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Alogliptin Side Effects

In 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 tablet

In addition to its needed effects, some unwanted effects may be caused by alogliptin. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking alogliptin:

More common:
  • Anxiety
  • blurred vision
  • chills
  • cold sweats
  • coma
  • confusion
  • cool, pale skin
  • depression
  • dizziness
  • fast heartbeat
  • headache
  • increased hunger
  • nausea
  • nightmares
  • seizures
  • shakiness
  • slurred speech
  • unusual tiredness or weakness
Less common:
  • Chest pain
  • decreased urine output
  • dilated neck veins
  • extreme fatigue
  • irregular breathing
  • irregular heartbeat
  • swelling of the face, fingers, feet, or lower legs
  • tightness in chest
  • troubled breathing
  • weight gain
Rare
  • Blistering, peeling, or loosening of the skin
  • bloating
  • constipation
  • cough
  • dark-colored urine
  • diarrhea
  • difficulty with swallowing
  • feeling of discomfort
  • fever
  • general feeling of tiredness or weakness
  • headache
  • hives, itching, or rash
  • indigestion
  • inflammation of the joints
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • light-colored stools
  • loss of appetite
  • muscle aches
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • stomach pain, continuing
  • swollen lymph glands
  • tightness in the chest
  • vomiting
  • yellow eyes or skin
Incidence not known:
  • Redness of the skin
  • severe joint pain

Minor Side Effects

Some of the side effects that can occur with alogliptin may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common:
  • Body aches or pain
  • ear congestion
  • loss of voice
  • sneezing
  • stuffy or runny nose

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

Common (1% to 10%): Abdominal pain, gastroesophageal reflux disease
Uncommon (0.1% to 1%): Pancreatitis
Postmarketing reports: Acute pancreatitis, diarrhea, constipation, nausea, ileus[Ref]

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]

Musculoskeletal

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]

Frequency not reported: Arthralgia[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[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. "Product Information. Nesina (alogliptin)." Takeda Pharmaceuticals America, Lincolnshire, IL.

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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. Available from: URL: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM460038.pdf." ([2015, Aug 28]):

Not all side effects for alogliptin may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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