FDA label
What is topiramate used for?
The FDA-approved uses of topiramate, 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 topiramate lists 3 uses: Monotherapy Epilepsy; Adjunctive Therapy Epilepsy; Migraine.
Run it in Rivvi
Which 2027 plans near you dropped or restricted topiramate?
Tier changes and new prior auth, step therapy or quantity limits, plan by plan.
Free to start. Opens Rivvi, the AI workspace for healthcare teams.
Topiramate, tablet, film coated
Indications and Usage, quoted from the label by Sun Pharmaceutical Industries, Inc. (ANDA090278). Cross-references to other label sections are left out.
Monotherapy Epilepsy
Topiramate tablets are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older.
Adjunctive Therapy Epilepsy
Topiramate tablets are indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older.
Migraine
Topiramate tablets are indicated for the preventive treatment of migraine in patients 12 years of age and older.
Source: DailyMed label, set id 3c909a53-ae66-4b28-a741-b60bb25a69cf, version 24, effective June 1, 2026. NDC 47335-707, one of 129 listings for this product.
Questions
What is topiramate used for?
The FDA label for topiramate lists 3 uses: Monotherapy Epilepsy; Adjunctive Therapy Epilepsy; Migraine.
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.
More on Topiramate
- Is Topiramate a controlled substance?Federal schedule
- Generic for Qudexy XRFDA Orange Book
- Generic for Trokendi XRFDA Orange Book
- Generic for TopamaxFDA Orange Book
- Generic for Topamax SprinkleFDA Orange Book
- Generic for EprontiaFDA Orange Book
- What is Topamax used for?FDA label uses
- Is Topamax a controlled substance?Federal schedule
- What is Trokendi XR used for?FDA label uses
- Is Trokendi XR a controlled substance?Federal schedule
- NDC 0245-1071Topiramate NDC record
- NDC 0245-1072Topiramate NDC record
- NDC 0245-1073Topiramate NDC record