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(Date of issue: April 2020, Version: 2)

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 venlafaxine use in pregnancy is available at


Venlafaxine is a serotonin and noradrenaline reuptake inhibitor (SNRI) indicated for the treatment of depression, anxiety and panic disorders.

Data from cohort studies on the use of venlafaxine in human pregnancy do not indicate an increased overall risk of congenital malformation. One study has described an increased risk of respiratory malformations following first trimester venlafaxine exposure; however, this finding was based on a small number of exposed and affected infants, which produced an imprecise risk estimate. No further studies have investigated the risk of respiratory anomalies specifically, therefore the association remains unconfirmed. A small number of retrospective case-control studies, which may be influenced by methodological bias and with some using data from the same source, have also shown associations with specific anomalies such as hypospadias, gastroschisis, cleft palate, limb and heart defects. However, a small number of better-quality population-based studies have not confirmed associations with cardiac malformations or hypospadias specifically. The available evidence concerning specific malformation risk is therefore currently conflicting, and further studies are required to exclude or confirm these findings.

An increased risk of miscarriage has been reported following gestational exposure to venlafaxine, however, the data are inconsistent and likely confounded by indication and other factors. Data currently do not suggest an increased risk of intrauterine death, small for gestational age infants, and preterm delivery following gestational venlafaxine exposure; however, the data are insufficient for an increased risk to be excluded.

Neonatal complications observed in infants exposed to venlafaxine in utero are similar to those reported with SSRIs and include respiratory problems, low Apgar score, and convulsions. Use of centrally acting drugs throughout pregnancy or around the time of delivery is associated with an increased risk of poor neonatal adaptation syndrome (PNAS). Monitoring of the neonate post-delivery is advised.

As in utero SSRI exposure is associated with an increase in the occurrence of persistent pulmonary hypertension of the newborn (PPHN), there are theoretical concerns that in utero venlafaxine exposure could also result in PPHN. Although there are no published data which identify an association, data are insufficient to disprove this theory. An increased risk of PPHN cannot be excluded, although the absolute risk is likely to be low.

Reports of lower than average IQ in children exposed to antidepressants in utero have been found, however the effects of venlafaxine exposure on neurodevelopment have not been widely studied. Preliminary findings suggest that children exposed to antidepressants in utero, including venlafaxine, and children of untreated depressed women have lower IQs and exhibit more behavioural problems than children of non-exposed children of non-depressed women.

Where maternal treatment with venlafaxine is clinically indicated it should be offered, provided the women is carefully counselled regarding the available human pregnancy safety data or the prescriber considers risk of not treating the maternal condition too great to withhold treatment on the basis of the undetermined fetal risk.

At present there is insufficient evidence to warrant additional fetal monitoring for congenital malformations. 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 considering the need for additional pregnancy monitoring. Discussion with UKTIS is recommended in all cases.
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.