Pharmacologic class (EPC) · 8 drug pages

Sodium-Glucose cotransporter 2 inhibitor: adverse event reports filed with FDA

104,698 reports list a drug in this class as a suspect or interacting product, 2008–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

104,698
reports across the class: 0.5% of all reports; 10,999
reports, 12 months to June 2026: 13,469 in the 12 months before; 68.2%
marked serious by the reporter: 57.4% across all reports; 8
drugs with a page: brand and generic names counted separately

Sodium-Glucose cotransporter 2 inhibitor is a pharmacologic class (an FDA Established Pharmacologic Class) with 8 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 104,698 adverse event reports received by FDA, 0.5% of the database, from December 2008 to June 2026.

10,999 reports arrived in the 12 months to June 2026, down 18% from 13,469 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 68.2% of the class's reports are marked serious, 10.4% record death among the outcomes and 31.3% record hospitalisation, as reported.

Across the class the reactions recorded most often are diabetic ketoacidosis (8.4%), death (8.1%) and fungal infection (4.7%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
Jardiance	generic	34,598	2,388	55.5%	Diabetic ketoacidosis
InvokanaCanagliflozin	brand	22,359	65	64.1%	Diabetic ketoacidosis
Dapagliflozin	generic	21,838	6,950	98.9%	Death
FarxigaDapagliflozin	brand	16,456	549	54%	Death
Empagliflozin	generic	4,887	746	86.7%	Euglycaemic diabetic ketoacidosis
Synjardy	generic	2,071	129	55.4%	Diabetic ketoacidosis
Canagliflozin	generic	1,975	84	94.4%	Diabetic ketoacidosis
InpefaSotagliflozin	brand	514	88	33.3%	Dizziness

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Diabetic ketoacidosisa serious complication of diabetes with acid build-up8.4%8,837
Deaththe patient died; cause not stated by this term8.1%8,513
Fungal infectiona fungal infection4.7%4,881
Acute kidney injurysudden loss of kidney function4.2%4,364
Weight decreasedweight loss4.1%4,303
Blood glucose increasedraised blood sugar reading4%4,199
Urinary tract infectionbladder or urinary infection3.5%3,705
Dizzinesslight-headedness or unsteadiness3.5%3,668
Nauseafeeling sick3.3%3,423
Euglycaemic diabetic ketoacidosis2.9%2,993
Dehydrationdehydration2.7%2,857
Vomitingbeing sick2.7%2,846
Diarrhoealoose or frequent stools2.6%2,760
Ketoacidosis2.6%2,742
Off label useused for a purpose or in a way not on the label2.5%2,624
Fatiguetiredness2.4%2,463
Toe amputation2.3%2,401
Dyspnoeashortness of breath2.3%2,385
Drug ineffectivethe medicine did not work as expected2.2%2,339
Osteomyelitis2.1%2,235
Malaisegeneral feeling of being unwell2%2,058
Pollakiuriapassing urine more often2%2,044
Myocardial infarctionheart attack1.8%1,844
Headachehead pain1.7%1,812
Fournier's gangrene1.7%1,810

Solid bar: share of all class reports. Hollow bar: the median share across the 8 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death10.4%10,848

Life-threatening5.9%6,213

Hospitalisation (initial or prolonged)31.3%32,755

Disability2.8%2,957

Congenital anomaly0.1%135

Other serious40.3%42,213

Not serious31.8%33,258

Patient age

Under 20.1%77

2 to 110%40

12 to 170.1%82

18 to 444.9%5,130

45 to 6423.2%24,277

65 to 7414.8%15,527

75 and over12.5%13,118

Age not given44.4%46,447

Who reported

Physician31.7%33,200

Pharmacist6.7%7,029

Other health professional14.3%14,983

Lawyer0.1%154

Consumer or non-health professional45.3%47,461

Not given1.8%1,871

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Sodium-Glucose cotransporter 2 inhibitor reports

Which drugs are in the Sodium-Glucose cotransporter 2 inhibitor class on this site?

Jardiance, Invokana, Dapagliflozin, Farxiga, Empagliflozin and Synjardy and 2 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

104,698 reports through June 2026, 10,999 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

diabetic ketoacidosis (8.4%), death (8.1%), fungal infection (4.7%), acute kidney injury (4.2%) and weight decreased (4.1%).

Can the members table be used to rank the drugs?

No. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.