Is Trazodone (Desyrel) safe during pregnancy?
What the FDA-approved label for Trazodone (Desyrel) 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 reports that published prospective cohort studies, case series, and case reports over several decades of trazodone use in pregnant women have not identified drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes, while noting these studies have methodological limitations and cannot definitively establish the absence of risk. In animal studies, trazodone caused increased fetal resorption and other fetal effects in rats and congenital anomalies in rabbits at doses several times the maximum recommended human dose. The label also notes an antidepressant pregnancy exposure registry and advises weighing the risk of untreated depression, which can relapse if antidepressants are discontinued in pregnancy. It does not tell patients to start or stop the drug on their own — discuss with the prescriber.
Frequently asked questions
Is Trazodone safe to take during pregnancy?
The label's §8.1 does not report a clear risk for Trazodone (summary above), which is reassuring but is not the same as a guarantee of safety — no drug is studied in pregnancy the way it is in other adults. Use it in pregnancy only after discussing it with your prescriber. 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 Trazodone 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 Trazodone 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.
The questions people actually ask about trazodone in pregnancy
Answered by MotherToBaby, the fact sheets written by the Organization of Teratology Information Specialists and published through the NIH. Quoted in full — we do not condense them.
I take trazodone. Can it make it harder for me to get pregnant?
Studies have not been done to see if trazodone could make it harder to get pregnant. Some conditions, including depression, can make it harder to get pregnant. This makes it hard to know if the medication, the condition being treated, or other factors might affect fertility (ability to get pregnant). For more information on depression, please see our fact sheet at https://mothertobaby.org/fact-sheets/depression-pregnancy/ .
Does taking trazodone increase the chance of miscarriage?
Miscarriage is common and can occur in any pregnancy for many different reasons. Two studies, with over 200 hundred people, found no increase in miscarriage when trazodone was taken during pregnancy. Some studies have reported a higher chance of miscarriage when depression is left untreated in pregnancy.
Does taking trazodone increase the chance of birth defects?
Every pregnancy starts out with a 3-5% chance of having a birth defect. This is called the background risk. Studies have looked at over 300 pregnancies where trazodone was taken during the first trimester. These studies did not find an increased chance of birth defects above the background risk.
Does taking trazodone in pregnancy increase the chance of other pregnancy-related problems?
One study found no greater chance for preterm delivery (delivery before week 37) or low birth weight (weighing less than 5 pounds, 8 ounces [2500 grams] at birth) in babies who had been exposed to trazodone during pregnancy.
Another study of over 200 pregnancies found no greater chance for low birth weight but did find a slightly higher chance for preterm delivery. However, research has also shown that when depression is left untreated during pregnancy, there could be an increased chance for pregnancy complications. This makes it hard to know if the medication, the condition being treated, or other factors might increase the chance of pregnancy complications.
I need to take trazodone throughout my entire pregnancy. Will it cause withdrawal symptoms in my baby after birth?
The use of trazodone during pregnancy can cause temporary symptoms in newborns soon after birth. These symptoms are sometimes referred to as withdrawal. Symptoms include jitteriness, breathing problems, or trouble feeding. Not all babies exposed to trazodone will have these symptoms. No withdrawal symptoms were reported in one study of 18 infants exposed to 50 mg/day of trazodone for insomnia in the third trimester. It is important that your healthcare providers know you are taking trazodone so that if symptoms do occur, your baby can get the care that is best for them.
Does taking trazodone in pregnancy affect future behavior or learning for the child?
Studies have not been done to see if trazodone can cause behavior or learning issues for the child.
If a male takes trazodone, could it affect fertility or increase the chance of birth defects?
Studies have not been done to see if trazodone could affect male fertility (ability to get partner pregnant) or increase the chance of birth defects. People with conditions such as depression may have lower sex drive (desire to have sex), which might make it harder for them to get their partner pregnant. In general, exposures that fathers or sperm donors have are unlikely to increase risks to a pregnancy. For more information, please see the MotherToBaby fact sheet Paternal Exposures at https://mothertobaby.org/fact-sheets/paternal-exposures-pregnancy/ .
Quoted from MotherToBaby Fact Sheets — Trazodone, published July 2023. MotherToBaby states its fact sheets should not take the place of medical care and advice from your healthcare providers.
Breastfeeding is a separate question — what LactMed says about trazodone
More guides for Trazodone
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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.