Is Sertraline (Zoloft) safe during pregnancy?
What the FDA-approved label for Sertraline (Zoloft) actually states in its Pregnancy Risk Summary — not a secondhand verdict. The decision is one to make with your prescriber.
What the label’s pregnancy summary says
The label (an older Pregnancy Category C label) states there are no adequate and well-controlled studies in pregnant women, and that sertraline should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It notes that neonates exposed to SSRIs/SNRIs late in the third trimester have developed complications (e.g., respiratory distress, feeding difficulty, temperature instability, jitteriness, tremor) requiring prolonged hospitalization, respiratory support, or tube feeding, consistent with either drug toxicity or a discontinuation syndrome. It also reports that SSRI-exposed infants may have an increased risk of persistent pulmonary hypertension of the newborn (PPHN). Anyone who is pregnant or planning pregnancy should discuss this with their prescriber rather than starting or stopping on their own.
Frequently asked questions
Is Sertraline safe to take during pregnancy?
The honest answer is uncertainty: the label does not have enough pregnancy data to call Sertraline safe or unsafe (summary above). That is a "decide with your prescriber" situation, weighing your condition against the unknown, not a green or red light. The one universal rule: do not start or stop a medication in pregnancy without medical advice — an untreated condition can carry its own risk to a pregnancy.
What does the FDA label say about Sertraline in pregnancy?
The summary above is transcribed from the label's Pregnancy Risk Summary (§8.1). Since 2015 FDA labels replaced the old A/B/C/D/X letter categories with a narrative that describes what human and animal data actually show, which is what you are reading here — not a single letter grade.
Is Sertraline safe while breastfeeding?
That is a separate question the label answers in a different section (§8.2, Lactation), and it does not always match the pregnancy verdict. This page covers pregnancy only. For breastfeeding, ask your prescriber or pharmacist, or check the NIH LactMed database, which summarizes the drug-in-breast-milk evidence.
More guides for Sertraline
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The pregnancy information is transcribed from the drug’s FDA-approved label (§8.1) and mirrors what the label states — “insufficient data” is never rounded up to “safe.” This is general reference information, not medical advice. Whether to take any medication in pregnancy is a decision for you and your prescriber; do not start or stop a drug on your own, because an untreated condition can also carry risk.