Summary

Commonly reported side effects of acarbose include: abdominal pain, diarrhea, and flatulence. Continue reading for a comprehensive list of adverse effects.

Applies to acarbose: oral tablet.

Serious side effects of Acarbose

Along with its needed effects, acarbose 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 as soon as possible if any of the following side effects occur while taking acarbose:

Rare

• Yellow eyes or skin

Other side effects of Acarbose

Some side effects of acarbose 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:

More common

• Abdominal or stomach pain
• bloated feeling or passing of gas
• diarrhea

For Healthcare Professionals

Applies to acarbose: oral tablet.

General

The most frequently reported adverse events include abdominal pain, diarrhea, and flatulence.^[Ref]

Gastrointestinal

In large-scale clinical trials, a majority of patients have complained of gastrointestinal (GI) side 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 severity of GI symptoms may be decreased by dosage reduction and by avoidance of gas-producing foods and sucrose.

There have been rare postmarketing reports of pneumatosis cystoides intestinalis associated with alpha-glucosidase inhibitors including this drug. If suspected, discontinue therapy and perform appropriate diagnostic testing.^[Ref]

Very common (10% or more): Abdominal pain (19%), diarrhea (31%), flatulence (74%)

Uncommon (0.1% to 1%): Nausea,, vomiting, dyspepsia

Postmarketing reports: Ileus/subileus, pneumatosis cystoides intestinalis^[Ref]

Hepatic

Very common (10% or more): Serum transaminase elevations (14%)

Postmarketing reports: Fulminant hepatitis with fatal outcome, jaundice and/or hepatitis and associated liver damage^[Ref]

Treatment-emergent elevations of AST and ALT to greater the upper limit of normal, greater than 1.8 x ULN) and greater than 3 x ULN have been observed in 14%, 6%, and 3% of patients in studies of up to 12 months with doses up to 300 mg 3 times a day. The elevations were more common in women and generally asymptomatic and reversible. Additionally, these elevations appear to be dose-related.

International postmarketing experience: There have been 62 reports of of serum transaminase elevations to greater than 500 international units/liter, 29 were associated with jaundice. Of these 62 cases, 41 were receiving treatment with 100 mg 3 times a day or greater, 33 of 45 patients for whom weight was reported weighed less than 60 kg. In the 59 cases for which follow-up was provided, 55 had improvement or resolution of hepatic abnormalities with drug discontinuation, in 2 cases the hepatic abnormalities remained unchanged. Five cases of fulminant hepatitis with fatal outcome have been reported in Japan.^[Ref]

Hematologic

Frequency not reported: Small reductions in hematocrit

Postmarketing reports: Thrombocytopenia^[Ref]

Dermatologic

Frequency not reported: Acute generalized exanthematous pustulosis^[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity skin reactions (e.g. rash, erythema, exanthema, urticaria)^[Ref]

Cardiovascular

Postmarketing reports: Edema^[Ref]

Metabolic

This drug when administered as monotherapy should not cause hypoglycemia, but when administered with other agents, it may increase the potential for hypoglycemia. Low serum calcium and low plasma vitamin B6 levels were associated with use of this drug, however, they are thought to be spurious or of no clinical significance.^[Ref]

Frequency not reported: Hypoglycemia, low serum calcium, low plasma vitamin B6 levels^[Ref]