Note: This document contains side effect information about alogliptin. Some dosage forms listed on this page may not apply to the brand name Nesina.

Summary

More frequent side effects include: upper respiratory tract infection, headache, and nasopharyngitis. Continue reading for a comprehensive list of adverse effects.

Applies to alogliptin: oral tablets.

Side effects include:

Alogliptin (the active ingredient contained in Nesina) monotherapy: Nasopharyngitis, headache, upper respiratory tract infection.

Alogliptin/metformin hydrochloride fixed combination: Upper respiratory tract infection, nasopharyngitis, diarrhea, hypertension, headache, back pain, urinary tract infection.

Alogliptin/pioglitazone fixed combination: Nasopharyngitis, back pain, upper respiratory tract infection.

For Healthcare Professionals

Applies to alogliptin: oral tablet.

General

The most frequently reported side effects included nasopharyngitis, headache, and upper respiratory tract infection.^[Ref]

Gastrointestinal

During clinical trials, acute pancreatitis was reported in 6 (0.2%) patients receiving 25 mg and 2 patients (less than 0.1%) who were treated with active comparators or placebo. In a cardiovascular outcome trial of patient with high cardiovascular risk, acute pancreatitis was reported in 10 patients receiving this drug and 7 patients receiving placebo (0.4% vs 0.3%).^[Ref]

Common (1% to 10%): Abdominal pain, gastroesophageal reflux disease

Uncommon (0.1% to 1%): Pancreatitis

Postmarketing reports: Acute pancreatitis, diarrhea, constipation, nausea, ileus^[Ref]

Musculoskeletal

Frequency not reported: Arthralgia^[Ref]

Between October 2006 and December 2013, thirty-three cases of severe arthralgia have been reported to the FDA Adverse Event Reporting System Database. Each case involved the use of 1 or more dipeptidyl peptidase-4 (DPP-4) inhibitor. In all cases, substantial reduction in prior activity level was reported, 10 patients were hospitalized due to disabling joint pain. In 22 cases, symptoms appeared within 1 month of starting therapy, in 23 cases symptoms resolved less than 1 month after discontinuation. A positive rechallenge was reported in 8 cases, with 6 cases involving use of a different DPP-4 inhibitor. Sitagliptin had the greatest number of cases reported (n=28) followed by saxagliptin (n=5), linagliptin (n=2), alogliptin (n=1), and vildagliptin (n=2).^[Ref]

Hepatic

Postmarketing reports: Hepatic enzyme elevations, fulminant hepatic failure^[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity reactions (0.6%)

Postmarketing reports: Anaphylaxis, angioedema, rash, urticaria, severe cutaneous adverse reactions (Stevens-Johnson syndrome)^[Ref]

Nervous system

Common (1% to 10%): Headache^[Ref]

Respiratory

Common (1% to 10%): Nasopharyngitis, upper respiratory tract infection^[Ref]

Dermatologic

Common (1% to 10%): Pruritus, rash

Postmarketing reports: Exfoliative skin conditions including Stevens-Johnson syndrome, erythema multiforme, angioedema, urticaria

Dipeptidyl peptidase-4 inhibitors:

Postmarketing reports: Bullous pemphigoid^[Ref]

Postmarketing reports of bullous pemphigoid requiring hospitalization have been reported with dipeptidyl peptidase-4 (DPP-4) inhibitors use. These case typically recovered with topical or systemic immunosuppressive treatment and discontinuation of DPP-4 inhibitor.^[Ref]

Metabolic

Common (1% to 10%): Hypoglycemia

Based on a pooled analysis the hypoglycemic risk of this drug was considered neutral.

Cardiovascular

In a clinical trial in patients with recent acute coronary syndrome, a greater proportion of patients receiving this drug were hospitalized for congestive heart failure compared with placebo (3.9% [n=106] vs 3.3% [n=89]),^[Ref]

Frequency not reported: Heart failure^[Ref]