{"id":"depakote-dr","safety":{"commonSideEffects":[{"rate":"25-30%","effect":"Tremor"},{"rate":"20-25%","effect":"Nausea"},{"rate":"15-20%","effect":"Somnolence"},{"rate":"12-15%","effect":"Diarrhea"},{"rate":"5-10%","effect":"Alopecia (hair loss)"},{"rate":"10-15%","effect":"Weight gain"},{"rate":"<1%","effect":"Hepatotoxicity"},{"rate":"<1%","effect":"Pancreatitis"},{"rate":"1-3%","effect":"Thrombocytopenia"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Divalproex sodium is a compound of sodium valproate and valproic acid that enhances inhibitory neurotransmission by increasing GABA synthesis and reducing GABA catabolism. It also inhibits histone deacetylase enzymes, which may contribute to its mood-stabilizing and anticonvulsant effects. The delayed-release formulation allows for once-daily dosing with reduced gastrointestinal side effects.","oneSentence":"Depakote DR (divalproex sodium delayed-release) increases brain GABA levels and inhibits histone deacetylase, stabilizing neuronal membranes and reducing abnormal electrical activity.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:32:18.921Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Epilepsy (seizure disorders)"},{"name":"Bipolar disorder (acute mania)"},{"name":"Migraine prophylaxis"}]},"trialDetails":[{"nctId":"NCT00864006","phase":"PHASE1","title":"Bioequivalence Study of Divalproex Sodium 125 MG Delayed Release Tablets Under Fasting Conditions","status":"COMPLETED","sponsor":"Sandoz","startDate":"2006-10","conditions":"Seizures","enrollment":28},{"nctId":"NCT00913848","phase":"PHASE1","title":"To Demonstrate the Relative Bioavailability of Divalproex Sodium 500 mg Delayed Release Tablets Under Fed Conditions","status":"COMPLETED","sponsor":"Sandoz","startDate":"2005-10","conditions":"Epilepsy, Bipolar Disorder","enrollment":30},{"nctId":"NCT00913874","phase":"PHASE1","title":"To Demonstrate the Relative Bioavailability of Divalproex Sodium 500 mg Delayed Release Tablets Under Fasting Conditions","status":"COMPLETED","sponsor":"Sandoz","startDate":"2005-10","conditions":"Epilepsy, Bipolar Disorder","enrollment":30},{"nctId":"NCT01581775","phase":"PHASE1","title":"Bioequivalence Study of Divalproex Sodium ER Tablets 500 mg of Dr. Reddy's Under Fasting Conditions","status":"COMPLETED","sponsor":"Dr. Reddy's Laboratories Limited","startDate":"2011-01","conditions":"Healthy","enrollment":54},{"nctId":"NCT01581788","phase":"PHASE1","title":"Bioequivalence Study of Divalproex Sodium ER Tablets, 500 mg Under Fed Conditions","status":"COMPLETED","sponsor":"Dr. Reddy's Laboratories Limited","startDate":"2011-01","conditions":"Healthy","enrollment":54},{"nctId":"NCT01132170","phase":"PHASE1","title":"Bioequivalency Study of Divalproex Sodium DR Tablets, 500 mg of Dr.Reddy's Under Fasting Conditions","status":"COMPLETED","sponsor":"Dr. Reddy's Laboratories Limited","startDate":"2006-08","conditions":"Healthy","enrollment":34},{"nctId":"NCT01132196","phase":"PHASE1","title":"Bioequivalence Study of Divalproex Sodium DR Tablets 500 mg of Dr. Reddy's Under Fed Conditions","status":"COMPLETED","sponsor":"Dr. Reddy's Laboratories Limited","startDate":"2006-08","conditions":"Healthy","enrollment":34},{"nctId":"NCT01132183","phase":"PHASE1","title":"Bioequivalence Study of Divalproex Sodium Capsules(Sprinkle),125 mg of Dr. Reddy's Under Fasting Condition (Apple Sauce)","status":"COMPLETED","sponsor":"Dr. Reddy's Laboratories Limited","startDate":"2007-02","conditions":"Healthy","enrollment":34},{"nctId":"NCT01056627","phase":"PHASE1","title":"Bioequivalence Study of Dr. Reddy's Divalproex Sodium Coated Particles in Capsules, 125 mg, Under Fed Condition","status":"COMPLETED","sponsor":"Dr. Reddy's Laboratories Limited","startDate":"2006-12","conditions":"Healthy","enrollment":34},{"nctId":"NCT01055938","phase":"PHASE1","title":"Bioequivalence Study of Dr. Reddy's Divalproex Sodium Capsules (Sprinkle), 125 mg Under Fasting Conditions","status":"COMPLETED","sponsor":"Dr. Reddy's Laboratories Limited","startDate":"2006-12","conditions":"Healthy","enrollment":34},{"nctId":"NCT00347152","phase":"NA","title":"Comparison of Immediate vs Gradual Switch to Divalproex in Adults With Intellectual Disability","status":"COMPLETED","sponsor":"University of Kansas","startDate":"2006-11","conditions":"Epilepsy","enrollment":18},{"nctId":"NCT00646711","phase":"PHASE2","title":"Pediatric Switch Study for Children and Adolescent Patients With Epilepsy","status":"COMPLETED","sponsor":"Abbott","startDate":"2003-02","conditions":"Pediatric Epilepsy","enrollment":16},{"nctId":"NCT00334347","phase":"PHASE4","title":"A Comparison Study of the Efficacy and Tolerability of Depakote ER and Depakote DR","status":"COMPLETED","sponsor":"Massachusetts General Hospital","startDate":"2006-06","conditions":"Mania, Mixed Mania","enrollment":5},{"nctId":"NCT00312676","phase":"PHASE4","title":"Compare Tolerability of an Overnight Switch to Gradual Switch Between Two Different Forms of Depakote","status":"UNKNOWN","sponsor":"Veterans Affairs Medical Center, Miami","startDate":"2006-03","conditions":"Epilepsy, Behavioral Disturbance","enrollment":20}],"_emaApprovals":[],"_faersSignals":[{"count":2,"reaction":"FALL"},{"count":2,"reaction":"PAIN"},{"count":2,"reaction":"PSYCHOTIC DISORDER"},{"count":2,"reaction":"UNRESPONSIVE TO STIMULI"},{"count":1,"reaction":"ABDOMINAL PAIN UPPER"},{"count":1,"reaction":"AGGRESSION"},{"count":1,"reaction":"AGITATION"},{"count":1,"reaction":"ANGIOEDEMA"},{"count":1,"reaction":"ANXIETY"},{"count":1,"reaction":"ASTHMA"}],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Depakote DR","genericName":"Depakote DR","companyName":"Massachusetts General Hospital","companyId":"massachusetts-general-hospital","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Depakote DR (divalproex sodium delayed-release) increases brain GABA levels and inhibits histone deacetylase, stabilizing neuronal membranes and reducing abnormal electrical activity. Used for Epilepsy (seizure disorders), Bipolar disorder (acute mania), Migraine prophylaxis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}