VIGABATRIN

N/A

Manufactured by Lundbeck Pharmaceuticals LLC

19,478 FDA adverse event reports analyzed

Last updated: 2026-04-14

About VIGABATRIN

VIGABATRIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Lundbeck Pharmaceuticals LLC. The most commonly reported adverse reactions for VIGABATRIN include SEIZURE, DRUG INEFFECTIVE, DRUG DOSE OMISSION, DEATH, SOMNOLENCE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for VIGABATRIN.

Top Adverse Reactions

SEIZURE2,561 reports
DRUG INEFFECTIVE1,361 reports
DRUG DOSE OMISSION990 reports
DEATH855 reports
SOMNOLENCE552 reports
PNEUMONIA523 reports
DRUG WITHDRAWAL CONVULSIONS465 reports
VOMITING457 reports
OFF LABEL USE423 reports
PRODUCT DOSE OMISSION ISSUE334 reports
HOSPITALISATION312 reports
EPILEPSY296 reports
INFANTILE SPASMS295 reports
CONDITION AGGRAVATED283 reports
IRRITABILITY273 reports
CONVULSION268 reports
PYREXIA267 reports
STATUS EPILEPTICUS252 reports
ADVERSE EVENT251 reports
INSOMNIA229 reports
FATIGUE225 reports
MAGNETIC RESONANCE IMAGING HEAD ABNORMAL197 reports
PRODUCT USE ISSUE171 reports
MALAISE169 reports
VISUAL IMPAIRMENT168 reports
DRUG RESISTANCE163 reports
MULTIPLE DRUG RESISTANCE163 reports
AGGRESSION159 reports
RESPIRATORY FAILURE158 reports
INCORRECT DOSE ADMINISTERED145 reports
ABNORMAL BEHAVIOUR143 reports
DECREASED APPETITE143 reports
DRUG INTERACTION142 reports
NASOPHARYNGITIS141 reports
DYSPNOEA140 reports
RESPIRATORY DISTRESS138 reports
VISUAL FIELD DEFECT138 reports
LETHARGY136 reports
URINARY TRACT INFECTION133 reports
RESPIRATORY DISORDER131 reports
RASH130 reports
PNEUMONIA ASPIRATION129 reports
DIARRHOEA127 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS127 reports
FALL125 reports
TREMOR124 reports
COUGH120 reports
DIZZINESS116 reports
WEIGHT INCREASED116 reports
CRYING113 reports
RETINOGRAM ABNORMAL112 reports
CONSTIPATION111 reports
GENERALISED TONIC CLONIC SEIZURE109 reports
TOXICITY TO VARIOUS AGENTS109 reports
AGITATION106 reports
INFLUENZA106 reports
HYPOTONIA105 reports
PRODUCT DOSE OMISSION104 reports
EAR INFECTION102 reports
MUSCLE SPASMS102 reports
VIRAL INFECTION101 reports
PRESCRIBED OVERDOSE91 reports
DYSKINESIA89 reports
PARTIAL SEIZURES89 reports
PRODUCT USE IN UNAPPROVED INDICATION89 reports
TREATMENT FAILURE89 reports
RESPIRATORY SYNCYTIAL VIRUS INFECTION88 reports
ADVERSE DRUG REACTION85 reports
SURGERY82 reports
ENCEPHALOPATHY81 reports
NAUSEA81 reports
DEHYDRATION80 reports
INFECTION78 reports
RHINOVIRUS INFECTION77 reports
BRAIN OPERATION75 reports
UPPER RESPIRATORY TRACT INFECTION74 reports
OXYGEN SATURATION DECREASED73 reports
INFANTILE SPITTING UP72 reports
PRODUCT PREPARATION ERROR72 reports
THERAPY NON RESPONDER70 reports
SEDATION67 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE67 reports
GAIT DISTURBANCE65 reports
BLINDNESS64 reports
HEADACHE64 reports
HYPERSOMNIA63 reports
WEIGHT DECREASED61 reports
ASPIRATION60 reports
EYE MOVEMENT DISORDER60 reports
RESPIRATORY TRACT INFECTION60 reports
DYSPHAGIA59 reports
TONIC CONVULSION59 reports
ACUTE RESPIRATORY FAILURE58 reports
RETINAL DISORDER58 reports
WRONG TECHNIQUE IN DRUG USAGE PROCESS58 reports
ASTHENIA57 reports
SLEEP DISORDER56 reports
POOR QUALITY PRODUCT ADMINISTERED55 reports
BRONCHITIS54 reports
COVID 1954 reports

Report Outcomes

Out of 14,065 classified reports for VIGABATRIN:

Serious 69.7%Non-Serious 30.3%

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

Male6,361 (51.3%)
Female6,031 (48.6%)
Unknown19 (0.2%)

Reports by Age

Age 1948 reports
Age 2723 reports
Age 3516 reports
Age 4440 reports
Age 6396 reports
Age 5384 reports
Age 7382 reports
Age 10344 reports
Age 8331 reports
Age 9326 reports
Age 11280 reports
Age 12171 reports
Age 13156 reports
Age 14145 reports
Age 0135 reports
Age 18120 reports
Age 17118 reports
Age 15115 reports
Age 16115 reports
Age 2099 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 VIGABATRIN?

This profile reflects 19,478 FDA FAERS reports that mention VIGABATRIN. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for VIGABATRIN?

Frequently reported terms in FAERS include SEIZURE, DRUG INEFFECTIVE, DRUG DOSE OMISSION, DEATH, SOMNOLENCE, PNEUMONIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures VIGABATRIN?

Labeling and FAERS entries often list Lundbeck Pharmaceuticals LLC in connection with VIGABATRIN. 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.