Which is major side effect of valproic acid?

warnings

What is the most important information I should know about Valproic Acid (Depakene)?

You should not use valproic acid if you are allergic to it, or if you have:

• 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.

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

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 take valproic acid for seizures or manic episodes: The benefit of preventing these conditions may outweigh any risks posed by this medicine. There may be other medications that are safer to use during pregnancy. Do not start or stop taking valproic acid without your doctor's advice.

Do not use valproic acid to prevent migraine headaches if you are pregnant or you could become pregnant.

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.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Side Effects

What are the side effects of Valproic Acid (Depakene)?

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Call your doctor at once if the person taking this medicine has signs of liver or pancreas problems, such as: loss of appetite, upper stomach pain (that may spread to your back), ongoing nausea or vomiting, dark urine, swelling in the face, or jaundice (yellowing of the skin or eyes).

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.

Call your doctor at once if you have any of these other side effects:

• 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.

Pregnancy & Breastfeeding

Can I take Valproic Acid (Depakene) if I’m pregnant or breastfeeding?

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 take valproic acid for seizures or manic episodes: The benefit of preventing these conditions may outweigh any risks posed by this medicine. There may be other medications that are safer to use during pregnancy. Do not start or stop taking valproic acid without your doctor's advice.

Do not use valproic acid to prevent migraine headaches if you are pregnant or you could become pregnant.

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.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Dosage Guidelines & Tips

How to take Valproic Acid (Depakene)?

Use Valproic Acid (Depakene) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

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.

Drink plenty of water while you are taking this medication. Your dose may need to be changed if you do not get enough fluids each day.

Take with food if this medicine upsets your stomach.

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.

Swallow the capsule whole and do not crush, chew, break, or open it.

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.

In case of emergency, wear or carry medical identification to let others know you use 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.

Store at room temperature away from moisture and heat.

What should I do if I missed a dose of Valproic Acid (Depakene)?

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.

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