FDA label
What is levetiracetam used for?
The FDA-approved uses of levetiracetam, 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 levetiracetam (tablet, film coated) lists 3 uses: Partial-Onset Seizures; Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy; Primary Generalized Tonic-Clonic Seizures.
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Levetiracetam, tablet, film coated
Indications and Usage, quoted from the label by NCS HealthCare of KY, LLC dba Vangard Labs (ANDA214815). Cross-references to other label sections are left out.
Partial-Onset Seizures
Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older.
Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy
Levetiracetam tablets are indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy.
Primary Generalized Tonic-Clonic Seizures
Levetiracetam tablets are indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy.
Source: DailyMed label, set id dfb7c640-623e-43d1-8ee8-479dccd53d0a, version 7, effective January 16, 2025. NDC 0615-8498, one of 121 listings for this product.
Levetiracetam, injection
Indications and Usage, quoted from the label by B. Braun Medical Inc. (ANDA209705). Cross-references to other label sections are left out.
Partial-Onset Seizures
Levetiracetam in Sodium Chloride Injection is indicated as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy.
Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy
Levetiracetam in Sodium Chloride Injection is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults with juvenile myoclonic epilepsy.
Primary Generalized Tonic-Clonic Seizures
Levetiracetam in Sodium Chloride Injection is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults with idiopathic generalized epilepsy.
Limitations of Use
Levetiracetam in Sodium Chloride Injection is an antiepileptic drug indicated for adult patients (16 years and older) when oral administration is temporarily not feasible.
Source: DailyMed label, set id ad32ec2f-b4e0-4811-8ea1-7a4abdd5c0a6, version 17, effective April 23, 2024. NDC 0264-1009, one of 40 listings for this product.
Questions
What is levetiracetam used for?
The FDA label for levetiracetam (tablet, film coated) lists 3 uses: Partial-Onset Seizures; Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy; Primary Generalized Tonic-Clonic Seizures.
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.
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