Valproic acid oral capsule side effects: A detailed guide

Specifically, the Food and Drug Administration (FDA) has approved valproic acid oral capsule for the treatment of:

• complex partial seizures
• simple and complex absence seizures
• multiple seizure types that include absence seizures

This article describes possible side effects of valproic acid oral capsule. To learn more about valproic acid, including the drug’s uses, side effects, ways to save on cost, and more, talk with your doctor or pharmacist.

Valproic acid oral capsule is a generic medication. The brand-name version is called Depakene, but this has been discontinued and is no longer available. Valproic acid also comes in an oral syrup, but this article does not describe this form. To learn more about the oral syrup form of valproic acid, talk with your doctor.

Boxed warnings

Valproic acid oral capsule has boxed warnings about the risk of liver failure and pancreatitis. It also has a boxed warning about the risk of fetal harm. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).

For details about the risks of liver failure and pancreatitis, see the “Side effects of valproic acid in detail” section below. For more information on the risk of fetal harm, see “Valproic acid and pregnancy” in the “Warnings for valproic acid” section below.

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More common side effects of valproic acid

Valproic acid oral capsule may cause mild or serious side effects. Below are some of the more common side effects of this medication.

Commonly reported side effects of valproic acid oral capsule include:

• nausea
• headache
• tremor (shakiness)
• vomiting
• sleepiness

Mild side effects of valproic acid

Valproic acid may cause certain mild side effects. Usually, mild side effects are temporary and are easily manageable. Tell your doctor or pharmacist if you have side effects that don’t go away or become bothersome.

Mild side effects of valproic acid oral capsule that occurred in studies include:

• nausea
• headache
• sleepiness
• vomiting
• weakness or lack of energy
• tremor (shakiness)
• dizziness
• stomach pain
• indigestion
• diarrhea
• low platelet count
• hair loss
• respiratory infections
• flu-like syndrome
• loss of appetite
• trouble sleeping
• nervousness
• blurry vision
• double vision
• mild allergic reaction*†

* To learn more about this side effect, see the “Side effects of valproic acid in detail” section below.
† An allergic reaction is possible with valproic acid oral capsule. But it’s unclear whether it occurred in the drug’s studies.

Valproic acid oral capsule may cause more mild side effects than those listed above. For details, see the drug’s prescribing information.

Serious side effects of valproic acid

Valproic acid may cause certain serious side effects. If you have any serious side effects from valproic acid oral capsule, call your doctor right away. But if you think you’re having a medical emergency or your side effects feel life threatening, take immediate action. Call 911 or a local emergency number or go to the nearest emergency room.

After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. Visit MedWatch’s website if you’d like to notify the FDA about a side effect you’ve had with valproic acid.

Serious side effects of valproic acid oral capsule that occurred in studies include:

• suicidal thoughts and behaviors*
• brain damage caused by high blood ammonia levels
• abnormal bleeding
• hypothermia (low body temperature)
• serious drug rash known as drug reaction with eosinophilia and systemic symptoms (DRESS)
• risk of liver failure*†
• risk of pancreatitis*†
• risk of fetal harm‡
• severe allergic reaction*§

* To learn more about this side effect, see the “Side effects of valproic acid in detail” section below.
† Valproic acid oral capsule has a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA. To learn more, see the “Side effects of valproic acid in detail” section below.
‡ Valproic acid oral capsule has a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA. To learn more, see the “Warnings for valproic acid” section below.
§ An allergic reaction is possible with valproic acid oral capsule. But it’s unclear whether it occurred in the drug’s studies

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Common questions about side effects of valproic acid

Here are answers to some common questions about side effects of valproic acid oral capsule. If you have other questions, talk with your doctor or pharmacist.

Does valproic acid cause long-term side effects?

Yes, in some cases valproic acid oral capsule may cause long-term side effects. These can last for a while after you’ve stopped taking the drug.

Examples of long-term side effects reported with valproic acid oral capsule include:

• liver problems*
• birth defects, including decreased IQ, brain and spinal cord problems, and hearing loss†
• pancreatitis*

Talk with your doctor to learn more about these side effects and how to manage them. Ask your doctor for more information about how long these side effects of valproic acid may last.

* Valproic acid oral capsule has a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA. To learn more, see the “Side effects of valproic acid in detail” section below.
† Valproic acid oral capsule has a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA. To learn more, see the “Warnings for valproic acid” section below.

Can valproic acid cause teeth-related side effects?

Typically no. In studies, valproic acid did not cause teeth-related side effects. However, the drug can increase the risk of abnormal bleeding. This includes bleeding from the mouth or nose.

If you have questions about the effect of valproic acid on your teeth, talk with your doctor.

Does valproic acid cause weight gain?

Potentially. In studies, valproic acid was associated with both weight loss and weight gain. Not everyone experiences this side effect. You can monitor your appetite and weight while taking valproic acid and discuss any concerns with your doctor.

Side effects of valproic acid in detail

Below you’ll find details on some of the side effects of valproic acid oral capsule.

Risk of liver failure

Valproic acid oral capsule has a boxed warning for serious and life threatening liver problems, such as liver failure, especially in children younger than 2 years old. Boxed warnings are the most serious warnings from the Food and Drug Administration (FDA).

In studies, liver failure was rare in people taking valproic acid oral capsule. This side effect is most commonly seen in the first 6 months of treatment. Sometimes, these problems may continue even after stopping the drug.

Symptoms of liver failure include:

• general discomfort
• weakness
• lethargy (tiredness)
• loss of appetite
• swelling in the face
• nausea or vomiting
• yellowing of the skin or eyes
• dark urine
• pain on the right side of your stomach

Certain factors can increase the risk of liver failure with valproic acid oral capsule. These include:

• history of liver disease
• taking multiple anticonvulsant medications
• children under the age of 2 years
• certain genetic conditions that affect your metabolism
• history of severe seizure disorders
• certain brain diseases

Ways to manage

Due to this risk, doctors may order tests to monitor your liver before and during treatment, especially during the first 6 months. If you experience symptoms of liver failure, tell your doctor right away. They’ll likely recommend that you stop taking valproic acid.

Risk of pancreatitis

Valproic acid capsule has a boxed warning for severe and life threatening inflammation of the pancreas (pancreatitis). Boxed warnings are the most serious warnings from the FDA.

In studies, pancreatitis was rare in people taking valproic acid oral capsule. With pancreatitis, your pancreas becomes inflamed and swollen, which can cause serious symptoms. These may include:

• sudden or slow pain in the upper abdomen
• pain that spreads to your back
• persistent pain that lasts several days
• fever
• nausea or vomiting that doesn’t go away
• swollen abdomen
• fast heart rate

Certain factors can increase the risk of pancreatitis with valproic acid oral capsule. These include:

• heavy alcohol use
• smoking
• family history of pancreatitis
• obesity

Ways to manage

If you experience symptoms of pancreatitis, tell your doctor right away. They’ll likely recommend that you stop taking valproic acid.

Suicidal thoughts and behaviors

In studies, suicidal thoughts and behaviors were rare in people taking valproic acid oral capsule. This side effect may be serious.

With suicidal thoughts and behaviors, you may experience:

• thoughts about suicide or dying
• new or worsening depression or anxiety
• trouble sleeping
• aggression, anger, or violent behavior
• panic attacks

Certain factors can increase the risk of suicidal thoughts and behaviors with valproic acid oral capsule. These include:

• history of mental health conditions
• taking other medications that cause suicidal thoughts or behaviors, such as antidepressants

Ways to manage

If you experience any changes in your mood, behaviors, thoughts, or feelings, tell your doctor. They’ll help determine the cause of your symptoms and may recommend treatment. They’ll also determine if you should continue taking valproic acid oral capsule.

Suicide prevention

If you or someone you know is in crisis and considering suicide or self-harm, please seek support:

• Call the 988 Suicide and Crisis Lifeline at 988.
• Text HOME to the Crisis Text Line at 741741.
• Not in the United States? Find a helpline in your country with Befrienders Worldwide.
• Call 911 or your local emergency services number if you feel safe to do so.

If you’re calling on behalf of someone else, stay with them until help arrives. You may remove weapons or substances that can cause harm if you can do so safely.

If you are not in the same household, stay on the phone with them until help arrives.

Allergic reaction

For some people, valproic acid oral capsule can cause an allergic reaction. However, it’s unclear whether this side effect occurred in the drug’s studies.

Symptoms can be mild or serious, and they may include:

• itchiness
• skin rash
• swelling under the skin, usually affecting eyelids, lips, hands, or feet
• swelling of the mouth, tongue, or throat, which can make it hard to breathe
• flushing (temporary warmth, redness, or deepening of skin color)

Ways to manage

For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.

For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to valproic acid oral capsule, your doctor may recommend taking a different medication instead.

Warnings for valproic acid

Below are some factors you may want to discuss with your doctor before taking valproic acid oral capsule.

Boxed warnings

This drug has boxed warnings about the risk of liver failure and pancreatitis. It also has a boxed warning for risk of fetal harm. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).

For details about risks liver failure and pancreatitis, see the “Side effects of valproic acid in detail” section above. For more information on risk of fetal harm, see the “Valproic acid and pregnancy” section below.

Other warnings

It may not be safe for you to take valproic acid oral capsule if you have specific health conditions. These are sometimes called drug-condition interactions. Other things may also affect whether valproic acid oral capsule is a safe treatment option for you.

Before taking valproic acid oral capsule, tell your doctor about your health and medications you take. Things to consider include:

• a history of liver problems
• a genetic problem called urea cycle disorder
• a history of mental health conditions, including depression, mood disorders, and suicidal thoughts and behavior
• alcohol use
• currently pregnant or breastfeeding
• a past allergic reaction to valproic acid

Valproic acid and pregnancy

You should not take valproic acid oral capsule during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before taking this medication. Your doctor may suggest birth control options to use during treatment with valproic acid.

Risk of fetal harm

Valproic acid oral capsule has a boxed warning for the risk of fetal harm. Boxed warnings are the most serious warnings from the Food and Drug Administration (FDA).

Taking valproic acid during pregnancy can increase the risk of serious birth defects in your unborn baby. These include defects that affect the brain, spinal cord, heart, head, arms, legs, and reproductive organs. It can also affect your unborn baby’s hearing and increase the risk of your child having a lower IQ, autism, or attention deficit hyperactivity disorder (ADHD).

Due to this risk, you should talk with your doctor about the risks and benefits of valproic acid oral capsule if you’re a female* of childbearing age. If your doctor prescribes valproic acid, you should use effective birth control during treatment. If you become pregnant during treatment, tell your doctor right away.

* Sex and gender exist on spectrums. In this article, we use the term “female” to refer to a person’s sex assigned at birth.

Valproic acid and breastfeeding

It is unknown whether you should take valproic acid oral capsule while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before taking this medication.

Valproic acid and alcohol

Valproic acid oral capsule is not known to interact with alcohol.

However, doctors may still recommend that you avoid drinking alcohol while taking valproic acid. This is because valproic acid and alcohol can both cause drowsiness and dizziness. Mixing these two can make these side effects worse.

Combining valproic acid and heavy alcohol use can also increase the risk of pancreatitis and liver problems.

If you drink alcohol, talk with your doctor about whether it’s safe to consume it during your treatment with valproic acid oral capsule.

What to ask your doctor

This article describes common and serious side effects of valproic acid oral capsule. If your doctor prescribes this medication, they can discuss possible side effects with you. Let your doctor know if you have concerns or questions about treatment with this medication.

Here’s a list of some possible questions you may want to ask your doctor:

• Is my risk of suicidal thoughts and behaviors highest when I first start treatment?
• Does my risk of drowsiness depend on the dosage I take?
• How do the side effects of valproic acid oral capsule compare with other drugs used to treat seizures?

Disclaimer: Optum Perks 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.