RUFINAMIDE

N/A

Manufactured by Eisai Inc.

5,100 FDA adverse event reports analyzed

Last updated: 2026-04-15

About RUFINAMIDE

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

Top Adverse Reactions

SEIZURE611 reports
DRUG INEFFECTIVE374 reports
OFF LABEL USE217 reports
SOMNOLENCE173 reports
DIARRHOEA114 reports
CONDITION AGGRAVATED113 reports
VOMITING102 reports
FATIGUE101 reports
DRUG INTERACTION99 reports
MULTIPLE DRUG RESISTANCE91 reports
PRODUCT USE IN UNAPPROVED INDICATION83 reports
FALL82 reports
DECREASED APPETITE81 reports
GENERALISED TONIC CLONIC SEIZURE80 reports
PNEUMONIA79 reports
CONVULSION77 reports
DRUG RESISTANCE77 reports
EPILEPSY77 reports
WEIGHT DECREASED76 reports
AGGRESSION73 reports
DEATH68 reports
STATUS EPILEPTICUS65 reports
HOSPITALISATION62 reports
PYREXIA61 reports
PRODUCT DOSE OMISSION ISSUE60 reports
DIZZINESS57 reports
TREATMENT FAILURE57 reports
PRODUCT USE ISSUE55 reports
LETHARGY52 reports
ATONIC SEIZURES51 reports
NAUSEA51 reports
RASH50 reports
INSOMNIA45 reports
THERAPY NON RESPONDER44 reports
URINARY TRACT INFECTION43 reports
CONSTIPATION41 reports
IRRITABILITY41 reports
PETIT MAL EPILEPSY40 reports
ABNORMAL BEHAVIOUR39 reports
TONIC CONVULSION39 reports
AGITATION38 reports
COGNITIVE DISORDER38 reports
GAIT DISTURBANCE37 reports
PNEUMONIA ASPIRATION36 reports
ASTHENIA34 reports
ATAXIA33 reports
WEIGHT INCREASED33 reports
RESPIRATORY FAILURE32 reports
BEHAVIOUR DISORDER31 reports
DRUG DOSE OMISSION31 reports
SEDATION30 reports
BALANCE DISORDER29 reports
HEADACHE29 reports
COUGH26 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION26 reports
MYOCLONIC EPILEPSY25 reports
SEIZURE CLUSTER25 reports
ANXIETY24 reports
MALAISE23 reports
TOXICITY TO VARIOUS AGENTS23 reports
TREMOR23 reports
ANGER22 reports
HYPERSOMNIA22 reports
STILLBIRTH22 reports
PRODUCT SUPPLY ISSUE21 reports
ABORTION SPONTANEOUS20 reports
NASOPHARYNGITIS20 reports
PRESCRIBED OVERDOSE20 reports
ABDOMINAL DISCOMFORT19 reports
MEMORY IMPAIRMENT19 reports
NEPHROLITHIASIS19 reports
ADVERSE DRUG REACTION18 reports
ANTICONVULSANT DRUG LEVEL INCREASED18 reports
CRYING18 reports
PARTIAL SEIZURES18 reports
PRODUCT ADMINISTRATION INTERRUPTED18 reports
DEPRESSION17 reports
INFLUENZA17 reports
INTENTIONAL OVERDOSE17 reports
MATERNAL EXPOSURE DURING PREGNANCY17 reports
MOTOR DYSFUNCTION17 reports
OXYGEN SATURATION DECREASED17 reports
PSYCHOTIC DISORDER17 reports
CONTUSION16 reports
ENCEPHALOPATHY16 reports
PAIN16 reports
SEPSIS16 reports
SUDDEN UNEXPLAINED DEATH IN EPILEPSY16 reports
CONFUSIONAL STATE15 reports
COVID 1915 reports
DRUG LEVEL INCREASED15 reports
HYPERAMMONAEMIA15 reports
ILLNESS15 reports
MITRAL VALVE INCOMPETENCE15 reports
PRODUCT DOSE OMISSION15 reports
SPEECH DISORDER15 reports
SUICIDAL IDEATION15 reports
TREATMENT NONCOMPLIANCE15 reports
TRICUSPID VALVE INCOMPETENCE15 reports
URINARY RETENTION15 reports

Report Outcomes

Out of 2,478 classified reports for RUFINAMIDE:

Serious 71.0%Non-Serious 29.0%

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

Male887 (51.4%)
Female833 (48.3%)
Unknown6 (0.3%)

Reports by Age

Age 1077 reports
Age 368 reports
Age 750 reports
Age 1548 reports
Age 445 reports
Age 842 reports
Age 641 reports
Age 1140 reports
Age 1339 reports
Age 1938 reports
Age 1436 reports
Age 1231 reports
Age 2830 reports
Age 229 reports
Age 2229 reports
Age 2128 reports
Age 2328 reports
Age 3328 reports
Age 527 reports
Age 1727 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 RUFINAMIDE?

This profile reflects 5,100 FDA FAERS reports that mention RUFINAMIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for RUFINAMIDE?

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

Who manufactures RUFINAMIDE?

Labeling and FAERS entries often list Eisai Inc. in connection with RUFINAMIDE. 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.