PHENOBARBITAL SODIUM

N/A

Manufactured by BPI Labs LLC

956 FDA adverse event reports analyzed

Last updated: 2026-04-15

About PHENOBARBITAL SODIUM

PHENOBARBITAL SODIUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by BPI Labs LLC. The most commonly reported adverse reactions for PHENOBARBITAL SODIUM include SEIZURE, OFF LABEL USE, DRUG INEFFECTIVE, EPILEPSY, PRODUCT USE IN UNAPPROVED INDICATION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PHENOBARBITAL SODIUM.

Top Adverse Reactions

SEIZURE64 reports
OFF LABEL USE56 reports
DRUG INEFFECTIVE54 reports
EPILEPSY26 reports
PRODUCT USE IN UNAPPROVED INDICATION19 reports
STATUS EPILEPTICUS19 reports
PALLOR18 reports
SEPSIS18 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION17 reports
PYREXIA16 reports
CONDITION AGGRAVATED15 reports
DRUG RESISTANCE15 reports
CONFUSIONAL STATE14 reports
DEATH14 reports
HEPATIC FUNCTION ABNORMAL14 reports
LOSS OF CONSCIOUSNESS14 reports
FALL13 reports
RESPIRATORY FAILURE13 reports
DRUG INTERACTION12 reports
MULTIPLE DRUG RESISTANCE12 reports
PLATELET COUNT DECREASED12 reports
NEW ONSET REFRACTORY STATUS EPILEPTICUS11 reports
PNEUMONIA11 reports
THROAT LESION11 reports
TOXICITY TO VARIOUS AGENTS11 reports
ANAEMIA10 reports
SOMNOLENCE10 reports
SWOLLEN TONGUE10 reports
AMNESIA9 reports
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS9 reports
HAEMOGLOBIN DECREASED9 reports
ILL DEFINED DISORDER9 reports
INTRAVENTRICULAR HAEMORRHAGE9 reports
OESOPHAGEAL DISORDER9 reports
PRODUCT USE ISSUE9 reports
RASH9 reports
TONGUE DISCOLOURATION9 reports
ABDOMINAL PAIN UPPER8 reports
ERYTHEMA8 reports
HYPONATRAEMIA8 reports
NEUTROPHIL COUNT INCREASED8 reports
ALANINE AMINOTRANSFERASE INCREASED7 reports
BLOOD GLUCOSE INCREASED7 reports
BRADYCARDIA7 reports
CONSTIPATION7 reports
HEART INJURY7 reports
HEART RATE INCREASED7 reports
HYPERHIDROSIS7 reports
LIVER DISORDER7 reports
LYMPHOCYTE COUNT DECREASED7 reports
PANCREATITIS ACUTE7 reports
UNRESPONSIVE TO STIMULI7 reports
VOMITING7 reports
ABORTION SPONTANEOUS6 reports
ALTERED STATE OF CONSCIOUSNESS6 reports
ASTHENIA6 reports
BLOOD CREATININE INCREASED6 reports
BLOOD PRESSURE DECREASED6 reports
COLD SWEAT6 reports
DIARRHOEA6 reports
DYSPNOEA6 reports
FATIGUE6 reports
HYPOTENSION6 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME6 reports
NEUTROPENIA6 reports
NYSTAGMUS6 reports
WHITE BLOOD CELL COUNT INCREASED6 reports
ABDOMINAL DISTENSION5 reports
ASPARTATE AMINOTRANSFERASE INCREASED5 reports
DISSEMINATED INTRAVASCULAR COAGULATION5 reports
DIZZINESS5 reports
DRUG ERUPTION5 reports
PARTIAL SEIZURES5 reports
PETIT MAL EPILEPSY5 reports
POSTICTAL STATE5 reports
PRODUCT DOSE OMISSION ISSUE5 reports
PRURITUS5 reports
RENAL IMPAIRMENT5 reports
RHABDOMYOLYSIS5 reports
STEVENS JOHNSON SYNDROME5 reports
WEIGHT DECREASED5 reports
ACUTE KIDNEY INJURY4 reports
COAGULOPATHY4 reports
COUGH4 reports
DECREASED APPETITE4 reports
DRUG INDUCED LIVER INJURY4 reports
HALLUCINATION, VISUAL4 reports
HYPOTONIA4 reports
INCISION SITE PAIN4 reports
INHIBITORY DRUG INTERACTION4 reports
KIDNEY TRANSPLANT REJECTION4 reports
MATERNAL EXPOSURE DURING PREGNANCY4 reports
MEMORY IMPAIRMENT4 reports
MYOCLONUS4 reports
PNEUMOTHORAX4 reports
POSTHAEMORRHAGIC HYDROCEPHALUS4 reports
PRODUCT COMPLAINT4 reports
PULMONARY EMBOLISM4 reports
RENAL FAILURE4 reports
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME4 reports

Report Outcomes

Out of 385 classified reports for PHENOBARBITAL SODIUM:

Serious 97.1%Non-Serious 2.9%

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

Female159 (50.2%)
Male157 (49.5%)
Unknown1 (0.3%)

Reports by Age

Age 3016 reports
Age 014 reports
Age 3710 reports
Age 78 reports
Age 408 reports
Age 658 reports
Age 748 reports
Age 47 reports
Age 607 reports
Age 36 reports
Age 106 reports
Age 166 reports
Age 556 reports
Age 706 reports
Age 15 reports
Age 215 reports
Age 225 reports
Age 335 reports
Age 365 reports
Age 575 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 SODIUM?

This profile reflects 956 FDA FAERS reports that mention PHENOBARBITAL SODIUM. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for PHENOBARBITAL SODIUM?

Frequently reported terms in FAERS include SEIZURE, OFF LABEL USE, DRUG INEFFECTIVE, EPILEPSY, PRODUCT USE IN UNAPPROVED INDICATION, STATUS EPILEPTICUS. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures PHENOBARBITAL SODIUM?

Labeling and FAERS entries often list BPI Labs LLC in connection with PHENOBARBITAL SODIUM. 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.