Janumetsitagliptin + metformin
According to the FDA label: JANUMET is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use JANUMET should not be used in patients with type 1 diabetes mellitus. JANUMET has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using JANUMET.
19,273 adverse event reports submitted to the FDA (2007–2026)
Top Reported Adverse Events
The most frequently reported events in association with Janumet in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Blood Glucose Increased 1,311 reports
A blood test result showing a higher than normal blood sugar level.
Full definition in the glossary →Diarrhoea 1,201 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Nausea 991 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Drug Ineffective 872 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Fatigue 815 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Acute Kidney Injury 808 reports
A sudden drop in how well the kidneys are working. It is often temporary and can have many causes.
Full definition in the glossary →Vomiting 696 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Weight Decreased 667 reports
Dyspnoea 576 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →- Pancreatic Carcinoma 575 reports
Pancreatitis 575 reports
Inflammation of the pancreas, which can cause severe belly pain.
Full definition in the glossary →Dizziness 570 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Death 555 reports
A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Full definition in the glossary →Off Label Use 555 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →- Lactic Acidosis 542 reports
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Male | 9,081 |
| Female | 8,905 |
| Unknown | 145 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 52 |
| 18-34 | 165 |
| 35-49 | 1,084 |
| 50-64 | 4,390 |
| 65-74 | 3,740 |
| 75+ | 2,461 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Janumet. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 8,092 |
| Hospitalization | 6,608 |
| Non-Serious | 6,165 |
| Death | 2,028 |
| Life-Threatening | 1,220 |
| Disability | 591 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Janumet. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2007 | 39 |
| 2008 | 131 |
| 2009 | 254 |
| 2010 | 384 |
| 2011 | 537 |
| 2012 | 839 |
| 2013 | 1,226 |
| 2014 | 1,687 |
| 2015 | 2,188 |
| 2016 | 1,897 |
| 2017 | 1,497 |
| 2018 | 1,632 |
| 2019 | 1,483 |
| 2020 | 1,378 |
| 2021 | 1,149 |
| 2022 | 910 |
| 2023 | 802 |
| 2024 | 665 |
| 2025 | 503 |
| 2026 (partial) | 72 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Janumet
In FDA adverse event reports that mention Janumet, these medications appeared most often in the same report.
- Aspirin (2,168 reports)
- Insulin Glargine (1,772 reports)
- Rosuvastatin (1,592 reports)
- Lisinopril (1,429 reports)
- Omeprazole (1,242 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026