Is Mirtazapine (Remeron) safe during pregnancy?
What the FDA-approved label for Mirtazapine (Remeron) 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 states there are no adequate and well-controlled studies in pregnant women. Animal reproduction studies in rats and rabbits revealed no evidence of teratogenic effects, but in rats there was an increase in post-implantation losses, an increase in pup deaths during the first 3 days of lactation, and a decrease in pup birth weights at doses about 20 times the maximum recommended human dose (not at 3 times); the cause of the deaths is not known. Because animal studies are not always predictive of human response, the label advises that mirtazapine should be used during pregnancy only if clearly needed. Discuss with your prescriber.
Frequently asked questions
Is Mirtazapine safe to take during pregnancy?
The honest answer is uncertainty: the label does not have enough pregnancy data to call Mirtazapine 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 Mirtazapine 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 Mirtazapine 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 Mirtazapine
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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.