds 1,810 reports that list canagliflozin and metformin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 23 are coded as a death and 625 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as canagliflozin and metformin?
23 other medicines are given the same way (oral) and in the same FDA class as canagliflozin and metformin or labeled mainly for the same use (type 2 diabetes), the same class first. Type 2 diabetes lists all 52 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Dapagliflozin | Type 2 diabetes | 22 labelers | $0.184 per tablet 10 mg tablet | No current entry |
| Empagliflozin | Type 2 diabetes | none listed | $11.19 per tablet 10 mg tablet | No current entry |
| Bexagliflozin | Type 2 diabetes | none listed | n/a | No current entry |
| Empagliflozin and linagliptin | Type 2 diabetes | none listed | $11.24 per tablet 10 mg-5 mg tablet | No current entry |
| Dapagliflozin and saxagliptin | Type 2 diabetes | 1 labeler | n/a | No current entry |
| Glipizide | Type 2 diabetes | 31 labelers | $0.0339 per tablet 5 mg tablet | No current entry |
| Glimepiride | Type 2 diabetes | 29 labelers | $0.0507 per tablet 4 mg tablet | No current entry |
| Pioglitazone | Type 2 diabetes | 22 labelers | $0.0675 per tablet 15 mg tablet | No current entry |
Every medicine labeled for the same conditions as canagliflozin and metformin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to canagliflozin and metformin
- 23 medicines for the same use
- Other biguanides
- the pharmacologic class, with prices and generics
- Canagliflozin and metformin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other