CLOBAZAM

N/A

Manufactured by Lundbeck Pharmaceuticals LLC

43,741 FDA adverse event reports analyzed

Last updated: 2026-04-14

About CLOBAZAM

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

Top Adverse Reactions

SEIZURE4,619 reports
DRUG INEFFECTIVE3,008 reports
OFF LABEL USE2,034 reports
SOMNOLENCE1,797 reports
DRUG INTERACTION1,122 reports
FATIGUE1,090 reports
EPILEPSY807 reports
CONDITION AGGRAVATED794 reports
STATUS EPILEPTICUS698 reports
PRODUCT USE IN UNAPPROVED INDICATION694 reports
PNEUMONIA663 reports
FALL630 reports
AGGRESSION622 reports
DECREASED APPETITE607 reports
DIARRHOEA598 reports
GENERALISED TONIC CLONIC SEIZURE595 reports
VOMITING584 reports
MULTIPLE DRUG RESISTANCE544 reports
PYREXIA543 reports
PRODUCT DOSE OMISSION ISSUE528 reports
DIZZINESS521 reports
FOETAL EXPOSURE DURING PREGNANCY497 reports
CONVULSION485 reports
PRODUCT USE ISSUE466 reports
INSOMNIA445 reports
TOXICITY TO VARIOUS AGENTS445 reports
HEADACHE443 reports
DEATH440 reports
WEIGHT DECREASED425 reports
RASH422 reports
GAIT DISTURBANCE415 reports
NAUSEA408 reports
ABNORMAL BEHAVIOUR392 reports
SEDATION375 reports
DRUG RESISTANCE364 reports
HOSPITALISATION353 reports
OVERDOSE353 reports
WEIGHT INCREASED350 reports
IRRITABILITY339 reports
AGITATION326 reports
CONFUSIONAL STATE324 reports
PARTIAL SEIZURES309 reports
MATERNAL EXPOSURE DURING PREGNANCY304 reports
DRUG WITHDRAWAL CONVULSIONS303 reports
PETIT MAL EPILEPSY303 reports
LETHARGY297 reports
BALANCE DISORDER292 reports
TREMOR290 reports
ATAXIA286 reports
ANXIETY284 reports
CONSTIPATION280 reports
TREATMENT FAILURE276 reports
HYPERSOMNIA275 reports
ASTHENIA274 reports
COGNITIVE DISORDER269 reports
MEMORY IMPAIRMENT269 reports
THROMBOCYTOPENIA267 reports
URINARY TRACT INFECTION264 reports
DYSPNOEA247 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION240 reports
EXPOSURE DURING PREGNANCY240 reports
ENCEPHALOPATHY239 reports
BEHAVIOUR DISORDER229 reports
DRUG DEPENDENCE223 reports
PNEUMONIA ASPIRATION222 reports
DEPRESSION217 reports
INTENTIONAL PRODUCT MISUSE208 reports
MALAISE208 reports
RESPIRATORY DEPRESSION207 reports
HYPOTENSION206 reports
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS202 reports
DYSARTHRIA202 reports
DISTURBANCE IN ATTENTION198 reports
DRUG DOSE OMISSION196 reports
DEPRESSED LEVEL OF CONSCIOUSNESS194 reports
RESPIRATORY FAILURE193 reports
COMA192 reports
PAIN182 reports
DRUG LEVEL INCREASED179 reports
FEELING ABNORMAL174 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS172 reports
SLEEP DISORDER171 reports
SUICIDAL IDEATION167 reports
DEHYDRATION166 reports
DRUG ABUSE165 reports
LOSS OF CONSCIOUSNESS165 reports
ANGER160 reports
HYPONATRAEMIA159 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE159 reports
COUGH157 reports
NASOPHARYNGITIS157 reports
ATONIC SEIZURES155 reports
CARDIAC ARREST151 reports
ABORTION SPONTANEOUS149 reports
SPEECH DISORDER149 reports
HYPERAMMONAEMIA148 reports
INTENTIONAL OVERDOSE148 reports
PRODUCT DOSE OMISSION147 reports
HYPERSENSITIVITY146 reports
ABDOMINAL PAIN145 reports

Report Outcomes

Out of 23,104 classified reports for CLOBAZAM:

Serious 78.4%Non-Serious 21.6%

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

Female9,129 (50.9%)
Male8,533 (47.6%)
Unknown263 (1.5%)

Reports by Age

Age 3527 reports
Age 11411 reports
Age 4402 reports
Age 7384 reports
Age 6379 reports
Age 5378 reports
Age 10357 reports
Age 8319 reports
Age 9316 reports
Age 16304 reports
Age 15294 reports
Age 2289 reports
Age 13288 reports
Age 1272 reports
Age 18248 reports
Age 17247 reports
Age 27232 reports
Age 26230 reports
Age 25227 reports
Age 22226 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 CLOBAZAM?

This profile reflects 43,741 FDA FAERS reports that mention CLOBAZAM. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for CLOBAZAM?

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

Who manufactures CLOBAZAM?

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