{"id":"phenobarbital-sodium-injection","safety":{"commonSideEffects":[{"rate":null,"effect":"Drowsiness and sedation"},{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Ataxia"},{"rate":null,"effect":"Respiratory depression"},{"rate":null,"effect":"Hypotension"},{"rate":null,"effect":"Dependence and tolerance"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Phenobarbital acts as a positive allosteric modulator of GABA-A receptors, increasing chloride channel conductance and neuronal hyperpolarization. This results in depression of the central nervous system, making it effective for seizure control, sedation, and anxiety relief. The drug also induces hepatic cytochrome P450 enzymes, affecting metabolism of other medications.","oneSentence":"Phenobarbital sodium is a barbiturate that enhances inhibitory GABA neurotransmission in the central nervous system, producing sedative, hypnotic, and anticonvulsant effects.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:35:31.684Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Seizure disorders and epilepsy"},{"name":"Acute seizure management"},{"name":"Sedation and anxiety"},{"name":"Status epilepticus"}]},"trialDetails":[{"nctId":"NCT07401433","phase":"NA","title":"Levetiracetam Versus Phenobarbitone for the Treatment of Neonatal Seizures in a Tertiary Care Hospital.","status":"COMPLETED","sponsor":"Hayat Abad Medical Complex, Peshawar","startDate":"2024-04-08","conditions":"Neonatal Seizures","enrollment":260},{"nctId":"NCT06081283","phase":"PHASE4","title":"Antiseizure Medication in Seizure Networks at Early Acute Brain Injury","status":"TERMINATED","sponsor":"University of North Carolina, Chapel Hill","startDate":"2023-11-20","conditions":"Brain Injuries, Acute, Brain Injuries, Traumatic, Brain Ischemia","enrollment":5},{"nctId":"NCT05610085","phase":"PHASE2","title":"A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures","status":"RECRUITING","sponsor":"University of California, San Diego","startDate":"2023-03-24","conditions":"Neonatal Seizure, Neonatal Encephalopathy, Hypoxic-Ischemic Encephalopathy","enrollment":133},{"nctId":"NCT07098728","phase":"NA","title":"Levetiracetam Versus Phenobarbital in Benzodiazepines Unresponsive Paediatric Prolonged Seizures","status":"RECRUITING","sponsor":"Ministry of Health and Sports, Myanmar","startDate":"2025-07-22","conditions":"Seizure","enrollment":180},{"nctId":"NCT04320940","phase":"PHASE3","title":"Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures","status":"TERMINATED","sponsor":"NEMA Research, Inc.","startDate":"2021-03-12","conditions":"Epilepsy, Benign Neonatal","enrollment":4},{"nctId":"NCT02497443","phase":"PHASE1, PHASE2","title":"Safety of Autologous MSC Infusion to Treat Epilepsy","status":"COMPLETED","sponsor":"Ministry of Public Health, Republic of Belarus","startDate":"2011-04","conditions":"Epilepsy","enrollment":60},{"nctId":"NCT03788889","phase":"PHASE4","title":"Alcohol Withdrawal Syndrome Treated With Adjunctive Phenobarbital or Ketamine","status":"WITHDRAWN","sponsor":"Santa Barbara Cottage Hospital","startDate":"2019-04-12","conditions":"Alcohol Withdrawal Syndrome","enrollment":""},{"nctId":"NCT03602118","phase":"PHASE3","title":"Study to Evaluate Phenobarbital Sodium Injection for the Treatment of Neonatal Seizures","status":"WITHDRAWN","sponsor":"PharPoint Research, Inc.","startDate":"2019-11","conditions":"Neonatal Seizure","enrollment":""}],"_emaApprovals":[],"_faersSignals":[{"count":1,"reaction":"DISEASE RECURRENCE"},{"count":1,"reaction":"DRUG INTERACTION"},{"count":1,"reaction":"EPILEPSY"},{"count":1,"reaction":"MESENTERIC VEIN THROMBOSIS"}],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Phenobarbital Sodium Injection 20 mg","Phenobarbital Sodium Injection 40 mg","phenobarbital","Phenobarbital"],"phase":"marketed","status":"active","brandName":"Phenobarbital Sodium Injection","genericName":"Phenobarbital Sodium Injection","companyName":"PharPoint Research, Inc.","companyId":"pharpoint-research-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Phenobarbital sodium is a barbiturate that enhances inhibitory GABA neurotransmission in the central nervous system, producing sedative, hypnotic, and anticonvulsant effects. Used for Seizure disorders and epilepsy, Acute seizure management, Sedation and anxiety.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}