Amitriptyline
MedicationElavil, Vanatrip
Tricyclic antidepressant
Research strength: 3 / 5
MotherToBaby reports that a small number of human studies have not found a higher chance of birth defects with amitriptyline used for depression; the DailyMed label says adequate, well-controlled studies in pregnant women are lacking. Chan et al. (2024) found no overall association between individual antidepressants and major malformations in a Hong Kong cohort that included 148 first-trimester amitriptyline-only exposures. Phillips et al. (2026) found higher miscarriage odds among women with migraine using amitriptyline; MotherToBaby says the overall chance is not known, and the authors call for more work to understand the cause. The DailyMed label's boxed warning states: “Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders.” It also says: “Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior.” Ask your provider about your situation.
Last reviewed: 2026-10-16
Research strength: 3 / 5
MotherToBaby says it is not known whether amitriptyline raises the chance of preterm delivery or low birth weight; the label also notes that adequate controlled pregnancy studies are lacking. Palmsten et al. (2013) found a preeclampsia association in pregnant women with depression, but the observational study cannot show that amitriptyline caused it. A 2026 UK, Norway, and Sweden cohort reported higher preterm delivery odds with antidepressants as a group, but its published abstract does not give an amitriptyline-specific estimate and notes likely residual confounding. The DailyMed label's boxed warning states: “Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders.” It also says: “Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior.” Ask your provider about your situation.
Last reviewed: 2026-10-16
Research strength: 3 / 5
MotherToBaby reports that some tricyclic antidepressants can cause short-term newborn symptoms, including colic, low oxygen, breathing problems, or irritability, and describes one amitriptyline case; it says not all exposed babies have symptoms. The NHS says babies may be monitored after delivery for temporary sleeping or feeding problems when amitriptyline is used around birth. The 2026 Wales cohort reported an amitriptyline-only group in a study of later special educational needs, but its subgroup estimates were uncertain and do not establish that medication caused a difference. The DailyMed label's boxed warning states: “Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders.” It also says: “Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior.” Ask your provider about your situation.
Last reviewed: 2026-10-16
Sources
Amitriptyline — Breastfeeding
Research strength: 4 / 5
LactMed reports low milk levels and no immediate side effects in its limited follow-up, but rare sedation has been reported in a newborn. NHS SPS says amitriptyline can be used with caution and prefers imipramine or nortriptyline; Uguz et al. (2017) reported severe sedation and poor feeding in a breastfed infant when the mother took 10 mg per day. The label warns of potential serious infant reactions and says the decision whether to discontinue nursing or the drug should take into account the importance of the drug to the mother. The DailyMed label's boxed warning states: “Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders.” It also says: “Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior.” Ask your provider about your situation.
Last reviewed: 2026-10-16
Sources
- LactMed: AmitriptylineUS government
- NHS Specialist Pharmacy Service: Tricyclics during breastfeedingUK government
- Uguz, 2017 breastfeeding case reportUS government
- DailyMed: Amitriptyline hydrochloride tablets label, RemedyRepackDrug company label
Pregnancy
Birth defects: Chan et al. (2024) studied 465,069 Hong Kong women with singleton first births; 1,705 had first-trimester antidepressant exposure and 148 used amitriptyline monotherapy. No overall association with major malformations was found for individual antidepressants; estimates for rare specific defects were imprecise. Miscarriage: Phillips et al. (2026) studied 193,208 migraine pregnancies and used a nested case-control analysis of 20,778 miscarriages and 40,122 matched non-miscarriage controls. Amitriptyline exposure was recorded in 380 miscarriage cases and 542 controls, with an adjusted odds ratio of 1.25 (95% CI 1.08 to 1.45). This association is limited to migraine pregnancies and does not establish causation. Preeclampsia: Palmsten et al. (2013) studied 100,942 pregnant women with depression and reported amitriptyline RR 1.72 (95% CI 1.24 to 2.40); the study was observational. Birth outcomes: Martin et al. (2026) analyzed pregnancy records from the UK, Norway, and Sweden and reported class-level associations with preterm delivery and low Apgar among 120,209 antidepressant-exposed pregnancies; its final published abstract does not provide amitriptyline-specific estimates and notes likely residual confounding. Child outcomes: Nulman et al. (2002) found no adverse group-level IQ, language, or behavior result among 46 TCA-exposed children, 40 fluoxetine-exposed children, and 36 unexposed children; this is not amitriptyline-specific. McIlvride et al. (2026) studied 167,447 children in Wales; its amitriptyline-only row (1,763/581,744) reports special educational needs risk differences of 3.4 additional cases per 100 (95% CI 0.0 to 6.8) without recorded maternal depression and 8.0 per 100 (95% CI -0.1 to 16.1) with recorded depression. Estimates are imprecise, and the authors identify confounding by indication and depression severity.
Breastfeeding
LactMed (last revised 15 Aug 2024) reports low milk levels. Small milk-level studies estimated infant intake at about 0.9% to 1.8% of the maternal weight-adjusted dose. LactMed reports at least 23 infants exposed to maternal doses of 75 to 175 mg per day through 2002 without reported adverse reactions, but the small reports cannot estimate uncommon effects. Uguz et al. (2017) reported severe sedation and poor feeding in a breastfed infant when the mother took 10 mg per day; LactMed reports that symptoms improved after the medicine was stopped and returned after it was restarted. NHS SPS says amitriptyline can be used with caution for full-term, healthy infants, but prefers imipramine or nortriptyline and advises monitoring for drowsiness, not waking to feed, poor feeding, weight gain, irritability, constipation, and fewer wet nappies.
Amitriptyline hydrochloride is the active ingredient in the reviewed tablet labels. The current RemedyRepack label lists croscarmellose sodium, magnesium stearate, and silicified microcrystalline cellulose as inactive ingredients; its tablet coating includes polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide. The 2016 Elavil 25 mg label lists different inactive ingredients, including lactose monohydrate, colorants, and sodium starch glycolate. Inactive ingredients can vary by manufacturer and strength.
What was tested
Pregnancy research consists mainly of observational cohorts and case-control studies; populations include people treated for depression and migraine, so the underlying condition can affect results. Late-pregnancy newborn findings include reports of temporary symptoms, but case reports cannot show how often they occur. Breastfeeding evidence includes small milk-level studies, infant follow-up, and individual case reports; these describe milk transfer and possible effects but cannot determine a precise rate for uncommon reactions.
Breastfeeding: product-label caution and clinical guidance
- Source A says
- DailyMed's label warns about potential serious adverse reactions in nursing infants and says a decision whether to discontinue nursing or the drug should account for the importance of the drug to the mother. (DailyMed: Amitriptyline hydrochloride tablets label, RemedyRepack)
- Source B says
- LactMed says adverse effects would usually not be expected, especially when the infant is older than 2 months; NHS SPS says amitriptyline can be used with caution while preferring imipramine or nortriptyline. (LactMed: Amitriptyline record, NHS Specialist Pharmacy Service: Tricyclic antidepressants during breastfeeding)
- Why they differ
- The label uses a conservative product-information warning. LactMed and NHS SPS summarize small milk-transfer studies and infant reports and discuss use with monitoring; they do not rule out uncommon effects.
- Other sources
- MotherToBaby describes small amounts in milk, no side effects in most reported infants, and a very sleepy 15-day-old after maternal use of 10 mg per day. (MotherToBaby: Amitriptyline fact sheet)
- What the evidence shows overall
- The product label is more cautious than LactMed and NHS SPS. Those clinical sources describe monitored use in selected infants, but a report includes severe sedation and poor feeding in a newborn after maternal use of 10 mg per day. The evidence is too small to estimate how often this occurs.
- MotherToBaby says that if someone plans to stop amitriptyline, a healthcare provider may suggest lowering the dose gradually because stopping suddenly can cause withdrawal symptoms. (MotherToBaby)
- The NHS says someone who becomes pregnant while taking amitriptyline does not need to stop unless their doctor advises it. (NHS)
- NHS SPS says amitriptyline can be used with caution during breastfeeding; imipramine or nortriptyline are preferred, and full-term healthy infants should be monitored for drowsiness, poor feeding, weight gain, and other symptoms. (NHS Specialist Pharmacy Service)
- The MHRA says patients should not stop an antidepressant without first speaking to a healthcare professional. (MHRA)
General research, not specific to pregnancy.
The current label includes a boxed warning about suicidal thinking and behavior in children, adolescents, and young adults compared with placebo in short-term studies, with monitoring for patients of all ages starting treatment. EMA added a DRESS warning to amitriptyline product information in 2024. In 2026, the MHRA announced patient-information changes for antidepressants, including amitriptyline, about suicidal thoughts and behaviors and persistent sexual dysfunction after stopping.
- The DailyMed boxed warning says antidepressants increased suicidal thinking and behavior compared with placebo in children, adolescents, and young adults in short-term studies, and calls for close monitoring of all ages starting treatment. (DailyMed: Amitriptyline hydrochloride tablets label, RemedyRepack)
- The EMA's 2024 product-information action says DRESS and other severe skin reactions can be life-threatening or fatal; most reported reactions occurred within 2 to 6 weeks. If signs appear, the product information calls for immediate withdrawal and no restart. (EMA PSUSA: Amitriptyline DRESS product-information action)
- On 15 Oct 2026, the MHRA announced a new patient card and patient-leaflet changes about suicidal thoughts and behaviors and persistent sexual dysfunction after stopping. Its page lists amitriptyline among the medicines included for the sexual-dysfunction information, says these are not new risks, and tells patients not to stop treatment without speaking to a healthcare professional. (MHRA: Antidepressant patient-information update, MHRA 2026 public assessment report on antidepressants)
- MotherToBaby: Amitriptyline fact sheetTeratology serviceSecondary
- LactMed: Amitriptyline recordUS governmentSecondaryPage dated 2024-08-15
- DailyMed: Amitriptyline hydrochloride tablets label, RemedyRepackDrug company labelTertiaryPage dated 2026-09-14
- DailyMed: Elavil 25 mg tablet labelDrug company labelTertiaryPage dated 2016-04-19
- NHS: Amitriptyline in pregnancy and breastfeedingUK governmentSecondaryPage dated 2025-02-28Independent check
- NHS Specialist Pharmacy Service: Tricyclic antidepressants during breastfeedingUK governmentSecondaryPage dated 2023-11-17Independent check
- EMA PSUSA: Amitriptyline DRESS product-information actionEU agencySecondaryPage dated 2024-10-28European guidance
- MHRA: Antidepressant patient-information updateUK governmentSecondaryPage dated 2026-10-15
- MHRA 2026 public assessment report on antidepressantsUK governmentSecondaryPage dated 2026-10-15
- Chan et al., Psychiatry Research 2024, Hong Kong cohortPrimaryIndependent check
- Phillips et al., Cephalalgia 2026, migraine and miscarriageUS governmentPrimaryPage dated 2026-01-28Independent check
- Palmsten et al., Epidemiology 2013, preeclampsia cohortUS governmentPrimaryIndependent check
- Nulman et al., American Journal of Psychiatry 2002, child developmentUS governmentPrimary
- Uguz, 2017, breastfeeding case reportUS governmentPrimaryIndependent check
- Martin et al., Pharmacoepidemiology and Drug Safety 2026, multinational cohortUS governmentPrimary
- McIlvride et al., PLOS Medicine 2026, Wales child-outcomes cohortUS governmentPrimaryPage dated 2026-09-29
Last reviewed 2026-10-16
Independent check 2026-10-16
Not yet clinician-reviewed
Ask your provider about your situation.
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