Since Bromocriptine is used to restore fertility in hyperprolactinemic women, its safety in pregnancy and the offspring was investigated in a stepwise approach: (i) the first survey in pregnancy was based on spontaneous reporting, (ii) the second investigation was conducted at 33 clinics as an intensive monitoring project and, (iii) the third study consisted in a full examination of children up to the age of 9 years who had been exposed to Bromocriptine in utero. The data collated in this program includes information on 2587 pregnancies in 2437 women treated with Bromocriptine during some stage of gestation, and follow-up examinations for 988 infants. The results show that the use of Bromocriptine in the treatment of infertility in women is not associated with an increased risk of spontaneous abortion, multiple pregnancy or the occurrence of congenital malformation in their progeny. Moreover, exposure to this drug in utero has no adverse influence on the postnatal development.