Divalproex sodium is not safe to take while pregnant or breastfeeding. Factors including the form you take or the condition being treated may determine whether you should take the drug during this time.

Divalproex sodium comes as delayed-release (DR)* and extended-release (ER)† tablets that you swallow. It also comes in DR capsules that you can swallow whole or open and sprinkle onto food.

* DR means the drug’s release is delayed until the tablet or capsule reaches your stomach.
† ER means the drug slowly releases its active ingredient into your system over a period of time. (An active ingredient is what makes a drug work.)

Boxed warnings

This drug has boxed warnings about the following risks. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous.

Risk of liver problems: Taking divalproex sodium may cause liver problems, such as liver failure. This risk is highest in people with mitochondrial disease and children younger than 2 years of age. (Keep in mind that this drug isn’t approved for use in children of this age.) In rare cases, liver problems with divalproex sodium may be fatal.

Risk of pancreas problems: Divalproex sodium may cause pancreatitis (swelling of the pancreas). In rare cases, this side effect may cause severe or fatal bleeding.

Risk of harm if used during pregnancy: Divalproex sodium may cause problems with fetal development (commonly known as birth defects) if the drug is used during pregnancy. To learn more about this risk, see the “Pregnancy and divalproex sodium” section.

For more information about these warnings, talk with your doctor or pharmacist.

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If you may be or can become pregnant, it’s important to consider whether divalproex sodium is a safe option for you.

Risk of harm if you take it during pregnancy

Divalproex sodium has a boxed warning about the risk of harm if you take the drug during pregnancy. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).

Studies* show that divalproex sodium may cause problems with fetal development (sometimes called birth defects) if you take it during pregnancy. Examples include problems with the brain and spinal cord, such as spina bifida.

Divalproex sodium may also lead to other developmental changes in children born to people who take this drug during pregnancy. Examples include autism spectrum disorder and lower IQ scores.

Due to these risks, your doctor will likely recommend that you use effective birth control while taking divalproex sodium. If you become pregnant while taking this drug, tell your doctor right away. They can speak with you about the risks and benefits of continuing treatment during pregnancy.

* See the prescribing information for divalproex sodium DR tablets, divalproex sodium ER tablets, and divalproex sodium DR capsules for details.

Pregnancy registry

If you become pregnant while taking divalproex sodium, you can take part in the North American Antiepileptic Drug Pregnancy Registry.

A pregnancy registry helps gather information on how certain drugs can affect pregnancy. To learn more, call 888-233-2334, visit the registry website, or talk with your doctor.

Divalproex sodium and fertility

There have been reports of infertility in males who have taken divaloproex sodium DR tablets and divalproex sodium ER tablets.

If you’re concerned about how this drug might affect your fertility, talk with your doctor before taking it.

Note: In this article, we use the terms “female” and “male” to refer to someone’s sex assigned at birth. For more information, see this article about the difference between sex and gender.

It may not be safe to breastfeed while taking divalproex sodium. The drug can pass into breast milk, which could cause side effects in a child who is breastfed.

If you breastfeed while taking divalproex sodium, check the child for the following symptoms:

  • jaundice (yellowing of the skin or the whites of the eyes)
  • unusual bleeding or bruising

If you’re currently breastfeeding or planning to breastfeed, talk with your doctor about the risks and benefits of taking divalproex sodium.

Divalproex sodium has a boxed warning about the risk of harm if you take the drug during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using divalproex sodium.

For females taking divalproex sodium

Females who can become pregnant should use birth control while taking divalproex sodium. If you have questions, talk with your doctor about the birth control method that’s best for you.

For males taking divalproex sodium

The manufacturer of divalproex sodium hasn’t given birth control recommendations for males using the drug. If you’re a male using divalproex sodium and have a sexual partner who can become pregnant, talk with your doctor about your birth control needs while using this drug.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.