valproic acid (oral/injection)

What is the most important information I should know about valproic acid?

Valproic acid can cause liver failure that may be fatal, especially in children under age 2 and in people with liver problems caused by certain genetic disorders.

Do not stop using valproic acid without your doctor's advice. Stopping suddenly may cause a serious, life-threatening type of seizure.

What is valproic acid?

Valproic acid is used to treat various types of seizure disorders. Valproic acid is sometimes used together with other seizure medications.

Valproic acid is also used to treat manic episodes related to bipolar disorder (manic depression), and to prevent migraine headaches.

Valproic acid may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking valproic acid?

• liver disease;
• a urea cycle disorder; or
• a genetic mitochondrial (MYE-toe-KON-dree-al) disorder such as Alpers' disease or Alpers-Huttenlocher syndrome, especially in a child younger than 2 years old.

Tell your doctor if you have ever had:

• liver problems caused by a genetic mitochondrial disorder;
• depression, mental illness, or suicidal thoughts or actions;
• a family history of a urea cycle disorder or infant deaths with unknown cause; or
• HIV or CMV (cytomegalovirus) infection.

Some young people have thoughts about suicide when first taking valproic acid. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Using valproic acid during pregnancy may increase the risk of serious birth defects that can develop early in pregnancy, even before you know you are pregnant. Using this medicine during pregnancy can also affect cognitive ability (reasoning, intelligence, problem-solving) later in your child's life. However, having a seizure during pregnancy could harm both the mother and the baby.

If you are not pregnant, use effective birth control to prevent pregnancy while using valproic acid. Tell your doctor if you start or stop using hormonal contraception that contains estrogen (birth control pills, injections, implants, skin patches, and vaginal rings). Estrogen can interact with valproic acid and make it less effective in preventing seizures.

How should I take valproic acid?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Valproic acid oral is taken by mouth. Valproic acid injection is given as an infusion into a vein. A healthcare provider will give you this injection if you are unable to take the medicine by mouth.

Measure liquid medicine with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Tell your doctor if you notice a capsule shell in your stool that was not absorbed or melted in the body. Your blood levels of valproic acid may need to be checked.

You may need frequent blood tests.

If you need surgery, tell the surgeon ahead of time that you are using valproic acid.

Do not stop using valproic acid suddenly, even if you feel fine. Stopping suddenly may cause a serious, life-threatening type of seizure. Follow your doctor's instructions about tapering your dose.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

What should I avoid while taking valproic acid?

What are the possible side effects of valproic acid?

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

• confusion, tiredness, cold feeling, vomiting, change in your mental state;
• easy bruising, unusual bleeding (nose, mouth, or gums), purple or red pinpoint spots under your skin;
• severe drowsiness; or
• worsening seizures.

Severe drowsiness may be more likely in older adults.

Common side effects may include:

• nausea, vomiting, stomach pain, diarrhea;
• dizziness, drowsiness, weakness;
• headache;
• tremors, problems with walking or coordination;
• blurred vision, double vision;
• hair loss; or
• changes in appetite, weight gain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect valproic acid?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can affect valproic acid. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about valproic acid.