Drug · FAERS side-effect profile with label screen

Canagliflozin and Metformin side effects: what 1,810 FDA adverse event reports show

Canagliflozin And Metformin Hydrochloride · 45 reaction terms · 1,292 drug–reaction co-reports · data 2026-09-14

Drug class

Sodium-glucose co-transporter 2 (sglt2) inhibitor

FDA label, Indications wording of the closest related product

Label matched

Canagliflozin (Invokana)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

1,810 reports · 55% serious · 23 with death outcome · 48% female

openFDA FAERS counts, all years, deduplication not applied

Used for

INVOKANA (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).

FDA label, Indications and Usage

What it is

INVOKANA ® (canagliflozin) contains canagliflozin, an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin, the active .

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 23 strongest signals

Labeled adverse reaction 4Labeled (related wording) 3Likely indication confounding 3Reporting / coding artifact 7Lab value / disease marker 3Not in label — unassessed 3

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 22 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Osteomyelitis	199	128.8 112.9–147.0ROR 144.6 · χ² 24,854 / p <1e-300	125.9 EB05 111.9 · IC025 +6.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 134.8 · ♀ 23% (drug 48%) · 85% consumer	no trial data cached
Diabetic ketoacidosis	163	79.3 68.5–91.9ROR 87.1 · χ² 12,455 / p <1e-300	78.1 EB05 68.5 · IC025 +5.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 82.2	no trial data cached
Full blood count abnormal	26	28.6 19.5–42.0ROR 29.0 · χ² 665 / p 7e-147	28.0 EB05 20.1 · IC025 +3.6 3/3 methods agree	Lab value / disease marker	serious PRR 39.5 · ♀ 100% (drug 48%)	no trial data cached
Drug prescribing error	42	25.0 18.6–33.8ROR 25.6 · χ² 944 / p 2e-207	24.7 EB05 19.1 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	serious n=7	no trial data cached
Skin ulcer	50	22.5 17.1–29.5ROR 23.1 · χ² 1,004 / p 1e-220	22.3 EB05 17.5 · IC025 +3.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 30.4 · ♀ 24% (drug 48%) · 84% consumer	no trial data cached
Cellulitis (skin infection)	92	21.2 17.3–25.8ROR 22.2 · χ² 1,748 / p <1e-300	21.0 EB05 17.7 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 23.9 · 89% consumer	no trial data cached
Fungal infection	54	18.8 14.5–24.5ROR 19.4 · χ² 893 / p 1e-196	18.7 EB05 14.8 · IC025 +3.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 10.6 · ♀ 79% (drug 48%)	no trial data cached
Glycosylated haemoglobin increased	40	18.4 13.6–25.0ROR 18.8 · χ² 641 / p 8e-142	18.2 EB05 13.9 · IC025 +3.4 3/3 methods agree	Lab value / disease marker	serious PRR 13.0	no trial data cached
Blood glucose fluctuation	11	11.6 6.4–20.9ROR 11.7 · χ² 96 / p 5e-23	9.7 EB05 5.2 · IC025 +2.0 3/3 methods agree	Lab value / disease marker	serious n=3	no trial data cached
Hyperglycaemia (high blood sugar)	28	8.9 6.2–12.9ROR 9.1 · χ² 190 / p 2e-43	8.2 EB05 5.8 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 10.5 · ♀ 96% (drug 48%)	no trial data cached
Type 2 diabetes mellitus	26	8.9 6.1–13.1ROR 9.0 · χ² 175 / p 3e-40	8.1 EB05 5.7 · IC025 +2.3 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 9.8 · ♀ 100% (drug 48%)	no trial data cached
Inappropriate schedule of drug administration	55	8.8 6.8–11.5ROR 9.1 · χ² 375 / p 6e-84	8.4 EB05 6.7 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 11.1 · ♀ 70% (drug 48%) · 71% consumer	no trial data cached
Metabolic acidosis	22	8.1 5.3–12.2ROR 8.1 · χ² 129 / p 3e-30	7.2 EB05 4.9 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.0	no trial data cached
Acute kidney injury (sudden kidney damage)	104	7.9 6.6–9.5ROR 8.3 · χ² 626 / p 2e-138	7.7 EB05 6.5 · IC025 +2.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.2 · 84% consumer	no trial data cached
Localised infection	15	7.2 4.3–11.9ROR 7.2 · χ² 74 / p 4e-18	6.1 EB05 3.8 · IC025 +1.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 9.0	no trial data cached
Blood glucose decreased	24	5.8 3.9–8.6ROR 5.8 · χ² 90 / p 1e-21	5.2 EB05 3.7 · IC025 +1.7 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 4.1 · 88% consumer	no trial data cached
Blood glucose increased	87	5.3 4.3–6.5ROR 5.5 · χ² 304 / p 2e-68	5.2 EB05 4.3 · IC025 +2.0 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 3.6 · 81% consumer	no trial data cached
Impaired healing	14	4.9 2.9–8.3ROR 5.0 · χ² 40 / p 1e-10	4.3 EB05 2.7 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious PRR 6.2	no trial data cached
Product prescribing error	10	4.9 2.6–9.1ROR 4.9 · χ² 27 / p 9e-8	4.1 EB05 2.4 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	serious PRR 5.3	no trial data cached
Adverse event	36	4.5 3.3–6.3ROR 4.6 · χ² 96 / p 6e-23	4.3 EB05 3.2 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 2.1 · ♀ 75% (drug 48%) · 78% consumer	no trial data cached
Drug dose omission	43	3.0 2.2–4.0ROR 3.0 · χ² 55 / p 7e-14	2.9 EB05 2.2 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	serious PRR 1.2 · 86% consumer	no trial data cached
Product dose omission	16	2.8 1.7–4.6ROR 2.8 · χ² 17 / p 2e-5	2.6 EB05 1.7 · IC025 +0.6	Reporting / coding artifact	serious PRR 1.5	no trial data cached
Injection site haemorrhage	14	2.0 1.2–3.4ROR 2.1 · χ² 6 / p 0.005	2.0 EB05 1.3 · IC025 +0.1	Not in label — unassessed	serious PRR 2.3	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Osteomyelitis	199	128.8 112.9–147.0ROR 144.6 · χ² 24,854 / p <1e-300	125.9 EB05 111.9 · IC025 +6.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 134.8 · ♀ 23% (drug 48%) · 85% consumer	no trial data cached
Diabetic ketoacidosis	163	79.3 68.5–91.9ROR 87.1 · χ² 12,455 / p <1e-300	78.1 EB05 68.5 · IC025 +5.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 82.2	no trial data cached
Acute kidney injury (sudden kidney damage)	104	7.9 6.6–9.5ROR 8.3 · χ² 626 / p 2e-138	7.7 EB05 6.5 · IC025 +2.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.2 · 84% consumer	no trial data cached
Cellulitis (skin infection)	92	21.2 17.3–25.8ROR 22.2 · χ² 1,748 / p <1e-300	21.0 EB05 17.7 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 23.9 · 89% consumer	no trial data cached
Blood glucose increased	87	5.3 4.3–6.5ROR 5.5 · χ² 304 / p 2e-68	5.2 EB05 4.3 · IC025 +2.0 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 3.6 · 81% consumer	no trial data cached
Inappropriate schedule of drug administration	55	8.8 6.8–11.5ROR 9.1 · χ² 375 / p 6e-84	8.4 EB05 6.7 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 11.1 · ♀ 70% (drug 48%) · 71% consumer	no trial data cached
Fungal infection	54	18.8 14.5–24.5ROR 19.4 · χ² 893 / p 1e-196	18.7 EB05 14.8 · IC025 +3.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 10.6 · ♀ 79% (drug 48%)	no trial data cached
Skin ulcer	50	22.5 17.1–29.5ROR 23.1 · χ² 1,004 / p 1e-220	22.3 EB05 17.5 · IC025 +3.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 30.4 · ♀ 24% (drug 48%) · 84% consumer	no trial data cached
Drug dose omission	43	3.0 2.2–4.0ROR 3.0 · χ² 55 / p 7e-14	2.9 EB05 2.2 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	serious PRR 1.2 · 86% consumer	no trial data cached
Drug prescribing error	42	25.0 18.6–33.8ROR 25.6 · χ² 944 / p 2e-207	24.7 EB05 19.1 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	serious n=7	no trial data cached
Glycosylated haemoglobin increased	40	18.4 13.6–25.0ROR 18.8 · χ² 641 / p 8e-142	18.2 EB05 13.9 · IC025 +3.4 3/3 methods agree	Lab value / disease marker	serious PRR 13.0	no trial data cached
Adverse event	36	4.5 3.3–6.3ROR 4.6 · χ² 96 / p 6e-23	4.3 EB05 3.2 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 2.1 · ♀ 75% (drug 48%) · 78% consumer	no trial data cached
Hyperglycaemia (high blood sugar)	28	8.9 6.2–12.9ROR 9.1 · χ² 190 / p 2e-43	8.2 EB05 5.8 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 10.5 · ♀ 96% (drug 48%)	no trial data cached
Type 2 diabetes mellitus	26	8.9 6.1–13.1ROR 9.0 · χ² 175 / p 3e-40	8.1 EB05 5.7 · IC025 +2.3 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 9.8 · ♀ 100% (drug 48%)	no trial data cached
Full blood count abnormal	26	28.6 19.5–42.0ROR 29.0 · χ² 665 / p 7e-147	28.0 EB05 20.1 · IC025 +3.6 3/3 methods agree	Lab value / disease marker	serious PRR 39.5 · ♀ 100% (drug 48%)	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Cellulitis — n=92, PRR 21.2
Hyperglycaemia — n=28, PRR 8.9

✓ A hand-written Bradford Hill causality assessment exists for this drug: Canagliflozin ↔ Amputation.

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Canagliflozin and Metformin?

In FDA FAERS, the most frequently co-reported reaction terms for Canagliflozin and Metformin are osteomyelitis, diabetic ketoacidosis, acute kidney injury, cellulitis, blood glucose increased, fungal infection. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Canagliflozin and Metformin have an FDA boxed warning?

No. The FDA label retrieved for Canagliflozin and Metformin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Canagliflozin and Metformin causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 5f76e16f-0c24-454a-81af-4080b312c940, effective 20260217; matched on openfda.generic_name.exact:"CANAGLIFLOZIN")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 45 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.