What the label lists and what reports show
Linagliptin and metformin side effects
Linagliptin and metformin's FDA label: “Most common adverse reactions (incidence ≥5% and more often than placebo) were nasopharyngitis and diarrhea ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc.” FAERS holds 1,262 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 (100 reports).
- Generic approved
- Boxed warning
Check it at the source: the linagliptin and metformin FDA label on DailyMed (effective August 19, 2026, 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 JENTADUETO?JENTADUETO may cause serious side effects, including: See " What is the most important information I should know about JENTADUETO? " Low blood sugar (hypoglycemia). If you take JENTADUETO 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 JENTADUETO. Signs and symptoms of low blood sugar may include: headache fast heartbeat irritability dizziness drowsiness sweating hunger confusion weakness shaking or feeling jittery Allergic (hypersensitivity) reactions. Serious allergic reactions have happened in people who are taking JENTADUETO. […]
Source: FDA drug label, Boehringer Ingelheim Pharmaceuticals, Inc., effective August 19, 2026 (SPL set f6dd9b86-0d18-95d4-2bc7-05591bfdd597), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥5% and more often than placebo) were nasopharyngitis and diarrhea ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc.
From the label: adverse reactions, continuedThe following serious adverse reactions are described below or elsewhere in the prescribing information: Lactic Acidosis [see Warnings and Precautions (5.1) ] Pancreatitis [see Warnings and Precautions (5.2) ] Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues [see Warnings and Precautions (5.3) ] Hypersensitivity Reactions [see Warnings and Precautions (5.4) ] Vitamin B 12 Deficiency [see Warnings and Precautions (5.5) ] Severe and Disabling Arthralgia [see Warnings and Precautions (5.6) ] Bullous Pemphigoid [see Warnings and Precautions (5.7) ] Heart Failure [see Warnings and Precautions (5.8) ] Most common adverse reactions (incidence ≥5% and more often than placebo) were nasopharyngitis and diarrhea ( 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. …
Source: FDA drug label, Boehringer Ingelheim Pharmaceuticals, Inc., effective August 19, 2026 (SPL set f6dd9b86-0d18-95d4-2bc7-05591bfdd597), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,262 reports list linagliptin and metformin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 53 are coded as a death and 351 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 22 reactions below, 13 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 and metformin: 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