The Basics

What is Sertraline?

Used to treat depression, obsessive-compulsive disorder (OCD), panic disorder, premenstrual dysphoric disorder (PMDD), posttraumatic stress disorder (PTSD), and social anxiety disorder (SAD).

Brand names for Sertraline

Zoloft

How Sertraline is classified

Antidepressive Agents, Serotonin Uptake Inhibitors

Sertraline During Pregnancy

Sertraline pregnancy category

Category Not AssignedNote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Sertraline while pregnant

Can you take sertraline while pregnant? Overall, available published epidemiologic studies of pregnant women exposed to sertraline in the first trimester suggest no difference in major birth defect risk compared to the background rate for major birth defects in comparator populations. Some studies have reported increases for specific major birth defects; however, these study results are inconclusive . There are clinical considerations regarding neonates exposed to SSRIs and SNRIs, including ZOLOFT, during the third trimester of pregnancy [See Clinical Considerations]. Although no teratogenicity was observed in animal reproduction studies, delayed fetal ossification was observed when sertraline was administered during the period of organogenesis at doses less than the maximum recommended human dose (MRHD) in rats and doses 3.1 times the MRHD in rabbits on a mg/m2 basis in adolescents. When sertraline was administered to female rats during the last third of gestation, there was an increase in the number of stillborn pups and pup deaths during the first four days after birth at the MRHD . The background risk of major birth defects and miscarriage for the indicated population are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Advise a pregnant woman of possible risks to the fetus when prescribing ZOLOFT. ZOLOFT oral solution contains 12% alcohol and is not recommended during pregnancy because there is no known safe level of alcohol exposure during pregnancy.

Taking Sertraline While Breastfeeding

What are recommendations for lactation if you're taking Sertraline?

Because of the low levels of sertraline in breastmilk, amounts ingested by the infant are small and is usually not detected in the serum of the infant, although the weakly active metabolite norsertraline (desmethylsertraline) is often detectable in low levels in infant serum. Rarely, preterm infants with impaired metabolic activity might accumulate the drug and demonstrate symptoms similar to neonatal abstinence. Most authoritative reviewers consider sertraline a preferred antidepressants during breastfeeding.[1][2][3][4][5][6][7] Mothers taking an SSRI during pregnancy and postpartum may have more difficulty breastfeeding, although this might be a reflection of their disease state.[8] These mothers may need additional breastfeeding support. Breastfed infants exposed to an SSRI during the third trimester of pregnancy have a lower risk of poor neonatal adaptation than formula-fed infants.

Maternal / infant drug levels

Because of the low levels of sertraline in breastmilk, amounts ingested by the infant are small and is usually not detected in the serum of the infant, although the weakly active metabolite norsertraline (desmethylsertraline) is often detectable in low levels in infant serum. Rarely, preterm infants with impaired metabolic activity might accumulate the drug and demonstrate symptoms similar to neonatal abstinence. Most authoritative reviewers consider sertraline a preferred antidepressants during breastfeeding.[1][2][3][4][5][6][7] Mothers taking an SSRI during pregnancy and postpartum may have more difficulty breastfeeding, although this might be a reflection of their disease state.[8] These mothers may need additional breastfeeding support. Breastfed infants exposed to an SSRI during the third trimester of pregnancy have a lower risk of poor neonatal adaptation than formula-fed infants.

Possible effects of Sertraline on milk supply

Sertraline has caused galactorrhea in nonpregnant, nonnursing patients.[35][36][37][38][39] However, in a study of cases of hyperprolactinemia and its symptoms (e.g., gynecomastia) reported to a French pharmacovigilance center, sertraline was not found to have an increased risk of causing hyperprolactinemia compared to other drugs.[40] The prolactin level in a mother with established lactation may not affect her ability to breastfeed.A midwife observed 6 patients who reported a decrease in milk supply after starting sertraline (dosages not reported). One of the mothers had been taking sertraline since the 6th month of pregnancy. She reported an increase in milk supply when she stopped sertraline for one week at 4 months postpartum. When she restarted sertraline, her milk supply reportedly decreased. In all of the women, the milk supply increased in 2 to 3 days after increasing fluid and the frequency of nursing.[41]In a small prospective study, 8 primiparous women who were taking a serotonin reuptake inhibitor (SRI; 3 taking fluoxetine and 1 each taking citalopram, duloxetine, escitalopram, paroxetine or sertraline) were compared to 423 mothers who were not taking an SRI. Mothers taking an SRI had an onset of milk secretory activation (lactogenesis II) that was delayed by an average of 16.7 hours compared to controls (85.8 hours postpartum in the SRI-treated mothers and 69.1 h in the untreated mothers), which doubled the risk of delayed feeding behavior in the untreated group. However, the delay in lactogenesis II may not be clinically important, since there was no statistically significant difference between the groups in the percentage of mothers experiencing feeding difficulties after day 4 postpartum.[42]A case control study compared the rate of predominant breastfeeding at 2 weeks postpartum in mothers who took an SSRI antidepressant throughout pregnancy and at delivery (n = 167) or an SSRI during pregnancy only (n = 117) to a control group of mothers who took no antidepressants (n = 182). Among the two groups who had taken an SSRI, 33 took citalopram, 18 took escitalopram, 63 took fluoxetine, 2 took fluvoxamine, 78 took paroxetine, and 87 took sertraline. Among the women who took an SSRI, the breastfeeding rate at 2 weeks postpartum was 27% to 33% lower than mother who did not take antidepressants, with no statistical difference in breastfeeding rates between the SSRI-exposed groups.[43]An observational study looked at outcomes of 2859 women who took an antidepressant during the 2 years prior to pregnancy. Compared to women who did not take an antidepressant during pregnancy, mothers who took an antidepressant during all 3 trimesters of pregnancy were 37% less likely to be breastfeeding upon hospital discharge. Mothers who took an antidepressant only during the third trimester were 75% less likely to be breastfeeding at discharge. Those who took an antidepressant only during the first and second trimesters did not have a reduced likelihood of breastfeeding at discharge.[44] The antidepressants used by the mothers were not specified.A retrospective cohort study of hospital electronic medical records from 2001 to 2008 compared women who had been dispensed an antidepressant during late gestation (n = 575; sertraline n = 200) to those who had a psychiatric illness but did not receive an antidepressant (n = 1552) and mothers who did not have a psychiatric diagnosis (n = 30,535). Women who received an antidepressant were 37% less likely to be breastfeeding at discharge than women without a psychiatric diagnosis, but no less likely to be breastfeeding than untreated mothers with a psychiatric diagnosis.[45]

Possible alternatives to Sertraline

Nortriptyline, Paroxetine.

List of References

Lactation sources: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/1. Weissman AM, Levy BT, Hartz AJ et al. Pooled analysis of antidepressant levels in lactating mothers, breast milk, and nursing infants. Am J Psychiatry. 2004;161:1066-78. PMID: 15169695
2. The Academy of Breastfeeding Medicine Protocol Committee. ABM clinical protocol #18: use of antidepressants in nursing mothers. Breastfeed Med. 2008;3:44-52. PMID: 18333769
3. Berle JO, Spigset O. Antidepressant use during breastfeeding. Curr Women’s Health Rev. 2011;7:28-34. PMID: 22299006
4. Orsolini L, Bellantuono C. Serotonin reuptake inhibitors and breastfeeding: A systematic review. Hum Psychopharmacol. 2015;30:4-20. PMID: 25572308
5. Pinheiro E, Bogen DL, Hoxha D, Ciolino JD, Wisner KL. Sertraline and breastfeeding: Review and meta-analysis. Arch Womens Ment Health. 2015;18:139-46. PMID: 25589155
6. McAllister-Williams RH, Baldwin DS, Cantwell R et al. British Association for Psychopharmacology consensus guidance on the use of psychotropic medication preconception, in pregnancy and postpartum 2017. J Psychopharmacol. 2017;31:519-52. PMID: 28440103
7. Molenaar NM, Kamperman AM, Boyce P et al. Guidelines on treatment of perinatal depression with antidepressants: An international review. Aust N Z J Psychiatry. 2018;52:320-27. PMID: 29506399
8. Grzeskowiak LE, Leggett C, Costi L et al. Impact of serotonin reuptake inhibitor use on breast milk supply in mothers of preterm infants: A retrospective cohort study. Br J Clin Pharmacol. 2018;84:1373-9. PMID: 29522259
9. Stowe ZN, Stowe MD, Hostetter AL et al. The pharmacokinetics of sertraline excretion into human breast milk: determinants of infant serum concentrations. J Clin Psychiatry. 2003;64:73-80. PMID: 12590627
10. Berle JO, Steen VM, Aamo TO et al. Breastfeeding during maternal antidepressant treatment with serotonin reuptake inhibitors: infant exposure, clinical symptoms, and cytochrome P450 genotypes. J Clin Psychiatry. 2004;65:1228-34. PMID: 15367050
11. Oberlander TF, Grunau RE, Fitzgerald C et al. Pain reactivity in 2-month-old infants after prenatal and postnatal serotonin reuptake inhibitor medication exposure. Pediatrics. 2005;115:411-25. PMID: 15687451
12. Muller MJ, Preuss C, Paul T et al. Serotonergic overstimulation in a preterm infant after sertraline intake via breastmilk. Breastfeed Med. 2013;8:327-9. PMID: 23249132
13. Salazar FR, D’Avila FB, de Oliveira MH et al. Development and validation of a bioanalytical method for five antidepressants in human milk by LC-MS. J Pharm Biomed Anal. 2016;129:502-8. PMID: 27497651
14. Weisskopf E, Panchaud A, Nguyen KA et al. Simultaneous determination of selective serotonin reuptake inhibitors and their main metabolites in human breast milk by liquid chromatography-electrospray mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2017;1057: 101-9. PMID: 28511118
15. Pogliani L, Baldelli S, Cattaneo D et al. Selective serotonin reuptake inhibitors passage into human milk of lactating women. J Matern Fetal Neonatal Med. 2019;32:3020-25. PMID: 29557689
16. Schoretsanitis G, Augustin M, Sassmannshausen H et al. Antidepressants in breast milk; comparative analysis of excretion ratios. Arch Womens Ment Health. PMID: 30116895
17. Hendrick V, Fukuchi A, Altshuler L et al. Use of sertraline, paroxetine and fluvoxamine by nursing women. Br J Psychiatry. 2001;179:163-6. PMID: 11483479
18. Sunder KR, Wisner KL, Hanusa BH et al. Postpartum depression recurrence versus discontinuation syndrome: observations from a randomized controlled trial. J Clin Psychiatry. 2004;65:1266-8. PMID: 15367055
19. Wisner KL, Hanusa BH, Perel JM et al. Postpartum depression: a randomized trial of sertraline versus nortriptyline. J Clin Psychopharmacol. 2006;26:353-60. PMID: 16855451
20. Mammen OK, Perel JM, Rudolph G et al. Sertraline and norsertraline levels in three breastfed infants. J Clin Psychiatry. 1997;58:100-3. PMID: 9108810
21. Rohan A. Drug distribution in human milk. Aust Prescriber. 1997;20:84.
22. Epperson N, Czarkowski KA, Ward-O’Brien D et al. Maternal sertraline treatment and serotonin transport in breast-feeding mother-infant pairs. Am J Psychiatry. 2001;158:1631-7. PMID: 11578995
23. Hendrick V, Smith LM, Hwang S et al. Weight gain in breastfed infants of mothers taking antidepressant medications. J Clin Psychiatry. 2003;64:410-2. PMID: 12716242
24. Lee A, Woo J, Ito S. Frequency of infant adverse events that are associated with citalopram use during breast-feeding. Am J Obstet Gynecol. 2004;190:218-21. PMID: 14749663
25. Hale TW, Kendall-Tackett K, Cong Z et al. Discontinuation syndrome in newborns whose mothers took antidepressants while pregnant or breastfeeding. Breastfeed Med. 2010. PMID: 20807106
26. Kelly LE, Poon S, Madadi P, Koren G. Neonatal benzodiazepines exposure during breastfeeding. J Pediatr. 2012;161:448-51. PMID: 22504099
27. Bolea-Alamanac BM, Green A, Verma G et al. Methylphenidate use in pregnancy and lactation: a systematic review of evidence. Br J Clin Pharmacol. 2014;77:96-101. PMID: 23593966
28. Hantsoo L, Ward-O’Brien D, Czarkowski KA et al. A randomized, placebo-controlled, double-blind trial of sertraline for postpartum depression. Psychopharmacology (Berl). 2014;231:939-48. PMID: 24173623
29. Kieviet N, Hoppenbrouwers C, Dolman KM et al. Risk factors for poor neonatal adaptation after exposure to antidepressants in utero. Acta Paediatr. 2015;104:384-91. PMID: 25559357
30. Uguz F, Arpaci N. Short-term safety of paroxetine and sertraline in breastfed infants: A retrospective cohort study from a university hospital. Breastfeed Med. 2016;11:487-9. PMID: 27575664
31. Morin C, Chevalier I. Severe hypernatremic dehydration and lower limb gangrene in an infant exposed to lamotrigine, aripiprazole, and sertraline in breast milk. Breastfeed Med. 2017;12:377-80. PMID: 28481632
32. Uguz F. Better tolerance of citalopram in a breastfed infant who could not tolerate sertraline and paroxetine. Breastfeed Med. 2018;13:89-90. PMID: 29185803
33. Uvais NA . Self-limiting diarrhea in an infant exposed to sertraline in breast milk. J Family Med Prim Care. 2017;6:876-7. PMID: 29564284
34. Lesaca TG. Sertraline and galactorrhea. J Clin Psychopharmacol. 1996;16:333-4. Letter. PMID: 8835712
35. Bronzo MR, Stahl SM. Galactorrhea induced by sertraline. Am J Psychiatry. 1993;150:1269-70. Letter. PMID: 8093119
36. Nebhinani N. Sertraline-induced galactorrhea: case report and review of cases reported with other SSRIs. Gen Hosp Psychiatry. 2013;35:576.e3-5. PMID: 23260337
37. Suthar N, Pareek V, Nebhinani N et al. Galactorrhea with antidepressants: A case series. Indian J Psychiatry. 2018;60:145-46. PMID: 29736080
38. Trenque T, Herlem E, Auriche P, Drame M. Serotonin reuptake inhibitors and hyperprolactinaemia: a case/non-case study in the French pharmacovigilance database. Drug Saf. 2011;34:1161-6. PMID: 22077504
39. Luo T, Liu QS, Yang YJ et al. Aripiprazole for the treatment of duloxetine-induced hyperprolactinemia: A case report. J Affect Disord. 2019;250:330-3. PMID: 30875676
40. Trenque T, Herlem E, Auriche P et al. Serotonin reuptake inhibitors and hyperprolactinaemia: a case/non-case study in the French pharmacovigilance database. Drug Saf. 2011;34:1161-6. PMID: 22077504
41. Holland D. An observation of the effect of sertraline on breast milk supply. Aust N Z J Psychiatry. 2000;34:1032. PMID: 11127615
42. Marshall AM, Nommsen-Rivers LA, Hernandez LL et al. Serotonin transport and metabolism in the mammary gland modulates secretory activation and involution. J Clin Endocrinol Metab. 2010;95:837-46. PMID: 19965920
43. Gorman JR, Kao K, Chambers CD. Breastfeeding among women exposed to antidepressants during pregnancy. J Hum Lact. 2012;28:181-8. PMID: 22344850
44. Venkatesh KK, Castro VM, Perlis RH et al. Impact of antidepressant treatment during pregnancy on obstetric outcomes among women previously treated for depression: An observational cohort study. J Perinatol. 2017;37:1003-9. PMID: 28682318
45. Leggett C, Costi L, Morrison JL et al. Antidepressant use in late gestation and breastfeeding rates at discharge from hospital. J Hum Lact. 2017;33:701-9. PMID: 28984528

Disclaimer: This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Consult your healthcare provider with any questions.

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