Acarbose Side Effects
Some side effects of acarbose 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 acarbose: oral tablet
Get emergency medical help if you have any of these signs of an allergic reaction while taking acarbose: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
severe stomach pain, severe constipation;
diarrhea that is watery or bloody;
easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin; or
nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Less serious side effects of acarbose may include:
mild stomach pain, gas, bloating;
mild diarrhea; or
mild skin rash or itching.
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 acarbose: oral tablet
In general, systemic side effects have been rare and unexpected because of the very low systemic bioavailability of acarbose.
Gastrointestinal side effects in large scale clinical trials have shown that 58% of patients complain of side effects. Of these patients with side effects, over 90% experienced gastrointestinal (GI) effects. GI side effects usually developed within the first few weeks of therapy, were usually mild to moderate in severity, and typically decreased over time. The most common GI side effects were due to the fermentation of unabsorbed carbohydrates and resultant gas production. The following side effects have been reported in large studies of patients treated with dosages ranging from 300 to 600 mg/day for periods up to 2 years: flatulence in 50% to 70%, and abdominal spasm, tenesmus, or general abdominal pain in 8% of patients. Intractable constipation, nausea, vomiting, ileus, or gastric complaints have been reported in 5% of patients or less. Pneumatosis cystoides intestinalis has also been reported.
The severity of GI symptoms may be decreased by dosage reduction and by avoidance of gas-producing foods and sucrose. Most studies have demonstrated that GI side effects decrease in severity over time.
Acarbose can cause a mild degree of carbohydrate malabsorption. It may adversely affect the absorption and metabolism of other nutrients and minerals as well. Data are available regarding significantly increased GI iron, chromium, and calcium losses. In some cases, iron-deficient anemia has resulted.
Coadministration of metronidazole or guar gum has not improved the GI tolerance of acarbose.
Nervous system side effects are uncommon and have included somnolence, weakness, dizziness, headache, and vertigo.
Endocrine side effects have included hypoglycemia, which was infrequently reported and was more likely to occur when insulin or sulfonylureas were coadministered. Approximately 2% of patients treated with acarbose, alone or in combination with sulfonylureas or insulin, developed hypoglycemia. Another 3% exhibited symptoms suggesting of hypoglycemia. In general, addition of acarbose to insulin typically resulted in decreased insulin requirements, reducing the risk of hypoglycemia.
Acarbose may have a potentially beneficial effect on the lipid profile of patients with diabetes. Specifically, a trend towards decreased plasma triglycerides, total cholesterol, and apolipoprotein B and significant reductions in plasma apolipoproteins AI and AII have been reported. Interestingly, these effects have not been observed in nondiabetic subjects.
Hepatic side effects have included isolated cases of elevated serum transaminases, indicating possible hepatic toxicity, in 3.8% of treated patients. These elevations were typically asymptomatic and reversible. Such elevations have also been more common in females, African-Americans, obese individuals (body mass index greater than 29), and those who have had diabetes for more than five years. Most cases of transaminase elevation have not been associated with other evidence of hepatic dysfunction. Fulminant hepatitis with fatal outcome has also been reported.
Data from large clinical trials have shown that the incidence of elevated serum transaminases at doses of 50 to 100 mg TID was the same as with placebo. In long-term trials of up to 12 months, however, elevations of AST and/or ALT occurred in 15% of patients.
Hematologic side effects have included anemia, which was probably due to decreased gastrointestinal iron absorption as a result of acarbose therapy. Sustained iron deficient anemia that required treatment has been reported in less than 1% of patients. Thrombocytopenia has also been reported.
Dermatologic side effects are rare and have included pruritus in 0.1% and exanthema in 0.3% of treated patients.
Other side effects have included reports that acarbose administration may have lead to an acute state of carbohydrate malabsorption that decreased with continued use.
Hypersensitivity side effects have included one case of generalized erythema multiforme. Additional hypersensitivity side effects reported from worldwide post marketing experience include hypersensitive skin reactions (e.g. rash, erythema, exanthema and urticaria), edema, ileus/sibilus, jaundice and/or hepatitis and associated liver damage.
More acarbose resources
- acarbose MedFacts Consumer Leaflet (Wolters Kluwer)
- acarbose Concise Consumer Information (Cerner Multum)
- acarbose Advanced Consumer (Micromedex) - Includes Dosage Information
- Acarbose Prescribing Information (FDA)
- Acarbose Professional Patient Advice (Wolters Kluwer)
- Acarbose Monograph (AHFS DI)
- Precose Prescribing Information (FDA)
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