Valproate in pregnancy and conception

Valproate is an ingredient contained in medications that are used to treat bipolar disorder and epilepsy.

The active ingredient in these medicines can include:

• valproic acid
• magnesium valproate
• sodium valproate
• valproate semi sodium
• valpromide.

You might sometimes hear medications containing valproate described as ‘sodium valproate’. In this resource, we will use the word ‘valproate’ to describe any medications containing valproate.

The brand names of medications containing valproate include:

• Depakote
• Epilim
• Epival 

Medications containing valproate are also used more rarely in people with schizophrenia or other psychotic conditions, in people with anxiety disorders or to treat impulsive or aggressive behaviour.

Valproate can have different effects on unborn babies if taken during pregnancy.

Neurodevelopmental conditions

Unborn babies that are exposed to valproate in the womb have a very high risk of developing neurodevelopmental conditions and developmental difficulties.

In babies that were exposed to valproate in the womb, around 30-40 in every 100 are born with neurodevelopmental conditions.

Birth defects

In babies that were not exposed to valproate in the womb, around 2-3 in every 100 are born with a birth defect.

Babies that are exposed to valproate in the womb are more likely to be born with birth defects. On average, 10 in every 100 babies exposed to valproate in the womb are born with a birth defect. These birth defects include:

• spina bifida (where the bones of the spine do not join up properly).
• cleft lip and cleft palate (where the upper lip or bones in the face are split).
• abnormalities of the heart, kidney, urinary tract and sexual organs.

This means this risk of birth defects is about 3-4 times higher when babies are exposed to valproate.

What about taking folic acid?

Folic acid is recommended for all women planning pregnancy to help protect against spina bifida. However, even in high doses, it does not prevent the increased risk of birth defects caused by taking valproate in pregnancy. High dose folic acid can also interfere with valproate’s effectiveness in bipolar disorder.

New guidance has been issued on when valproate can and cannot be used. You can find this information on the Government website.

Valproate in women and girls

This information also applies to anyone who can get pregnant, regardless of gender identity.

If you are pregnant
Valproate cannot be prescribed to people with bipolar disorder who are pregnant. It can only be prescribed for the treatment of epilepsy in people who are pregnant if two specialists independently agree that there is no other treatment available.

If you are not pregnant
Drugs containing valproate must not be started or continued in women and girls under the age of 55, unless:

• two specialists independently agree that there is no alternative, effective treatment available that the person can use instead
• it is clear that the reproductive risks do not apply. For example, because the person is unable to get pregnant.

Women and girls under 55 can only be prescribed valproate according to the Valproate Pregnancy Prevention Programme (also called prevent). This programme is designed to make sure patients are fully aware of the risks and the need to avoid becoming pregnant.

If you are being prescribed valproate, the prescriber must:

• Consider the risks of you becoming pregnant, and make sure that you have received information on preventing pregnancy.
• Ensure that you are taking effective contraception (birth control) for the entire time that you are taking valproate.
• Give you the MHRA Patient Guide, and ensure you understand:
• Ensure that you have taken a pregnancy test before you start taking treatment.

If your child is using valproate, the person prescribing their medication should explain to you the importance of contacting your GP or prescriber once your child has started menstruating (having their period).

You will need to sign an Annual Risk Acknowledgement Form every year. You can see what this form looks like on the MHRA website. However, you will be given this form in your appointment and do not need to print it off yourself.

Valproate in men and boys

This information also applies to anyone who can impregnate someone, regardless of gender identity.

Drugs containing valproate must not be started or continued in boys and men under the age of 55, unless:

• two specialists independently agree that there is no alternative effective treatment available that the person can use instead
• it is clear that the infertility risks do not apply.

Fertility while using valproate
There is an increased risk of infertility in men who take valproate. This can make it difficult to have a baby. This infertility may be reversible after valproate is stopped or reduced. It is important that you speak to your doctor before stopping or reducing any medication you are taking.

Effects on the reproductive system
If you use valproate you will need to complete a Risk Acknowledgment Form, which will include information about testicular toxicity.

This is because some studies in male animals have shown valproate to have a negative effect on parts of the male reproductive system. These include toxic effects on the testes (testicles). It is unclear what this means for humans.

Effects on children
A study suggests a possible increased risk of neurodevelopmental disorders in children born to men who use valproate in the three months before conception. This potential risk is much lower than the risk of neurodevelopmental disorders in children born to mothers taking valproate during pregnancy.

Using contraception
Men should use effective contraception while taking valproate, and for three months after stopping valproate. This will ensure that their sperm is not exposed to valproate if they choose to conceive. Effective contraception means using a condom and your partner also using a form of contraception.

Men taking valproate who are planning a family in the next year should be referred to a specialist who can discuss alternative treatment options.

Men should not donate sperm while they are taking valproate, and for three months after stopping valproate.

Men taking valproate are required to sign a Risk Acknowledgement Form. You can see what this form looks like on the MHRA website. However, you will be given this form in your appointment and do not need to print it off yourself.

Patient Guide and Patient Card

If you are prescribed medication containing valproate, you should be given a copy of the MHRA Patient Guide for information about the risks of valproate. You should also be given a Patient Card, which contains important information about the risks of taking valproate and the requirements of taking it.

• the risks described in the previous section of this resource
• the importance of speaking to your GP immediately if you are planning a pregnancy or if you become pregnant.

If you could become pregnant or are planning to become pregnant and you are taking valproate, it is important that you do not stop the medication suddenly. This will increase your risk of becoming unwell. Make an appointment with the doctor who prescribes your valproate. Together you can think about what medicine might be safer for you to take to treat your illness.

If you are taking valproate and you think you might be pregnant, don’t stop your medication suddenly. Speak to your GP, psychiatrist or anyone who is involved in your mental health care straight away.

If you do not have a psychiatrist, you should be referred to one. Together you can decide what medication would be safest for you to take for the rest of your pregnancy, and after you have your baby.

You will also be referred to a specialist who can offer scans and counselling if you have been exposed to valproate during pregnancy.

If you need to stop taking valproate, you should only do this with support from your doctor. Stopping valproate should be done gradually to reduce the risk of you becoming unwell. However, it may be done more quickly than would usually be recommended, to minimise the risks of continuing to take valproate while you are pregnant.

You might be given another medication at the same time to make coming off valproate easier.

You and your prescriber might also create a Relapse Prevention Plan to help you to avoid becoming unwell again when coming off valproate and moving onto another treatment.

Valproate safety measures, MHRA – The latest information on the safety measures required when prescribing valproate from the Medicines and Healthcare products Regulatory Agency (MHRA).

Risk acknowledgement forms – These are the forms you will be asked to read and complete when you are prescribed valproate:

• Annual Risk Acknowledgement Form - Females
• Risk Acknowledgement Form when starting valproate - Males

PS01/25 Valproate in psychiatry: Female and male reproductive health risks, pregnancy harms, withdrawal and safer alternatives, Royal College of Psychiatrists – The College’s position statement on the use of valproate.

This information was produced by the Royal College of Psychiatrists’ Public Engagement Editorial Board (PEEB). It reflects the best available evidence at the time of writing.

This resource was originally produced through the ‘Building Capacity, Psychiatry Leadership in Perinatal Mental Health Services’ project: commissioned by NHS England in partnership with Health Education England and delivered by the Royal College of Psychiatrists.

• Expert authors: Dr Gillian Strachan, Dr Sarah Jones and Dr Lucinda Green
• Expert review: The Royal College of Psychiatrists’ Psychopharmacology Committee
• Service users and carers: Action on Postpartum Psychosis

This resource was updated in 2025, in line with the update of the College’s Position Statement ‘Valproate in psychiatry: Female and male reproductive health risks, pregnancy harms, withdrawal and safer alternatives’ PS01/25

Full references available on request.