Kazano Side Effects

Generic name: alogliptin / metformin

Medically reviewed by Drugs.com. Last updated on Sep 4, 2024.

Note: This document provides detailed information about Kazano Side Effects associated with alogliptin / metformin. Some dosage forms listed on this page may not apply specifically to the brand name Kazano.

Applies to alogliptin / metformin: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Under certain conditions, too much metformin can cause lactic acidosis. It usually occurs when other serious health problems are present, such as a heart attack or kidney failure. Symptoms of lactic acidosis include stomach discomfort, decreased appetite, diarrhea, fast or shallow breathing, a general feeling of discomfort, muscle pain or cramping, and unusual sleepiness, tiredness, or weakness. If you have more than one of these symptoms together, you should get immediate emergency medical help.

Do not let yourself get dehydrated. Be sure to drink extra fluids when you exercise or increase your activity, or if you have vomiting or diarrhea.

Pancreatitis (swelling and inflammation of the pancreas) may occur while you are using this medicine. Check with your doctor right away if you have a sudden and severe stomach pain, chills, constipation, nausea, vomiting, loss of appetite, fever, or lightheadedness.

Check with your doctor right away if you have chest pain or tightness, decreased urine output, dilated neck veins, extreme fatigue, irregular breathing, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, trouble breathing, or weight gain. These may be signs of heart failure.

This medicine may cause serious allergic reactions, including anaphylaxis, angioedema, or certain skin conditions (eg, Stevens-Johnson syndrome), which can be life-threatening and require immediate medical attention. Call your doctor right away if you have blistering, peeling, or loosening of the skin, chest tightness, chills, cough, diarrhea, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, joint or muscle pain, large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness while you are using this medicine.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine before having a major surgery or diagnostic tests, especially tests that use a contrast dye.

It is very important to carefully follow any instructions from your health care team about:

• Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
• Other medicines—Do not take other medicines unless they have been discussed with your doctor. This especially includes nonprescription medicines, such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
• Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about the changes in the dosing of their diabetes medicine that might occur with lifestyle changes, such as changes in exercise or diet. Furthermore, counseling on contraception and pregnancy may be needed, because of the problems that can occur in patients with diabetes during pregnancy.
• Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.
• In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says you have diabetes and that lists all of your medicines.

This medicine may cause hypoglycemia (low blood sugar). This is more common when this medicine is taken together with certain medicines. Low blood sugar must be treated before it causes you to pass out (unconsciousness). It is important that you learn which symptoms you usually have so you can treat it quickly. Some symptoms of low blood sugar include: behavior changes that are similar to being drunk, blurred vision, cold sweats, confusion, cool, pale skin, difficulty with thinking, drowsiness, excessive hunger, a fast heartbeat, headaches that continue, nausea, shakiness, slurred speech, or unusual tiredness or weakness. Talk to your doctor about how to treat low blood sugar.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your medicine, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual. High blood sugar can be very serious and must be treated right away. It is important that you learn which symptoms you have in order to treat it quickly. Talk to your doctor about the best way to treat high blood sugar.

This medicine may cause severe and disabling joint pain. Call your doctor right away if you have severe joint pain while using this medicine.

This medicine may cause bullous pemphigoid. Tell your doctor right away if you have large, hard skin blisters while you are using this medicine.

Limit the amount of alcohol you drink while you are using this medicine. Heavy alcohol use can increase your chances of serious side effects.

This medicine may cause some women who do not have regular monthly periods to ovulate. This can increase the chance of pregnancy. If you are a woman of childbearing potential, you should discuss birth control options with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Kazano

Along with its needed effects, alogliptin / metformin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking alogliptin / metformin:

Other side effects of Kazano

Some side effects of alogliptin / metformin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to alogliptin / metformin: oral tablet.

General adverse events

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

Gastrointestinal

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]

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]

Hepatic

Alogliptin:

• Postmarketing reports: Hepatic enzyme elevations, fulminant hepatic failure

Metformin:

• 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]

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

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]

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

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]

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]

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

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]

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]

Other

Metformin:

• Common (1% to 10%): Asthenia^[Ref]

See also:

Further information

Kazano side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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