Sertraline

Pregnancy

MotherToBaby reports more than 25,000 sertraline-exposed pregnancies in its combined evidence summary. This is a compiled count, not one identifiable study, so the count is not used in the period summaries. For first-trimester birth defects, the ZOLOFT label says available epidemiologic studies show no difference in overall major-defect risk, while specific-defect findings are inconclusive. Huybrechts et al. (2014) studied 949,504 pregnancies; after restricting to people with depression and adjusting for confounders, the relative risk for any cardiac defect with SSRI use was 1.06 (95% CI 0.93-1.22), and the sertraline estimate for ventricular septal defects was 1.04 (0.76-1.41). Bérard et al. (2015) studied 18,493 depressed or anxious pregnancies, including 366 with first-trimester sertraline exposure. The study found no significant overall malformation association, but reported 9 exposed cases of atrial or ventricular defects (RR 1.34, 95% CI 1.02-1.76) and 3 exposed cases of craniosynostosis (RR 2.03, 95% CI 1.09-3.75). Reefhuis et al. (2015), a US case-control study with 17,952 birth-defect cases and 9,857 controls, did not confirm any of five previously reported sertraline-defect associations. These studies leave specific rare-defect signals inconclusive. MotherToBaby says miscarriage studies are limited and have not shown an overall increase for sertraline. Martin et al. (2025) studied 1,021,384 pregnancies and found a small association between first-trimester antidepressant prescriptions and miscarriage after adjustment (aHR 1.04, 95% CI 1.02-1.06), while those taking antidepressants before pregnancy and continuing into the first trimester had an aHR of 1.00 (0.98-1.03); this was not sertraline-specific. MotherToBaby reports possible links between sertraline and preterm birth or low birth weight, with untreated or undertreated depression or anxiety also affecting pregnancy outcomes. Hwang et al. (2024) reported a sertraline preterm-birth signal among patients with pre-pregnancy depression: 3,214 were exposed, and the risk ratio was 1.28 (1.14-1.45) compared with matched patients without sertraline. The authors described this as hypothesis-generating; the analysis used a p-value threshold of 0.1 and did not correct for multiple testing. A separate sertraline-specific low-birth-weight estimate was not found in the primary sources reviewed. Martin et al. (2026) found a class-wide association between antidepressant use and preterm delivery (aOR 1.26, 95% CI 1.23-1.30) in a study of 120,209 exposed pregnancies; the result was not sertraline-specific and residual confounding remained possible. For PPHN, MotherToBaby reports mixed findings and says a possible increase would remain below 1%. Huybrechts et al. (2015) studied 3,789,330 pregnancies in a US Medicaid cohort restricted to depression. Late-pregnancy SSRI exposure had 31.5 cases per 10,000 births versus 20.8 per 10,000 among births without antidepressant exposure. The adjusted odds ratio was 1.10 (95% CI 0.94-1.29); restricting the outcome to primary PPHN gave 1.28 (1.01-1.64). These figures apply to SSRIs as a group, not sertraline alone. McIlvride et al. (2026) followed 167,447 Welsh children to a mean age of 5.68 years and found associations between antidepressant prescriptions and special educational needs, including autism and ADHD outcomes. The authors said depression severity and confounding by indication could partly explain the results. This cohort did not identify a sertraline-specific effect. The FDA label reports that SSRI exposure, especially late in pregnancy, may be followed by PPHN and neonatal complications. It also describes an observational association between SSRI use in the month before delivery and a less-than-twofold increase in postpartum hemorrhage. The label's postpartum hemorrhage statement is a relative association, not an absolute risk estimate. A 2025-2026 literature search also identified an observational sertraline pharmacokinetic study of 185 women and 205 pregnancies; it examined maternal drug levels and postpartum mood symptoms, not fetal safety. No randomized trial of sertraline in pregnancy was identified in the sources reviewed.

Breastfeeding

LactMed reports that small amounts of sertraline enter breast milk, and infant serum sertraline is usually not detected, although norsertraline may be detectable at low levels. LactMed describes sertraline as a preferred antidepressant during breastfeeding and notes that a rare preterm infant with impaired metabolism could accumulate the drug. Den Besten-Bertholee et al. (2024) measured milk and plasma in 37 lactating women and one blood sample in 37 infants, including 15 infants exposed to sertraline. Sertraline was not detectable in the plasma of those 15 infants. Müller et al. (2013) reported one preterm infant exposed both before birth and through breast milk who developed signs of serotonergic overstimulation; the infant's serum levels were in the adult therapeutic range, and symptoms improved after breastfeeding stopped. This is a single case report and cannot estimate how often the event occurs. LactMed reports no adverse developmental effects in infants followed up to 5 years, but the primary study behind that specific five-year statement was not identified in the LactMed references reviewed, so the duration claim is not repeated in the summary. MotherToBaby reports that most infants exposed through milk have no side effects and advises contacting the child's provider for unusual irritability or sleepiness. LactMed says mothers taking SSRIs during pregnancy and postpartum may have more breastfeeding difficulty and may need support. In a retrospective cohort of 3,024 mothers of preterm infants, Grzeskowiak et al. (2018) found low milk supply associated with psychiatric illness without antidepressant use (aRR 1.64, 95% CI 1.16-2.30), but not late-pregnancy SRI exposure (aRR 1.00, 0.59-1.70). The 2026 Ontario NeoWISE cohort included 5,079 newborns with in-utero SSRI exposure; 3,321 were exclusively breastfed. Compared with formula-fed newborns, exclusively breastfed newborns had shorter stays of at least 3 days (11.6% versus 16.3%; adjusted RR 0.84, 95% CI 0.72-0.97), but more emergency visits (adjusted RR 1.42, 1.03-1.97) and readmissions (1.78, 1.21-2.62), primarily due to jaundice. The study compared feeding methods after prenatal SSRI exposure and did not establish a sertraline-through-milk effect.

What was tested

Pregnancy evidence includes population cohorts, birth-defect case-control studies, medical-record and prescription studies, and postpartum reports. Most outcome studies are observational and can be affected by differences in illness severity, smoking, other medication use, and care access. The pregnancy studies reviewed do not include randomized safety trials. Lactation evidence includes milk and infant blood-level studies, small infant follow-up cohorts, case reports, and a 2026 cohort comparing newborn feeding methods after in-utero SSRI exposure. The 2024 sertraline lactation study used milk and plasma samples; the 2026 feeding cohort did not isolate sertraline exposure through breast milk.