Januvia: adverse event reports filed with FDA

30,212

reports as suspect product

0.2% of all reports · about 1,537 a year

310

reports, 12 months to June 2026

491 in the 12 months before

51.2%

marked serious by the reporter

57% across the class

9%

record death among outcomes, as reported

2,729 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 Januvia reports recording the termmedian drug in dipeptidyl peptidase 4 inhibitor

1. Blood glucose increasedraised blood sugar reading7.9%2,378
2. Pancreatitisinflammation of the pancreas6.5%1,976
3. Drug ineffectivethe medicine did not work as expected5.6%1,694
4. Pancreatic carcinoma5.2%1,582
5. Nauseafeeling sick4.7%1,421
6. Headachehead pain4%1,195
7. Product dose omission issuea dose was missed3.8%1,161
8. No adverse eventno adverse event was reported3.5%1,072
9. Diarrhoealoose or frequent stools3.5%1,064
10. Hypoglycaemialow blood sugar3.2%977
11. Dizzinesslight-headedness or unsteadiness2.9%884
12. Vomitingbeing sick2.6%790
13. Rashskin rash2.6%777
14. Deaththe patient died; cause not stated by this term2.5%754
15. Fatiguetiredness2.4%714
16. Astheniaweakness or lack of energy2.3%703
17. Malaisegeneral feeling of being unwell2.3%700
18. Arthralgiajoint pain2.3%698
19. Diabetes mellitus inadequate controldiabetes not well controlled2.2%662
20. Weight decreasedweight loss2.1%643
21. Constipationconstipation2.1%624
22. Dyspnoeashortness of breath2%616
23. Cerebrovascular accidentstroke1.9%583
24. Painpain, site not specified1.9%574
25. Glycosylated haemoglobin increaseda raised HbA1c, the long-term sugar measure1.9%563
26. Hypertensionhigh blood pressure1.8%556
27. Abdominal painstomach or belly pain1.8%546
28. Adverse eventan unwanted medical event, type not specified1.8%540
29. Falla fall1.8%537
30. Anxietyanxiety1.8%534

Top 30 of 2,117 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 10 drugs in the dipeptidyl peptidase 4 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 46,081 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. 74.6% 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 30,212 reports.

Drugs most often listed in the same reports

Other products listed in reports where Januvia 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 dipeptidyl peptidase 4 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 Januvia as a suspect or interacting product; reports listing it only as a concomitant medication (31,905) 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.