What the label lists and what reports show
Alogliptin and pioglitazone side effects
Alogliptin and pioglitazone's FDA label: “The most common adverse reactions (4% or greater incidence) are nasopharyngitis, back pain and upper respiratory tract infection.” FAERS holds 249 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 weight increased (21 reports).
- No generic listed
- Boxed warning
Check it at the source: the alogliptin and pioglitazone FDA label on DailyMed (effective February 28, 2025, 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 OSENI?OSENI can cause serious side effects, including: See “ What is the most important information I should know about OSENI? ” 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 OSENI and contact your healthcare provider right away or go to the nearest hospital emergency room Liver problems. Call your healthcare provider 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 Broken bones (fractures). Usually in the hand, upper arm or foot in women. […]
Source: FDA drug label, Takeda Pharmaceuticals America, Inc., effective February 28, 2025 (SPL set 4c619ed9-fe3e-4158-9938-80c6c3493d55), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (4% or greater incidence) are nasopharyngitis, back pain and upper respiratory tract infection.
Table 7. PROactive: Number of First and Total Events for Each Component Within the Cardiovascular Composite Endpoint
| Reaction | First Events n (%) | Total Events n | First Events n (%) | Total Events n |
|---|---|---|---|---|
| Any Event | 572 (21.7) | 900 | 514 (19.7) | 803 |
| All-Cause Mortality | 122 (4.6) | 186 | 110 (4.2) | 177 |
| Nonfatal Myocardial Infarction (MI) | 118 (4.5) | 157 | 105 (4) | 131 |
| Stroke | 96 (3.6) | 119 | 76 (2.9) | 92 |
| Acute Coronary Syndrome | 63 (2.4) | 78 | 42 (1.6) | 65 |
| Cardiac Intervention (CABG/PCI) | 101 (3.8) | 240 | 101 (3.9) | 195 |
| Major Leg Amputation | 15 (0.6) | 28 | 9 (0.3) | 28 |
| Leg Revascularization | 57 (2.2) | 92 | 71 (2.7) | 115 |
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: Congestive Heart Failure [see Boxed Warning and Warnings and Precautions (5.1) ] Pancreatitis [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Hepatic Effects [see Warnings and Precautions (5.4) ] Edema [see Warnings and Precautions (5.5) ] Fractures [see Warnings and Precautions (5.6) ] Urinary Bladder Tumors [see Warnings and Precautions (5.7) ] Hypoglycemia with Concomitant Use with Insulin or Insulin Secretagogues [see Warnings and Precautions (5.8) ] Macular Edema [see Warnings and Precautions (5.9) ] Severe and Disabling Arthralgia [see Warnings and Precautions (5.10) ] Bullous Pemphigoid [see Warnings and Precautions (5.11) ] The most common adverse reactions (4% or greater incidence) are nasopharyngitis, back pain and upper respiratory 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. …
Source: FDA drug label, Takeda Pharmaceuticals America, Inc., effective February 28, 2025 (SPL set 4c619ed9-fe3e-4158-9938-80c6c3493d55), via openFDA; the full label on DailyMed
What do FAERS reports show?
249 reports list alogliptin and pioglitazone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 4 are coded as a death and 36 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, 12 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 pioglitazone: 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