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Alogliptin Side Effects

Medically reviewed by Drugs.com. Last updated on Jun 21, 2021.

Summary

More frequently reported side effects include: upper respiratory tract infection, headache, and nasopharyngitis. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to alogliptin: oral tablets

Side effects include:

Alogliptin 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]

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.