Drugs › Dipeptidyl peptidase 4 inhibitor
Generic name
Linagliptin: adverse event reports filed with FDA
2,781 reports list it as a suspect or interacting product, 2011–2026. Class: Dipeptidyl peptidase 4 inhibitor.
- 2,781
- reports as suspect product
- 0% of all reports · about 179 a year
- 280
- reports, 12 months to June 2026
- 335 in the 12 months before
- 90.4%
- marked serious by the reporter
- 57% across the class
- 10.9%
- record death among outcomes, as reported
- 303 reports · not verified by FDA
2,781 adverse event reports received by FDA list linagliptin, a generic name as a suspect or interacting product, from January 2011 to June 2026. A further 6,253 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 280 reports listed it, down 16% from 335 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 179 reports a year and 0% of the 20,646,523 reports in the database, and 6% of the reports for the dipeptidyl peptidase 4 inhibitor class. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded blood glucose increased (16.4%), dyspnoea (16%) and nausea (15.7%). A report can list several reactions, so shares add to more than 100%; 531 different terms appear across these reports. Blood glucose increased is recorded in 16.4% of these reports, a larger share than in the median dipeptidyl peptidase 4 inhibitor drug (5.7%).
90.4% of the reports are marked serious by the reporter (57% across the class); 10.9% record death among the outcomes and 42.4% record hospitalisation, as reported. 31.2% of the reports came from other health professionals, and the largest patient age group is 75 and over (33.1%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
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 Linagliptin reports recording the termmedian drug in dipeptidyl peptidase 4 inhibitor
- Blood glucose increasedraised blood sugar reading16.4%455
- Dyspnoeashortness of breath16%446
- Nauseafeeling sick15.7%437
- Pruritusitching15.7%436
- Vomitingbeing sick15.6%435
- Dizzinesslight-headedness or unsteadiness15.6%433
- Subarachnoid haemorrhage15.5%432
- Malaisegeneral feeling of being unwell15.4%427
- Diarrhoealoose or frequent stools15.3%426
- Fatiguetiredness15.2%423
- Dehydrationdehydration15%418
- Palpitationsawareness of the heartbeat14.9%414
- Covid-19COVID-19 infection14.8%412
- Pyrexiafever14.8%412
- Ventricular tachycardiaa fast rhythm from the lower heart chambers14.5%404
- Hyperhidrosisexcessive sweating14.5%403
- Visual impairmentreduced vision14.3%397
- Amnesiamemory loss14.2%394
- Headachehead pain14.2%394
- Arthralgiajoint pain14.1%393
- Muscular weaknessmuscle weakness14.1%392
- Myocardial infarctionheart attack14.1%392
- Abdominal discomfortstomach discomfort14.1%391
- Angioedemadeep swelling of skin or mucous membranes14.1%391
- Chest painchest pain14%390
- Feeling abnormalfeeling odd or not right14%390
- Blindnessloss of sight14%389
- Disturbance in attentiondifficulty concentrating14%389
- Cognitive disorderproblems with thinking or memory14%388
- Tachycardiafast heart rate14%388
Top 30 of 531 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
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 22.7% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Type 2 diabetes mellitus | 472 | 17% |
| Diabetes mellitus | 354 | 12.7% |
| Blood glucose increased | 26 | 0.9% |
| Ill-defined disorder | 19 | 0.7% |
| Glucose tolerance impaired | 6 | 0.2% |
| Hypoglycaemia | 4 | 0.1% |
The indication field is filled in by the reporter and is often blank; shares are of all 2,781 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Linagliptin reports |
|---|---|---|
| Metformin | 531 | 19.1% |
| Lansoprazole | 511 | 18.4% |
| Simvastatin | 489 | 17.6% |
| Bisoprolol | 482 | 17.3% |
| Hydrochlorothiazide | 461 | 16.6% |
| Digoxin | 446 | 16% |
| Omeprazole | 435 | 15.6% |
| Dapagliflozin | 432 | 15.5% |
| Apixaban | 424 | 15.2% |
| Isosorbide mononitrate | 418 | 15% |
Other products listed in reports where Linagliptin 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
| Measure | Linagliptin | Dipeptidyl peptidase 4 inhibitor | All reports |
|---|---|---|---|
| Reports as suspect product | 2,781 | 46,081 | 20,646,523 |
| Share of that pool | — | 6% | 0% |
| Reports, latest 12 months | 280 | — | 1,332,454 |
| Marked serious | 90.4% | 57% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 109 | 87 | 91 |
| Hospitalisation recorded, per 1,000 reports | 424 | 292 | 213 |
| Consumer-filed share | 30.2% | 38.4% | 45.8% |
| Top term, share of reports | Blood glucose increased 16.4% | median 5.7% | 0.9% |
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
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Januvia | brand | 30,212 | 310 | 51.2% |
| Tradjenta | brand | 4,627 | 31 | 34.2% |
| Sitagliptin | generic | 2,805 | 373 | 95.8% |
| Glyxambi | brand | 1,475 | 39 | 42% |
| Sitagliptin phosphate | generic | 1,399 | 136 | 91.9% |
| Nesina | brand | 792 | 11 | 81.3% |
| Alogliptin | generic | 698 | 7 | 86.1% |
| Saxagliptin | generic | 668 | 21 | 91.6% |
| Jentadueto | brand | 624 | 4 | 42% |
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.
Questions about Linagliptin reports
How many adverse event reports has FDA received for Linagliptin?
2,781 reports list Linagliptin as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 280 of them arrived in the latest 12 months. Another 6,253 list it only as a concomitant medication.
What reactions are recorded in Linagliptin reports?
blood glucose increased (16.4%), dyspnoea (16%), nausea (15.7%), pruritus (15.7%) and vomiting (15.6%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Linagliptin was responsible.
How serious are the reports?
90.4% are marked serious by the reporter. Among the outcomes recorded, 10.9% of reports include death and 42.4% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
other health professional (31.2%), physician (30.8%) and consumer or non-health professional (30.2%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Linagliptin rising?
280 reports in the 12 months to June 2026, down 16% from 335 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Linagliptin was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Linagliptin?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
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 Linagliptin as a suspect or interacting product; reports listing it only as a concomitant medication (6,253) 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.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.