Glimepiride Side Effects

Some side effects of glimepiride may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to glimepiride: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking glimepiride: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• severe skin rash, itching, redness, or irritation;

• pale skin, easy bruising or bleeding, fever, unusual weakness;

• numbness or tingly feeling;

• trouble breathing;

• feeling like you might pass out;

• dark urine, clay-colored stools;

• upper stomach pain, low fever, jaundice (yellowing of the skin or eyes); or

• nausea, vomiting, loss of appetite, feeling restless or irritable, confusion, hallucinations, muscle pain or weakness, and/or seizure.

Less serious side effects of glimepiride may include:

• dizziness, headache, tired feeling;

• mild nausea, vomiting, stomach pain, diarrhea;

• increased skin sensitivity to sunlight; or

• mild itching or skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to glimepiride: oral tablet

Cardiovascular

The administration of oral hypoglycemic drugs has been associated with increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin. This warning is based on a study of 823 patients, which reported that patients treated for 5 to 8 years with diet plus a fixed dose of tolbutamide (1.5 G per day) had a rate of cardiovascular mortality approximately 2.5 times that of patients treated with diet alone. Although only one drug in the sulfonylurea class (tolbutamide) was included in this study, this warning may also apply to other drugs in this class in view of their close similarities in mode of action and chemical structure.

Cardiovascular side effects have included reports of increased mortality with some sulfonylurea agents, however, no such data exists for glimepiride.

Metabolic

Metabolic side effects have included hypoglycemia (blood sugars less than 60 mg/dl) in 0.9% to 1.7%. Hyponatremia occurred rarely. The syndrome of inappropriate antidiuretic hormone (SIADH) secretion, hepatic porphyria reactions, and disulfiram reactions have also been reported.

Nervous system

Nervous system side effects have included dizziness (1.7%), asthenia (1.6%), and headache (1.5%).

Ocular

Ocular side effects have included blurred vision and loss of accommodation in less than 1% of treated patients.

Dermatologic

Dermatologic side effects have included pruritus, erythema, urticaria, and morbilliform or maculopapular rashes in less than 1% of cases. Sulfonylureas have caused porphyria cutanea tarda and photosensitivity reactions.

Gastrointestinal

Gastrointestinal side effects have included nausea (1.1%). Vomiting, diarrhea, and pain were noted in less than 1% of cases.

Hematologic

Hematologic side effects have included leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia, aplastic anemia, and pancytopenia.

Hepatic

Hepatic side effects have included cholestatic jaundice with other sulfonylureas. However, no data exists for glimepiride.

Hypersensitivity

Hypersensitivity side effects have included allergic skin reactions, e.g., pruritus, erythema, urticaria, and morbilliform or maculopapular eruptions, which occurred in less than 1% of treated patients. Some of these were transient and disappeared despite continued use of glimepiride. Allergic vasculitis has also been reported. Additional reports included hypersensitivity reactions worsening: such as dyspnea, fall in blood pressure, and shock.

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