Valproic acid is an anti-epileptic agent indicated for monotherapy and adjunctive therapy of complex partial seizures, sole and adjunctive therapy of simple and complex absence seizures, among other approved uses. MedsAcross supplies Valproic acid 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.
Valproic acid is indicated for: Monotherapy and adjunctive therapy of complex partial seizures, sole and adjunctive therapy of simple and complex absence seizures, adjunctive therapy in patients with multiple seizure types that include absence seizures
Source: US FDA prescribing information
Valproic acid 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
Valproic acid is intended for oral administration. Simple and Complex Absence Seizures: Start at 10 to 15 mg/kg/day, increasing at 1 week intervals by 5 to 10 mg/kg/week until seizure control or limiting side effects. Safety of doses above 60 mg/kg/day is not established
Source: US FDA prescribing information
Valproic acid should not be administered to patients with hepatic disease or significant hepatic dysfunction. Valproic acid is contraindicated in patients 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. Valproic acid is contraindicated in patients with known hypersensitivity to the drug. Valproic acid is contraindicated in patients with known urea cycle disorders.
Source: US FDA prescribing information
Boxed warning (life threatening adverse reactions warning: life threatening adverse reactions): Hepatotoxicity, including fatalities, usually during the first 6 months of treatment. Children under the age of two years and patients with mitochondrial disorders are at higher risk. Monitor patients closely, and perform serum liver testing prior to therapy and at frequent intervals thereafter. Hepatotoxicity, evaluate high risk populations and monitor serum liver tests. 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, Valproic acid 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 E xposure Pancreatitis Hyperammonemic encephalopathy Suicidal behavior and ideation Bleeding and other hematopoietic disorders Hypothermia Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan hypersensitivity reactions 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: 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 at 20° to 25°C (68° to 77°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
2 presentations of Valproic acid, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Valproic acid 250 mg/5 mL oral solutionOralGeneric name | — | US FDA | Available on request |
| Valproic acid 250 mg capsuleOralGeneric name | — | US FDA | Available on request |
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 28 February 1978 | 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 Valproic acid in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 2 presentations of Valproic acid and sources them for licensed hospitals, importers and physicians against valid import documents.
Yes. The US FDA first approved Valproic acid on 28 February 1978, according to Drugs@FDA.
No listed presentation of Valproic acid is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Valproic acid is classified under ATC code N03AG01 (Valproic acid).
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