Ovulant Use In Pregnancy & Lactation

Fetal Risk Summary: Pregnancy Category X. Clomifene citrate use in pregnant women is contraindicated, as Clomifene citrate treatment does not offer benefit in this population.
Available human data do not suggest an increased risk for congenital anomalies above the background population risk. However, animal reproductive toxicology studies showed increased embryo-fetal and structural malformations in offspring. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risks to the fetus.
Clinical Considerations: To avoid inadvertent Clomifene citrate administration during early pregnancy, appropriate tests should be utilized during each treatment cycle to determine whether ovulation and/or pregnancy occurs. Patients should be evaluated carefully to exclude ovarian enlargement or ovarian cyst formation between each treatment cycle. The next course of Clomifene citrate therapy should be delayed until these conditions have been excluded.
Lactation: It is not known whether Clomifene citrate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised if Clomifene citrate is administered to a nursing woman. In some patients, Clomifene citrate may reduce lactation.