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(Date of issue: March 2016, 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.


Amisulpride is an atypical antipsychotic used in the treatment of schizophrenic disorders.

There are no studies which specifically investigate the use of amisulpride in pregnancy. Although amisulpride exposures are included in a number of studies which report on fetal outcome of women exposed to various antipsychotics, amisulpride exposures generally represented only a tiny proportion of the study cohort and were not analysed separately.

As amisulpride has not been adequately studied, there are currently insufficient data to exclude or quantify risk of adverse pregnancy outcome with use during pregnancy. Increased risks for spontaneous abortion, congenital malformation, intrauterine death, small for gestational age, preterm delivery, neonatal complications and neurodevelopmental impairment have been reported for antipsychotics as a group, however, the data are limited and for some outcomes conflicting, and the relative contribution of the underlying maternal illness and co-exposure to other psychoactive substances remains undefined.

Maternal hyperglycaemia and increased fetal growth have been reported with use of atypical antipsychotics in pregnancy, although an association with impaired fetal growth has also been reported and data are thus conflicting. Given that weight gain is a recognised complication of amisulpride therapy and that maternal obesity, pre-pregnancy diabetes and both low and high infant birth weight are associated with increased risk of adverse pregnancy outcome, additional maternal and fetal monitoring may be prudent until more robust data are available.

Use of antipsychotics throughout pregnancy or near delivery has been 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. Delivery should be planned in a unit with neonatal intensive care facilities. Increased rates of neonatal complications in general have been reported in the offspring of both medicated and unmedicated women with psychotic illnesses. The relative contribution of the underlying maternal condition and other confounders (e.g. concurrent exposures) has, however, not been clearly defined.

It is important to ensure that maternal mental health is treated appropriately. Where a patient is stabilised on amisulpride, 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. Where clinically appropriate, clinicians are encouraged to discuss the advantages and disadvantages of continued amisulpride use during pregnancy with the patient. Where the benefit of continued treatment is considered to outweigh any potential or known risks, amisulpride use in pregnancy may be the best option for both mother and baby.
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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.