What the label lists and what reports show
Alogliptin and metformin side effects
Alogliptin and metformin's FDA label: “Most common adverse reactions (incidence ≥4%) are upper respiratory tract infection, nasopharyngitis, diarrhea, hypertension, headache, back pain and urinary tract infection.” FAERS holds 138 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 diarrhoea (16 reports).
- No generic listed
- Boxed warning
Check it at the source: the alogliptin and metformin FDA label on DailyMed (effective August 17, 2026, Takeda Pharmaceuticals America, 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 KAZANO?KAZANO can cause serious side effects, including: See "What is the most important information I should know about KAZANO?" Serious allergic (hypersensitivity) reactions, such as: swelling of your face, lips, throat and other areas on your skin raised, red areas on your skin (hives) difficulty swallowing or breathing skin rash, itching, flaking or peeling If you have these symptoms, stop taking KAZANO and contact your doctor right away or go to the nearest hospital emergency room. Liver problems. Call your doctor right away or go to the nearest hospital emergency room if you have unexplained symptoms, such as: nausea or vomiting loss of appetite stomach pain dark urine unusual or unexplained tiredness yellowing of your skin or the whites of your eyes Low Vitamin B 12 levels (vitamin B 12 deficiency). […]
Source: FDA drug label, Takeda Pharmaceuticals America, Inc., effective August 17, 2026 (SPL set 83cb7914-a683-47bb-a713-f2bc6a596bd2), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥4%) are upper respiratory tract infection, nasopharyngitis, diarrhea, hypertension, headache, back pain and urinary tract infection.
Table 1 . Adverse Reactions Reported in ≥ 4% of Adults with Type 2 Diabetes Mellitus…
| 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) |
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 (5.2) ] Heart Failure [see Warnings and Precautions (5.3) ] Hypersensitivity Reactions [see Warnings and Precautions (5.4) ] Hepatic Effects [see Warnings and Precautions (5.5) ] Severe and Disabling Arthralgia [see Warnings and Precautions (5.8) ] Bullous Pemphigoid [see Warnings and Precautions (5.9) ] Most common adverse reactions (incidence ≥4%) are upper respiratory tract infection, nasopharyngitis, diarrhea, hypertension, headache, back pain and urinary tract infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals America, Inc. at 1-877-TAKEDA-7 (1-877-825-3327) 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. Alogliptin and Metformin HCl Over 2,700 patients with type 2 diabetes mellitus have received alogliptin coadministered with metformin in four large, randomized, double-blind controlled clinical trials. …
Source: FDA drug label, Takeda Pharmaceuticals America, Inc., effective August 17, 2026 (SPL set 83cb7914-a683-47bb-a713-f2bc6a596bd2), via openFDA; the full label on DailyMed
What do FAERS reports show?
138 reports list alogliptin and metformin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 4 are coded as a death and 25 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 24 reactions below, 9 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.
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?
- Alogliptin 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