May 23 2022

Classification of the active ingredient cilostazol

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

There are no adequate and well-controlled studies on the use of cilostazol in pregnant women.

Experimental studies in rats indicate that administration of high doses of this substance (1000 mg cilostazol / kg / day) was associated with decreased fetal weight and an increased incidence of cardiovascular, renal and skeletal abnormalities.

A study in rabbits allowed to observe an increase in the incidence of delayed ossification of the sternum with doses of 150 mg/kg/day.

During the late phase of gestation and lactation stage was observed an increase in the incidence of stillbirths and decreased birth weight when administered dose of 150 mg/kg/day.

The manufacturer recommends not administering cilostazol during pregnancy and lactation.

Update 31.07.2009

Meaning of category C

Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.