Is Duloxetine (Cymbalta) safe during pregnancy?
What the FDA-approved label for Duloxetine (Cymbalta) 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's §8.1 Risk Summary says published data and a postmarketing cohort study have NOT identified a clear drug-associated risk of major birth defects or other adverse developmental outcomes. However, it names specific risks: use in the month before delivery may be associated with an increased risk of postpartum hemorrhage, and neonates exposed to duloxetine (and other SNRIs/SSRIs) late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (respiratory distress, apnea, seizures, temperature instability, feeding difficulty, hypoglycemia, jitteriness, irritability), consistent with a toxic effect or drug-discontinuation syndrome. The label also stresses the risks of untreated depression, noting women who stop antidepressants in pregnancy are more likely to relapse. Any decision to start, stop, or change treatment during pregnancy should be made with the prescriber.
Frequently asked questions
Is Duloxetine safe to take during pregnancy?
The label flags a real concern for Duloxetine — see the summary above. This is not a drug to start or continue in pregnancy on your own; it needs a prescriber weighing the specific risks against the reason you would take it. 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 Duloxetine 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 Duloxetine 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 Duloxetine
Source
Duloxetine Delayed-Release Capsules — FDA label (DailyMed) ↗
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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.