Felbamate: Side Effects, Uses & Monitoring
Felbamate oral suspension is not indicated as a first line antiepileptic treatment (see Warnings ).
- Data source
- FDA labeling via NIH DailyMed (label 2e325d79…)
- 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* |
|---|---|
| Nausea | 34.2% |
| Somnolence | 19.3% |
| Anorexia | 19.3% |
| Dizziness | 18.4% |
| Headache | 18% |
| Purpura | 12.9% |
| Hiccup | 9.7% |
| Insomnia | 8.6% |
| Dyspepsia | 8.6% |
| Vomiting | 8.6% |
| Urinary incontinence | 7.4% |
| Nervousness | 7% |
| Upper respiratory tract infection | 7% |
| Fatigue | 6.9% |
| Constipation | 6.9% |
| Rhinitis | 6.9% |
| Pain | 6.5% |
| Thinking abnormal | 6.5% |
| Emotional lability | 6.5% |
| Miosis | 6.5% |
*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)
Felbamate oral suspension is not indicated as a first line antiepileptic treatment (see Warnings ). Felbamate oral suspension 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 acknowledgment, felbamate oral suspension 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.
Conditions associated with Felbamate in labeling
Anemia
A condition in which the blood has a lower than normal number of red blood cells or hemoglobin, reducing oxyge...
Epilepsy
A neurological disorder characterized by recurrent, unprovoked seizures. Management focuses on seizure control...
Lennox-Gastaut syndrome
Lennox-Gastaut syndrome is a medical condition that may be associated with various symptoms and signs....
Frequently Asked Questions
What is Felbamate 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 Felbamate?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Felbamate. Individual risk varies.
Does Felbamate require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Felbamate.
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.