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Acarbose Side Effects

In Summary

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

For the Consumer

Applies to acarbose: oral tablet

In addition to its needed effects, some unwanted effects may be caused by acarbose. In the event that any of these side effects do occur, they may require medical attention.

Severity: Moderate

If any of the following side effects occur while taking acarbose, check with your doctor or nurse as soon as possible:

Rare
  • Yellow eyes or skin

Severity: Minor

Some of the side effects that can occur with acarbose may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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

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]

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]

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]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Precose (acarbose)." Bayer, West Haven, CT.

Not all side effects for acarbose may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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