Is Fluoxetine Safe in Pregnancy

Reason

Pregnancy use needs provider review. Official labeling says use only if benefit justifies fetal risk.

Drug Information

Brand Name

Prozac

Generic Name

fluoxetine

Drug Class

Selective serotonin reuptake inhibitor (SSRI) antidepressant

FDA Category

C

Rx Status

prescription

Safe Amount

Dosage must be determined by your provider based on individual risk/benefit.

Effects

Pregnancy

First-trimester exposure is not expected to greatly increase birth defect risk, but late-pregnancy use has been linked to newborn symptoms and possible preterm birth or low birth weight.

Mother

May help treat depression or anxiety, but untreated illness also carries pregnancy risks. Do not stop or start without prescriber guidance.

Baby

May cause poor neonatal adaptation, breathing trouble, feeding problems, jitteriness, or withdrawal-like symptoms after late pregnancy exposure.

Trimester Notes

1st Trimester

Human data do not suggest a major increase in birth defects, but use still needs provider review.

2nd Trimester

Continue only if benefits outweigh risks; monitor maternal mental health and fetal growth as advised by your provider.

3rd Trimester

Late pregnancy exposure can cause newborn adaptation symptoms and may require longer hospital care or respiratory support.

Risk-Benefit Note

For antidepressants, the benefit of treating depression or anxiety in pregnancy may outweigh the risks for some patients. Untreated illness can also harm pregnancy. Review with your prescriber before changing treatment.

Conditions & Warnings

• Consult OB/GYN or prescriber
• Do not stop or continue without provider review
• Depression
• Anxiety disorders
• History of preterm birth
• History of low birth weight infant

Alternatives

• Talk therapy
• Other antidepressants only if your prescriber recommends them
• Non-medicine supports for depression or anxiety, such as counseling and sleep support

References

• FDA fluoxetine label (Prozac)
  https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018936s108lbl.pdf
• MotherToBaby Fluoxetine fact sheet
  https://www.ncbi.nlm.nih.gov/books/NBK582711/