Pregina Use In Pregnancy & Lactation

Pregnancy: Pregnancy Category X.
Clomifene citrate should not be administered during pregnancy. Although no causative evidence of a deleterious effect of clomifene on the human fetus has been established, birth anomalies (e.g., Down's syndrome, exstrophy, club foot, tibial torsion, blocked tear duct, hemangioma, neural tube defects) have been reported. These observations in clinical studies have occurred at an incidence within the range reported for the general population.
In order to avoid the unintentional administration of clomifene in early pregnancy, the basal body temperature should be monitored throughout all treatment cycles and therapy withheld if there is a suspected pregnancy. A sensitive pregnancy test should be performed in the absence of menses; the possibility of an ovarian cyst and/or pregnancy should be excluded. Only those with negative results may be given the course of clomifene citrate.
Lactation: It is not known whether clomifene citrate is excreted in human milk. In some patients, clomifene citrate may suppress lactation.