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(Date of issue: February 2018, 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 varenicline use in pregnancy is available at


Varenicline is a partial agonist of the α2β4 nicotinic acetylcholine receptor, and is licensed as a tobacco use cessation aid for adults.

In comparison with both placebo and other tobacco use cessation therapies, varenicline has shown an increased efficacy for tobacco use cessation in non-pregnant adults. No studies investigating the efficacy of varenicline during pregnancy have been located in the literature.

Published human pregnancy exposure data are currently scarce. Due to the small number of exposed pregnancies, limited conclusions can be provided concerning the fetal effects of maternal varenicline use in pregnancy. Currently, no evidence of an increased risk of spontaneous abortion, major congenital malformation or intrauterine death has been provided from the controlled studies. There are insufficient data to provide risk assessments for other adverse pregnancy outcomes.

Due to the limited efficacy and pregnancy safety data, varenicline is not routinely recommended as a smoking cessation aid for pregnant women. Where varenicline use during pregnancy is being considered, patients should be made aware of the limited data available and other therapeutic options should be discussed.

Given the lack of data concerning safety of varenicline use during pregnancy, a detailed fetal anomaly scan is recommended where exposure has occurred during the first trimester. As additional risk factors may be present in individual cases which may independently increase the risk of adverse pregnancy outcome, the need for additional fetal monitoring should be determined on a case-by-case basis. 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.