What the label lists and what reports show
Canagliflozin and metformin side effects
Canagliflozin and metformin's FDA label: “Most common adverse reactions associated with canagliflozin (5% or greater incidence): female genital mycotic infections, urinary tract infection, and increased urination ( 6.1 ).” FAERS holds 1,810 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is osteomyelitis (199 reports).
- 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 FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of INVOKAMET or INVOKAMET XR?INVOKAMET or INVOKAMET XR may cause serious side effects including: See " What is the most important information I should know about INVOKAMET or INVOKAMET XR? " serious urinary tract infections. Serious urinary tract infections that may lead to hospitalization have happened in people who are taking canagliflozin, one of the medicines in INVOKAMET and INVOKAMET XR. Tell your healthcare provider if you have any signs or symptoms of a urinary tract infection such as a burning feeling when passing urine, a need to urinate often, the need to urinate right away, pain in the lower part of your stomach (pelvis), or blood in the urine. Sometimes people may also have a fever, back pain, nausea, or vomiting. low blood sugar (hypoglycemia). […]
Source: FDA drug label, Janssen Pharmaceuticals, Inc., effective August 24, 2026 (SPL set 6868666b-c25e-40d1-9d1f-306bbe9390c1), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions associated with canagliflozin (5% or greater incidence): female genital mycotic infections, urinary tract infection, and increased urination ( 6.1 ).
Table 3: Adverse Reactions from Pool of Four 26-Week Placebo-Controlled Trials Reported in ≥ 2% of Canagliflozin-Treated Adult Patients The four placebo-controlled trials included one monotherapy trial and three add-on…
| Adverse Reaction | Placebo N=646 | Canagliflozin 100 mg N=833 | Canagliflozin 300 mg N=834 |
|---|---|---|---|
| Urinary tract infections Urinary tract infections include the following adverse… | 3.8% | 5.9% | 4.4% |
| Increased urination Increased urination includes the following adverse reactions:… | 0.7% | 5.1% | 4.6% |
| Thirst Thirst includes the following adverse reactions: Thirst, Dry mouth, and Polydipsia. | 0.1% | 2.8% | 2.4% |
| Constipation | 0.9% | 1.8% | 2.4% |
| Nausea | 1.6% | 2.1% | 2.3% |
| Female genital mycotic infections Female genital mycotic infections include the following… | 2.8% | 10.6% | 11.6% |
| Vulvovaginal pruritus | 0.0% | 1.6% | 3.2% |
| Male genital mycotic infections Male genital mycotic infections include the following… | 0.7% | 4.2% | 3.8% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following important adverse reactions are also discussed elsewhere in the labeling: Lactic Acidosis [see Boxed Warning and Warnings and Precautions (5.1 , 5.4) ] Diabetic Ketoacidosis in Patients with Type 1 Diabetes and Other Ketoacidosis [see Warnings and Precautions (5.2) ] Lower Limb Amputation [see Warnings and Precautions (5.3) ] Volume Depletion [see Warnings and Precautions (5.4) ] Genitourinary Infections, including Urosepsis, Pyelonephritis, Necrotizing Fasciitis of the Perineum (Fournier's Gangrene), and Genital Mycotic Infections [see Warnings and Precautions (5.5) ] Hypoglycemia with Concomitant Use with Insulin or Insulin Secretagogues [see Warnings and Precautions (5.6) ] Hypersensitivity Reactions [see Warnings and Precautions (5.7) ] Bone Fracture [see Warnings and Precautions (5.8) ] Vitamin B 12 Deficiency [see Warnings and Precautions (5.9) ] Most common adverse reactions associated with canagliflozin (5% or greater incidence): female genital mycotic infections, urinary tract infection, and increased urination ( 6.1 ). Most common adverse reactions associated with metformin HCl (5% or greater incidence) are diarrhea, nausea, vomiting, flatulence, asthenia, indigestion, abdominal discomfort, and headache ( 6.1 ).
Source: FDA drug label, 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?
1,810 reports list canagliflozin and metformin among the medicines taken, 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. Of the 21 reactions below, 11 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Canagliflozin and metformin: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions