Skip to Content
Reach blood sugar goals with long-acting insulin. Go >

Miglitol Pregnancy and Breastfeeding Warnings

Miglitol is also known as: Glyset

Miglitol Pregnancy Warnings

Use only if clearly needed US FDA pregnancy category: B The safety in pregnant women has not been established.

Fetotoxicity was indicated by a slight but significant reduction in fetal weight in rats given 450 mg/kg, and a slight reduction in fetal weight, delayed ossification of the fetal skeleton, and an increase in the percentage of nonviable fetuses in rabbits given 200 mg/kg (12 and 10 times the maximum recommended human dose based on body surface area, respectively). These studies revealed no evidence of fetal malformations. There are no controlled data in human pregnancy. FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

See references

Miglitol Breastfeeding Warnings

This drug has been shown to be poorly excreted into human milk with 0.02% of a 100 mg dose or 0.2% of the weight-adjusted maternal dose being excreted. Despite these low levels the manufacturer recommends this drug not be administered to nursing women. There is no published information available to describe effects in breastfed infants.

Use is not recommended Excreted into human milk: Yes Comments: The effects in the nursing infant are unknown

See references

References for pregnancy information

  1. "Product Information. Glyset (miglitol)." Bayer, West Haven, CT.

References for breastfeeding information

  1. "Product Information. Glyset (miglitol)." Bayer, West Haven, CT.

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and 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 drug 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 that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. 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 drugs you are taking, check with your doctor, nurse, or pharmacist.