FDA label
What is valproic acid used for?
The FDA-approved uses of valproic acid, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for valproic acid (capsule, liquid filled) lists 2 uses: Epilepsy; Important Limitations.
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Valproic Acid, solution
Indications and Usage, quoted from the label by Xttrium Laboratories Inc. (ANDA070868). Cross-references to other label sections are left out.
1.1 Epilepsy
Valproic acid is indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. Valproic acid is indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types which include absence seizures. Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present. See Warnings and Precautions for statement regarding fatal hepatic dysfunction.
1.2 Important Limitations Because of the risk to the fetus of decreased IQ, neurodevelopmental disorders, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, 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. For prophylaxis of migraine headaches, valproate is contraindicated in women who are pregnant and in women of childbearing potential who are not using effective contraception.
Source: DailyMed label, set id 3b124a29-30bd-d30e-e063-6294a90ac4ca, version 2, effective April 2, 2026. NDC 0116-4021, one of 19 listings for this product.
Valproic Acid, capsule, liquid filled
Indications and Usage, quoted from the label by Actavis Pharma, Inc. (ANDA073229). Cross-references to other label sections are left out.
Epilepsy
Valproic Acid is indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. Valproic Acid is indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types which include absence seizures.
Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present.
See Warnings and Precaution for statement regarding fatal hepatic dysfunction.
Important Limitations
Because of the risk to the fetus of decreased IQ, neurodevelopment disorders, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, 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.
For prophylaxis of migraine headaches, valproate is contraindicated in women who are pregnant and in women of childbearing potential who are not using effective contraception.
Source: DailyMed label, set id cef3e335-5891-412f-89c4-79fcd2f145b7, version 20, effective June 2, 2026. NDC 0591-4012, one of 8 listings for this product.
Valproic Acid, capsule
Indications and Usage, quoted from the label by Upsher-Smith Laboratories, LLC (ANDA073229). Cross-references to other label sections are left out.
Epilepsy
Valproic acid capsules are indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures.
Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present.
See Warnings and Precautions for statement regarding fatal hepatic dysfunction.
Important Limitations
Because of the risk to the fetus of decreased IQ, neurodevelopmental disorders, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, 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 [see Warnings and Precautions, Use in Specific Populations, and Patient Counseling Information].
For prophylaxis of migraine headaches, valproate is contraindicated in women who are pregnant and in women of childbearing potential who are not using effective contraception [see Contraindications].
Source: DailyMed label, set id 7d4df6ad-3d53-4664-9200-749487bf3689, version 13, effective July 9, 2025. NDC 0832-0310, one of 3 listings for this product.
Questions
What is valproic acid used for?
The FDA label for valproic acid (capsule, liquid filled) lists 2 uses: Epilepsy; Important Limitations.
What drug class is valproic acid?
FDA lists valproic acid in the Anti-epileptic Agent and Mood Stabilizer established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.