Important Safety Information | Depakote® (divalproex sodium) (2023)


DEPAKOTE comes in different dosage forms. DEPAKOTE® (divalproex sodium) delayed-release tablets, for oral use, and DEPAKOTE® ER (divalproex sodium) extended-release tablets, for oral use, are prescription medications used:

  • to treat manic episodes associated with bipolar disorder
  • alone or with other medicines to treat:
    • complex partial seizures in adults and children 10 years of age and older
    • simple and complex absence seizures, with or without other seizure types
  • to prevent migraine headaches

DEPAKOTE® Sprinkle Capsules (divalproex sodium delayed release capsules), for oral use, is a prescription medicine used alone or with other medicines to treat:

  • complex partial seizures in adults and children 10 years of age and older
  • simple and complex absence seizures, with or without other seizure types


The most important information about DEPAKOTE is:

Do not stop taking DEPAKOTE without first talking to your healthcare provider. Stopping DEPAKOTE suddenly can cause serious problems.

DEPAKOTE can cause serious side effects, including:

  • Serious liver damage that can cause death, especially in children younger than 2 years old. The risk of getting this serious liver damage is more likely to happen within the first 6 months of treatment. In some cases, liver damage may continue despite stopping the drug. Call your healthcare provider right away if you get any of the following symptoms: nausea or vomiting that does not go away, loss of appetite, pain on the right side of your stomach (abdomen), dark urine, swelling of your face, or yellowing of your skin or the whites of your eyes.
  • DEPAKOTE may harm your unborn baby. If you take DEPAKOTE during pregnancy for any medical condition, your baby is at risk for serious birth defects that affect the brain and spinal cord and are called spina bifida or neural tube defects. These defects occur in 1 to 2 out of every 100 babies born to mothers who use this medicine during pregnancy. These defects can begin in the first month, even before you know you are pregnant. Other birth defects that affect the structures of the heart, head, arms, legs, and the opening where the urine comes out (urethra) on the bottom of the penis can also happen. Birth defects may occur even in children born to women who are not taking any medicines and do not have other risk factors. Taking folic acid supplements before getting pregnant and during early pregnancy can lower the chance of having a baby with a neural tube defect. If you take DEPAKOTE during pregnancy for any medical condition, your child is at risk for having a lower IQ and may be at risk for developing autism or attention-deficit/hyperactivity disorder. There may be other medicines to treat your condition that have a lower chance of causing birth defects, decreased IQ, or other disorders in your child. Women who are pregnant must not take DEPAKOTE to prevent migraine headaches. All women of childbearing age (including girls from the start of puberty) should talk to their healthcare provider about using other possible treatments instead of DEPAKOTE. If the decision is made to use DEPAKOTE, you should use effective birth control (contraception). Tell your healthcare provider right away if you become pregnant while taking DEPAKOTE. You and your healthcare provider should decide if you will continue to take DEPAKOTE while you are pregnant. Pregnancy Registry: If you become pregnant while taking DEPAKOTE, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling toll-free 1-888-233-2334 or by visiting the website, The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.
  • Inflammation of your pancreas that can cause death. Call your healthcare provider right away if you have any of these symptoms: severe stomach pain that you may also feel in your back, nausea or vomiting that does not go away.
  • Like other antiepileptic drugs, DEPAKOTE may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying; attempts to commit suicide; new or worse depression; new or worse anxiety; feeling agitated or restless; panic attacks; trouble sleeping (insomnia); new or worse irritability; acting aggressive, being angry, or violent; acting on dangerous impulses; an extreme increase in activity and talking (mania); other unusual changes in behavior or mood. How can I watch for early symptoms of suicidal thoughts and actions? Pay attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not take DEPAKOTE if you:

  • have liver problems
  • have or think you have a genetic liver problem caused by a mitochondrial disorder (e.g., Alpers Huttenlocher Syndrome)
  • are allergic to divalproex sodium, valproic acid, sodium valproate, or any of the ingredients in DEPAKOTE
  • have a genetic problem called urea cycle disorder
  • are taking it to prevent migraine headaches and are either pregnant or may become pregnant because you are not using effective birth control (contraception)

Before taking DEPAKOTE, tell your healthcare provider if you:

  • have a genetic liver problem caused by a mitochondrial disorder (e.g., Alpers Huttenlocher Syndrome)
  • drink alcohol
  • are pregnant or breastfeeding since DEPAKOTE can pass into breast milk. Ask your healthcare provider about the best way to feed your baby.
  • have or have had depression, mood problems, or suicidal thoughts or behavior
  • have any other medical condition

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, herbalsupplements.

Taking DEPAKOTE with certain other medicines, even for a short period of time, can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.

DEPAKOTE can cause other serious side effects, including:

  • Bleeding problems: red or purple spots on your skin, bruising, pain and swelling into your joints due to bleeding or bleeding from your mouth ornose.
  • High ammonia levels in your blood: feeling tired, vomiting, changes in mental status.
  • Low body temperature (hypothermia): drop in your body temperature to less than 95º F, feeling tired, confusion, coma.
  • Allergic (hypersensitivity) reactions: fever, skin rash, hives, sores in your mouth, blistering and peeling of your skin, swelling of your lymph nodes, swelling of your face, eyes, lips, tongue, or throat, trouble swallowing or breathing.
  • Drowsiness or sleepiness in the elderly. This extreme drowsiness may cause you to eat or drink less than you normally would. Tell your doctor if you are not able to eat or drink as you normally do. Your doctor may start you at a lower dose of DEPAKOTE.

Common side effects of DEPAKOTE include:

  • nausea
  • vomiting
  • dizziness
  • double vision
  • weight gain
  • problems with walking or coordination
  • headache
  • weakness
  • stomach pain
  • diarrhea
  • hair loss
  • sleepiness
  • tremor
  • blurry vision
  • increased appetite
  • loss of appetite

Please see the full Prescribing Information, including Medication Guide, for additional information about DEPAKOTE. Talk to your healthcare provider if you have questions.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088.

If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit to learn more.

If you have any questions about AbbVie's website that have not been answered, click here. This website and the information contained herein is intended for use by US residents only, is provided for informational purposes only, and is not intended to replace a discussion with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider and consider the unique characteristics of eachpatient.


What are the precautions of divalproex sodium? ›

Divalproex sodium may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. Do not stop using this medicine without first checking with your doctor.

What is the safety of Depakote? ›

It is a safe and effective medication when used as directed. It is important to note that some of the side effects listed above (particularly changes in platelets, liver or pancreas problems, and suicidal thoughts) may continue to occur or worsen if you continue taking the medication.

What are the warnings and precautions for Depakote? ›

See also Warning section. Diarrhea, dizziness, drowsiness, hair loss, blurred/double vision, change in menstrual periods, ringing in the ears, shakiness (tremor), unsteadiness, weight changes may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

What information concerning valproate Depakote should you communicate to the patient? ›

Patients and guardians should be warned that abdominal pain, nausea, vomiting, and/or anorexia can be symptoms of pancreatitis that require prompt medical evaluation. If pancreatitis is diagnosed, valproate should ordinarily be discontinued.

What should I monitor with divalproex? ›

THREE things that should be “routinely” checked in persons taking valproate are discussed below–complete blood count, hepatic function tests, and serum valproic acid level.

What are the special instructions for divalproex? ›

Take this medication by mouth as directed by your doctor. You may take it with food if stomach upset occurs. Swallow the tablet whole. Do not crush or chew the tablet, which can irritate the mouth or throat.

Why is divalproex a hazardous drug? ›

DEPAKOTE can cause serious side effects, including: Serious liver damage that can cause death, especially in children younger than 2 years old. The risk of getting this serious liver damage is more likely to happen within the first 6 months of treatment.

Is Depakote high risk? ›

Taking Depakote has been linked to some serious and even deadly side effects. Liver damage is one of the side effects that may be fatal. This is especially true in children under 2. This risk is highest in the first months of taking the medication.

What are signs of Depakote toxicity? ›

CNS findings in cases of VPA overdose may include the following:
  • Coma.
  • Confusion.
  • Somnolence.
  • Worsened seizure control.
  • Dizziness.
  • Hallucinations.
  • Irritability.
  • Headache.
Oct 25, 2021

What can you teach a patient about Depakote? ›

Divalproex sodium should be taken with food, so take your doses with a snack or just after you have had a meal. If you have been given delayed or extended release tablets, swallow them whole with a drink of water. Do not chew or crush the tablets because they have a special protective coating.

Does Depakote need monitoring? ›

Depakote levels are routinely checked with blood tests to make sure you have neither too little nor too much in your system. Too little will render it ineffective while too much may be toxic.

Is there a black box warning on Depakote? ›

Depakote side effects include damage to the liver and pancreas. In 2006, the FDA required that the drug's label feature a black-box warning indicating an increased risk of pancreatitis and liver failure. Evidence suggests that hepatotoxicity most typically occurs within the patient's first six months taking Depakote.

What are the nursing considerations for valproic acid? ›

Nursing considerations
  • History: Hypersensitivity to valproic acid; hepatic impairment; pregnancy, lactation.
  • Physical: Weight; skin color, lesions; orientation, affect, reflexes; bowel sounds, normal output; CBC and differential, bleeding time tests, LFTs, serum ammonia level, exocrine pancreatic function tests, EEG.

What do I report when taking valproic acid? ›

Report pain in the abdomen, upset stomach, vomiting, or loss of appetite to the doctor right away. Problems with blood clotting are more likely in people who take large amounts of valproic acid. Sometimes the blood returns to normal without stopping the medicine.

What is contraindicated with Depakote? ›

Depakote is contraindicated in patients with known hypersensitivity to the drug [see Warnings and Precautions (5.11)]. Depakote is contraindicated in patients with known urea cycle disorders [see Warnings and Precautions (5.5)]. Hepatic failure resulting in fatalities has occurred in patients receiving valproate.

What is the black box warning for divalproex? ›

Suicidal Behavior and Ideation Antiepileptic drugs, (AEDs), including Depakote, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication.

What are the most common side effects of divalproex? ›

A: Common side effects experienced with Depakote include drowsiness, nausea, abdominal pain, diarrhea, vomiting, low platelet count, tremors, tiredness, and hair loss. The side effects may be mild to moderate, but they may also be signs of a more serious condition.

How often should divalproex levels be checked? ›

Typically, when taking divalproex-ER once daily in the morning, a blood sample collected 21 to 24 hours later is expected to have a concentration within 3% of the trough value.

Should divalproex be taken with food? ›

You may take this medicine with food to avoid stomach upset. Swallow the sprinkle capsules whole. It may also be opened and the contents may be sprinkled onto a teaspoonful of soft food, such as applesauce or pudding.

Can you drink coffee while taking divalproex? ›

Talk to your doctor before starting any exercise program to make sure it won't interfere with your medication. Get plenty of sleep. If you have trouble sleeping, talk to your doctor or mental health provider about what you can do. Avoid caffeine.

Can divalproex be taken on an empty stomach? ›

Most doctors recommend taking Depakote with food to avoid an upset stomach, but it can also be taken without food. Because food affects the way medicine is used by the body, try to be consistent day in and day out.

What precautions should be taken for hazardous medication? ›

When possible, avoid cutting, crushing, or otherwise manipulating pills or capsules. This might produce powder that can contaminate a workplace and may expose workers. When manipulating hazardous drugs, use effective engineering controls and personal protective equipment.

Is divalproex a safe drug? ›

Divalproex sodium may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you notice any of these side effects, tell your doctor right away.

How common is liver damage with Depakote? ›

Liver damage is a rare side effect of Depakote or Depakote ER. These drugs have a boxed warning about risk of liver damage. Boxed warnings are the most serious warnings from the Food and Drug Administration (FDA). They alert doctors and patients about drug effects that may be dangerous.

How often should Depakote levels be monitored? ›

Monitor Depakote levels, liver function tests, and CBC with diff every 3-6 months.

What are the 5 high risk medications? ›

High risk medications
  • A – Antimicrobials.
  • P – Potassium and other electrolytes, psychotropic medications.
  • I – Insulin.
  • N – Narcotics, opioids and sedatives.
  • C – Chemotherapeutic agents.
  • H – Heparin and other anticoagulants.
  • S – Safer systems (e.g. safe administration of liquid medications using oral syringes)

Why do doctors check Depakote levels? ›

A Depakote blood test measures the levels of valproic acid in your blood. It's important to monitor this level if you are taking this medication because it can pose risks to children and pregnant women, and increase the risk of liver damage or pancreatic inflammation, among other side effects.

What are the two rare significant side effects of valproic acid? ›

In men valproic acid has been reported to cause infertility. However, this is rare. In women it can change your menstrual cycle, causing delayed or missed periods. Valproic acid has also been reported to cause polycystic ovary syndrome (PCOS), though this happens rarely.

Does Depakote damage the brain? ›

MRI scans showed that those taking Depakote had thinning of the parietal lobes of the brain, had lower total brain volume, and lower white matter volume. This was a small study, but it was conducted because of previous reports of brain atrophy.

When should I start checking my Depakote levels? ›

Trough levels should be obtained 12 hours post-dose for DR and 24 hours post-dose for ER formulations.

Does Depakote raise blood pressure? ›

Depakote (divalproex) is good for long-term prevention of seizures, manic episodes in bipolar disorder, and migraines. Lowers blood pressure and controls heart rate.

What are the nursing considerations? ›

With medication administration, a nursing consideration would include the following: Are there any reasons why this patient shouldn't have this medication? What will the effect of this medicine be on this patient? Is there anything I need to ask or teach this patient before or after the administration?

What are the five things to check before giving medication to a client? ›

One of the recommendations to reduce medication errors and harm is to use the “five rights”: the right patient, the right drug, the right dose, the right route, and the right time.

What are nurses responsibilities with respect to medications? ›

Nurses' responsibility for medication administration includes ensuring that the right medication is properly drawn up in the correct dose, and administered at the right time through the right route to the right patient. To limit or reduce the risk of administration errors, many hospitals employ a single-dose system.

What to avoid while taking valproic acid? ›

Some products that may interact with this drug include: certain antidepressants (such as amitriptyline, nortriptyline, phenelzine), certain antibiotics (carbapenems such as imipenem), irinotecan, mefloquine, orlistat, other medications for seizure (such as ethosuximide, lamotrigine, rufinamide, topiramate), rifampin, ...

How do you monitor sodium valproate? ›

  1. do not routinely measure plasma valproate evels unless there is evidence of ineffectiveness, poor adherence or toxicity.
  2. measure the person's weight or BMI and carry out liver function tests and a full blood count again after 6 months of treatment with valproate and repeat annually.

What is the warning on valproate? ›

Valproate (Epilim, Depakote and other generic brands) is associated with a significant risk of birth defects and developmental disorders in children born to women who take valproate during pregnancy.

Who should not take divalproex? ›

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.

Does divalproex affect blood clotting? ›

Valproic acid inhibits the formation of blood clots by interfering with the clot-promoting effects of platelets. This can cause abnormal bleeding.

What are the long term side effects of divalproex sodium? ›

Divalproex sodium may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you notice any of these side effects, tell your doctor right away.

What are the long term side effects of Depakote? ›

Yes, it's possible for Depakote and Depakote ER to cause long-term side effects. Liver damage, including liver failure, has been reported. Pancreatitis (swelling and damage of the pancreas) has also been reported, including in people who've taken Depakote for years.


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