Valproate Information
Valproate products are FDA-approved drugs to treat seizures. Some valproate products are also approved to treat manic or mixed episodes associated with bipolar disorder (manic-depressive disorder), or for the prevention of migraine headaches. FDA-approved product labeling identifies approved indications for each product. They are also used off-label (for unapproved uses) for other conditions, particularly for other psychiatric conditions.
Valproate products include: valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and their generics.
Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program using the contact information at the bottom of this page.
Related Information
- FDA Drug Safety Communication: Valproate Anti-seizure Products Contraindicated for Migraine Prevention in Pregnant Women due to Decreased IQ Scores in Exposed Children
- FDA Drug Safety Podcast for Healthcare Professionals: Children born to mothers who took Valproate products while pregnant may have impaired cognitive development
- FDA Drug Safety Communication: Children born to mothers who took Valproate products while pregnant may have impaired cognitive development
- Questions and Answers: Children born to mothers who took the anti-seizure medication Valproate while pregnant may have impaired cognitive development
- Information for Healthcare Professionals: Risk of Neural Tube Birth Defects following prenatal exposure to Valproate
- Suicidal Behavior and Ideation and Antiepileptic Drugs
- FDA Requires Warnings about Risk of Suicidal Thoughts and Behavior for Antiepileptic Medications
- Information for Healthcare Professionals: Suicidal Behavior and Ideation and Antiepileptic Drugs
- FDA Alerts Health Care Providers to Risk of Suicidal Thoughts and Behavior with Antiepileptic Medications
Labeling and Regulatory History from Drugs@FDA
- Depakote (divalproex sodium) Delayed Release Tablets – Prescribing and Labeling Information
- Depakote (divalproex sodium) Delayed Release Capsules – Prescribing and Labeling Information
- Depakote (divalproex sodium) Extended Release Tablets – Prescribing and Labeling Information
- Depakene (valproic acid) – Prescribing and Labeling Information