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(Date of issue: March 2018, Version: 3)

This is a UKTIS monograph for use by health care professionals. For case-specific advice please contact UKTIS on 0344 892 0909. To report an exposure please download and complete a pregnancy reporting form. Please encourage all women to complete an online reporting form.

A corresponding patient information leaflet on duloxetine use in pregnancy is available at


Duloxetine is a serotonin noradrenaline re-uptake inhibitor (SNRI) indicated for the treatment of major depressive disorder, diabetic peripheral neuropathic pain, generalised anxiety disorder, and also for the treatment of moderate to severe urinary stress incontinence. 

There are limited data available on the use of duloxetine in pregnancy, therefore its use would not be routinely recommended. However, where duloxetine is being used effectively prior to conception in the treatment of a maternal psychiatric condition, the risks of destabilisation and maternal relapse must be taken into account when considering switching a patient from duloxetine to another medication because of pregnancy.

The limited data on duloxetine exposure in pregnancy do not suggest an increased risk of congenital malformation, preterm delivery, stillbirth or neonatal complications, but are insufficient to exclude a teratogenic effect. Studies investigating exposure to SNRIs as a class have suggested increased risks for prematurity and neonatal complications following in utero exposure. However, data confounding cannot be excluded as study methodology did not consider the impact of the underlying maternal illness on preterm delivery, or of gestational age at delivery when analysing rates of neonatal complications. Data regarding risk of spontaneous abortion are conflicting. Further, more robust data are needed before an adequate assessment of fetal risk can be made.

Although there are no published data which identify an increased risk of persistent pulmonary hypertension of the newborn (PPHN) with maternal duloxetine use, SNRIs share similar mechanistic properties with SSRIs which are associated with an increased risk of PPHN following use in pregnancy. The possibility of an increased risk of PPHN in the neonate should therefore be considered, particularly as other neonatal problems similar to those reported with SSRIs have also been observed in infants exposed to SNRIs in utero. These include respiratory problems, low Apgar score, hypoglycaemia and convulsions. Infants exposed to antidepressants in utero should ideally be delivered in a unit with neonatal support and the delivery team made aware of the exposure. The neonate should be monitored for adverse effects post-delivery.

Exposure to duloxetine at any stage in pregnancy would not usually be regarded as medical grounds for termination of pregnancy or any additional fetal monitoring. However, other risk factors may 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.

This document is regularly reviewed and updated. Only use full UKTIS monographs downloaded directly from to be sure you are using the most up-to-date version. The summaries of these monographs are openly available on

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 health care professionals at

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 or to ensure you are using the most up-to-date version.