Janumet: adverse event reports filed with FDA

10,509

reports as suspect product

0.1% of all reports · about 546 a year

133

reports, 12 months to June 2026

223 in the 12 months before

64.9%

marked serious by the reporter

81.3% across the class

12.8%

record death among outcomes, as reported

1,345 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 Janumet reports recording the termmedian drug in biguanide

1. Blood glucose increasedraised blood sugar reading8.4%881
2. Diarrhoealoose or frequent stools6.3%662
3. Inappropriate schedule of drug administrationthe medicine was taken at the wrong times5.6%589
4. No adverse eventno adverse event was reported5.5%580
5. Pancreatitisinflammation of the pancreas5.4%567
6. Pancreatic carcinoma5.4%563
7. Lactic acidosisa build-up of lactic acid in the blood4.7%494
8. Acute kidney injurysudden loss of kidney function4.6%486
9. Product dose omission issuea dose was missed4.6%484
10. Nauseafeeling sick4.4%458
11. Drug ineffectivethe medicine did not work as expected4.3%457
12. Diabetes mellitus inadequate controldiabetes not well controlled3.5%369
13. Vomitingbeing sick3.5%363
14. Deaththe patient died; cause not stated by this term2.9%306
15. Weight decreasedweight loss2.8%297
16. Dizzinesslight-headedness or unsteadiness2.6%273
17. Hypoglycaemialow blood sugar2.6%272
18. Inappropriate schedule of product administrationthe product was taken at the wrong times2.5%266
19. Hypertensionhigh blood pressure2.4%248
20. Fatiguetiredness2%215
21. Malaisegeneral feeling of being unwell2%212
22. Product use issuea problem in how the product was used2%212
23. Pancreatic carcinoma metastatic2%209
24. Abdominal painstomach or belly pain2%207
25. Blood glucose abnormal2%206
26. Headachehead pain2%206
27. Astheniaweakness or lack of energy1.9%197
28. Hyperkalaemiahigh blood potassium1.9%197
29. Abdominal pain upperupper stomach pain1.9%196
30. Drug dose omissiona dose was missed1.8%191

Top 30 of 1,232 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 7 drugs in the biguanide 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 116,598 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. 57.8% 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 10,509 reports.

Drugs most often listed in the same reports

Other products listed in reports where Janumet 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 biguanide 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 Janumet as a suspect or interacting product; reports listing it only as a concomitant medication (11,183) 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.