Short answer: In 14 pooled placebo-controlled trials, the side effects seen in at least 2% of people and more often than on placebo were stuffy or runny nose with sore throat (7.0% vs 6.1%), diarrhea (3.3% vs 3.0%) and cough (2.1% vs 1.4%). Low blood sugar was more common with a sulfonylurea or insulin. Tradjenta has no boxed warning; pancreatitis, including fatal cases, is its first listed serious risk.
What Tradjenta is approved for: Tradjenta is a DPP-4 inhibitor approved, along with diet and exercise, to improve blood sugar control in adults with type 2 diabetes (section 1). It is not recommended in type 1 diabetes, and it has not been studied in people who have had pancreatitis.
Source
TRADJENTA (linagliptin) tablets, for oral use, prescribing information and Medication Guide. Boehringer Ingelheim. DailyMed, version published March 27, 2025. DailyMed setid c797ea5c-cab7-494b-9044-27eba0cfe40f
No. The current Tradjenta label has no boxed warning.
These are the label's own numbers from the Adverse Reactions section. Where the label compares with placebo (a dummy treatment), both columns are shown, so you can see how much more often a reaction happened on Tradjenta.
| Adverse reactions | TRADJENTA 5 mg (%) n = 3,625 | Placebo (%) n = 2,176 |
|---|---|---|
| Nasopharyngitis | 7.0 | 6.1 |
| Diarrhea | 3.3 | 3.0 |
| Cough | 2.1 | 1.4 |
Pooled data from 14 placebo-controlled trials; mean time on Tradjenta 29.6 weeks, longest follow-up 78 weeks. Nasopharyngitis means a stuffy or runny nose with sore throat.
| Study and measure | Placebo | TRADJENTA |
|---|---|---|
| Add-on to Sulfonylurea (18 Weeks), N = 84 vs 161: plasma glucose <54 mg/dL (%) | 1.2 | 1.9 |
| Add-on to Sulfonylurea (18 Weeks): Severe hypoglycemia (%) | 0 | 0 |
| Add-on to Metformin and Sulfonylurea (24 Weeks), N = 263 vs 792: plasma glucose <54 mg/dL (%) | 5.3 | 8.1 |
| Add-on to Metformin and Sulfonylurea (24 Weeks): Severe hypoglycemia (%) | 0.8 | 0.6 |
| Add-on to Basal Insulin (52 Weeks), N = 630 vs 631: plasma glucose <54 mg/dL (%) | 21.6 | 19.8 |
| Add-on to Basal Insulin (52 Weeks): Severe hypoglycemia (%) | 1.1 | 1.7 |
Severe means low blood sugar needing another person to give carbohydrate, glucagon or other resuscitation.
With specific add-on medicines, Tradjenta vs placebo: urinary tract infection 3.1% vs 0% and high triglycerides 2.4% vs 0% with a sulfonylurea; high lipids 2.7% vs 0.8% and weight gain 2.3% vs 0.8% with pioglitazone; constipation 2.1% vs 1% with basal insulin.
In a 104-week trial against glimepiride (both with metformin): back pain 9.1% vs 8.4%, joint pain 8.1% vs 6.1%, upper respiratory infection 8.0% vs 7.6%, headache 6.4% vs 5.2%, cough 6.1% vs 4.9%, and pain in a limb 5.3% vs 3.9%.
Pancreatitis in the trial program: 15.2 cases per 10,000 patient-years on Tradjenta vs 3.7 on comparators.
Severe low blood sugar in the CAROLINA trial (median 5.9 years): 0.3% on Tradjenta vs 2.2% on glimepiride.
In 133 people with severe kidney impairment, any low blood sugar was 63% on Tradjenta vs 49% on placebo, mostly without symptoms; severe events were 4.4% vs 4.6%.
Lab changes: uric acid increases 2.7% vs 1.3% on placebo. Lipase above 3 times normal in 8.2% vs 1.7% in one trial; the label says the meaning is unknown without signs of pancreatitis.
The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.
Pancreatitis. Acute pancreatitis, including fatal cases, has been reported. In the CARMELINA trial it occurred in 0.3% on Tradjenta vs 0.1% on placebo, and two people on Tradjenta died of it. Tradjenta is stopped promptly if pancreatitis is suspected.
Low blood sugar with insulin or a sulfonylurea. The risk of low blood sugar rises when Tradjenta is used with a sulfonylurea or insulin, and was higher with insulin in severe kidney impairment. A lower dose of those medicines may be needed.
Allergic reactions. Serious allergic reactions, including anaphylaxis, angioedema and skin peeling conditions, have been reported, mostly within the first 3 months and some after the first dose. Tradjenta is stopped if one is suspected.
Severe and disabling joint pain. Severe joint pain has been reported, starting from one day to years after starting. It eased after stopping and in some people came back on restarting a DPP-4 inhibitor.
Bullous pemphigoid. This blistering skin condition occurred in 0.2% on Tradjenta vs none on placebo in CARMELINA, and 3 people were hospitalized. Tradjenta is stopped if it is suspected.
Heart failure. Heart failure was linked to two other DPP-4 inhibitors in heart outcome trials. Risks and benefits are weighed in people at risk, such as those with past heart failure or kidney problems, and they are watched for symptoms.
From the Medication Guide that comes with Tradjenta:
Dose Track has a side-effect log. Each entry records the symptom, a severity (none, mild, moderate, severe or life-threatening), the date and an optional note, and can be tied to a specific dose or logged on its own. The history screen shows what you logged over time, which makes it easier to tell your prescriber when a reaction started and whether it is easing. The app records what you enter; it does not judge whether a symptom is serious. For anything on the label's call-your-doctor list, call your doctor.
This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.