May 23 2022

Classification of the active ingredient acarbose


Risk level in pregnancy: This medicine is classified as Category B.

Has not been established the safety of this medication in pregnant women, as it lacks properly designed and controlled studies.

Studies in rats at doses nine times greater than those used in humans (480 mg / kg) have not detected alterations in fertility or harm to the fetus. In other laboratory animals is detected a decrease of the expected increase in weight, possibly due to the effect of high doses of acarbose on intestinal absorption.

Update 18.07.2009

Meaning of 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 OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.