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Depakote
Divalproex Sodium (Valproate semisodium)
$90.00
250mg · 2 × 90 tablets · 3 months supply
BrandBranded medicine· By Sanofi
$30.00 per month
Strength
How long a supply?
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Annual cost
$360a year at this pack size
Prescription required
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250mg
500mg
FDA boxed warningLife threatening adverse reactions
Hepatotoxicity
General Population:
Patients with Mitochondrial Disease: There is an increased risk of valproate-induced acute liver failure and resultant deaths in patients with hereditary neurometabolic syndromes caused by DNA mutations of the mitochondrial DNA Polymerase γ (POLG) gene (e.g. Alpers Huttenlocher Syndrome). Depakote ER is contraindicated in patients known to have mitochondrial disorders caused by POLG mutations and children under two years of age who are clinically suspected of having a mitochondrial disorder. In patients over two years of age who are clinically suspected of having a hereditary mitochondrial disease, Depakote ER should only be used after other anticonvulsants have failed. This older group of patients should be closely monitored during treatment with Depakote ER for the development of acute liver injury with regular clinical assessments and serum liver testing. POLG mutation screening should be performed in accordance with current clinical practice.
Fetal Risk
Valproate can cause major congenital malformations, particularly neural tube defects (e.g., spina bifida). In addition, valproate can cause decreased IQ scores following in utero exposure.
Valproate is therefore contraindicated in pregnant women treated for prophylaxis of migraine. Valproate should only be used to treat pregnant women with epilepsy or bipolar disorder if other medications have failed to control their symptoms or are otherwise unacceptable.
Valproate should not be administered to a woman of childbearing potential unless the drug is essential to the management of her medical condition. This is especially important when valproate use is considered for a condition not usually associated with permanent injury or death (e.g., migraine). Women should use effective contraception while using valproate.
A Medication Guide describing the risks of valproate is available for patients.
Pancreatitis
About Depakote
Overview
Depakote contains divalproex sodium, an anti-epileptic medicine. It treats acute manic or mixed episodes associated with bipolar disorder, and is used alone or with other medicines for certain seizures in adults and children aged 10 years and older. It also helps prevent migraine headaches but has not been shown to treat a migraine once it starts. How it works is not fully established, but its effects on seizures may be related to increased levels of a brain chemical called GABA.
What it treats
- Acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features. - Complex partial seizures and simple or complex absence seizures in adults and children aged 10 years and older, alone or alongside other medicines. Also used alongside other medicines for multiple seizure types that include absence seizures. - Prevention of migraine headaches, not treatment of an active migraine attack. It must not be used for migraine prevention during pregnancy.
Safety information
Side effects
Common side effects include nausea, vomiting, stomach pain, indigestion, diarrhea, constipation, sleepiness, dizziness, weakness, headache and tremor. Changes in appetite, weight gain, hair loss, rash, blurred or double vision, problems with balance or coordination, sleep problems, mood changes and memory or thinking difficulties have also been reported. Serious side effects require prompt medical attention: • Liver damage or liver failure, which can be fatal, most often during the first six months of treatment. Warning signs include unusual weakness or tiredness, facial swelling, loss of appetite, vomiting or worsening seizure control. • Inflammation of the pancreas, which can be life-threatening and can occur soon after starting treatment or after years of use. Stomach pain, nausea, vomiting or loss of appetite need prompt medical assessment. • Low platelet counts and problems with blood clotting. Contact a doctor about unusual bruising or bleeding. • Raised ammonia levels that can affect brain function. Unexplained marked tiredness, vomiting or changes in mental alertness need prompt assessment. • Suicidal thoughts or behavior. Seek medical help immediately if these occur. • Serious allergic reactions affecting several organs, abnormally low body temperature, and excessive sleepiness in older adults. Valproate can cause major birth defects and lower IQ in children exposed during pregnancy. Contact your prescriber promptly if you become pregnant or plan a pregnancy. It must not be used to prevent migraine during pregnancy. Do not stop treatment abruptly, as this can trigger life-threatening seizures.
FDA boxed warning
Life threatening adverse reactions
Hepatotoxicity
General Population:
Patients with Mitochondrial Disease: There is an increased risk of valproate-induced acute liver failure and resultant deaths in patients with hereditary neurometabolic syndromes caused by DNA mutations of the mitochondrial DNA Polymerase γ (POLG) gene (e.g. Alpers Huttenlocher Syndrome). Depakote ER is contraindicated in patients known to have mitochondrial disorders caused by POLG mutations and children under two years of age who are clinically suspected of having a mitochondrial disorder. In patients over two years of age who are clinically suspected of having a hereditary mitochondrial disease, Depakote ER should only be used after other anticonvulsants have failed. This older group of patients should be closely monitored during treatment with Depakote ER for the development of acute liver injury with regular clinical assessments and serum liver testing. POLG mutation screening should be performed in accordance with current clinical practice.
Fetal Risk
Valproate can cause major congenital malformations, particularly neural tube defects (e.g., spina bifida). In addition, valproate can cause decreased IQ scores following in utero exposure.
Valproate is therefore contraindicated in pregnant women treated for prophylaxis of migraine. Valproate should only be used to treat pregnant women with epilepsy or bipolar disorder if other medications have failed to control their symptoms or are otherwise unacceptable.
Valproate should not be administered to a woman of childbearing potential unless the drug is essential to the management of her medical condition. This is especially important when valproate use is considered for a condition not usually associated with permanent injury or death (e.g., migraine). Women should use effective contraception while using valproate.
A Medication Guide describing the risks of valproate is available for patients.
Pancreatitis
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
Do not take Depakote if you have liver disease or significantly impaired liver function, an allergy to divalproex sodium, a known urea cycle disorder, or a mitochondrial disorder caused by a POLG gene mutation, such as Alpers-Huttenlocher syndrome. It must not be used in children under two years with a suspected POLG-related disorder, or during pregnancy to prevent migraine. Valproate can cause major birth defects and reduced IQ in children exposed during pregnancy. For epilepsy or bipolar disorder, it should be used during pregnancy or when planning pregnancy only if other treatments have failed or are unacceptable. If you could become pregnant, it should be used only when essential, with effective contraception. Discuss pregnancy plans and folic acid supplementation with your prescriber. Do not stop treatment abruptly to avoid potentially life-threatening seizures. Particular caution is needed with a history of liver disease, suspected hereditary mitochondrial disease, congenital metabolic disorders, severe seizure disorders with intellectual disability, organic brain disease, or use of several anticonvulsants. Children under two years have a much higher risk of fatal liver injury. Liver tests are needed before treatment and regularly afterward, especially during the first six months. A personal or family history suggesting a urea cycle disorder may require assessment before treatment. Other serious risks include pancreatitis, suicidal thoughts or behaviour, low platelet counts and clotting problems, raised blood ammonia, low body temperature, severe allergic reactions affecting several organs, and reported brain shrinkage. Platelet counts and clotting tests require monitoring. Unexplained lethargy, vomiting or mental changes require assessment for raised ammonia, particularly with topiramate use. Abdominal pain, nausea, vomiting or loss of appetite require prompt medical assessment for pancreatitis. Older adults need monitoring for excessive sleepiness and inadequate food or fluid intake.
Interactions
Depakote (divalproex sodium) can interact with other medicines. Important combinations to discuss with your doctor include: • Aspirin: may increase the amount of unbound valproate in the blood. Monitoring of valproate levels is recommended. • Carbapenem antibiotics, such as ertapenem, imipenem and meropenem: can substantially lower valproate levels and lead to loss of seizure control. Frequent blood-level monitoring is recommended. • Phenytoin, carbamazepine, phenobarbital, primidone and rifampin: can increase how quickly valproate is removed from the body. Felbamate can increase valproate levels. Closer monitoring may be needed when these medicines are started or stopped. • Lamotrigine: valproate slows its removal from the body. Serious skin reactions have been reported with this combination. • Topiramate: this combination has been associated with high blood ammonia, sometimes with effects on brain function. • Phenobarbital and primidone: valproate may increase their effects. Severe suppression of nervous system activity has been reported with barbiturates, requiring close monitoring. • Clonazepam: the combination may trigger prolonged absence seizures in people with a history of absence seizures. • Warfarin and other anticoagulants: blood-clotting tests should be monitored when valproate is started. • Amitriptyline, nortriptyline, diazepam, ethosuximide and zidovudine: valproate can affect their levels or how quickly the body removes them. Monitoring or prescriber-led treatment adjustments may be needed. Valproate can also alter phenytoin and carbamazepine levels or their breakdown products. Breakthrough seizures have been reported with phenytoin. This is not a complete list of possible medicine interactions.
Using Depakote
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store below 25°C in a dry place, in the original pack, away from direct light and moisture. Do not keep it in a bathroom. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label DEPAKOTE ER (DIVALPROEX SODIUM) TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] (DailyMed, retrieved 19 September 2026).
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