Nesina Side Effects
Generic name: alogliptin
Medically reviewed by Drugs.com. Last updated on Jun 21, 2021.
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]
More about Nesina (alogliptin)
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- Drug class: dipeptidyl peptidase 4 inhibitors
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References
1. Cerner Multum, Inc. "Australian Product Information." O 0
2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
3. "Product Information. Nesina (alogliptin)." Takeda Pharmaceuticals America (2013):
4. US Food and Drug Administration "FDA Drug Safety Communication: FDA warns that DPP-4 inhibitors for type 2 diabetes may cause severe joint pain. http://www.fda.gov/downloads/Drugs/DrugSafety/UCM460038.pdf" (2015):
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.
