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Kazano Side Effects

Generic Name: alogliptin / metformin

Note: This page contains information about the side effects of alogliptin / metformin. Some of the dosage forms included on this document may not apply to the brand name Kazano.

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

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.

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
  • chills
  • cold sweats
  • coma
  • confusion
  • cool, pale skin
  • depression
  • difficult, burning, or painful urination
  • frequent urge to urinate
  • increased hunger
  • lower back or side pain
  • nausea
  • nightmares
  • seizures
  • shakiness
  • slurred speech
  • unusual tiredness or weakness
  • Blistering, peeling, or loosening of the skin
  • bloating
  • constipation
  • cough
  • darkened urine
  • diarrhea
  • difficulty with swallowing
  • fever
  • hives
  • indigestion
  • itching
  • 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
  • tightness in the chest
  • unusual tiredness or weakness
  • vomiting
  • yellow eyes or skin
Incidence not known
  • Dark-colored urine
  • general feeling of tiredness or weakness
  • light-colored stools
  • redness of the skin
  • stomach pain, continuing
  • welts

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
  • difficulty with breathing
  • 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


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


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

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

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]

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]


Postmarketing reports: Hepatic enzyme elevations, fulminant hepatic failure

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

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


Common (1% to 10%): Hypoglycemia

Common (1% to 10%): Hypoglycemia

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]


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]


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

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

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


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

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

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

Nervous system

Common (1% to 10%): Headache

Common (1% to 10%): Headache

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


Common (1% to 10%): Hypertension

Common (1% to 10%): Hypertension

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


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

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

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

Common (1% to 10%): Back pain

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

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


Common (1% to 10%): Asthenia[Ref]


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 warns that DPP-4 inhibitors for type 2 diabetes may cause severe joint pain. Available from: URL:" ([2015, Aug 28]):

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