Is Zoloft Safe During Pregnancy?
Zoloft (sertraline) is the most studied antidepressant in pregnancy, and the research is largely reassuring. The American College of Obstetricians and Gynecologists (ACOG) names sertraline as a reasonable first-line choice for depression or anxiety in pregnancy, and notes it is often preferred because of its extensive, reassuring safety evaluation.
No medication is risk-free, and all pregnancy research on antidepressants is observational rather than from randomized trials. But the question is not “Zoloft or perfect safety.” It is Zoloft compared with the real risks of untreated depression. For the full picture across antidepressants, see antidepressants during pregnancy.
Zoloft and Birth Defects
About 3 in 100 babies have a birth defect regardless of medication.
- MotherToBaby: most studies have not found a higher chance of birth defects when sertraline is used in pregnancy.
- In a U.S. study of nearly 950,000 pregnancies, heart defects occurred in about 92 per 10,000 sertraline-exposed babies and 72 per 10,000 unexposed babies, and specific heart-wall defects were not increased after accounting for other factors.
- A large CDC birth defects study did not confirm any of the five birth defects previously linked to sertraline.
- The current FDA label states that first-trimester studies suggest no difference in major birth defect risk compared with the background rate.
Some smaller studies have reported a possible link with septal heart defects, but those findings rested on few cases and were not confirmed in the largest analyses.
Other Pregnancy Risks
- Miscarriage: studies overall have not shown sertraline increases the chance of miscarriage, though data are limited.
- Preterm birth and low birth weight: some studies suggest a higher chance. It is difficult to separate the medication’s effect from depression itself, which is also linked to both.
- PPHN (a rare newborn lung condition): the overall chance with SSRIs is under 1%, and in an analysis cited by ACOG, sertraline ranked as the SSRI least likely to be associated with it.
- Newborn adaptation symptoms: some babies exposed late in pregnancy are jittery, irritable or feed poorly at first. In most cases symptoms are mild and go away within a couple of weeks. Stopping before delivery is not recommended.
- Postpartum bleeding: the label notes SSRI use in the month before delivery has been linked to a less than twofold increase in postpartum hemorrhage, which your delivery team can plan for.
- Development: most large studies have not found that sertraline in pregnancy increases the chance of behavior or learning problems, and sibling studies found no link with autism or ADHD.
Is Zoloft Category C?
Zoloft was labeled “Pregnancy Category C” before 2015. The FDA removed all pregnancy letter categories from drug labels because they were confusing and overly simplistic. Category C was based largely on animal studies and a lack of human trials, and Lexapro, Prozac and Wellbutrin carried the same letter. Today’s Zoloft label uses a written risk summary instead.
Should You Keep Taking Zoloft If You Get Pregnant?
- ACOG recommends against stopping mental health medication because of pregnancy alone.
- In a study of women with prior major depression, 68% of those who stopped their antidepressant in pregnancy relapsed, compared with 26% who continued.
- Do not stop suddenly. Stopping sertraline abruptly can cause withdrawal symptoms. If you want to change anything, plan it with your prescriber.
Zoloft and Breastfeeding
Sertraline is generally considered a preferred antidepressant during breastfeeding, according to the NIH’s LactMed database.
- Very little reaches the baby: an exclusively breastfed baby receives an estimated 0.5% of the mother’s weight-adjusted dose.
- Sertraline is usually undetectable in the baby’s blood; across 53 mother-baby pairs, babies’ levels averaged 2% of their mothers’.
- No developmental harm has been found in children followed for up to 5 years.
- Rarely, preterm babies with immature metabolism may accumulate the drug, so tell your pediatrician if your baby was born early.
- Most babies exposed through breast milk have no side effects. Call your baby’s doctor if your baby seems unusually sleepy or irritable.
Does Zoloft Affect Milk Supply?
There are no data showing sertraline reduces milk production. Mothers taking SSRIs may have more difficulty breastfeeding, but that may reflect depression itself, and one small study found milk came in about 17 hours later on average, a delay that may not be clinically important. Extra breastfeeding support can help.
Do I Need to Pump and Dump?
No. No guideline recommends discarding milk, and routine blood tests for the baby are not needed without a specific concern. ACOG says breastfeeding can continue uninterrupted with SSRIs.
Is There a Zoloft Breastfeeding Lawsuit?
You may see ads or articles about a “Zoloft while breastfeeding lawsuit.” The Zoloft litigation that actually went through the courts concerned birth defects from use during pregnancy, not breastfeeding. A federal court dismissed those cases, and in 2017 the U.S. Court of Appeals for the Third Circuit upheld the decision in Pfizer’s favor; the ruling does not mention breastfeeding. We found no documented court case about sertraline exposure through breast milk.
Talk to Your Prescriber
If sertraline has kept you well, the evidence generally supports staying on it through pregnancy and breastfeeding. Your prescriber and ob-gyn can help you weigh your personal history, dose and plan for after birth.
Find a perinatal mental health therapist
If you have thoughts of harming yourself, call or text 988, or call or text the National Maternal Mental Health Hotline at 1-833-TLC-MAMA (1-833-852-6262).
Frequently Asked Questions
Is Zoloft safe during pregnancy?
It is the most studied antidepressant in pregnancy, and most studies have not found an increased risk of birth defects. ACOG considers it a reasonable first-line choice, and it is often preferred.
Can Zoloft cause birth defects?
Large studies have not confirmed an increased risk. A few smaller studies reported possible heart defect links that were not confirmed in larger analyses.
What pregnancy category is Zoloft?
It was formerly Category C, but the FDA removed letter categories in 2015. Category C did not mean it was risky.
Can you take Zoloft while breastfeeding?
Yes. Sertraline is considered a preferred antidepressant during breastfeeding because very little reaches the baby.
Will Zoloft affect my baby after birth?
Some babies have mild, temporary symptoms such as jitteriness or feeding trouble that usually resolve within two weeks.
Should I stop Zoloft before giving birth?
No. Tapering before delivery is not recommended and raises the risk of relapse.
