Substance / Medication

Felbamate

Overview

Active Ingredient
felbamate
RxNorm CUI
24812

Indications

Warnings Felbamate tablets, USP are not indicated as a first line antiepileptic treatment (see). Felbamate tablets, USP are 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,

Labeler: Viona Pharmaceuticals IncUpdated: 2026-01-29T00:00:00.000ZFull label on DailyMed

Boxed Warning

FDA Black Box Warning

WARNING: 1 APLASTIC ANEMIA INDICATIONS THE USE OF FELBAMATE IS ASSOCIATED WITH A MARKED INCREASE IN THE INCIDENCE OF APLASTIC ANEMIA. ACCORDINGLY, FELBAMATE SHOULD ONLY BE USED IN PATIENTS WHOSE EPILEPSY IS SO SEVERE THAT THE RISK OF APLASTIC ANEMIA IS DEEMED ACCEPTABLE IN LIGHT OF THE BENEFITS CONF

Contraindications

When this intervention should not be used

Felbamate is contraindicated in patients with known hypersensitivity to felbamate, its ingredients, or known sensitivity to other carbamates. It should not be used in patients with a history of any blood dyscrasia or hepatic dysfunction.

Indications & Related Conditions

Conditions associated via SNOMED clinical relationships

Administration & Protocol

Dosing, route, and treatment protocol

Detailed dosage and administration information is available in the full FDA drug label.

View full prescribing information on DailyMed

Monitoring & Follow-Up

Biomarkers relevant to this intervention via related conditions

No monitoring biomarkers have been mapped yet. Biomarker-intervention linkages are derived through related conditions and will expand as the knowledge graph grows.

Clinical Trials

91 trials linked to this intervention

91
Total Trials
16
Recruiting
33
With Results

Research Evidence

Published studies and systematic reviews

Sort:
Felbamate add-on therapy for drug-resistant focal epilepsy.
Shi Li Li, Bresnahan Rebecca, Martin-McGill Kirsty J et al. · Cochrane Database Syst Rev · 2022
PMID: 35914010Meta-AnalysisFull text (PMC)
Felbamate add-on therapy for drug-resistant focal epilepsy.
Shi Li Li, Bresnahan Rebecca, Martin-McGill Kirsty J et al. · Cochrane Database Syst Rev · 2019
PMID: 31425617Meta-AnalysisFull text (PMC)
Felbamate as an add-on therapy for refractory partial epilepsy.
Shi Li Li, Dong JianCheng, Ni HengJian et al. · Cochrane Database Syst Rev · 2017
PMID: 28718506Meta-AnalysisFull text (PMC)
Felbamate as an add-on therapy for refractory epilepsy.
Shi Li Li, Dong JianCheng, Ni Hengjian et al. · Cochrane Database Syst Rev · 2014
PMID: 25036694Meta-Analysis
Felbamate as an add-on therapy for refractory epilepsy.
Shi Li Li, Dong Jiancheng, Ni Hengjian et al. · Cochrane Database Syst Rev · 2011
PMID: 21249704Meta-Analysis
Comparison of immunological, histological and oxidative effects of felbamate and levetiracetam in traumatic brain injury.
Bayhan I, Turtay M G, Ciftci O et al. · Eur Rev Med Pharmacol Sci · 2020
PMID: 32633403Observational
Long-term use of felbamate: clinical outcomes and effect of age and concomitant antiepileptic drug use on its clearance.
White James R, Leppik Ilo E, Beattie Jeanne L et al. · Epilepsia · 2009
PMID: 19563346Observational
Felbamate reduces hormone release and locomotor hypoactivity induced by repeated stress of social defeat in mice.
Pistovcakova J, Makatsori A, Sulcova A et al. · Eur Neuropsychopharmacol · 2005
PMID: 15695059Observational
Stability and comparative metabolism of selected felbamate metabolites and postulated fluorofelbamate metabolites by postmitochondrial suspensions.
Parker Robert J, Hartman Neil R, Roecklein Bryan A et al. · Chem Res Toxicol · 2005
PMID: 16359174Observational

Research data from MEDLINE/PubMed

Benefits & Expected Outcomes

Benefits, expected outcomes, efficacy data, and NNT (Number Needed to Treat) are pending physician authorship and evidence review.

Risks & Side Effects

Adverse reaction and safety data for this drug is sourced from the FDA-approved label.

View adverse reactions & drug interactions on DailyMed

Related Symptoms

Symptoms associated with conditions this intervention addresses

No related symptoms have been mapped yet. Symptom linkages are derived through associated conditions.

Alternatives & Comparisons

Alternative treatments, comparison data, and clinical decision support are pending physician authorship.

Medical Disclaimer

This information is for educational purposes only and does not constitute medical advice, diagnosis, or treatment. Always consult with a qualified healthcare provider regarding any medical condition or treatment plan.

Do not start, stop, or change any treatment without consulting your healthcare provider.

Quick Facts

Type
Substance / Medication
Fully Specified Name
Felbamate (substance)
SNOMED CT
96194006
UMLS CUI
C0060135
RxNorm CUI
24812
Labeler
Viona Pharmaceuticals Inc

Clinical Data

This intervention maps to 3 entities in the Healos knowledge graph.

3
Conditions
0
Biomarkers
0
Specialists
0
Symptoms
91
Clinical Trials

Data is sourced from SNOMED CT, UMLS, and the Healos clinical knowledge graph. Content sections marked as pending require physician authorship. Consult a healthcare provider before starting any treatment.