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Depakote XR Extended Release
Divalproex Sodium (Valproate semisodium)
$65.00
250mg · 150 tablets · 6 months supply
BrandBranded medicine· By Sanofi
$10.83 per month
Strength
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Annual cost
$130a 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). Divalproex sodium extended-release tablets are 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, divalproex sodium extended-release tablets should only be used after other anticonvulsants have failed. This older group of patients should be closely monitored during treatment with divalproex sodium extended-release tablets 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 and neurodevelopmental disorders following in utero exposure.
Valproate is therefore contraindicated for prophylaxis of migraine headaches in pregnant women and in women of childbearing potential who are not using effective contraception
Valproate should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant unless other medications have failed to provide adequate symptom control or are otherwise unacceptable.
Valproate should not be administered to a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable. In such situations, effective contraception should be used
A Medication Guide describing the risks of valproate is available for patients
Pancreatitis
About Depakote XR Extended Release
Overview
Depakote XR is a prescription medicine containing divalproex sodium in extended-release tablets. It treats acute manic or mixed episodes associated with bipolar disorder and certain seizures, including complex partial and absence seizures, in adults and children aged 10 years and older. It is also used to prevent migraines, but there is no evidence that it treats a migraine already underway. How it works is not established, but its effect on seizures may be linked to increased levels of the brain chemical 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, used alone or with other medicines. Also used with other medicines for multiple seizure types that include absence seizures. - Prevention of migraine headaches, not treatment of an attack already in progress.
Safety information
Side effects
Common side effects include nausea, vomiting, stomach pain, indigestion, diarrhea, sleepiness, dizziness, headache, tremor, weakness, hair loss, double vision, difficulty sleeping, infections and a low blood platelet count. Serious side effects include liver failure, inflammation of the pancreas (pancreatitis), increased ammonia in the blood that can affect brain function, bleeding and other blood disorders, abnormally low body temperature, severe skin reactions, serious allergic reactions that can affect several organs, and swelling beneath the skin (angioedema). Sleepiness is also a particular concern in older adults. Antiepileptic medicines, including divalproex sodium, increase the risk of suicidal thoughts or behavior. Seek prompt medical attention for stomach pain, nausea, vomiting or loss of appetite, as these may be symptoms of pancreatitis. Liver injury can be fatal and occurs most often during the first six months of treatment. Contact a doctor promptly for unusual weakness, marked tiredness, facial swelling, loss of appetite, vomiting or worsening seizure control. Unexplained lethargy, vomiting or changes in mental state may indicate raised ammonia levels. Contact a doctor immediately for suicidal thoughts or behavior, unusual bleeding, severe skin reactions or swelling beneath the skin. Exposure during pregnancy can cause major birth defects, reduced IQ and developmental disorders in the child. Contact your prescriber if you become pregnant or plan a pregnancy. Do not stop valproate abruptly, as this can trigger prolonged, 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). Divalproex sodium extended-release tablets are 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, divalproex sodium extended-release tablets should only be used after other anticonvulsants have failed. This older group of patients should be closely monitored during treatment with divalproex sodium extended-release tablets 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 and neurodevelopmental disorders following in utero exposure.
Valproate is therefore contraindicated for prophylaxis of migraine headaches in pregnant women and in women of childbearing potential who are not using effective contraception
Valproate should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant unless other medications have failed to provide adequate symptom control or are otherwise unacceptable.
Valproate should not be administered to a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable. In such situations, effective contraception should be used
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 divalproex sodium extended-release tablets if you have liver disease or significant liver dysfunction; a known mitochondrial disorder caused by a POLG gene mutation, such as Alpers-Huttenlocher syndrome; a known urea cycle disorder; or an allergy to divalproex sodium, sodium valproate or valproic acid. They must not be used in children under two years old with a suspected POLG-related disorder. Do not use this medicine to prevent migraines if you are pregnant, or if you could become pregnant and are not using effective contraception. Valproate can cause major birth defects, reduced IQ and neurodevelopmental disorders in children exposed during pregnancy. For epilepsy or bipolar disorder, it should not be used during pregnancy or when planning pregnancy unless other medicines have not worked adequately or are unsuitable. The same restriction applies to anyone who could become pregnant, and effective contraception is needed during treatment. Do not stop treatment abruptly, as this can trigger life-threatening seizures. Serious, sometimes fatal liver injury can occur, usually during the first six months. Liver tests are needed before treatment and frequently afterwards. Extra caution is needed with a history of liver disease, use of several seizure medicines, congenital metabolic disorders or certain severe neurological conditions. Children under two years old are at particularly high risk. In patients over two with suspected hereditary mitochondrial disease, this medicine should be used only after other seizure medicines have failed, with close liver monitoring. Other important risks include life-threatening inflammation of the pancreas, suicidal thoughts or behaviour, bleeding problems, raised blood ammonia, low body temperature and severe allergic or skin reactions. Abdominal pain, nausea, vomiting or loss of appetite require prompt medical assessment. Unexplained marked tiredness, vomiting or changes in mental state may require ammonia testing, particularly with topiramate use. Platelet counts and blood-clotting tests should be monitored. Older adults need monitoring for drowsiness and adequate food and fluid intake.
Interactions
Valproate can interact with several medicines. Your doctor may need to check medicine levels, monitor for side effects or adjust treatment when another medicine is started or stopped. Important interactions include: • Other seizure medicines, including phenytoin, carbamazepine, phenobarbital, primidone, ethosuximide, felbamate and rufinamide. These can change valproate levels or have their own levels affected by valproate. Phenobarbital and primidone may cause severe effects on alertness and nervous system function when combined with valproate. • Lamotrigine: valproate slows its removal from the body. Serious skin reactions have been reported with this combination. • Topiramate: the combination can cause high blood ammonia levels, sometimes with impaired brain function. • Clonazepam: the combination may trigger prolonged absence seizures in people with a history of this seizure type. • Carbapenem antibiotics, such as ertapenem, imipenem and meropenem: these can substantially lower valproate levels and lead to loss of seizure control. • Estrogen-containing hormonal contraceptives and methotrexate: these may lower valproate levels. Seizures may become more frequent; methotrexate may also lead to increased bipolar symptoms. • Rifampin and ritonavir: these may increase how quickly valproate is removed from the body. • Aspirin: this can increase the amount of unbound valproate in the blood and slow its breakdown. Caution and monitoring are recommended. • Amitriptyline, nortriptyline, diazepam and zidovudine: valproate can affect their levels or removal from the body. • Propofol: valproate can increase its blood levels, with a risk of increased sedation and reduced breathing or heart function. • Warfarin and other anticoagulants: blood-clotting tests should be monitored when valproate is started. • Cannabidiol: use with valproate can raise liver enzyme levels. This is not a complete list of possible medicine interactions.
Using Depakote XR Extended Release
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 DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [REMEDYREPACK INC.] (DailyMed, retrieved 19 September 2026).
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