{"id":"depakote-dr-tablets","safety":{"boxedWarning":"Hepatotoxicity: Fatal hepatic failure has occurred, particularly in children under 2 years and patients with mitochondrial disorders. Teratogenicity: Use during pregnancy can cause major congenital malformations and decreased IQ. Pancreatitis: Cases of life-threatening pancreatitis have been reported.","commonSideEffects":["Nausea","Somnolence","Dizziness","Vomiting","Tremor","Weight gain","Hair loss","Thrombocytopenia"],"contraindications":["Hepatic disease or significant hepatic dysfunction","Known urea cycle disorders","Pregnancy (for migraine prophylaxis)","Hypersensitivity to divalproex sodium or valproic acid"]},"_chembl":null,"modality":"Small molecule","_dailymed":null,"mechanism":{"target":"GABA neurotransmitter system and voltage-gated sodium channels","explanation":"Divalproex sodium is converted to valproic acid in the body. It enhances GABAergic neurotransmission by inhibiting GABA degradation and increasing GABA synthesis. It also blocks voltage-dependent sodium channels, reducing repetitive neuronal firing and stabilizing hyperexcitable neuronal membranes.","oneSentence":"Increases brain levels of gamma-aminobutyric acid (GABA) and modulates voltage-gated sodium channels to reduce neuronal excitability."},"_scrapedAt":"2026-03-28T05:01:52.494Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"_claudeStub":{"ts":1779123400,"model":"claude-sonnet-4-5-20250929"},"competitors":[{"name":"lamotrigine","brand":"Lamictal","company":"GlaxoSmithKline","rationale":"Anticonvulsant and mood stabilizer for epilepsy and bipolar disorder"},{"name":"carbamazepine","brand":"Tegretol","company":"Novartis","rationale":"Anticonvulsant for partial and generalized seizures"},{"name":"topiramate","brand":"Topamax","company":"Janssen","rationale":"Anticonvulsant also used for migraine prophylaxis"},{"name":"lithium carbonate","brand":"Lithobid","company":null,"rationale":"Mood stabilizer for bipolar disorder treatment"}],"description":"Depakote DR (divalproex sodium delayed-release) is an anticonvulsant and mood stabilizer used to treat epilepsy, bipolar disorder, and migraine prevention. It works by increasing GABA levels in the brain and modulating neuronal excitability. Available in delayed-release tablet formulation.","indications":{"approved":[{"status":"approved","condition":"Complex partial seizures","patientPopulation":"Adults and pediatric patients (monotherapy and adjunctive therapy)"},{"status":"approved","condition":"Simple and complex absence seizures","patientPopulation":"Adults and pediatric patients"},{"status":"approved","condition":"Manic episodes associated with bipolar disorder","patientPopulation":"Adults"},{"status":"approved","condition":"Migraine prophylaxis","patientPopulation":"Adults"}]},"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}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_1","status":"active","brandName":"Depakote DR Tablets","genericName":"Depakote DR Tablets","companyName":"Sandoz","companyId":"sandoz","firstApprovalDate":"","aiSummary":"","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}