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Date of issue: December 2023, Version: 3.0

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A corresponding patient information leaflet on USE OF TRICYCLIC ANTIDEPRESSANTS IN PREGNANCY is available.

Tricyclic antidepressants (TCAs) block the re-uptake of both serotonin and noradrenaline and are used in the management of depression, anxiety disorders and neuropathic pain. Currently available TCAs include amitriptyline, clomipramine, dosulepin, doxepin, imipramine, lofepramine, nortriptyline and trimipramine.

The available data provide no strong evidence of an association between maternal use of TCAs as a class during pregnancy and an increased risk of congenital malformation overall, or of any specific malformations (including cardiac defects). There is limited or no information on use of specific TCAs, therefore an increased risk of malformations cannot be ruled out. A possible association between in utero clomipramine exposure and cardiac malformation has been suggested but remains to be confirmed. Other findings are conflicting; however possible associations with miscarriage, preterm delivery, preeclampsia, and autism spectrum disorder have been identified, though data confounding is likely.

An increased risk of neonatal complications has been reported in the offspring of women with psychiatric illnesses; however the relative contributions of the underlying maternal condition and specific drug treatments have not been clearly defined. Use of TCAs throughout pregnancy or near delivery may be associated with withdrawal symptoms in the neonate and/or poor neonatal adaptation syndrome (PNAS). These symptoms are likely to be more severe in infants exposed in utero to more than one CNS acting drug.

A small number of studies have described associations between maternal TCA use and adverse maternal outcomes. Maternal TCA use in pregnancy may be a prognostic risk factor for gestational diabetes and pre-eclampsia.

It is important to ensure that maternal mental health disorders are treated appropriately during pregnancy. Where a patient is stabilised on a TCA, either prior to conception or during pregnancy, the risk of discontinuing or changing medication, or reducing the dose, should be carefully weighed against the risk of relapse of the maternal condition.

The currently available data do not support the need for any additional fetal monitoring following in utero exposure to TCAs; however data on individual TCAs is limited and the need for additional monitoring should therefore be determined on a case-by-case basis. Other risk factors may also be present in individual cases which may independently increase the risk of adverse pregnancy outcome. Clinicians are reminded of the importance of consideration of such factors when performing case-specific risk assessments.

There is a separate UKTIS monograph on Use of amitriptyline in pregnancy.

This is a summary of the full UKTIS monograph for health care professionals and should not be used in isolation. The full UKTIS monograph and access to any hyperlinked related documents is available to NHS health care professionals who are logged in.

If you have a patient with exposure to a drug or chemical and require assistance in making a patient-specific risk assessment, please telephone UKTIS on 0344 892 0909 to discuss the case with a teratology specialist.

If you would like to report a pregnancy to UKTIS please click here to download our pregnancy reporting form. Please encourage all women to complete an online reporting form.

Disclaimer: Every effort has been made to ensure that this monograph was accurate and up-to-date at the time of writing, however it cannot cover every eventuality and the information providers cannot be held responsible for any adverse outcomes of the measures recommended. The final decision regarding which treatment is used for an individual patient remains the clinical responsibility of the prescriber. This material may be freely reproduced for education and not for profit purposes within the UK National Health Service, however no linking to this website or reproduction by or for commercial organisations is permitted without the express written permission of this service. This document is regularly reviewed and updated. Only use UKTIS monographs downloaded directly from to ensure you are using the most up-to-date version.