What is VALPROATE SODIUM used for?

VALPROATE SODIUM (brand name Valproate Sodium) is a Anticonvulsant indicated for neurodevelopmental disorders, neural tube defects, and other major congenital malformations.

What are the most common side effects of VALPROATE SODIUM?

Reported side effects vary by individual. The side-effects section on this page lists the events most frequently reported to FDA FAERS for VALPROATE SODIUM. FAERS is voluntary reporting, so it reflects what was reported, not absolute incidence.

Is VALPROATE SODIUM the same as Valproate Sodium?

Valproate Sodium is a brand name for VALPROATE SODIUM. They share the same active ingredient and FDA-approved indications. Biosimilars and authorised generics may differ in inactive ingredients such as buffers or preservatives.

VALPROATE SODIUM

Q: How does VALPROATE SODIUM work?

VALPROATE SODIUM works through the following mechanism: 12.1 Mechanism of Action Valproate sodium exists as the valproate ion in the blood. 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)..

Anticonvulsant

Brand names: Valproate Sodium, Depakote, Depakene

Intravenous

Mechanism of Action

12.1 Mechanism of Action Valproate sodium exists as the valproate ion in the blood. 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).

Indications

neurodevelopmental disorders

neural tube defects

and other major congenital malformations

which may occur very early in pregnancy

5.3

5.4 )

Contraindications

• e.g.
• 5.3
• 5.4 ) and Use in Specific Populations ( 8.1 )] . • Hepatic disease or significant hepatic dysfunction ( 4
• 5.1 ) • Known mitochondrial disorders caused by mutations in mitochondrial DNA polymerase γ (POLG) ( 4
• 5.1 ) • Suspected POLG-related disorder in children under two years of age ( 4

FDA Warnings

5 WARNINGS AND PRECAUTIONS • Hepatotoxicity; evaluate high risk populations and monitor serum liver tests ( 5
1 Hepatotoxicity General Information on Hepatotoxicity Hepatic failure resulting in fatalities has occurred in patients receiving valproate
Serious or fatal hepatotoxicity may be preceded by non-specific symptoms such as malaise, weakness, lethargy, facial edema, anorexia, and vomiting
Patients on multiple anticonvulsants, children, those with congenital metabolic disorders, those with severe seizure disorders accompanied by mental retardation, and those with organic brain disease may be at particular risk

Known Side Effects

7 documented side effects by frequency

Drug Not Working

>10%

Drowsiness

1-10%

Fever

1-10%

Vomiting

0.1-1%

Diarrhea

0.1-1%

Weight Gain

0.1-1%

Condition Worsened

0.1-1%

Community Discussions

No community discussions found for VALPROATE SODIUM yet.

Primary sources

Every figure on this page links back to its primary source. See data sources for full provenance.

DailyMed FDA label search → VALPROATE SODIUM openFDA label JSON → VALPROATE SODIUM FAERS adverse-event reports → VALPROATE SODIUM ClinicalTrials.gov → completed Phase 2+ trials of VALPROATE SODIUM

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Formulations

Dosage Forms

Tablet

Route

Intravenous