Short answer: In 14 pooled controlled trials, the side effects seen in at least 4% on Nesina 25 mg and more often than on placebo were stuffy or runny nose with sore throat (5% vs 4%), upper respiratory infection (4% vs 4%) and headache (4% vs 3%). Low blood sugar on Nesina alone was 1.5% vs 1.6% on placebo. Nesina has no boxed warning; its serious risks include pancreatitis, heart failure and liver injury.
What Nesina is approved for: Nesina is alogliptin, a DPP-4 inhibitor. It is approved, along with diet and exercise, to improve blood sugar control in adults with type 2 diabetes (section 1). It is not recommended for type 1 diabetes.
Source
NESINA (alogliptin) tablets, for oral use, prescribing information and Medication Guide. Takeda Pharmaceuticals America. DailyMed, version published March 24, 2025. DailyMed setid a3768c7e-aa4c-44d3-bc53-43bb7346c0b0
No. The current Nesina 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 Nesina.
| Adverse reaction | NESINA 25 mg N=6447 | Placebo N=3469 | Active Comparator N=2257 |
|---|---|---|---|
| Nasopharyngitis | 309 (5) | 152 (4) | 113 (5) |
| Upper Respiratory Tract Infection | 287 (4) | 121 (4) | 113 (5) |
| Headache | 278 (4) | 101 (3) | 121 (5) |
Number of patients (%) across 14 randomized controlled trials. Nasopharyngitis means a stuffy or runny nose with sore throat.
| Trial and measure | NESINA 25 mg | Placebo or comparator |
|---|---|---|
| Add-on to glyburide, 26 weeks (N=198 vs 99): Overall (%) | 19 (10) | 11 (11) |
| Add-on to glyburide: Severe (%) | 0 | 1 (1) |
| Add-on to insulin (± metformin), 26 weeks (N=129 vs 129): Overall (%) | 35 (27) | 31 (24) |
| Add-on to insulin: Severe (%) | 1 (1) | 2 (2) |
| Add-on to metformin, 26 weeks (N=207 vs 104): Overall (%) | 0 | 3 (3) |
| Add-on to metformin: Severe (%) | 0 | 0 |
| Add-on to pioglitazone (± metformin or sulfonylurea), 26 weeks (N=199 vs 97): Overall (%) | 14 (7) | 5 (5) |
| Add-on to pioglitazone: Severe (%) | 0 | 1 (1) |
| Compared to glipizide, 52 weeks (N=222 vs 219): Overall (%) | 12 (5) | Glipizide: 57 (26) |
| Compared to glipizide: Severe (%) | 0 | Glipizide: 3 (1) |
| Compared to metformin 500 mg twice daily, 26 weeks (N=112 vs 109): Overall (%) | 2 (2) | Metformin: 2 (2) |
| Compared to metformin: Severe (%) | 0 | Metformin: 0 |
| Add-on to metformin compared to glipizide, 52 weeks (N=877 vs 869): Overall (%) | 12 (1) | Glipizide: 207 (4) |
| Add-on to metformin compared to glipizide: Severe (%) | 0 | Glipizide: 4 (1) |
Based on all reports of low blood sugar, with or without symptoms; a glucose reading was not required. Severe means needing medical help, or with reduced consciousness or a seizure. The comparator column is placebo unless the row names another medicine.
In the 14 pooled trials, any side effect was reported by 73% on Nesina 25 mg vs 75% on placebo and 70% on an active comparator. Stopping for side effects was 6.8% vs 8.4% on placebo and 6.2% on comparator.
In the EXAMINE heart outcome trial, low blood sugar was 6.7% on Nesina vs 6.5% on placebo, and serious low blood sugar 0.8% vs 0.6%. In elderly people, low blood sugar was 5.4% on Nesina vs 26% on glipizide.
Kidney side effects in blood sugar trials were 3.4% on Nesina vs 1.3% on placebo. In EXAMINE, eGFR fell by 25% or more in 21.1% on Nesina vs 18.7% on placebo, and kidney disease stage worsened in 16.8% vs 15.5%.
ALT (a liver enzyme) above three times normal: 1.3% on Nesina 25 mg vs 1.7% on comparators or placebo in blood sugar trials, and 2.4% vs 1.8% in EXAMINE.
Reported after approval, with frequency unknown: acute pancreatitis; diarrhea, constipation, nausea and ileus; fulminant liver failure; allergic reactions including anaphylaxis, angioedema, rash, hives and Stevens-Johnson syndrome; liver enzyme rises; severe joint pain; rhabdomyolysis; kidney inflammation (tubulointerstitial nephritis); and bullous pemphigoid.
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 was reported in 0.2% on Nesina 25 mg vs under 0.1% on comparators, and in EXAMINE 0.4% vs 0.3% on placebo. Nesina is stopped promptly if it is suspected.
Heart failure. In EXAMINE, 3.9% on Nesina vs 3.3% on placebo were hospitalized for heart failure. 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.
Hypersensitivity reactions. Serious allergic reactions, including anaphylaxis, angioedema and Stevens-Johnson syndrome, have been reported. Nesina is stopped if one is suspected, with caution in people who had angioedema with another DPP-4 inhibitor.
Hepatic effects. Fatal and non-fatal liver failure has been reported. Liver tests are checked promptly if there are signs such as tiredness, loss of appetite, right upper belly discomfort, dark urine or yellowing, and Nesina is interrupted if they are abnormal.
Low blood sugar with insulin or a sulfonylurea. A lower dose of insulin or a medicine that makes the body release insulin may be needed with Nesina.
Severe and disabling joint pain. Severe joint pain has been reported with DPP-4 inhibitors, starting from one day to years after starting, and easing after stopping.
Bullous pemphigoid. A blistering skin condition needing hospital care has been reported with DPP-4 inhibitors. Nesina is stopped if it is suspected.
From the Medication Guide that comes with Nesina:
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.