Divalproex is an anti-epileptic agent indicated for treatment of manic episodes associated with bipolar disorder, among other approved uses. It is available as delayed-release tablets, extended-release tablets and capsules for oral use. MedsAcross supplies Divalproex for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
Depakote is an anti-epileptic drug indicated for: Treatment of manic episodes associated with bipolar disorder. Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures, adjunctive therapy in patients with multiple seizure types that include absence seizures. Prophylaxis of migraine headaches
Source: US FDA prescribing information
Divalproex sodium dissociates to the valproate ion in the gastrointestinal tract. The mechanisms by which valproate exerts its therapeutic effects have not been established. It has been suggested that its activity in epilepsy is related to increased brain concentrations of gamma-aminobutyric acid (GABA).
Source: US FDA prescribing information
Depakote tablets are intended for oral administration. Depakote tablets should be swallowed whole and should not be crushed or chewed. Patients should be informed to take Depakote every day as prescribed. If a dose is missed it should be taken as soon as possible, unless it is almost time for the next dose. If a dose is skipped, the patient should not double the next dose. Depakote is administered orally in divided doses. Depakote should be swallowed whole and should not be crushed or chewed. Mania: Initial dose is 750 mg daily, increasing as rapidly as possible to achieve therapeutic response or desired plasma level. The maximum recommended dosage is 60 mg/kg/day.
Source: US FDA prescribing information
Depakote is contraindicated in patients: • with hepatic disease or significant hepatic dysfunction. • known to have mitochondrial disorders caused by mutations in mitochondrial DNA polymerase γ (POLG, e.g., Alpers-Huttenlocher Syndrome) and children under two years of age who are suspected of having a POLG-related disorder. • with known hypersensitivity to divalproex sodium, sodium valproate, or valproic acid. Reactions have included multiorgan hypersensitivity, serious dermatologic reactions, and angioedema. • with known urea cycle disorders.
Source: US FDA prescribing information
Boxed warning (life threatening adverse reactions): Hepatotoxicity General Population: Hepatic failure resulting in fatalities has occurred in patients receiving valproate and its derivatives. These incidents usually have occurred during the first six months of treatment. Serious or fatal hepatotoxicity may be preceded by non-specific symptoms such as malaise, weakness, lethargy, facial edema, anorexia, and vomiting. Birth defects, decreased IQ, and neurodevelopmental disorders following in utero exposure: Should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant or to treat a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable. Pancreatitis: Depakote should ordinarily be discontinued.
Source: US FDA prescribing information
The following serious adverse reactions are described below and elsewhere in the labeling: Hepatic Failure Birth Defects Decreased IQ and Neurodevelopmental Disorders Following in utero Exposure Pancreatitis Hyperammonemic Encephalopathy Suicidal Behavior and Ideation Bleeding and Other Hematopoietic Disorders Hypothermia Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity Reactions Serious Dermatologic Reactions Angioedema Somnolence in the Elderly Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Source: US FDA prescribing information
Hepatic enzyme-inducing drugs (e.g., phenytoin, carbamazepine, phenobarbital, primidone, rifampin) can increase valproate clearance, while enzyme inhibitors (e.g., felbamate) can decrease valproate clearance. Therefore increased monitoring of valproate and concomitant drug concentrations and dosage adjustment are indicated whenever enzyme-inducing or inhibiting drugs are introduced or withdrawn. Aspirin, carbapenem antibiotics, estrogen-containing hormonal contraceptives, methotrexate: Monitoring of valproate concentrations is recommended. Co-administration of valproate can affect the pharmacokinetics of other drugs (e.g., diazepam, ethosuximide, lamotrigine, phenytoin) by inhibiting their metabolism or protein binding displacement. Patients stabilized on rufinamide should begin valproate therapy at a low dose, and titrate to clinically effective dose.
Source: US FDA prescribing information
Store tablets below 86°F (30°C).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
13 presentations of Divalproex, sorted by availability.
3 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 10 March 1983 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Divalproex in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 13 presentations of Divalproex and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 3 brand names for Divalproex, including Depakote, Depakote ER, Depakote Sprinkles.
Yes. The US FDA first approved Divalproex on 10 March 1983, according to Drugs@FDA.
No listed presentation of Divalproex is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Divalproex is classified under ATC code N03AG01 (Valproic acid).
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