Prescription medicine

Felbamate Brand names: Felbatol

Felbamate (Felbatol) is a prescription medicine with an FDA approval on record since 1993. FDA's NDC Directory lists it from 9 generic labelers, and pharmacies paid $1.00 per felbamate 600 mg tablet in the October 7, 2026 NADAC survey.

Generic listed
Boxed warning

Check it at the source: the felbamate FDA label on DailyMed (effective August 15, 2025, Viatris Specialty LLC); the NDA 20189 record on Drugs@FDA; every felbamate label on DailyMed.

Highlights of the record

FDA label of August 15, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Boxed warning

APLASTIC ANEMIA THE USE OF FELBATOL ®.

(felbamate) IS ASSOCIATED WITH A MARKED INCREASE IN THE INCIDENCE OF APLASTIC ANEMIA. ACCORDINGLY, FELBATOL ® 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 CONFERRED BY ITS USE (SEE INDICATIONS ). ORDINARILY, A PATIENT SHOULD NOT BE PLACED ON AND/OR CONTINUED ON FELBATOL ® WITHOUT CONSIDERATION OF APPROPRIATE EXPERT HEMATOLOGIC CONSULTATION. AMONG FELBATOL ® TREATED PATIENTS, APLASTIC ANEMIA (PANCYTOPENIA IN THE PRESENCE OF A BONE MARROW LARGELY DEPLETED OF HEMATOPOIETIC PRECURSORS) OCCURS AT AN INCIDENCE THAT MAY BE MORE THAN A 100 FOLD GREATER THAN THAT SEEN IN THE UNTREATED POPULATION (I.E., 2 TO 5 PER MILLION PERSONS PER YEAR). THE RISK OF DEATH IN PATIENTS WITH APLASTIC ANEMIA GENERALLY VARIES AS A FUNCTION OF ITS SEVERITY AND ETIOLOGY; CURRENT ESTIMATES OF THE OVERALL CASE FATALITY RATE ARE IN THE RANGE OF 20 TO 30%, BUT RATES AS HIGH AS 70% HAVE BEEN REPORTED IN THE PAST. THERE ARE TOO FEW FELBATOL ® ASSOCIATED CASES, AND TOO LITTLE KNOWN ABOUT THEM TO PROVIDE A RELIABLE ESTIMATE OF THE SYNDROME’S INCIDENCE OR ITS CASE FATALITY RATE OR TO IDENTIFY THE FACTORS, IF ANY, THAT MIGHT CONCEIVABLY BE USED TO PREDICT WHO IS AT GREATER OR LESSER RISK. […]

Used for

From the label: indications and usage
Felbatol ® is not indicated as a first line antiepileptic treatment (see Warnings ).

Forms and strengths

400 mg
600 mg
600 mg/5ml

Tablet; suspension.

On the market

Earliest approval on file: July 29, 1993 Felbatol, Mylan Speciality Lp; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: 8 first September 13, 2011; 7 with a marketed status in Drugs@FDA
Labelers listed (NDC): 10 of which 9 under generic applications, 1 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC): $1.00 per tablet Felbamate 600 mg tablet
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded
FAERS reports: 1,751 through July 30, 2026

What is felbamate used for?

From the label: indications and usage
Felbatol ® is not indicated as a first line antiepileptic treatment (see Warnings ). Felbatol ® 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. […]

Conditions named in the indications of felbamate's FDA labels, with every medicine labeled for each:

Seizures and epilepsy

From other felbamate labels
Seizures and epilepsy: … 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 …

FDA pharmacologic class: Anti-epileptic Agent.

Source: FDA drug label (Felbatol), NDA020189 (Mylan Speciality Lp), as published by Viatris Specialty LLC, effective August 15, 2025 (SPL set 2f522701-397a-11de-8a39-0800200c9a66), via openFDA; the full label on DailyMed

What does the patient leaflet for felbamate say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What is the most important information I should know about FELBATOL?
Do not stop taking FELBATOL without first talking to your healthcare provider. Stopping FELBATOL suddenly can cause serious problems. FELBATOL can cause serious side effects, including: 1. FELBATOL may cause serious blood problems that may be life-threatening. Call your healthcare provider right away if you have any of the following symptoms: • Fever, sore throat or other infections that come and go or do not go away • Frequent infections or an infection that does not go away • Easy bruising • Red or purple spots on your body • Bleeding gums or nose bleeds • Severe fatigue or weakness 2. Liver problems that may be life-threatening. Call your healthcare provider right away if you have any of these symptoms: • yellowing of your skin or the whites of your eyes (jaundice) • dark urine • nausea or vomiting • loss of appetite • pain on the right side of your stomach (abdomen) 3. Like other antiepileptic drugs, FELBATOL may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: • thoughts about suicide or dying • new or worse depression • attempts to commit suicide • feeling agitated or restless • new or worse anxiety • trouble sleeping (insomnia) • panic attacks • acting aggressive, being angry, or violent • new or worse irritability • acting on dangerous impulses • an extreme increase in activity and talking (mania) • other unusual changes in behavior or mood How can I watch for early symptoms of suicidal thoughts and actions? • Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. • Keep all follow-up visits with your healthcare provider as scheduled. […]

From the patient leaflet: What should I avoid while taking FELBATOL?
FELBATOL can cause drowsiness and dizziness. Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking FELBATOL, until you talk with your doctor. Taking FELBATOL with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.

From the patient leaflet: How should I store FELBATOL?
Store FELBATOL at room temperature between 68°F to 77°F (20°C to 25°C). Keep FELBATOL and all medicines out of the reach of children.

Is there a generic for felbamate (Felbatol)?

The FDA approved the first generic felbamate on September 13, 2011. 8 generic applications are approved; 7 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.

FDA's NDC Directory lists felbamate from 9 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

1993 earliest approval on file
2011 first generic approved

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do pharmacies pay for felbamate (Felbatol)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.00 per Felbamate 600 mg tablet, down 29% from $1.41 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.

Felbamate 600 mg tablet (generic)
Felbatol 400 mg tablet (brand)

$14.83

$1.00

January 2024October 2026

NADAC per unit, October 7, 2026
Strength and form	Brand or generic	Pharmacy cost	30 tablets, or one pen or vial	12-month change
Felbamate 400 mg tablet	Generic	$0.798 per tablet	$23.93	-17%
Felbamate 600 mg tablet	Generic	$1.00 per tablet	$30.05	-29%
Felbamate 600 mg/5 mL suspension	Generic	$0.356 per mL	n/a	-2%
Felbatol 400 mg tablet	Brand	$14.69 per tablet	$440.55	-1%
Felbatol 600 mg tablet	Brand	$16.82 per tablet many times the lowest per-tablet cost; NADAC records the price, not why	$504.66	-0.7%

Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price

What does the felbamate label say about other medicines?

The felbamate label names 4 other medicines in its interaction, contraindication or warning sections. The labels of 22 other medicines name felbamate. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine named	Section	What the label says
Carbamazepine	drug interactions	Carbamazepine Felbatol ® causes a decrease in the steady-state carbamazepine plasma concentrations and an increase in the steady-state carbamazepine epoxide plasma concentration.
Erythromycin	drug interactions	Effects of Erythromycin on Felbatol ® The coadministration of erythromycin (1000 mg/day) for 10 days did not alter the pharmacokinetic parameters of C max, C min, AUC, Cl/kg or T max at felbamate daily doses of 3000 or 3600 mg/day in 10 otherwise healthy subjects with epilepsy.
Phenobarbital	drug interactions	AED/Coadministered: Phenobarbital; AED/Concentration: ↑; Felbatol ®/Concentration: ↓
Phenytoin	drug interactions	AED/Coadministered: Phenytoin; AED/Concentration: ↑; Felbatol ®/Concentration: ↓

Other labels that name felbamate

Check felbamate against other medicines

What do FAERS reports show for felbamate?

The FDA Adverse Event Reporting System holds 1,751 reports that list felbamate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 89 are coded as a death and 542 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

The most reported reactions

Seizure352
Drug Ineffective (a use or a product term, not a reaction)257
Off Label Use (a use or a product term, not a reaction)129
Convulsion124
Somnolence (named in the label)110
Condition Aggravated (a use or a product term, not a reaction)92
Fatigue (named in the label)87
Drug Interaction (a use or a product term, not a reaction)71

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as felbamate?

20 other medicines are given the same way (oral) and in the same FDA class as felbamate or labeled mainly for the same use (seizures and epilepsy), the same class first. Seizures and epilepsy lists all 27 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Medicine	Shared indication	Generic labelers (oral)	Pharmacy cost	Shortage
Gabapentin	Seizures and epilepsy	87 labelers	$0.0218 per capsule 100 mg capsule	No current entry
Lamotrigine	Seizures and epilepsy	50 labelers	$0.0268 per tablet 25 mg tablet	A presentation being discontinued
Divalproex	Seizures and epilepsy	44 labelers	$0.194 per tablet 500 mg tablet	No current entry
Oxcarbazepine	Seizures and epilepsy	43 labelers	$0.167 per tablet 300 mg tablet	No current entry
Zonisamide	Seizures and epilepsy	20 labelers	$0.106 per capsule 100 mg capsule	No current entry
Valproic acid	Seizures and epilepsy	19 labelers	$0.243 per capsule 250 mg capsule	Listed; available
Phenytoin	Seizures and epilepsy	23 labelers	$0.145 per capsule 100 mg capsule	No current entry
Primidone	Seizures and epilepsy	21 labelers	$0.0914 per tablet 50 mg tablet	No current entry

Every medicine labeled for the same conditions as felbamate

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

How does felbamate compare with medicines for the same use?

1 side-by-side page set felbamate beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.

Cenobamate

What next?

Alternatives to felbamate: 20 medicines for the same use
Other anti-seizure medicines: the pharmacologic class, with prices and generics
Felbamate side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other