Levetiracetam: Side Effects, Uses & Monitoring
1.1 Partial Onset Seizures Levetiracetam tablets USP are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.
- Data source
- FDA labeling via NIH DailyMed (label f691fe85…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
| Adverse reaction (as reported in labeling) | Reported frequency* |
|---|---|
| Asthenia | 15% |
| Somnolence | 15% |
| Vomiting | 15% |
| Nasopharyngitis | 15% |
| Headache | 14% |
| Infection | 13% |
| Fatigue | 11% |
| Aggression | 10% |
| Dizziness | 9% |
| Abdominal pain upper | 9% |
| Cough | 9% |
| Nasal congestion | 9% |
| Decreased appetite | 8% |
| Pain | 7% |
| Abnormal behavior | 7% |
| Irritability | 7% |
| Pharyngolaryngeal pain | 7% |
| Pharyngitis | 6% |
| Diarrhea | 6% |
| Lethargy | 6% |
*Highest percentage reported for the active moiety across placebo-controlled trial tables in current FDA labeling. Values reflect trial reporting, not your individual risk.
Labeled uses (from FDA prescribing information)
1.1 Partial Onset Seizures Levetiracetam tablets USP are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy. Information describing the use of levetiracetam in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.'s levetiracetam tablets. However, due to UCB, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy Levetiracetam tablets USP are indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. 1.3 Primary Generalized Tonic-Clonic Seizures Levetiracetam tablets USP are indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.
Conditions associated with Levetiracetam in labeling
Frequently Asked Questions
What is Levetiracetam used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Levetiracetam?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Levetiracetam. Individual risk varies.
Does Levetiracetam require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Levetiracetam.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.