Is Sertraline Safe in Pregnancy

Reason

Pregnancy data are reassuring overall, but late-pregnancy exposure can cause newborn complications and needs provider review.

Drug Information

Brand Name

Zoloft

Generic Name

sertraline

Drug Class

SSRI antidepressant

FDA Category

N/A

Rx Status

prescription

Safe Amount

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

Effects

Pregnancy

Official labeling warns that third-trimester SSRI exposure may increase risk of PPHN and neonatal discontinuation syndrome. Untreated depression also carries pregnancy risks.

Mother

May help treat depression/anxiety during pregnancy; stopping or changing treatment can raise relapse risk. Side effects can include nausea, sleep changes, and serotonin syndrome.

Baby

First-trimester exposure does not appear to raise overall major birth defect risk above background in official labeling; late-pregnancy exposure may cause neonatal adaptation symptoms, respiratory support needs, tube feeding, and PPHN.

Trimester Notes

1st Trimester

Official labeling says available data do not show a higher overall major birth defect risk, but evidence is not perfect.

2nd Trimester

Continue only with provider review. Watch for maternal side effects and ongoing benefit vs risk.

3rd Trimester

Use only after provider review. Late exposure may increase risk of neonatal complications, PPHN, and withdrawal/discontinuation symptoms.

Risk-Benefit Note

For antidepressants, stopping treatment can cause relapse of depression. Official labeling says the risks of untreated depression should be weighed against medication risks in pregnancy.

Conditions & Warnings

• Consult OB/GYN or prescriber
• Do not stop or change treatment without prescriber guidance
• Review all medicines for serotonin syndrome interactions
• If used in third trimester, newborn monitoring may be needed

Alternatives

• Psychotherapy
• CBT
• Other antidepressants only if your prescriber recommends a switch
• Non-drug support such as sleep, exercise, and counseling

References

• FDA sertraline label (DailyMed/FDA labeling)
  https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215133s000lbl.pdf
• FDA Zoloft label (DailyMed/FDA labeling)
  https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019839s74s86s87_20990s35s44s45lbl.pdf
• NHS sertraline overview
  https://www.nhs.uk/medicines/sertraline/
• ACOG statement on SSRIs during pregnancy
  https://www.acog.org/news/news-releases/2025/07/statement-on-benefit-of-access-to-ssris-during-pregnancy