Pharmacologic class (EPC) · 10 drug pages

Dipeptidyl peptidase 4 inhibitor: adverse event reports filed with FDA

46,081 reports list a drug in this class as a suspect or interacting product, 2006–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

46,081
reports across the class: 0.2% of all reports; 1,212
reports, 12 months to June 2026: 1,464 in the 12 months before; 57%
marked serious by the reporter: 57.4% across all reports; 10
drugs with a page: brand and generic names counted separately

Dipeptidyl peptidase 4 inhibitor is a pharmacologic class (an FDA Established Pharmacologic Class) with 10 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 46,081 adverse event reports received by FDA, 0.2% of the database, from November 2006 to June 2026.

1,212 reports arrived in the 12 months to June 2026, down 17% from 1,464 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 57% of the class's reports are marked serious, 8.7% record death among the outcomes and 29.2% record hospitalisation, as reported.

Across the class the reactions recorded most often are blood glucose increased (7.8%), pancreatitis (5.4%) and nausea (5.3%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
JanuviaSitagliptin	brand	30,212	310	51.2%	Blood glucose increased
TradjentaLinagliptin	brand	4,627	31	34.2%	Blood glucose increased
Sitagliptin	generic	2,805	373	95.8%	Acute kidney injury
Linagliptin	generic	2,781	280	90.4%	Blood glucose increased
GlyxambiEmpagliflozin and linagliptin	brand	1,475	39	42%	Diabetic ketoacidosis
Sitagliptin phosphate	generic	1,399	136	91.9%	Diabetes mellitus inadequate control
NesinaAlogliptin	brand	792	11	81.3%	Pemphigoid
Alogliptin	generic	698	7	86.1%	Pancreatitis
Saxagliptin	generic	668	21	91.6%	Renal failure acute
JentaduetoLinagliptin and metformin hydrochloride	brand	624	4	42%	Blood glucose increased

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Blood glucose increasedraised blood sugar reading7.8%3,596
Pancreatitisinflammation of the pancreas5.4%2,471
Nauseafeeling sick5.3%2,447
Drug ineffectivethe medicine did not work as expected4.9%2,244
Diarrhoealoose or frequent stools4.1%1,901
Headachehead pain4%1,826
Pancreatic carcinoma3.7%1,707
Dizzinesslight-headedness or unsteadiness3.5%1,634
Hypoglycaemialow blood sugar3.5%1,619
Vomitingbeing sick3.4%1,566
Fatiguetiredness3%1,402
Dyspnoeashortness of breath2.8%1,296
Malaisegeneral feeling of being unwell2.8%1,296
Arthralgiajoint pain2.8%1,288
Product dose omission issuea dose was missed2.7%1,253
Rashskin rash2.6%1,208
Painpain, site not specified2.5%1,147
No adverse eventno adverse event was reported2.5%1,133
Pruritusitching2.4%1,112
Abdominal pain upperupper stomach pain2.4%1,094
Deaththe patient died; cause not stated by this term2.3%1,056
Anxietyanxiety2.2%1,002
Astheniaweakness or lack of energy2.2%997
Diabetes mellitus inadequate controldiabetes not well controlled2.1%967
Back painback pain2%932

Solid bar: share of all class reports. Hollow bar: the median share across the 10 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death8.7%4,005

Life-threatening5.9%2,703

Hospitalisation (initial or prolonged)29.2%13,453

Disability4%1,837

Congenital anomaly0.2%101

Other serious36.1%16,647

Not serious43%19,813

Patient age

Under 20.1%42

2 to 110%14

12 to 170.1%28

18 to 443.3%1,520

45 to 6420.3%9,369

65 to 7417%7,853

75 and over17.1%7,867

Age not given42.1%19,388

Who reported

Physician31.8%14,649

Pharmacist5.9%2,727

Other health professional16.2%7,467

Lawyer0.6%277

Consumer or non-health professional38.4%17,714

Not given7%3,247

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Dipeptidyl peptidase 4 inhibitor reports

Which drugs are in the Dipeptidyl peptidase 4 inhibitor class on this site?

Januvia, Tradjenta, Sitagliptin, Linagliptin, Glyxambi and Sitagliptin phosphate and 4 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

46,081 reports through June 2026, 1,212 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

blood glucose increased (7.8%), pancreatitis (5.4%), nausea (5.3%), drug ineffective (4.9%) and diarrhoea (4.1%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. 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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.