Meds & supplements › Felbamate
Medicine · Anti-epileptic Agent
Felbamate oral suspension, USP is not indicated as a first line antiepileptic treatment (see Warnings ).
Selected manufacturer label information, organised into consistent sections by Sofidex. Read the full label at DailyMed ↗
WARNING 1. APLASTIC ANEMIA THE USE OF FELBAMATE ORAL SUSPENSION, USP IS ASSOCIATED WITH A MARKED INCREASE IN THE INCIDENCE OF APLASTIC ANEMIA. ACCORDINGLY, FELBAMATE ORAL SUSPENSION 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 FELBAMATE ORAL SUSPENSION WITHOUT CONSIDERATION OF APPROPRIATE EXPERT HEMATOLOGIC CONSULTATION. AMONG FELBAMATE 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 FELBAMATE 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. IN MANAGING PATIENTS ON FELBAMATE ORAL SUSPENSION, IT SHOULD BE BORNE IN MIND THAT THE CLINICAL MANIFESTATION OF APLASTIC ANEMIA MAY NOT BE SEEN UNTIL AFTER A PATIENT HAS BEEN ON FELBAMATE ORAL SUSPENSION FOR SEVERAL MONTHS (E.G., ONSET OF APLASTIC ANEMIA AMONG FELBAMATE EXPOSED PATIENTS FOR WHOM DATA ARE AVAILABLE HAS RANGED FROM 5 TO 30 WEEKS). HOWEVER, THE INJURY TO BONE MARROW STEM CELLS THAT IS HELD TO BE ULTIMATELY RESPONSIBLE FOR THE ANEMIA MAY OCCUR WEEKS TO MONTHS EARLIER. ACCORDINGLY, PATIENTS WHO ARE DISCONTINUED FROM FELBAMATE ORAL SUSPENSION REMAIN AT RISK FOR DEVELOPING ANEMIA FOR A VARIABLE, AND UNKNOWN, PERIOD AFTERWARDS. IT IS NOT KNOWN WHETHER OR NOT THE RISK OF DEVELOPING APLASTIC ANEMIA CHANGES WITH DURATION OF EXPOSURE. CONSEQUENTLY, IT IS NOT SAFE TO ASSUME THAT A PATIENT WHO HAS BEEN ON FELBAMATE ORAL SUSPENSION WITHOUT SIGNS OF HEMATOLOGIC ABNORMALITY FOR LONG PERIODS OF TIME IS WITHOUT RISK. IT IS NOT KNOWN WHETHER OR NOT THE DOSE OF FELBAMATE ORAL SUSPENSION AFFECTS THE INCIDENCE OF APLASTIC ANEMIA. IT IS NOT KNOWN WHETHER OR NOT CONCOMITANT USE OF ANTIEPILEPTIC DRUGS AND/OR OTHER DRUGS AFFECTS THE INCIDENCE OF APLASTIC ANEMIA. APLASTIC ANEMIA TYPICALLY DEVELOPS WITHOUT PREMONITORY CLINICAL OR LABORATORY SIGNS, THE FULL BLOWN SYNDROME PRESENTING WITH SIGNS OF INFECTION, BLEEDING, OR ANEMIA. ACCORDINGLY, ROUTINE BLOOD TESTING CANNOT BE RELIABLY USED TO REDUCE THE INCIDENCE OF APLASTIC ANEMIA, BUT, IT WILL, IN SOME CASES, ALLOW THE DETECTION OF THE HEMATOLOGIC CHANGES BEFORE THE SYNDROME DECLARES ITSELF CLINICALLY. FELBAMATE ORAL SUSPENSION SHOULD BE DISCONTINUED IF ANY EVIDENCE OF BONE MARROW DEPRESSIO
Felbamate oral suspension is a prescription medicine used when other treatments have failed in:
Do not stop taking felbamate oral suspension without first talking to your healthcare provider.
Stopping felbamate oral suspension suddenly can cause serious problems.
Felbamate oral suspension can cause serious side effects, including:
1. Felbamate oral suspension may cause serious blood problems that may be life-threatening.
Call your healthcare provider right away if you have any of the following symptoms:
2. Liver problems that may be life-threatening. Call your healthcare provider right away if you have any of these symptoms:
3. Like other antiepileptic drugs, felbamate oral suspension 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:
Felbamate oral suspension may cause serious side effects including:
The most common side effects of felbamate oral suspension include:
These are not all the possible side effects of felbamate oral suspension. For more information, ask your healthcare provider or pharmacist.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Do not take felbamate oral suspension if you:
Before you take felbamate oral suspension, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Taking felbamate oral suspension with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.
Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
Keep felbamate oral suspension and all medicines out of the reach of children.
General information about felbamate oral suspension.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use felbamate oral suspension for a condition for which it was not prescribed. Do not give felbamate oral suspension to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about felbamate oral suspension. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about felbamate oral suspension that is written for health professionals.
For more information call Taro at 1-866-923-4914.
Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
Do not stop felbamate oral suspension without first talking to a healthcare provider.
Stopping felbamate oral suspension suddenly can cause serious problems. You should talk to your health care provider before stopping. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures.
Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.
sofidex [Internet]. Daloreum; c2026. Felbamate; [reviewed 2026 Aug 2; cited 2026 Nov 10]. Available from: https://sofidex.com/patients/medicines/felbamate
sofidex. (2026, August 2). Felbamate. Daloreum. Retrieved November 10, 2026, from https://sofidex.com/patients/medicines/felbamate
Felbamate. sofidex. Reviewed August 2, 2026. Accessed November 10, 2026. https://sofidex.com/patients/medicines/felbamate
The cited date is today’s, because a citation records when you read the page. The reviewed date is when a clinician last checked it.