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  1. Postmarket Drug Safety Information for Patients and Providers

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

Labeling and Regulatory History from Drugs@FDA

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