Acarbose Side Effects

Brand Names: Precose

Please note - some side effects for Acarbose may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Acarbose - for the Consumer

Acarbose

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 Acarbose:

Bloating; diarrhea; gas; nausea; stomach pain; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Acarbose:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); severe stomach pain; symptoms of liver problems (eg, dark urine; pale stools; unusual or severe nausea, tiredness, or loss or appetite; yellowing of the skin or eyes).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Acarbose Side Effects - for the Professional

Acarbose

Digestive Tract

Gastrointestinal symptoms are the most common reactions to Acarbose. In U.S. placebo-controlled trials, the incidences of abdominal pain, diarrhea, and flatulence were 19%, 31%, and 74% respectively in 1255 patients treated with Acarbose  50 to 300 mg t.i.d., whereas the corresponding incidences were 9%, 12%, and 29% in 999 placebo-treated patients.

In a one-year safety study, during which patients kept diaries of gastrointestinal symptoms, abdominal pain and diarrhea tended to return to pretreatment levels over time, and the frequency and intensity of flatulence tended to abate with time. The increased gastrointestinal tract symptoms in patients treated with Acarbose are a manifestation of the mechanism of action of Acarbose and are related to the presence of undigested carbohydrate in the lower GI tract.

If the prescribed diet is not observed, the intestinal side effects may be intensified. If strongly distressing symptoms develop in spite of adherence to the diabetic diet prescribed, the doctor must be consulted and the dose temporarily or permanently reduced.

Elevated Serum Transaminase Levels

See PRECAUTIONS.

Other Abnormal Laboratory Findings

Small reductions in hematocrit occurred more often in Acarbose-treated patients than in placebo-treated patients but were not associated with reductions in hemoglobin. Low serum calcium and low plasma vitamin B6 levels were associated with Acarbose therapy but are thought to be either spurious or of no clinical significance.

Post Marketing Adverse Event Reports

Additional adverse events reported from worldwide post marketing experience include fulminant hepatitis with fatal outcome, hypersensitive skin reactions (for example, rash, erythema, exanthema and uticaria), edema, ileus/subileus, jaundice and/or hepatitis and associated liver damage, thrombocytopenia, and pneumatosiscystoides intestinalis.

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Side Effects by Body System - for Healthcare Professionals

General

In general, systemic side effects have been rare and unexpected because of the very low systemic bioavailability of acarbose.

Gastrointestinal

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

Nervous system side effects are uncommon and have included somnolence, weakness, dizziness, headache, and vertigo.

Endocrine

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

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

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

Dermatologic side effects are rare and have included pruritus in 0.1% and exanthema in 0.3% of treated patients.

Other

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

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.

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