Short-Term Safety of Paroxetine and Sertraline in Breastfed Infants: A Retrospective Cohort Study from a University Hospital

Breastfeed Med. 2016 Nov:11:487-489. doi: 10.1089/bfm.2016.0095. Epub 2016 Aug 30.


Objective: Primary pharmacological agents for depression and anxiety disorders are antidepressants, especially selective serotonine reuptake inhibitors. The aim of this study was to examine the features and prevalence of adverse effects of paroxetine and sertraline in breastfed infants.

Methods: The study had a retrospective cohort design. Five-year clinical data of 72 patients were included in the study. Psychiatric diagnoses were ascertained by means of the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition.

Results: The prevalence rate of adverse events in the infants was 12.5%. Insomnia (88.9%), restlessness (55.6%), and constant crying (22.2%) were the most frequent adverse events. A switch between paroxetine and sertraline performed in five patients, who reported an adverse event in their breastfed infants, resulted in cessation of the adverse events.

Conclusion: The results suggest that the prevalence rate of adverse events in the infants exposed to sertraline or paroxetine is relatively low and mostly mild.

Keywords: breastfeeding; infant; lactation; paroxetine; sertraline.

MeSH terms

  • Breast Feeding*
  • Depression, Postpartum / drug therapy*
  • Female
  • Hospitals, University*
  • Humans
  • Infant
  • Infant, Newborn
  • Milk, Human / chemistry*
  • Mothers
  • Paroxetine / adverse effects*
  • Paroxetine / pharmacokinetics
  • Paroxetine / therapeutic use
  • Practice Guidelines as Topic
  • Pregnancy
  • Retrospective Studies
  • Risk Assessment
  • Selective Serotonin Reuptake Inhibitors / adverse effects
  • Selective Serotonin Reuptake Inhibitors / pharmacokinetics
  • Selective Serotonin Reuptake Inhibitors / therapeutic use*
  • Sertraline / adverse effects*
  • Sertraline / pharmacokinetics
  • Sertraline / therapeutic use


  • Serotonin Uptake Inhibitors
  • Paroxetine
  • Sertraline