Farxiga: adverse event reports filed with FDA

16,456

reports as suspect product

0.1% of all reports · about 978 a year

549

reports, 12 months to June 2026

2,304 in the 12 months before

54%

marked serious by the reporter

68.2% across the class

21.6%

record death among outcomes, as reported

3,558 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 Farxiga reports recording the termmedian drug in sodium-glucose cotransporter 2 inhibitor

1. Deaththe patient died; cause not stated by this term20.5%3,368
2. Fungal infectiona fungal infection7.4%1,223
3. Blood glucose increasedraised blood sugar reading4.8%787
4. Weight decreasedweight loss4.8%784
5. Urinary tract infectionbladder or urinary infection3.6%598
6. Dizzinesslight-headedness or unsteadiness3.6%592
7. Diabetic ketoacidosisa serious complication of diabetes with acid build-up3.3%536
8. Nauseafeeling sick2.8%455
9. Fatiguetiredness2.7%440
10. Pollakiuriapassing urine more often2.4%397
11. Drug ineffectivethe medicine did not work as expected2.2%358
12. Diarrhoealoose or frequent stools2.2%356
13. Dehydrationdehydration2.1%342
14. Glycosylated haemoglobin increaseda raised HbA1c, the long-term sugar measure2%332
15. Dyspnoeashortness of breath2%326
16. Rashskin rash1.9%318
17. Cerebrovascular accidentstroke1.9%312
18. Pruritusitching1.9%306
19. Astheniaweakness or lack of energy1.8%303
20. Product dose omission issuea dose was missed1.8%295
21. Feeling abnormalfeeling odd or not right1.7%279
22. Malaisegeneral feeling of being unwell1.7%278
23. Headachehead pain1.6%266
24. Painpain, site not specified1.6%257
25. Product use issuea problem in how the product was used1.5%248
26. Myocardial infarctionheart attack1.5%244
27. Vomitingbeing sick1.5%243
28. Acute kidney injurysudden loss of kidney function1.4%230
29. Renal failurekidney failure1.3%216
30. Blood glucose decreasedlow blood sugar reading1.3%215

Top 30 of 1,070 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. 99.7% 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 16,456 reports.

Drugs most often listed in the same reports

Other products listed in reports where Farxiga 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 Farxiga as a suspect or interacting product; reports listing it only as a concomitant medication (9,219) 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.