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Alogliptin / metformin Side Effects

In Summary

Commonly reported side effects of alogliptin/metformin include: lactic acidosis, nausea, vomiting, and hypoglycemia. Other side effects include: upper respiratory tract infection, abdominal distress, headache, and nasopharyngitis. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to alogliptin / metformin: oral tablet

In addition to its needed effects, some unwanted effects may be caused by alogliptin / metformin. 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 / metformin:

More common:
  • Blurred vision
  • dizziness
  • headache
  • nervousness
  • pounding in the ears
  • slow or fast heartbeat
Less common:
  • Anxiety
  • bladder pain
  • bloody or cloudy urine
  • chest pain
  • chills
  • cold sweats
  • coma
  • confusion
  • cool, pale skin
  • decreased urine output
  • depression
  • difficult, burning, or painful urination
  • dilated neck veins
  • extreme fatigue
  • frequent urge to urinate
  • increased hunger
  • irregular breathing
  • irregular heartbeat
  • lower back or side pain
  • nausea
  • nightmares
  • seizures
  • shakiness
  • slurred speech
  • swelling of the face, fingers, feet, or lower legs
  • tightness in chest
  • troubled breathing
  • unusual tiredness or weakness
  • weight gain
Rare
  • Blistering, peeling, or loosening of the skin
  • bloating
  • constipation
  • cough
  • darkened urine
  • diarrhea
  • difficulty with swallowing
  • fever
  • hives or itching
  • indigestion
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of appetite
  • 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
  • vomiting
  • yellow eyes or skin
Incidence not known:
  • Dark-colored urine
  • general feeling of tiredness or weakness
  • light-colored stools
  • redness of the skin
  • severe joint pain
  • stomach pain, continuing
  • welts

Minor Side Effects

Some of the side effects that can occur with alogliptin / metformin 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:

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

For Healthcare Professionals

Applies to alogliptin / metformin: oral tablet

General

The most common adverse reactions reported include upper respiratory tract infection, nasopharyngitis, diarrhea, hypertension, headache, back pain, and urinary tract infection.[Ref]

Gastrointestinal

Acute pancreatitis has been associated with DPP-4 inhibitors. In a pooled analysis of 13 studies, the overall rate of pancreatitis reported with alogliptin 25 mg, 12.5 mg, active control, or placebo was 2, 1, 1, or 0, events per 1000 patient years, respectively.[Ref]

Alogliptin-Metformin:
Common (1% to 10%): Diarrhea, gastroenteritis, abdominal pain, vomiting, gastritis, gastroesophageal reflux disease

Alogliptin:
Common (1% to 10%): Diarrhea, abdominal pain, gastroesophageal reflux disease
Uncommon (0.1% to 1%): Pancreatitis
Postmarketing reports: Acute pancreatitis

Metformin:
Very common (10% or more): Diarrhea (up to 53.2%), Nausea/vomiting (25.5%), flatulence (12.1%)
Common (1% to 10%): Indigestion, abdominal discomfort[Ref]

Hepatic

Cases of hepatic dysfunction including hepatic failure have been received in the postmarketing period with alogliptin-treated patients; causality has not been established.[Ref]

Alogliptin:
Postmarketing reports: Hepatic enzyme elevations, fulminant hepatic failure

Metformin:
Very rare (less than 0.01%): Hepatitis, liver function test abnormalities[Ref]

Metabolic

Alogliptin-Metformin:
Common (1% to 10%): Hypoglycemia

Alogliptin:
Common (1% to 10%): Hypoglycemia

Metformin:
Common (1% to 10%): Hypoglycemia, loss of appetite
Very rare (less than 0.01%): Lactic acidosis, vitamin B12 deficiency[Ref]

In metformin-treated patients, lactic acidosis has been reported in approximately 0.03 cases per 1000 patient-years with approximately half these cases resulting in fatalities. In more than 20,000 patient-years exposure in clinical trials, there were no cases of lactic acidosis. Reported cases have occurred primarily in patients with significant renal insufficiency, often in the setting of multiple concomitant medical/surgical problems and multiple concomitant medications.

In an alogliptin monotherapy study, the incidence of hypoglycemia was 1.5% (compared with 1.6% in placebo). Adding alogliptin to glyburide or insulin did not increase the incidence of hypoglycemia compared with placebo. In elderly patients, the incidence of hypoglycemia was 5.4% with alogliptin compared with 26% for glipizide. In a 26-week, placebo-controlled study of alogliptin once daily as add-on to a metformin regimen, hypoglycemic events were reported in 0.9% of patients in the alogliptin-metformin group compared with 2.9% in the placebo group.[Ref]

Hypersensitivity

Alogliptin:
Uncommon (0.1% to 1%): Hypersensitivity reactions (0.6%)
Postmarketing reports: Anaphylaxis, angioedema, rash, urticaria, severe cutaneous adverse reactions (Stevens-Johnson syndrome), erythema multiforme[Ref]

Dermatologic

Alogliptin-metformin:
Common (1% to 10%): Pruritus, rash

Alogliptin:
Common (1% to 10%): Pruritus, rash
Postmarketing reports: Exfoliative skin conditions including Stevens-Johnson syndrome, angioedema, urticaria

Metformin:
Very rare (less than 0.01%): Erythema, pruritus, urticaria[Ref]

Respiratory

Alogliptin-Metformin:
Common (1% to 10%): Upper respiratory tract infection, nasopharyngitis

Alogliptin:
Common (1% to 10%): Nasopharyngitis, upper respiratory tract infection

Metformin:
Common (1% to 10%): Upper respiratory tract infection, nasopharyngitis[Ref]

Nervous system

Alogliptin-Metformin:
Common (1% to 10%): Headache

Alogliptin:
Common (1% to 10%): Headache

Metformin:
Common (1% to 10%): Headache, metallic taste[Ref]

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]

Alogliptin-Metformin:
Common (1% to 10%): Hypertension

Alogliptin:
Common (1% to 10%): Hypertension
Frequency not reported: Heart failure

Metformin:
Common (1% to 10%): Hypertension[Ref]

Genitourinary

Alogliptin-Metformin:
Common (1% to 10%): Urinary tract infection

Alogliptin:
Common (1% to 10%): Urinary tract infection

Metformin:
Common (1% to 10%): Urinary tract infection[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]

Alogliptin-Metformin:
Common (1% to 10%): Back pain

Alogliptin:
Uncommon (0.1% to 1%): Back pain
Frequency not reported: Arthralgia

Metformin:
Common (1% to 10%): Back pain[Ref]

Other

Metformin:
Common (1% to 10%): Asthenia[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. Kazano (alogliptin-metFORMIN)." Takeda Pharmaceuticals America, Lincolnshire, IL.

4. US Food and Drug Administration "FDA Drug Safety Communication: FDA adds warnings about heart failure risk to labels of type 2 diabetes medicines containing saxagliptin and alogliptin. Available from: URL: http://www.fda.gov/Drugs/DrugSafety/ucm486096.htm?source=govdelivery&utm_medium=em" ([11 Feb 2014]):

5. 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 / metformin 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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