Glimepiride

Applies to glimepiride: oral tablet

Along with its needed effects, glimepiride 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 glimepiride:

Rare

• Difficulty with swallowing
• dizziness
• fast heartbeat
• hives
• itching
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• shortness of breath
• skin rash
• tightness in the chest
• unusual tiredness or weakness
• wheezing

Incidence not known

• Abdominal or stomach pain
• agitation
• back, leg, or stomach pains
• bleeding gums
• blistering, peeling, or loosening of the skin
• bloating of abdomen
• blood in the urine or stools
• bloody, black, or tarry stools
• chest pain
• chills
• coma
• confusion
• cough or hoarseness
• dark urine
• decreased urine output
• depression
• diarrhea
• difficulty with breathing
• fever with or without chills
• fluid-filled skin blisters
• general body swelling
• general tiredness and weakness
• headache
• high fever
• hostility
• irritability
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• lethargy
• light-colored stools
• loss of appetite
• lower back or side pain
• muscle twitching
• nausea and vomiting
• nosebleeds
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid weight gain
• red, irritated eyes
• red skin lesions, often with a purple center
• seizures
• sensitivity to the sun
• skin thinness
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stupor
• swelling of face, ankles, or hands
• swollen or painful glands
• unusual bleeding or bruising
• upper right abdominal or stomach pain
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking glimepiride:

Symptoms of overdose

• Anxiety
• blurred vision
• cold sweats
• cool, pale skin
• increased hunger
• nightmares
• shakiness
• slurred speech

Some side effects of glimepiride 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:

Less common

• Lack or loss of strength

Incidence not known

• Redness or other discoloration of the skin
• severe sunburn

Applies to glimepiride: oral tablet

The most commonly reported adverse events included hypoglycemia, headache, nausea, asthenia, and dizziness.

Hyponatremia and syndrome of inappropriate antidiuretic hormone secretion (SIADH) occurred in mostly in patients who were on other medications or who had medical conditions known to cause hyponatremia or increased release of antidiuretic hormone.

Very common (10% or more): Hypoglycemia (up to 19.7%)

Frequency not reported: Weight gain

Postmarketing reports: Hyponatremia, SIADH

Rare (less than 0.1%): Thrombocytopenia, leukopenia, agranulocytosis, granulocytopenia, erythropenia, aplastic anemia, pancytopenia

Postmarketing reports: Hemolytic anemia in patients without G6PD deficiency, thrombocytopenia purpura

Uncommon (0.1% to 1%): Allergic reactions such as pruritus, erythema, urticaria, a morbilliform or maculopapular eruptions

Frequency not reported: Cutaneous eruptions with or without pruritus, cross-allergenicity with sulfonylureas, sulfonamides, or related substances

Postmarketing reports: Anaphylaxis, angioedema, Stevens-Johnson syndrome, dyspnea

Temporary visual impairment due to changes in blood glucose levels may occur due to temporary alteration in the turgidity and hence the refractive index of the lens which is dependent on blood glucose levels.

Frequency not reported: Transient visual disturbances

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.

Common (1% to 10%): Headache, dizziness

Rare (less than 0.1%): Nausea, vomiting, diarrhea, abdominal discomfort, abdominal pain, sensations of pressure or fullness in the epigastrium

Common (1% to 10%): Elevated ALT

Very rare (less than 0.01%): Hepatic function abnormal, hepatitis, hepatic failure

Postmarketing reports: Hepatitis and liver impairment, e.g. with cholestasis and jaundice, hepatic porphyria reactions and disulfiram-like reactions

Common (1% to 10%): Flu syndrome

Very rare (less than 0.01%): Leukocytoclastic vasculitis

Common (1% to 10%): Asthenia, accidental injury

Accidental injury was reported more frequently in patients receiving this drug (5.4% vs 3.4%). There was insufficient information available to determine if these events were associated with hypoglycemia.