Short answer: In pooled trials of alogliptin with metformin, the side effects seen in at least 4% and more often than on alogliptin, metformin or placebo alone were upper respiratory infection (8% vs 3% on placebo), stuffy or runny nose (7% vs 2%), diarrhea (6% vs 3%), high blood pressure (6% vs 6%), headache (5% vs 3%), back pain and urinary tract infection (4% each). Kazano has a boxed warning for lactic acidosis from its metformin part.
What Kazano is approved for: Kazano combines alogliptin, a DPP-4 inhibitor, with metformin, a biguanide. 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
KAZANO (alogliptin and metformin hydrochloride) tablets, for oral use, prescribing information and Medication Guide. Takeda Pharmaceuticals America. DailyMed, version published August 21, 2026. DailyMed setid 83cb7914-a683-47bb-a713-f2bc6a596bd2
WARNING: LACTIC ACIDOSIS
Cases of metformin-associated lactic acidosis reported after approval have resulted in death, low body temperature, low blood pressure and slow heart rhythms that resist treatment. It often starts subtly, with only vague symptoms such as feeling unwell, muscle aches, trouble breathing, sleepiness and abdominal pain. It was marked by blood lactate above 5 mmol/L, anion gap acidosis without ketones, a raised lactate to pyruvate ratio, and metformin levels generally above 5 mcg/mL. Risk factors include kidney impairment, certain drugs (for example carbonic anhydrase inhibitors such as topiramate), age 65 or older, a radiology study with contrast, surgery and other procedures, low-oxygen states such as acute heart failure, heavy alcohol use, liver impairment and mitochondrial diseases. If it is suspected, Kazano is stopped immediately and supportive care is started in a hospital; prompt hemodialysis is recommended.
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 Kazano.
| Adverse reaction | Alogliptin and Metformin N=2794 | Alogliptin N=222 | Metformin N=1592 | Placebo N=106 |
|---|---|---|---|---|
| Upper respiratory tract infection | 224 (8) | 6 (3) | 105 (7) | 3 (3) |
| Nasopharyngitis | 191 (7) | 7 (3) | 93 (6) | 2 (2) |
| Diarrhea | 155 (6) | 4 (2) | 105 (7) | 3 (3) |
| Hypertension | 154 (6) | 5 (2) | 96 (6) | 6 (6) |
| Headache | 149 (5) | 11 (5) | 74 (5) | 3 (3) |
| Back pain | 119 (4) | 1 (1) | 72 (5) | 1 (1) |
| Urinary tract infection | 116 (4) | 4 (2) | 59 (4) | 2 (2) |
Number of patients (%), pooled from four controlled trials. The combination column pools alogliptin 25 mg and 12.5 mg with various metformin doses. Nasopharyngitis means a stuffy or runny nose with sore throat.
| Adverse reaction | Metformin Monotherapy (n=141) | Placebo (n=145) |
|---|---|---|
| Diarrhea | 53.2 | 11.7 |
| Nausea/vomiting | 25.5 | 8.3 |
| Flatulence | 12.1 | 5.5 |
| Asthenia | 9.2 | 5.5 |
| Indigestion | 7.1 | 4.1 |
| Abdominal discomfort | 6.4 | 4.8 |
| Headache | 5.7 | 4.8 |
% of patients. Reactions that were more common on metformin than on placebo. Asthenia means weakness.
In the four pooled trials, any side effect was reported by 74% on alogliptin with metformin vs 75% on placebo. Stopping for side effects was 6.2% vs 1.9% on placebo, 6.4% on metformin and 5.0% on alogliptin.
Alogliptin 25 mg alone in 14 pooled trials (Table 2): stuffy or runny nose 5% vs 4% on placebo, upper respiratory infection 5% vs 4%, and headache 4% vs 3%.
Low blood sugar: 1.9% on alogliptin 12.5 mg with metformin 500 mg and 5.3% with metformin 1,000 mg in a 26-week trial; 0% on alogliptin added to metformin vs 2.9% on placebo; 1.4% on alogliptin with metformin vs 23.8% on glipizide with metformin at an interim 104-week analysis.
In the EXAMINE heart outcome trial, low blood sugar was 6.7% on alogliptin vs 6.5% on placebo, and serious low blood sugar 0.8% vs 0.6%. In metformin trials of 29 weeks, vitamin B12 fell below normal in about 7%.
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); bullous pemphigoid; and, for metformin, liver injury.
The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.
Lactic acidosis. The boxed-warning risk. Kazano is not used with an eGFR below 30 and is not recommended at 30 to 60, because those people need a lower alogliptin dose than the combination has. eGFR is checked before starting and at least yearly. It is stopped around some iodinated contrast scans, paused while food and fluids are restricted, stopped in shock, heart attack, sepsis or acute heart failure with low oxygen, avoided with liver disease, and not recommended with mitochondrial diseases such as MELAS and MIDD.
Pancreatitis. Acute pancreatitis was reported in 0.2% on alogliptin 25 mg vs under 0.1% on comparators, and in EXAMINE 0.4% vs 0.3% on placebo. Alogliptin is stopped promptly if it is suspected.
Heart failure. In EXAMINE, 3.9% on alogliptin vs 3.3% on placebo were hospitalized for heart failure. Risks and benefits are weighed in people at risk, and they are watched for symptoms.
Hypersensitivity reactions. Serious allergic reactions to alogliptin, including anaphylaxis, angioedema and Stevens-Johnson syndrome, have been reported. Kazano is stopped if one is suspected.
Hepatic effects. Fatal and non-fatal liver failure has been reported with alogliptin. Liver tests are checked promptly if there are signs such as tiredness, loss of appetite, right upper belly discomfort, dark urine or yellowing, and Kazano is interrupted if they are abnormal.
Vitamin B12 deficiency. Metformin may lower vitamin B12. Blood counts are measured yearly and vitamin B12 every 2 to 3 years.
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 Kazano.
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. Kazano is stopped if it is suspected.
From the Medication Guide that comes with Kazano:
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.