BRIVARACETAM

N/A

Manufactured by Apotex Corp.

10,449 FDA adverse event reports analyzed

Last updated: 2026-04-15

About BRIVARACETAM

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

Top Adverse Reactions

SEIZURE1,810 reports
DRUG INEFFECTIVE568 reports
OFF LABEL USE552 reports
THERAPY INTERRUPTED280 reports
OVERDOSE233 reports
FATIGUE230 reports
SOMNOLENCE216 reports
DIZZINESS213 reports
PRODUCT AVAILABILITY ISSUE211 reports
FALL199 reports
PRODUCT USE ISSUE168 reports
MULTIPLE DRUG RESISTANCE165 reports
GENERALISED TONIC CLONIC SEIZURE162 reports
EPILEPSY151 reports
AGGRESSION148 reports
HEADACHE144 reports
MEMORY IMPAIRMENT128 reports
DEPRESSION127 reports
ANXIETY120 reports
STATUS EPILEPTICUS120 reports
CONDITION AGGRAVATED118 reports
MATERNAL EXPOSURE DURING PREGNANCY109 reports
NAUSEA105 reports
SUICIDAL IDEATION101 reports
VOMITING99 reports
IRRITABILITY96 reports
DRUG INTERACTION95 reports
INSOMNIA93 reports
PRODUCT DOSE OMISSION ISSUE90 reports
PARTIAL SEIZURES87 reports
PETIT MAL EPILEPSY83 reports
CONFUSIONAL STATE81 reports
DEATH81 reports
TREMOR80 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS79 reports
BALANCE DISORDER76 reports
WEIGHT INCREASED73 reports
PRODUCT USE IN UNAPPROVED INDICATION71 reports
DRUG INTOLERANCE69 reports
HOSPITALISATION69 reports
COGNITIVE DISORDER66 reports
RASH66 reports
FEELING ABNORMAL65 reports
INSURANCE ISSUE64 reports
GAIT DISTURBANCE61 reports
BEHAVIOUR DISORDER60 reports
DECREASED APPETITE60 reports
PRESCRIBED OVERDOSE59 reports
WEIGHT DECREASED59 reports
ANGER57 reports
INABILITY TO AFFORD MEDICATION57 reports
PNEUMONIA57 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE56 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION54 reports
ABNORMAL BEHAVIOUR52 reports
STRESS52 reports
ADVERSE DRUG REACTION51 reports
ASTHENIA51 reports
SLEEP DISORDER50 reports
DEPRESSED MOOD49 reports
HEAD INJURY49 reports
CEREBROVASCULAR ACCIDENT47 reports
LOSS OF CONSCIOUSNESS47 reports
MENTAL DISORDER47 reports
SPEECH DISORDER47 reports
ATAXIA46 reports
DRUG RESISTANCE46 reports
HYPONATRAEMIA46 reports
AMNESIA45 reports
HALLUCINATION45 reports
MOOD SWINGS45 reports
DYSPNOEA44 reports
INTENTIONAL PRODUCT MISUSE44 reports
MYOCLONUS44 reports
HYPERSENSITIVITY43 reports
DIPLOPIA42 reports
AGITATION41 reports
INCORRECT DOSE ADMINISTERED41 reports
MALAISE41 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION40 reports
TREATMENT FAILURE40 reports
BRAIN OPERATION39 reports
DIARRHOEA39 reports
DISTURBANCE IN ATTENTION39 reports
MATERNAL EXPOSURE BEFORE PREGNANCY39 reports
TOXICITY TO VARIOUS AGENTS39 reports
THERAPY NON RESPONDER38 reports
COVID 1936 reports
FOETAL EXPOSURE DURING PREGNANCY36 reports
SYNCOPE36 reports
FOCAL DYSCOGNITIVE SEIZURES35 reports
URINARY TRACT INFECTION35 reports
DYSARTHRIA34 reports
MOOD ALTERED34 reports
PAIN34 reports
ALOPECIA32 reports
PYREXIA32 reports
RESTLESSNESS32 reports
SALIVARY HYPERSECRETION32 reports
VISION BLURRED32 reports

Report Outcomes

Out of 4,286 classified reports for BRIVARACETAM:

Serious 94.3%Non-Serious 5.7%

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

Female1,929 (52.8%)
Male1,721 (47.1%)
Unknown2 (0.1%)

Reports by Age

Age 2290 reports
Age 6073 reports
Age 3071 reports
Age 2864 reports
Age 3462 reports
Age 2559 reports
Age 2654 reports
Age 3354 reports
Age 2950 reports
Age 3950 reports
Age 6150 reports
Age 3749 reports
Age 3148 reports
Age 4048 reports
Age 5148 reports
Age 2747 reports
Age 4547 reports
Age 2145 reports
Age 3245 reports
Age 4445 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 BRIVARACETAM?

This profile reflects 10,449 FDA FAERS reports that mention BRIVARACETAM. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for BRIVARACETAM?

Frequently reported terms in FAERS include SEIZURE, DRUG INEFFECTIVE, OFF LABEL USE, THERAPY INTERRUPTED, OVERDOSE, FATIGUE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures BRIVARACETAM?

Labeling and FAERS entries often list Apotex Corp. in connection with BRIVARACETAM. 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.