Effects of first-trimester fluoxetine exposure on the newborn

Obstet Gynecol. 1997 May;89(5 Pt 1):713-8. doi: 10.1016/s0029-7844(97)00070-7.


Objective: To determine whether first-trimester exposure to fluoxetine, a selective serotonin reuptake inhibitor commonly used to treat depression and obsessive-compulsive disorders, is associated with increased frequency of fetal malformations.

Methods: We evaluated outcomes of all pregnancies identified prospectively with confirmed first-trimester fluoxetine exposure contained in the Eli Lilly and Company worldwide fluoxetine pregnancy registry. These outcomes were compared with historic reports of newborn surveys.

Results: Outcomes were available for 796 pregnancies, 37 from fluoxetine clinical trials and 759 from spontaneous reports. Spontaneous abortions were reported in 110 of the 796 (13.8%) pregnancies. Of the remaining 686, malformations, deformations, and disruptions, including those identified after the perinatal period, were reported in 34 (5.0%). No consistent or recurring pattern of abnormalities was observed.

Conclusion: Based on comparison with historic reports of newborn surveys, it is unlikely that maternal fluoxetine use during the first trimester of pregnancy results in increased risk of fetal malformations.

MeSH terms

  • Abnormalities, Drug-Induced / etiology*
  • Abortion, Spontaneous / chemically induced
  • Adverse Drug Reaction Reporting Systems
  • Antidepressive Agents, Second-Generation / adverse effects*
  • Female
  • Fluoxetine / adverse effects*
  • Humans
  • Infant, Newborn
  • Maternal-Fetal Exchange*
  • Pregnancy
  • Pregnancy Outcome
  • Pregnancy Trimester, First
  • Prospective Studies
  • Registries
  • Retrospective Studies
  • Risk Factors
  • Serotonin Uptake Inhibitors / adverse effects*


  • Antidepressive Agents, Second-Generation
  • Serotonin Uptake Inhibitors
  • Fluoxetine