May 27 2022


Risks to the infant

Have been some cases of abdominal colic, sleep disturbance, vomiting, loose stools and more rarely hyperactivity or irritability in neonates and infants whose mothers received fluoxetine. The Australian Pharmacovigilance system records the increase in blood glucose in an infant exposed during five months at fluoxetine through milk.

It has been observed a decrease in weight in infants of mothers who received fluoxetine, but without exceeding the normal range. This data would require confirmation. The follow-up of infants exposed to fluoxetine seems to detect differences in development regarding unexposed children. In some children was detected a slight delay in psychomotor development, although it can not determine the possible influence of the drug, given the concurrence of other factors.

Platelet serotonin record (PS) in infants and mothers showed no influence of the fluoxetine on PS of children.

Influence on lactation

Fluoxetine passes into breast milk in higher degree that other antidepressants and can be detected in most of infants during the first trimester of life.

Published studies indicate varying values ??for the amount of fluoxetine that ingests an infant whose mother received a standard dose of the drug, typically varying between 2.4% and 3.8% of the weight adjusted dose and 7% including norfluoxetine, the major active metabolite.

Fluoxetine in infants can reach a figure of 7% maternal rate, although in some cases there has been up to 10% or greater. In infants whose mothers took the drug during pregnancy can be achieved blood concentrations three or four times higher, which are interpreted as transplacental origin.

Fluoxetine, like other drugs, can cause elevated blood prolactin and galactorrhea. The clinical significance of this effect on lactation is unknown, although probably not directly affects to breastfeeding.


The effect on infants whose mothers received fluoxetine is unknown, but may be of concern and should be monitored closely for symptoms of fluoxetine impact on children.


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