What is the most important information I should know about divalproex sodium?
You should not use divalproex sodium if you have liver disease, a urea cycle disorder, or a genetic disorder such as Alpers' disease or Alpers-Huttenlocher syndrome.
Do not start or stop taking divalproex sodium during pregnancy without your doctor's advice. Divalproex sodium may harm an unborn baby, but having a seizure during pregnancy could harm both mother and baby. Do not use divalproex sodium to prevent migraine headaches if you are pregnant.
Divalproex sodium 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.
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).
Do not stop using divalproex sodium without your doctor's advice. Stopping suddenly may cause a serious, life-threatening type of seizure.
What is divalproex sodium?
Divalproex sodium comes in different pill forms that are for different uses.
Divalproex sodium tablets and capsules are used to treat seizures in people with epilepsy who are at least 10 years old. Divalproex sodium tablets are sometimes used together with other seizure medications.
Divalproex sodium tablets are also used in adults to prevent migraine headaches, or to treat manic episodes related to bipolar disorder (manic depression).
Divalproex sodium may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking divalproex sodium?
You should not use divalproex sodium 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.
Divalproex sodium 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; or
- a family history of a urea cycle disorder or infant deaths with unknown cause.
Some people have thoughts about suicide while taking divalproex sodium. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.
Using divalproex sodium 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 divalproex sodium for seizures or manic episodes: The benefit of preventing seizures or manic episodes 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 divalproex sodium without your doctor's advice.
Do not use divalproex sodium 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 divalproex sodium. 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 divalproex sodium 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.
How should I take divalproex sodium?
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.
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.
Swallow the capsule or tablet whole and do not crush, chew, break, or open it.
If you cannot swallow a sprinkle capsule whole, open it and sprinkle the medicine into a spoonful of pudding or applesauce. Swallow the mixture right away. Do not save it for later use.
You may need frequent blood tests.
If you need surgery, tell the surgeon ahead of time that you are using divalproex sodium.
In case of emergency, wear or carry medical identification to let others know you use divalproex sodium.
Do not stop using divalproex sodium 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 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?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking divalproex sodium?
Drinking alcohol may increase certain side effects of divalproex sodium.
Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.
What are the possible side effects of divalproex sodium?
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:
- easy bruising, unusual bleeding (nose, mouth, or gums), purple or red pinpoint spots under your skin;
- fever, swollen glands, mouth sores;
- confusion, tiredness, cold feeling, vomiting, change in your mental state;
- severe drowsiness; or
- worsening seizures.
Common side effects may include:
- nausea, vomiting, stomach pain, diarrhea, constipation;
- headache, back pain;
- dizziness, drowsiness, weakness, tremors;
- memory problems, mood changes, trouble sleeping;
- bruising or bleeding;
- runny nose, sore throat, cough, wheezing, trouble breathing;
- fever, flu symptoms;
- problems with walking or coordination;
- swelling in your hands or feet;
- blurred vision, double vision, unusual eye movements;
- ringing in your ears;
- rash, hair loss; or
- changes in weight or appetite.
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 divalproex sodium?
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 divalproex sodium. 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 divalproex sodium.
