Glucovance Side Effects
Generic Name: glyburide / metformin
Medically reviewed by Drugs.com. Last updated on Jan 12, 2019.
Note: This document contains side effect information about glyburide / metformin. Some of the dosage forms listed on this page may not apply to the brand name Glucovance.
Common side effects of Glucovance include: diarrhea. See below for a comprehensive list of adverse effects.
For the Consumer
Applies to glyburide / metformin: oral tablet
Oral route (Tablet)
Post-marketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. Onset is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels, anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio, and elevated metformin plasma levels. Risk factors include renal impairment, concomitant use of certain drugs (eg, carbonic anhydrase inhibitors), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (eg, acute congestive heart failure), excess alcohol intake, and hepatic impairment. Immediately discontinue use if suspected and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended.
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:
More Common
Anxious feeling
behavior change similar to being drunk
cold sweats
cool, pale skin
difficulty with concentrating
excessive hunger
headache (continuing)
unusual tiredness or weakness
Abdominal or stomach discomfort
fast shallow breathing
general feeling of discomfort
muscle pain or cramping
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:
The most commonly reported adverse reactions include hypoglycemia, upper respiratory infection, gastrointestinal events, and dizziness.[Ref]
Metabolic
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.
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
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]
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]
Frequency not reported: Disseminated intravascular coagulation, hemorrhage
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
Common (1% to 10%): Subnormal vitamin B12 levels
Frequency not reported: Anemia[Ref]
Very common (10% or more): Upper respiratory infection (17.3%)
Frequency not reported: Pulmonary hypertension[Ref]
Common (1% to 10%): Headache, dizziness
Frequency not reported: Dystonia, involuntary muscle contractions, grand mal seizure, unconsciousness, unresponsiveness
Frequency not reported: Paresthesia, tremor, convulsions, encephalopathy, cerebrovascular disorders, headache,
Common (1% to 10%): Taste disturbances[Ref]
Frequency not reported: Dermatitis
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
Rare (less than 0.1%): Skin reactions such as erythema, pruritus and urticaria[Ref]
Frequency not reported: Cross-reactivity to sulfonamide(s) and their derivatives[Ref]
Glyburide-Metformin
Frequency not reported: Cholethiasis
Very rare (less than 0.01%): Liver function test abnormalities, hepatitis
Postmarketing reports: Cholestatic jaundice
Frequency not reported: Hepatic porphyria, increased liver enzymes (AST, ALT), abnormal liver function, cholestasis, cholestatic hepatitis, granulomatous hepatitis, and bilirubinemia[Ref]
Frequency not reported: Acute renal failure
Frequency not reported: Abnormal renal function, acute renal failure[Ref]
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]
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]
Frequency not reported: Syndrome of inappropriate secretion of antidiuretic hormone (SIADH)[Ref]
Frequency not reported: Arthralgia, arthritis[Ref]
Frequency not reported: Disorientation
Frequency not reported: Confusion, acute psychosis[Ref]
Frequency not reported: Deafness[Ref]
1. Cerner Multum, Inc. "Australian Product Information." O 0
2. "Product Information. Glucovance (glyburide-metformin)" Bristol-Myers Squibb, Princeton, NJ.
Some side effects may not be reported. You may report them to the FDA.
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More about Glucovance (glyburide / metformin)
During Pregnancy
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Drug class: antidiabetic combinations
Glucovance (Advanced Reading)
Glucovance (FDA)
Availability Prescription only
Approval History Drug history at FDA
Bristol-Myers Squibb Company
Antidiabetic combinations
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