Amaryl Side Effects
Generic Name: Glimepiride
Please note - some side effects for Amaryl may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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For the consumer For the professional
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Side Effects of Amaryl - for the consumer
Amaryl
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Amaryl:
Seek medical attention right away if any of these SEVERE side effects occur when using Amaryl:Nausea.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain or irregular heartbeat; confusion; dark urine; fainting; fever, chills, or persistent sore throat; low blood sugar symptoms (eg, anxiety, dizziness, drowsiness, fast heartbeat, headache, lightheadedness, tremors, unusual sweating, weakness); severe or persistent blurred vision or other vision problems; unusual bruising or bleeding; unusual tiredness or weakness; yellowing of the eyes or skin.
For the professional
Amaryl
Adult Patients
The incidence of hypoglycemia with Amaryl, as documented by blood glucose values <60 mg/dL, ranged from 0.9–1.7% in two large, well controlled, 1-year studies.
Amaryl has been evaluated for safety in 2,013 patients in US controlled trials, and in 1,551 patients in foreign controlled trials. More than 1,650 of these patients were treated for at least 1 year. Adverse events, other than hypoglycemia, considered to be possibly or probably related to study drug that occurred in US placebo-controlled trials in more than 1% of patients treated with Amaryl are shown below.
| Adverse Events Occurring in ≥1% Amaryl Patients | ||||
|---|---|---|---|---|
| Amaryl | Placebo | |||
| No. | % | No. | % | |
| Total Treated | 746 | 100 | 294 | 100 |
| Dizziness | 13 | 1.7 | 1 | 0.3 |
| Asthenia | 12 | 1.6 | 3 | 1.0 |
| Headache | 11 | 1.5 | 4 | 1.4 |
| Nausea | 8 | 1.1 | 0 | 0.0 |
Vomiting, gastrointestinal pain, and diarrhea have been reported, but the incidence in placebo-controlled trials was less than 1%. In rare cases, there may be an elevation of liver enzyme levels. In isolated instances, impairment of liver function (e.g. with cholestasis and jaundice), as well as hepatitis, which may also lead to liver failure have been reported with sulfonylureas, including Amaryl.
Dermatologic ReactionsAllergic skin reactions, e.g., pruritus, erythema, urticaria, and morbilliform or maculopapular eruptions, occur in less than 1% of treated patients. These may be transient and may disappear despite continued use of Amaryl. If those hypersensitivity reactions persist or worsen, the drug should be discontinued. Porphyria cutanea tarda, photosensitivity reactions, and allergic vasculitis have been reported with sulfonylureas, including Amaryl.
Hematologic ReactionsLeukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia, aplastic anemia, and pancytopenia have been reported with sulfonylureas, including Amaryl.
Metabolic ReactionsHepatic porphyria reactions and disulfiram-like reactions have been reported with sulfonylureas, including Amaryl. Cases of hyponatremia have been reported with glimepiride and all other sulfonylureas, most often in patients who are on other medications or have medical conditions known to cause hyponatremia or increase release of antidiuretic hormone. The syndrome of inappropriate antidiuretic hormone (SIADH) secretion has been reported with sulfonylureas, including Amaryl, and it has been suggested that certain sulfonylureas may augment the peripheral (antidiuretic) action of ADH and/or increase release of ADH.
Other ReactionsChanges in accommodation and/or blurred vision may occur with the use of Amaryl. This is thought to be due to changes in blood glucose, and may be more pronounced when treatment is initiated. This condition is also seen in untreated diabetic patients, and may actually be reduced by treatment. In placebo-controlled trials of Amaryl, the incidence of blurred vision was placebo, 0.7%, and Amaryl, 0.4%.
Pediatric Patients
In a clinical trial, 135 pediatric patients with Type 2 diabetes were treated with Amaryl. The profile of adverse reactions in these patients was similar to that observed in adults.
TopMore resources:
Amaryl - Includes detailed dosage instructions.
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