Glucovance Side Effects

Generic name: glyburide / metformin

Medically reviewed by Drugs.com. Last updated on Aug 23, 2024.

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

Applies to glyburide / metformin: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Do not take this medicine together with bosentan (Tracleer®). Also, make sure your doctor knows about all other medicines you are using for diabetes, including insulin.

Under certain conditions, too much metformin can cause lactic acidosis. The symptoms of lactic acidosis are severe and quick to appear. They usually occur when other health problems not related to the medicine are present and very severe, such as a heart attack or kidney failure. The symptoms of lactic acidosis include abdominal or stomach discomfort, decreased appetite, diarrhea, fast, shallow breathing, a general feeling of discomfort, muscle pain or cramping, and unusual sleepiness, tiredness, or weakness. If you have any symptoms of lactic acidosis, get emergency medical help right away.

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 diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and 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 your 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 that you have diabetes and a list of all your medicines.

Check with your doctor right away if you start having chest pain or discomfort, nausea, pain or discomfort in the arms, jaw, back, or neck, trouble breathing, sweating, or vomiting while you are using this medicine. These may be symptoms of a serious heart problem, and could be a heart attack.

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). People feel different symptoms of low blood sugar. It is important that you learn which symptoms you usually have so you can treat it quickly. Talk to your doctor about the best way 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 interact with the dye used for an X-ray or CT scan. Your doctor should advise you to stop taking it before you have any medical exams or diagnostic tests that might cause less urine output than usual. You may be advised to start taking the medicine again 48 hours after the exams or tests if your kidney function is tested and found to be normal.

Serious side effects of Glucovance

Along with its needed effects, glyburide / 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 glyburide / metformin:

Other side effects of Glucovance

Some side effects of glyburide / 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 glyburide / metformin: oral tablet.

General adverse events

The most commonly reported adverse reactions include hypoglycemia, upper respiratory infection, gastrointestinal events, and dizziness.^[Ref]

Metabolic

Glyburide-Metformin:

• Very common (10% or more): Hypoglycemia (up to 37.7%)
• Very rare (less than 0.01%): Disulfiram-like reactions
• Frequency not reported: Weight gain, hypoglycemic coma, elevated blood glucose level, dehydration, metabolic acidosis

Glyburide:

• Very common (10% or more): Hypoglycemia (21.3%)
• Very rare (less than 0.01%): Disulfiram-like reactions, hyponatremia
• Frequency not reported: Moderate elevations in serum urea and creatinine concentrations

Metformin:

• Common (1% to 10%): Hypoglycemia
• Rare (less than 0.1%): Lactic acidosis

In clinical trials, all hypoglycemic episodes were managed by patients, no episodes required medical intervention or pharmacologic therapy. The incidence of hypoglycemia was highest in patients with a baseline HbA1c less than 7%. For patients with a baseline HbA1c between 8% and 11% receiving glyburide 2.5 mg-metformin 500 mg as initial therapy, the frequency of hypoglycemic symptoms was 30% to 35%. As second-line therapy in patients inadequately controlled on a sulfonylurea alone, 6.8% of patients experienced hypoglycemic episodes. The addition of rosiglitazone resulted in 22% of patients reporting a fingerstick glucose measurement of 50 mg/DL or lower (compared to 3.3% of placebo patients). Additionally in rosiglitazone-treated patients, a mean weight gain of 3 kg was observed.

Metabolic side effects, including lactic acidosis, which is a potentially fatal metabolic complication of biguanide therapy, has been reported in patients receiving metformin. The incidence of lactic acidosis has been about 0.03 cases per 1,000 patient years with approximately 0.015 fatal cases per 1,000 patient-years. The risk of lactic acidosis is particularly high in patients with underlying renal insufficiency. Cases of lactic acidosis occurring in patients with normal renal function have been rarely reported. Concomitant cardiovascular or liver disease, sepsis, and hypoxia may also increase the risk of lactic acidosis.

Gastrointestinal

Glyburide-Metformin:

• Very common (10% or more): Diarrhea (17%)
• Common (1% to 10%): Nausea/vomiting, abdominal pain
• Frequency not reported: Pancreatitis, acute gallstone pancreatitis, gastrointestinal hemorrhage^[Ref]

The incidence of gastrointestinal (GI) side effects including diarrhea, nausea/vomiting, and abdominal pain in the initial therapy trials were 31.6% (50/158) and 38.3% (n=62/162) in the glyburide 1.25 mg-metformin 250 mg and the glyburide 2.5 mg-metformin 500 mg groups, respectively. Across all trials, GI symptoms were the most common adverse event and were more frequent at higher dose levels; less than 2% of patients discontinued therapy due to GI adverse events.^[Ref]

Hematologic

Glyburide-Metformin:

• Frequency not reported: Disseminated intravascular coagulation, hemorrhage

Glyburide:

• Rare (less than 0.1%): Agranulocytosis, eosinophilia, hemolytic anemia, aplastic anemia, bone marrow aplasia, pancytopenia, coagulation disorders
• Frequency not reported: Leukopenia, thrombocytopenia, thrombocytopenia purpura
• Postmarketing reports: Hemolytic anemia in patients not known to have G6PD deficiency

Metformin:

• Common (1% to 10%): Subnormal vitamin B12 levels
• Frequency not reported: Anemia^[Ref]

Respiratory

Glyburide-Metformin:

• Very common (10% or more): Upper respiratory infection (17.3%)
• Frequency not reported: Pulmonary hypertension^[Ref]

Nervous system

Glyburide-Metformin:

• Common (1% to 10%): Headache, dizziness
• Frequency not reported: Dystonia, involuntary muscle contractions, grand mal seizure, unconsciousness, unresponsiveness

Glyburide:

• Frequency not reported: Paresthesia, tremor, convulsions, encephalopathy, cerebrovascular disorders, headache,

Metformin:

• Common (1% to 10%): Taste disturbances^[Ref]

Dermatologic

Glyburide-Metformin:

• Frequency not reported: Dermatitis

Glyburide:

• Common (1% to 10%): Pruritus, erythema, urticaria erythematous, maculopapular rash and bullous skin eruptions or psoriasiform drug eruption
• Frequency not reported: Alopecia/hypotrichosis, angioedema, facial edema, increased sweating

Sulfonylureas:

• Very rare (less than 0.01%): cutaneous or visceral allergic angitis, exfoliative dermatitis, urticaria evolving to shock
• Frequency not reported: Porphyria cutanea tarda, pellagra-like changes, photosensitization

Metformin:

• Rare (less than 0.1%): Skin reactions such as erythema, pruritus and urticaria^[Ref]

Hypersensitivity

Sulfonylureas:

• Frequency not reported: Cross-reactivity to sulfonamide(s) and their derivatives^[Ref]

Hepatic

• Frequency not reported: Cholethiasis

Metformin:

• Very rare (less than 0.01%): Liver function test abnormalities, hepatitis
• Postmarketing reports: Cholestatic jaundice

Sulfonylureas:

• Frequency not reported: Hepatic porphyria, increased liver enzymes (AST, ALT), abnormal liver function, cholestasis, cholestatic hepatitis, granulomatous hepatitis, and bilirubinemia^[Ref]

Glyburide-Metformin

Renal

Glyburide-Metformin:

• Frequency not reported: Acute renal failure

Glyburide:

• Frequency not reported: Abnormal renal function, acute renal failure^[Ref]

Ocular

Glyburide:

• Frequency not reported: Transient visual disturbances at the start of treatment (due to decrease in glycemic levels), blindness, diplopia, visual disturbances, ocular disturbances (accommodation changes, crystalline lens changes)^[Ref]

Cardiovascular

Glyburide-Metformin:

• Common (1% to 10%): Edema
• Frequency not reported: Myocardial infarction, tachycardia, chest pain^[Ref]

In add-on rosiglitazone clinical trials, edema was reported in 7.7% (14/181) patients compared to 2.2% in placebo patients.^[Ref]

Endocrine

Glyburide:

• Frequency not reported: Syndrome of inappropriate secretion of antidiuretic hormone (SIADH)^[Ref]

Musculoskeletal

Glyburide:

• Frequency not reported: Arthralgia, arthritis^[Ref]

Psychiatric

Glyburide-Metformin:

• Frequency not reported: Disorientation

Glyburide:

• Frequency not reported: Confusion, acute psychosis^[Ref]

Other

Glyburide:

• Frequency not reported: Deafness^[Ref]

See also:

Further information

Glucovance 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.

Medical Disclaimer