FDA label
What is felbamate used for?
The FDA-approved uses of felbamate, 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 says: “Felbamate tablets, USP is not indicated as a first line antiepileptic treatment (see Warnings ). Felbamate is recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use.”
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Felbamate, tablet
Indications and Usage, quoted from the label by Sun Pharmaceutical Industries, Inc. (ANDA207093). Cross-references to other label sections are left out.
Felbamate tablets, USP is not indicated as a first line antiepileptic treatment (see Warnings ). Felbamate is recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use.
If these criteria are met and the patient has been fully advised of the risk, and has provided written acknowledgement, felbamate can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome in children.
Source: DailyMed label, set id f2edb3ed-da20-4093-88ea-00fe781e47e0, version 7, effective June 3, 2026. NDC 51672-4185, one of 16 listings for this product.
Questions
What is felbamate used for?
The FDA label says: “Felbamate tablets, USP is not indicated as a first line antiepileptic treatment (see Warnings ). Felbamate is recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use.”
What drug class is felbamate?
FDA lists felbamate in the Anti-epileptic Agent 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.