Canagliflozin side effects: what 29,747 FDA adverse event reports show

Canagliflozin · Invokana · 1,109 reaction terms · 80,286 drug–reaction co-reports · data 2026-09-14

Drug class

Sodium-glucose co-transporter 2 (sglt2) inhibitor

FDA label, Indications wording

Brand names

Invokana

openFDA label

Who reports

29,747 reports · 65% serious · 685 with death outcome · 49% 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 40 strongest signals

Labeled adverse reaction 11Labeled (related wording) 12Likely indication confounding 1Lab value / disease marker 1Not in label — unassessed 15

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.
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. 1,069 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
Metatarsal excision	102	1,864.5 1,284.9–2,705.6ROR 1,870.9 · χ² 51,060 / p <1e-300	462.6 EB05 392.1 · IC025 +6.9 3/3 methods agree	Not in label — unassessed	serious n=102 · ♀ 27% (drug 49%) · 100% consumer	not reported in cached trials
Limb amputation	269	1,448.5 1,174.6–1,786.2ROR 1,461.7 · χ² 125,649 / p <1e-300	454.9 EB05 411.0 · IC025 +7.8 3/3 methods agree	Labeled adverse reaction exact term	serious n=269 · ♀ 23% (drug 49%) · 84% consumer	not reported in cached trials
Diabetic foot infection	834	1,007.5 906.5–1,119.8ROR 1,036.5 · χ² 341,834 / p <1e-300	407.9 EB05 385.2 · IC025 +8.3 3/3 methods agree	Labeled (related wording) related wording	serious n=834 · ♀ 28% (drug 49%) · 88% consumer	NCT01989754: 3/2,904 (0.1%) on Canagliflozin; 4/2,903 (0.1%) control (serious AE)
Osteomyelitis acute	283	764.9 646.3–905.3ROR 772.2 · χ² 102,391 / p <1e-300	355.8 EB05 322.3 · IC025 +7.6 3/3 methods agree	Labeled (related wording) related wording	serious n=283 · ♀ 26% (drug 49%) · 86% consumer	NCT01989754: 6/2,904 (0.2%) on Canagliflozin; 5/2,903 (0.2%) control (serious AE)
Malignant mediastinal neoplasm	56	762.7 522.0–1,114.4ROR 764.2 · χ² 19,943 / p <1e-300	323.8 EB05 258.6 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	serious n=56 · ♀ 100% (drug 49%)	not reported in cached trials
Diabetic neuropathic ulcer	11	545.8 247.8–1,202.1ROR 546.0 · χ² 3,051 / p <1e-300	200.2 EB05 119.3 · IC025 +3.4 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=11	not reported in cached trials
Toe amputation	2,195	535.9 507.5–565.9ROR 578.5 · χ² 661,413 / p <1e-300	302.2 EB05 291.7 · IC025 +8.1 3/3 methods agree	Labeled (related wording) related wording	serious n=2,192 · ♀ 27% (drug 49%) · 88% consumer	NCT02065791: 1/2,197 (0.0%) control (serious AE)
Foot amputation	582	470.6 423.9–522.5ROR 480.0 · χ² 162,317 / p <1e-300	278.4 EB05 259.9 · IC025 +7.7 3/3 methods agree	Labeled (related wording) related wording	serious n=582 · ♀ 23% (drug 49%) · 88% consumer	not reported in cached trials
Genital infection fungal	281	364.8 315.9–421.3ROR 368.3 · χ² 66,612 / p <1e-300	235.7 EB05 213.5 · IC025 +7.2 3/3 methods agree	Labeled adverse reaction exact term	serious n=64	NCT01989754: 1/2,904 (0.0%) on Canagliflozin (serious AE)
Gas gangrene	117	362.8 290.2–453.6ROR 364.2 · χ² 27,494 / p <1e-300	229.7 EB05 196.9 · IC025 +6.6 3/3 methods agree	Labeled (related wording) related wording	serious n=117 · ♀ 25% (drug 49%) · 87% consumer	NCT01989754: 2/2,903 (0.1%) control (serious AE)
Diabetic ulcer	225	320.3 273.6–374.9ROR 322.7 · χ² 48,796 / p <1e-300	215.5 EB05 192.9 · IC025 +7.0 3/3 methods agree	Labeled (related wording) related wording	serious n=225 · ♀ 25% (drug 49%) · 94% consumer	NCT01989754: 1/2,904 (0.0%) on Canagliflozin; 1/2,903 (0.0%) control (serious AE)
Amputation	325	247.8 218.4–281.1ROR 250.5 · χ² 58,704 / p <1e-300	181.0 EB05 165.1 · IC025 +7.0 3/3 methods agree	Labeled adverse reaction exact term	serious n=325 · ♀ 22% (drug 49%) · 71% consumer	NCT02065791: 1/2,197 (0.0%) control (serious AE)
Diabetic foot	788	244.7 225.8–265.2ROR 251.3 · χ² 141,263 / p <1e-300	180.4 EB05 170.1 · IC025 +7.2 3/3 methods agree	Labeled adverse reaction exact term	serious n=787 · ♀ 22% (drug 49%) · 91% consumer	NCT01989754: 3/2,904 (0.1%) on Canagliflozin; 4/2,903 (0.1%) control (serious AE)
Ischaemic skin ulcer	19	194.1 116.7–322.7ROR 194.2 · χ² 2,704 / p <1e-300	132.1 EB05 89.4 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious n=19	not reported in cached trials
Leg amputation	792	167.3 154.9–180.6ROR 171.8 · χ² 105,380 / p <1e-300	134.6 EB05 126.9 · IC025 +6.8 3/3 methods agree	Labeled (related wording) related wording	serious n=792 · 87% consumer	NCT02065791: 1/2,197 (0.0%) control (serious AE)
Osteomyelitis chronic	114	158.4 129.3–194.0ROR 159.0 · χ² 14,390 / p <1e-300	126.5 EB05 108.1 · IC025 +6.1 3/3 methods agree	Labeled (related wording) related wording	serious n=114 · ♀ 27% (drug 49%) · 87% consumer	NCT01989754: 6/2,904 (0.2%) on Canagliflozin; 5/2,903 (0.2%) control (serious AE)
Dry gangrene	114	155.0 126.5–189.8ROR 155.6 · χ² 14,133 / p <1e-300	124.3 EB05 106.3 · IC025 +6.0 3/3 methods agree	Labeled (related wording) related wording	serious n=114 · ♀ 28% (drug 49%) · 91% consumer	NCT01989754: 2/2,903 (0.1%) control (serious AE)
Gangrene	1,086	153.9 144.2–164.2ROR 159.7 · χ² 134,954 / p <1e-300	125.9 EB05 119.7 · IC025 +6.8 3/3 methods agree	Labeled adverse reaction exact term	serious n=1,086 · ♀ 28% (drug 49%) · 88% consumer	NCT01989754: 2/2,903 (0.1%) control (serious AE)
Neuropathic arthropathy	114	152.0 124.1–186.1ROR 152.6 · χ² 13,906 / p <1e-300	122.4 EB05 104.6 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	serious n=114 · ♀ 23% (drug 49%) · 89% consumer	NCT02065791: 3/2,197 (0.1%) control (serious AE)
Diabetic gangrene	50	148.4 109.4–201.4ROR 148.7 · χ² 5,912 / p <1e-300	117.1 EB05 92.3 · IC025 +5.3 3/3 methods agree	Labeled (related wording) related wording	serious n=50 · ♀ 18% (drug 49%) · 100% consumer	NCT01989754: 2/2,903 (0.1%) control (serious AE)
Cellulitis of male external genital organ	16	118.2 69.6–200.9ROR 118.3 · χ² 1,491 / p <1e-300	90.6 EB05 59.1 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=16	not reported in cached trials
Diabetic ketoacidosis	3,435	118.0 114.0–122.1ROR 133.3 · χ² 340,938 / p <1e-300	101.0 EB05 98.2 · IC025 +6.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 90.0	NCT01989754: 5/2,904 (0.2%) on Canagliflozin; 2/2,903 (0.1%) control (serious AE)
Osteomyelitis	2,165	95.8 91.8–100.1ROR 103.3 · χ² 178,615 / p <1e-300	84.3 EB05 81.3 · IC025 +6.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 76.2 · ♀ 26% (drug 49%) · 91% consumer	NCT01989754: 6/2,904 (0.2%) on Canagliflozin; 5/2,903 (0.2%) control (serious AE)
Balanoposthitis	92	91.3 73.5–113.4ROR 91.6 · χ² 7,182 / p <1e-300	79.5 EB05 66.8 · IC025 +5.5 3/3 methods agree	Labeled adverse reaction exact term	serious n=33 · ♀ 0% (drug 49%) · 91% clinician	NCT01989754: 1/2,904 (0.0%) on Canagliflozin (serious AE)
Urine output increased	239	70.6 61.8–80.6ROR 71.1 · χ² 14,816 / p <1e-300	63.8 EB05 57.3 · IC025 +5.6 3/3 methods agree	Labeled adverse reaction exact term	serious n=52	not reported in cached trials
Cellulitis gangrenous	18	70.2 43.3–114.0ROR 70.3 · χ² 1,054 / p 2e-231	60.0 EB05 40.2 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=18	not reported in cached trials
Ketoacidosis	643	66.3 61.2–71.8ROR 67.8 · χ² 37,714 / p <1e-300	60.5 EB05 56.7 · IC025 +5.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 54.3	NCT01989754: 5/2,904 (0.2%) on Canagliflozin; 2/2,903 (0.1%) control (serious AE)
Genital infection	28	65.7 44.6–96.8ROR 65.8 · χ² 1,571 / p <1e-300	57.9 EB05 42.0 · IC025 +4.3 3/3 methods agree	Labeled adverse reaction exact term	serious n=17 · 100% clinician	NCT01989754: 1/2,904 (0.0%) on Canagliflozin (serious AE)
Euglycaemic diabetic ketoacidosis	293	55.9 49.7–62.9ROR 56.4 · χ² 14,573 / p <1e-300	51.6 EB05 46.9 · IC025 +5.4 3/3 methods agree	Labeled (related wording) related wording	serious n=293 · 91% clinician	not reported in cached trials
Staphylococcal osteomyelitis	13	52.2 29.7–91.7ROR 52.2 · χ² 560 / p 3e-124	45.6 EB05 28.4 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=13	not reported in cached trials
Vascular stenosis	20	43.6 27.7–68.4ROR 43.6 · χ² 743 / p 7e-164	39.6 EB05 27.1 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=20	NCT01989754: 1/2,903 (0.0%) control (serious AE)
Joint ankylosis	33	43.0 30.3–61.1ROR 43.1 · χ² 1,236 / p 5e-271	39.7 EB05 29.6 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=33 · ♀ 0% (drug 49%) · 100% clinician	not reported in cached trials
Extremity necrosis	95	40.3 32.8–49.5ROR 40.4 · χ² 3,403 / p <1e-300	37.9 EB05 31.9 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=95 · 81% consumer	NCT01989754: 3/2,904 (0.1%) on Canagliflozin; 5/2,903 (0.2%) control (serious AE)
Ketonuria	41	37.5 27.4–51.3ROR 37.5 · χ² 1,347 / p 4e-295	35.1 EB05 27.0 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=36 · ♀ 26% (drug 49%)	NCT01989754: 1/2,904 (0.0%) on Canagliflozin (serious AE)
Urinary tract infection fungal	28	36.4 24.9–53.1ROR 36.4 · χ² 881 / p 5e-194	33.9 EB05 24.6 · IC025 +3.8 3/3 methods agree	Labeled (related wording) related wording	serious n=28	NCT02065791: 1/2,200 (0.0%) on Canagliflozin (serious AE)
Blood ketone body	17	36.2 22.2–59.0ROR 36.2 · χ² 520 / p 2e-115	33.3 EB05 22.0 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=11	not reported in cached trials
Urine ketone body present	77	36.1 28.7–45.3ROR 36.2 · χ² 2,463 / p <1e-300	34.1 EB05 28.2 · IC025 +4.4 3/3 methods agree	Lab value / disease marker	serious n=55	not reported in cached trials
Acetonaemia	12	35.8 20.0–63.9ROR 35.8 · χ² 353 / p 4e-79	32.5 EB05 19.8 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious n=12	not reported in cached trials
Necrotising soft tissue infection	11	35.5 19.4–65.1ROR 35.6 · χ² 319 / p 1e-71	32.1 EB05 19.1 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious n=11	not reported in cached trials
Penile erythema	17	33.3 20.4–54.1ROR 33.3 · χ² 477 / p 4e-106	30.8 EB05 20.4 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=7	not reported in cached trials

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Canagliflozin as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (23 of 40 signal terms matched).

NCT01989754 — A Study of the Effects of Canagliflozin (JNJ-28431754) on Renal Endpoints in Adult Participants With Type 2 Di (N=5813, PHASE4; 647 AE terms posted; arms: Placebo (Placebo); Canagliflozin (Experimental))
NCT02065791 — Evaluation of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Participants With Diabetic (N=4401, PHASE3; 752 AE terms posted; arms: Placebo; Canagliflozin 100 mg)

Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.

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
Diabetic ketoacidosis	3,435	118.0 114.0–122.1ROR 133.3 · χ² 340,938 / p <1e-300	101.0 EB05 98.2 · IC025 +6.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 90.0	NCT01989754: 5/2,904 (0.2%) on Canagliflozin; 2/2,903 (0.1%) control (serious AE)
Toe amputation	2,195	535.9 507.5–565.9ROR 578.5 · χ² 661,413 / p <1e-300	302.2 EB05 291.7 · IC025 +8.1 3/3 methods agree	Labeled (related wording) related wording	serious n=2,192 · ♀ 27% (drug 49%) · 88% consumer	NCT02065791: 1/2,197 (0.0%) control (serious AE)
Osteomyelitis	2,165	95.8 91.8–100.1ROR 103.3 · χ² 178,615 / p <1e-300	84.3 EB05 81.3 · IC025 +6.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 76.2 · ♀ 26% (drug 49%) · 91% consumer	NCT01989754: 6/2,904 (0.2%) on Canagliflozin; 5/2,903 (0.2%) control (serious AE)
Acute kidney injury (sudden kidney damage)	1,998	9.4 9.0–9.8ROR 10.0 · χ² 14,817 / p <1e-300	9.2 EB05 8.9 · IC025 +3.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.2 · 79% consumer	NCT01989754: 7/2,904 (0.2%) on Canagliflozin; 15/2,903 (0.5%) control (serious AE)
Fungal infection	1,447	32.0 30.4–33.7ROR 33.6 · χ² 41,574 / p <1e-300	30.6 EB05 29.3 · IC025 +4.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 12.4 · ♀ 79% (drug 49%)	NCT01989754: 1/2,904 (0.0%) on Canagliflozin (serious AE)
Weight decreased (weight loss)	1,346	3.4 3.2–3.6ROR 3.5 · χ² 2,312 / p <1e-300	3.4 EB05 3.2 · IC025 +1.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 2.2	NCT02065791: 1/2,197 (0.0%) control (serious AE)
Blood glucose increased	1,234	4.6 4.4–4.9ROR 4.8 · χ² 3,508 / p <1e-300	4.6 EB05 4.4 · IC025 +2.1 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 4.0 · 73% consumer	NCT01989754: 3/2,903 (0.1%) control (serious AE)
Gangrene	1,086	153.9 144.2–164.2ROR 159.7 · χ² 134,954 / p <1e-300	125.9 EB05 119.7 · IC025 +6.8 3/3 methods agree	Labeled adverse reaction exact term	serious n=1,086 · ♀ 28% (drug 49%) · 88% consumer	NCT01989754: 2/2,903 (0.1%) control (serious AE)
Cellulitis (skin infection)	1,035	14.7 13.9–15.7ROR 15.2 · χ² 13,006 / p <1e-300	14.5 EB05 13.7 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 14.0 · ♀ 28% (drug 49%) · 89% consumer	NCT01989754: 9/2,904 (0.3%) on Canagliflozin; 11/2,903 (0.4%) control (serious AE)
Urinary tract infection (bladder infection)	1,018	4.2 4.0–4.5ROR 4.4 · χ² 2,521 / p <1e-300	4.2 EB05 4.0 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.7 · ♀ 71% (drug 49%)	NCT01989754: 2/2,904 (0.1%) on Canagliflozin; 1/2,903 (0.0%) control (serious AE)
Off label use (used outside approved label)	1,016	0.8 0.8–0.9ROR 0.8 · χ² 39 / p 2e-10	0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious PRR 0.9	not reported in cached trials
Nausea	1,015	0.9 0.9–1.0ROR 0.9 · χ² 10 / p 8e-4	0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC	Labeled adverse reaction exact term	serious PRR 0.8	NCT02065791: 54/2,200 (2.5%) on Canagliflozin; 52/2,197 (2.4%) control
Drug ineffective (drug did not work)	1,012	0.5 0.5–0.6ROR 0.5 · χ² 418 / p 3e-93	0.5 EB05 0.5 · IC025 -1.0 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious PRR 0.6	not reported in cached trials
Dizziness	843	1.2 1.1–1.3ROR 1.2 · χ² 27 / p 1e-7	1.2 EB05 1.1 · IC025 +0.1	Labeled adverse reaction exact term	serious PRR 0.8	NCT01989754: 2/2,904 (0.1%) on Canagliflozin; 2/2,903 (0.1%) control (serious AE)
Diabetic foot infection	834	1,007.5 906.5–1,119.8ROR 1,036.5 · χ² 341,834 / p <1e-300	407.9 EB05 385.2 · IC025 +8.3 3/3 methods agree	Labeled (related wording) related wording	serious n=834 · ♀ 28% (drug 49%) · 88% consumer	NCT01989754: 3/2,904 (0.1%) on Canagliflozin; 4/2,903 (0.1%) control (serious AE)

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.

Metatarsal excision — n=102, PRR 1,864.5
Malignant mediastinal neoplasm — n=56, PRR 762.7
Neuropathic arthropathy — n=114, PRR 152.0 (also seen in trial arm)
Vascular stenosis — n=20, PRR 43.6 (also seen in trial arm)
Joint ankylosis — n=33, PRR 43.0
Extremity necrosis — n=95, PRR 40.3 (also seen in trial arm)
Ketonuria — n=41, PRR 37.5 (also seen in trial arm)

✓ 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?

In FDA FAERS, the most frequently co-reported reaction terms for Canagliflozin are diabetic ketoacidosis, toe amputation, osteomyelitis, acute kidney injury, fungal infection, weight decreased. 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 have an FDA boxed warning?

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

Do FAERS signals prove that Canagliflozin 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, 1,109 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
ClinicalTrials.gov API v2 (query CANAGLIFLOZIN, results-bearing studies sorted by enrollment)

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.