Is Amitriptyline safe during pregnancy?
What the FDA-approved label for Amitriptyline 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 classifies amitriptyline as Pregnancy Category C. It states there are no adequate and well-controlled studies in pregnant women. Animal studies found it teratogenic in mice and hamsters at high doses (producing malformations), and it crosses the placenta. The label notes a few reports of adverse events — including CNS effects, limb deformities, or developmental delay — in infants whose mothers had taken amitriptyline during pregnancy, though a causal relationship has not been established. It advises that amitriptyline should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. Discuss use in pregnancy with your prescriber.
Frequently asked questions
Is Amitriptyline safe to take during pregnancy?
The honest answer is uncertainty: the label does not have enough pregnancy data to call Amitriptyline 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 Amitriptyline 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 Amitriptyline 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 amitriptyline 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 amitriptyline. Can it make it harder for me to get pregnant?
Studies have not been done to see if amitriptyline could make it harder to get pregnant.
Does taking amitriptyline increase the chance of miscarriage?
Miscarriage is common and can occur in any pregnancy for many different reasons. It is not known if amitriptyline can increase the chance of miscarriage. Untreated depression might increase the chance of miscarriage. More information on depression can be found in our fact sheet here: https://mothertobaby.org/fact-sheets/depression-pregnancy/ .
Does taking amitriptyline increase the chance of birth defects?
Out of all babies born each year, about 3 out of 100 (3%) will have a birth defect. We look at research studies to try to understand if an exposure, like amitriptyline, might increase the chance of birth defects in a pregnancy. A small number of human studies have not found a higher chance for birth defects with doses of amitriptyline used for treatment of depression.
Does taking amitriptyline in pregnancy increase the chance of other pregnancy-related problems?
Studies have not been done to see if amitriptyline can increase the chance of other pregnancy-related problems such as preterm delivery (birth before week 37) or low birth weight (weighing less than 5 pounds, 8 ounces [2500 grams] at birth). One report found a small increase in the chance of preeclampsia (high blood pressure and problems with organs, such as the kidneys) when amitriptyline was used in the second and third trimester of pregnancy.
Research has also shown that when depression is left untreated during pregnancy, there could be an increased chance of pregnancy complications. This makes it hard to know if the medication, untreated depression, or other factors are increasing the chance of these problems.
I need to take amitriptyline throughout my entire pregnancy. Will it cause withdrawal symptoms in my baby after birth?
The use of some tricyclic antidepressants during pregnancy can cause temporary symptoms in newborns soon after birth. These symptoms are sometimes referred to as withdrawal. Symptoms seen during the first month of life included colic, low oxygen levels, breathing problems, and irritability. If a baby develops these symptoms, they usually go away in a few days without any long-term health effects.
There is one case report of an infant who had temporary withdrawal symptoms after exposure to amitriptyline throughout pregnancy. The infant and the mother were found to have high blood levels of amitriptyline. Not all babies exposed to amitriptyline will have these symptoms. It is important that your healthcare providers know you are taking amitriptyline so that if symptoms occur your baby can get the care that is best for them.
Does taking amitriptyline in pregnancy affect future behavior or learning for the child?
One study looking at 29 children exposed to amitriptyline during pregnancy did not find any behavioral or learning problems.
If a man takes amitriptyline, could it affect fertility or increase the chance of birth defects?
Some studies report amitriptyline lowered sex drive and caused sexual dysfunction in men, which can affect fertility (ability to get a woman pregnant). These problems can also be side effects of untreated depression. Studies have not been done to see if amitriptyline could increase the chance of birth defects. In general, exposures that men 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 — Amitriptyline, published October 2024. 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 amitriptyline
More guides for Amitriptyline
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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.