Jardiance: adverse event reports filed with FDA

34,598

reports as suspect product

0.2% of all reports · about 2,925 a year

2,388

reports, 12 months to June 2026

3,069 in the 12 months before

55.5%

marked serious by the reporter

68.2% across the class

4.2%

record death among outcomes, as reported

1,442 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Jardiance reports recording the termmedian drug in sodium-glucose cotransporter 2 inhibitor

1. Diabetic ketoacidosisa serious complication of diabetes with acid build-up9.5%3,304
2. Fungal infectiona fungal infection5.9%2,026
3. Blood glucose increasedraised blood sugar reading5.2%1,799
4. Weight decreasedweight loss4.7%1,636
5. Ketoacidosis3.9%1,337
6. Dizzinesslight-headedness or unsteadiness3.8%1,301
7. Euglycaemic diabetic ketoacidosis3.7%1,268
8. Urinary tract infectionbladder or urinary infection3.6%1,244
9. Nauseafeeling sick3.5%1,221
10. Vomitingbeing sick3.1%1,079
11. Diarrhoealoose or frequent stools2.8%957
12. Dehydrationdehydration2.6%903
13. Fournier's gangrene2.6%890
14. Pollakiuriapassing urine more often2.5%878
15. Drug ineffectivethe medicine did not work as expected2.3%790
16. Off label useused for a purpose or in a way not on the label2.2%770
17. Deaththe patient died; cause not stated by this term2.2%766
18. Glycosylated haemoglobin increaseda raised HbA1c, the long-term sugar measure2.2%757
19. Fatiguetiredness2.2%756
20. Dyspnoeashortness of breath2.1%714
21. Acute kidney injurysudden loss of kidney function2%709
22. Malaisegeneral feeling of being unwell1.8%625
23. Astheniaweakness or lack of energy1.8%616
24. Cerebrovascular accidentstroke1.5%536
25. Pruritusitching1.5%535
26. Myocardial infarctionheart attack1.5%509
27. Hypotensionlow blood pressure1.4%492
28. Headachehead pain1.4%485
29. Falla fall1.4%471
30. Rashskin rash1.3%449

Top 30 of 1,797 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 8 drugs in the sodium-glucose cotransporter 2 inhibitor class; it describes the reports, not the patients. 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."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 104,698 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 66.2% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 34,598 reports.

Drugs most often listed in the same reports

Other products listed in reports where Jardiance is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. 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."

Other drugs in the sodium-glucose cotransporter 2 inhibitor class

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." A brand and its generic are separate rows because reporters name them separately.

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 report counts here when it lists Jardiance as a suspect or interacting product; reports listing it only as a concomitant medication (22,978) are excluded. 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.