PHENOBARBITAL

N/A

Manufactured by Chartwell Governmental & Specialty RX, LLC.

25,712 FDA adverse event reports analyzed

Last updated: 2026-04-14

About PHENOBARBITAL

PHENOBARBITAL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Chartwell Governmental & Specialty RX, LLC.. The most commonly reported adverse reactions for PHENOBARBITAL include DRUG INEFFECTIVE, SEIZURE, OFF LABEL USE, DRUG INTERACTION, TOXICITY TO VARIOUS AGENTS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PHENOBARBITAL.

Top Adverse Reactions

DRUG INEFFECTIVE2,390 reports
SEIZURE1,534 reports
OFF LABEL USE1,358 reports
DRUG INTERACTION634 reports
TOXICITY TO VARIOUS AGENTS621 reports
STATUS EPILEPTICUS482 reports
MULTIPLE DRUG RESISTANCE442 reports
SOMNOLENCE433 reports
CONDITION AGGRAVATED413 reports
FALL397 reports
EPILEPSY396 reports
HYPOTENSION391 reports
PYREXIA377 reports
PRODUCT USE IN UNAPPROVED INDICATION374 reports
CONVULSION368 reports
FATIGUE342 reports
DEATH328 reports
VOMITING325 reports
OVERDOSE318 reports
PNEUMONIA316 reports
PRODUCT USE ISSUE309 reports
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS302 reports
DIARRHOEA292 reports
HEADACHE288 reports
NAUSEA284 reports
DYSPNOEA283 reports
DIZZINESS282 reports
PAIN265 reports
FOETAL EXPOSURE DURING PREGNANCY263 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION261 reports
DRUG ABUSE253 reports
GENERALISED TONIC CLONIC SEIZURE240 reports
DRUG RESISTANCE237 reports
RASH235 reports
COGNITIVE DISORDER224 reports
COMA223 reports
ASTHENIA218 reports
SEDATION218 reports
COMPLETED SUICIDE216 reports
DRUG HYPERSENSITIVITY215 reports
RESPIRATORY FAILURE214 reports
CONSTIPATION201 reports
WEIGHT DECREASED196 reports
MATERNAL EXPOSURE DURING PREGNANCY193 reports
TREATMENT FAILURE191 reports
MALAISE187 reports
CARDIAC ARREST185 reports
INSOMNIA180 reports
GAIT DISTURBANCE178 reports
DRUG DEPENDENCE174 reports
TREMOR170 reports
DECREASED APPETITE169 reports
RESPIRATORY DEPRESSION168 reports
DRUG DOSE OMISSION167 reports
TACHYCARDIA167 reports
BALANCE DISORDER162 reports
DEPRESSED LEVEL OF CONSCIOUSNESS161 reports
PNEUMONIA ASPIRATION159 reports
CONFUSIONAL STATE156 reports
THROMBOCYTOPENIA152 reports
COUGH150 reports
DEPRESSION145 reports
IRRITABILITY143 reports
AGITATION142 reports
ANXIETY139 reports
WEIGHT INCREASED134 reports
ACUTE KIDNEY INJURY132 reports
ATAXIA132 reports
ARTHRALGIA131 reports
INTENTIONAL PRODUCT MISUSE131 reports
FEELING ABNORMAL130 reports
THERAPY NON RESPONDER129 reports
URINARY TRACT INFECTION129 reports
ANAEMIA127 reports
HYPERTENSION125 reports
LOSS OF CONSCIOUSNESS125 reports
PARTIAL SEIZURES125 reports
HYPONATRAEMIA123 reports
ABDOMINAL DISTENSION121 reports
PRODUCT PRESCRIBING ERROR121 reports
PRURITUS118 reports
SEPSIS118 reports
PAIN IN EXTREMITY117 reports
SUICIDE ATTEMPT117 reports
AGGRESSION116 reports
HYPERAMMONAEMIA115 reports
INTENTIONAL OVERDOSE112 reports
EXPOSURE DURING PREGNANCY111 reports
HOSPITALISATION111 reports
HYPERSENSITIVITY111 reports
LETHARGY111 reports
MEMORY IMPAIRMENT110 reports
METABOLIC ACIDOSIS110 reports
PRODUCT DOSE OMISSION ISSUE108 reports
OXYGEN SATURATION DECREASED107 reports
BRADYCARDIA104 reports
RENAL FAILURE104 reports
ABDOMINAL PAIN103 reports
CHEST PAIN99 reports
INFECTION99 reports

Report Outcomes

Out of 13,995 classified reports for PHENOBARBITAL:

Serious 84.5%Non-Serious 15.5%

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

Female6,550 (54.1%)
Male5,510 (45.5%)
Unknown58 (0.5%)

Reports by Age

Age 2305 reports
Age 6304 reports
Age 3303 reports
Age 4256 reports
Age 1240 reports
Age 11237 reports
Age 5210 reports
Age 10186 reports
Age 8178 reports
Age 26162 reports
Age 21158 reports
Age 7154 reports
Age 63154 reports
Age 9152 reports
Age 52141 reports
Age 58141 reports
Age 67141 reports
Age 29140 reports
Age 56138 reports
Age 12134 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 PHENOBARBITAL?

This profile reflects 25,712 FDA FAERS reports that mention PHENOBARBITAL. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for PHENOBARBITAL?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, SEIZURE, OFF LABEL USE, DRUG INTERACTION, TOXICITY TO VARIOUS AGENTS, STATUS EPILEPTICUS. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures PHENOBARBITAL?

Labeling and FAERS entries often list Chartwell Governmental & Specialty RX, LLC. in connection with PHENOBARBITAL. 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.