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Glyburide / metformin Side Effects

In Summary

Commonly reported side effects of glyburide/metformin include: diarrhea. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to glyburide / metformin: oral tablet

In addition to its needed effects, some unwanted effects may be caused by glyburide / metformin. In the event that any of these side effects do occur, they may require medical attention.

Severity: Major

You should check with your doctor immediately if any of these side effects occur when taking glyburide / metformin:

More common:
  • Anxious feeling
  • behavior change similar to being drunk
  • blurred vision
  • cold sweats
  • confusion
  • convulsions (seizures)
  • cool pale skin
  • cough
  • difficulty in concentrating
  • drowsiness
  • excessive hunger
  • fast heartbeat
  • fever
  • headache (continuing)
  • nausea
  • nervousness
  • nightmares
  • restless sleep
  • shakiness
  • slurred speech
  • sneezing
  • sore throat
  • unconsciousness
  • unusual tiredness or weakness
Rare:
  • Abdominal or stomach discomfort
  • decreased appetite
  • diarrhea
  • fast shallow breathing
  • general feeling of discomfort
  • muscle pain or cramping
  • unusual sleepiness

Severity: Minor

Some of the side effects that can occur with glyburide / 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:
  • Dizziness
  • headache
  • vomiting

For Healthcare Professionals

Applies to glyburide / metformin: oral tablet

General

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

Gastrointestinal

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]

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]

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

Glyburide-Metformin
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]

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]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. "Product Information. Glucovance (glyburide-metformin)" Bristol-Myers Squibb, Princeton, NJ.

Not all side effects for glyburide / 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.

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