What the label lists and what reports show
Linagliptin side effects
Linagliptin's FDA label: “Most common adverse reaction (incidence ≥5% and more often than placebo) was nasopharyngitis ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc.” FAERS holds 18,132 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is blood glucose increased (1,376 reports).
- No generic listed
Check it at the source: the linagliptin FDA label on DailyMed (effective March 21, 2025, Boehringer Ingelheim Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of TRADJENTA?TRADJENTA may cause serious side effects, including: See " What is the most important information I should know about TRADJENTA? " Low blood sugar (hypoglycemia). If you take TRADJENTA with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take TRADJENTA. Signs and symptoms of low blood sugar may include: headache irritability drowsiness hunger weakness fast heartbeat dizziness sweating confusion shaking or feeling jittery Allergic (hypersensitivity) reactions. Serious allergic reactions have happened in people who are taking TRADJENTA. […]
Source: FDA drug label, Boehringer Ingelheim Pharmaceuticals, Inc., effective March 21, 2025 (SPL set c797ea5c-cab7-494b-9044-27eba0cfe40f), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reaction (incidence ≥5% and more often than placebo) was nasopharyngitis ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc.
Table 2 Incidence (%) of Hypoglycemia in Placebo-Controlled Clinical Studies of TRADJENTA in Patients with Type 2 Diabetes Mellitus
| Add-on to Sulfonylurea (18 Weeks) | Placebo (N=84) | TRADJENTA (N=161) |
|---|---|---|
| Hypoglycemia with plasma glucose <54 mg/dL (%) | 1.2 | 1.9 |
| Severe* hypoglycemia (%) | 0 | 0 |
| Hypoglycemia with plasma glucose <54 mg/dL (%) | 5.3 | 8.1 |
| Severe* hypoglycemia (%) | 0.8 | 0.6 |
| Hypoglycemia with plasma glucose <54 mg/dL (%) | 21.6 | 19.8 |
| Severe* hypoglycemia (%) | 1.1 | 1.7 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious adverse reactions are described below or elsewhere in the prescribing information: Pancreatitis [see Warnings and Precautions (5.1) ] Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Severe and Disabling Arthralgia [see Warnings and Precautions (5.4) ] Bullous Pemphigoid [see Warnings and Precautions (5.5) ] Heart Failure [see Warnings and Precautions (5.6) ] Most common adverse reaction (incidence ≥5% and more often than placebo) was nasopharyngitis ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety evaluation of TRADJENTA 5 mg once daily in patients with type 2 diabetes mellitus is based on 14 placebo-controlled trials, 1 active-controlled trial, and one trial in patients with severe renal impairment. …
Source: FDA drug label, Boehringer Ingelheim Pharmaceuticals, Inc., effective March 21, 2025 (SPL set c797ea5c-cab7-494b-9044-27eba0cfe40f), via openFDA; the full label on DailyMed
What do FAERS reports show?
18,132 reports list linagliptin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,687 are coded as a death and 6,903 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 23 reactions below, 6 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Linagliptin: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions