Prescription medicine
Canagliflozin Brand names: Invokana
Canagliflozin (Invokana) is a prescription medicine with an FDA approval on record since 2013. No generic is listed; pharmacies paid $19.13 per Invokana 100 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the canagliflozin FDA label on DailyMed (effective June 11, 2026, Janssen Pharmaceuticals, Inc.); the NDA 204042 record on Drugs@FDA; every canagliflozin label on DailyMed.
Highlights of the record
FDA label of June 11, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageINVOKANA (canagliflozin) is 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
- 100 mg
- 300 mg
Film-coated tablet.
On the market
- Earliest approval on file
- March 29, 2013 Invokana, Janssen Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first April 14, 2026; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 0 under generic applications, 3 under brand applications, repackagers included
- Last listed patent
- August 26, 2029 Invokana tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $19.13 per tablet Invokana 100 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 29,747 through July 30, 2026
What is canagliflozin used for?
From the label: indications and usageINVOKANA (canagliflozin) is 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. to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD). to reduce the risk of end-stage kidney disease (ESKD), doubling of serum creatinine, cardiovascular (CV) death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria greater than 300 mg/day. […]
Conditions named in the indications of canagliflozin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Sodium-Glucose Cotransporter 2 Inhibitor.
Source: FDA drug label (INVOKANA), Janssen Pharmaceuticals, Inc., effective June 11, 2026 (SPL set b9057d3b-b104-4f09-8a61-c61ef9d4a3f3), via openFDA; the full label on DailyMed
What does the patient leaflet for canagliflozin 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 INVOKANA?INVOKANA can cause serious side effects, including: Diabetic ketoacidosis (increased ketones in your blood or urine) in people with type 1 and other ketoacidosis. INVOKANA can cause ketoacidosis that can be life-threatening and may lead to death. Ketoacidosis is a serious condition which needs to be treated in a hospital. People with type 1 diabetes have a high risk of getting ketoacidosis. People with type 2 diabetes or pancreas problems also have an increased risk of getting ketoacidosis. Ketoacidosis can also happen in people who: are sick, cannot eat or drink as usual, skip meals, are on a diet high in fat and low in carbohydrates (ketogenic diet), take less than the usual amount of insulin or miss insulin doses, drink too much alcohol, have a loss of too much fluid from the body (volume depletion), or who have surgery or a procedure that requires not having food for a long time (prolonged fasting). Ketoacidosis can happen even if your blood sugar is less than 250 mg/dL. […] 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: How should I store INVOKANA?Store INVOKANA at room temperature between 68 °F to 77 °F (20 °C to 25 °C). Keep INVOKANA and all medicines out of the reach of children.
Source: FDA drug label (INVOKANA), Janssen Pharmaceuticals, Inc., effective June 11, 2026 (SPL set b9057d3b-b104-4f09-8a61-c61ef9d4a3f3), via openFDA; the full label on DailyMed
Is there a generic for canagliflozin (Invokana)?
The FDA approved the first generic canagliflozin on April 14, 2026. 2 generic applications are approved; 1 of them carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 4 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 3 patents for Invokana tablets: the compound patent runs to February 26, 2029 (pediatric exclusivity to August 26, 2029). A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2013 earliest approval on file
- 2026 first generic approved
- 2029 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for canagliflozin (Invokana)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $19.13 per Invokana 100 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.
- Invokana 300 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Invokana 100 mg tablet | Brand | $19.13 per tablet | $573.81 | no change |
| Invokana 300 mg tablet | Brand | $19.12 per tablet | $573.74 | -0.1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the canagliflozin label say about other medicines?
The canagliflozin label names 6 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name canagliflozin. 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 |
|---|---|---|
| Digoxin | drug interactions | Digoxin Clinical Impact: Canagliflozin increases digoxin exposure. Intervention: Monitor patients taking INVOKANA with concomitant digoxin for a need to adjust the dosage of digoxin. |
| 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 INVOKANA 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 INVOKANA. … require additional glycemic control [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 INVOKANA. … patients who require additional glycemic control [see and ]. Examples: Rifampin, phenytoin, phenobarbital, ritonavir |
| Rifampin | drug interactions | UGT Enzyme Inducers Clinical Impact: UGT enzyme inducers decrease canagliflozin exposure which may reduce the effectiveness of INVOKANA. … in patients who require additional glycemic control [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 INVOKANA. … glycemic control [see and ]. Examples: Rifampin, phenytoin, phenobarbital, ritonavir |
Source: FDA drug label (INVOKANA), Janssen Pharmaceuticals, Inc., effective June 11, 2026 (SPL set b9057d3b-b104-4f09-8a61-c61ef9d4a3f3), via openFDA; the full label on DailyMed
What do FAERS reports show for canagliflozin?
The FDA Adverse Event Reporting System holds 29,747 reports that list canagliflozin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 685 are coded as a death and 10,711 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 rose sharply in 2018 (4,643, against a median of 824 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
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?
13 other medicines are given the same way (oral) and in the same FDA class as canagliflozin or labeled mainly for the same use (heart attack and coronary artery disease), the same class first. Heart attack and coronary artery disease lists all 38 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, Chronic kidney disease | 22 labelers | $0.184 per tablet 10 mg tablet | No current entry |
| Dapagliflozin and metformin | Type 2 diabetes | 8 labelers | $0.720 per tablet 10-1,000 mg tablet | No current entry |
| Empagliflozin | Type 2 diabetes, Chronic kidney disease | none listed | $11.19 per tablet 10 mg tablet | No current entry |
| Empagliflozin and metformin | Type 2 diabetes | none listed | $5.60 per tablet 12.5-1,000 mg tablet | No current entry |
| Empagliflozin and linagliptin and metformin | Type 2 diabetes | none listed | $11.28 per tablet 10-5-1,000 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 |
Every medicine labeled for the same conditions as canagliflozin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to canagliflozin
- 13 medicines for the same use
- Other SGLT2 inhibitors
- the pharmacologic class, with prices and generics
- Canagliflozin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other