FELBAMATE

N/A

Manufactured by Viatris Specialty LLC

3,510 FDA adverse event reports analyzed

Last updated: 2026-04-15

About FELBAMATE

FELBAMATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Viatris Specialty LLC. The most commonly reported adverse reactions for FELBAMATE include SEIZURE, DRUG INEFFECTIVE, CONVULSION, OFF LABEL USE, SOMNOLENCE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for FELBAMATE.

Top Adverse Reactions

SEIZURE345 reports
DRUG INEFFECTIVE251 reports
CONVULSION124 reports
OFF LABEL USE115 reports
SOMNOLENCE108 reports
CONDITION AGGRAVATED92 reports
FATIGUE85 reports
DRUG INTERACTION71 reports
TOXICITY TO VARIOUS AGENTS71 reports
VOMITING70 reports
FALL60 reports
GENERALISED TONIC CLONIC SEIZURE60 reports
DIARRHOEA59 reports
WEIGHT DECREASED52 reports
PNEUMONIA50 reports
DECREASED APPETITE47 reports
EPILEPSY47 reports
NAUSEA46 reports
DIZZINESS42 reports
PRODUCT USE IN UNAPPROVED INDICATION42 reports
PYREXIA42 reports
MULTIPLE DRUG RESISTANCE41 reports
TACHYCARDIA41 reports
TREATMENT FAILURE41 reports
LETHARGY40 reports
ATONIC SEIZURES32 reports
RASH32 reports
AGGRESSION31 reports
STATUS EPILEPTICUS30 reports
ASTHENIA29 reports
GAIT DISTURBANCE29 reports
HOSPITALISATION29 reports
NEPHROLITHIASIS29 reports
PRODUCT SUBSTITUTION ISSUE29 reports
WEIGHT INCREASED28 reports
HEADACHE27 reports
INSOMNIA27 reports
URINARY TRACT INFECTION27 reports
DRUG DOSE OMISSION26 reports
IRRITABILITY26 reports
PRODUCT DOSE OMISSION ISSUE26 reports
BALANCE DISORDER25 reports
DRUG WITHDRAWAL CONVULSIONS25 reports
OVERDOSE25 reports
PETIT MAL EPILEPSY25 reports
AGITATION24 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION24 reports
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS24 reports
ABNORMAL BEHAVIOUR23 reports
CARDIAC ARREST22 reports
CONSTIPATION22 reports
COUGH22 reports
DRUG HYPERSENSITIVITY22 reports
MALAISE22 reports
SEDATION22 reports
TREMOR21 reports
AMNESIA20 reports
DEATH20 reports
DYSPNOEA20 reports
HYPERSOMNIA20 reports
DEPRESSED LEVEL OF CONSCIOUSNESS19 reports
PNEUMONIA ASPIRATION19 reports
APHASIA18 reports
ELECTROCARDIOGRAM QRS COMPLEX PROLONGED18 reports
INCORRECT DOSE ADMINISTERED18 reports
ABDOMINAL PAIN UPPER16 reports
CARDIOTOXICITY16 reports
CIRCULATORY COLLAPSE16 reports
CONFUSIONAL STATE16 reports
DIPLOPIA16 reports
ELECTROCARDIOGRAM ST SEGMENT ELEVATION16 reports
MEMORY IMPAIRMENT16 reports
ADVERSE DRUG REACTION15 reports
ATRIOVENTRICULAR BLOCK FIRST DEGREE15 reports
DEHYDRATION15 reports
FEELING ABNORMAL15 reports
GRAND MAL CONVULSION15 reports
HYPOTENSION15 reports
LARYNGEAL STENOSIS15 reports
NASOPHARYNGITIS15 reports
ABDOMINAL PAIN14 reports
BEHAVIOUR DISORDER14 reports
RENAL FAILURE14 reports
RESPIRATORY ACIDOSIS14 reports
SEIZURE CLUSTER14 reports
UNMASKING OF PREVIOUSLY UNIDENTIFIED DISEASE14 reports
VENTRICULAR EXTRASYSTOLES14 reports
DRUG LEVEL DECREASED13 reports
ELECTROCARDIOGRAM REPOLARISATION ABNORMALITY13 reports
HEAD INJURY13 reports
HYPERTENSION13 reports
SINUS BRADYCARDIA13 reports
DEPRESSION12 reports
DEVELOPMENTAL DELAY12 reports
DROOLING12 reports
GASTROOESOPHAGEAL REFLUX DISEASE12 reports
JOINT INJURY12 reports
PAIN12 reports
RESPIRATORY FAILURE12 reports
ROAD TRAFFIC ACCIDENT12 reports

Report Outcomes

Out of 1,714 classified reports for FELBAMATE:

Serious 70.9%Non-Serious 29.1%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female694 (51.6%)
Male643 (47.8%)
Unknown7 (0.5%)

Reports by Age

Age 638 reports
Age 1736 reports
Age 235 reports
Age 431 reports
Age 731 reports
Age 1231 reports
Age 327 reports
Age 1826 reports
Age 2326 reports
Age 2624 reports
Age 3024 reports
Age 1323 reports
Age 5223 reports
Age 1922 reports
Age 2822 reports
Age 1121 reports
Age 2221 reports
Age 2721 reports
Age 820 reports
Age 1020 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with FELBAMATE?

This profile reflects 3,510 FDA FAERS reports that mention FELBAMATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for FELBAMATE?

Frequently reported terms in FAERS include SEIZURE, DRUG INEFFECTIVE, CONVULSION, OFF LABEL USE, SOMNOLENCE, CONDITION AGGRAVATED. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures FELBAMATE?

Labeling and FAERS entries often list Viatris Specialty LLC in connection with FELBAMATE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.