{"id":"hydralazine-isorsorbide-dinitrate","safety":{"commonSideEffects":[{"rate":"20-30","effect":"Headache"},{"rate":"10-20","effect":"Dizziness"},{"rate":"5-10","effect":"Palpitations"},{"rate":"5-10","effect":"Lupus-like syndrome (hydralazine)"},{"rate":"10-15","effect":"Hypotension"},{"rate":"5-10","effect":"Tachycardia"}]},"_chembl":{"chemblId":"CHEMBL276832","moleculeType":"Small molecule","molecularWeight":"160.18"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Hydralazine is a direct-acting vasodilator that preferentially dilates arterioles, reducing systemic vascular resistance and afterload. Isosorbide dinitrate is an organic nitrate that donates nitric oxide, causing venous and arterial dilation to reduce preload and afterload. The combination synergistically improves cardiac output and reduces workload on the failing heart.","oneSentence":"Hydralazine relaxes blood vessel smooth muscle while isosorbide dinitrate provides nitric oxide to dilate vessels, together reducing cardiac afterload and preload to improve heart function.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:36:56.024Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Heart failure in self-identified Black patients"},{"name":"Heart failure with reduced ejection fraction"}]},"trialDetails":[{"nctId":"NCT02228408","phase":"PHASE4","title":"Safety and Cardiovascular Efficacy of Hydralazine and Isosorbide Dinitrate in Dialysis-Dependent ESRD","status":"COMPLETED","sponsor":"Brigham and Women's Hospital","startDate":"2017-08-28","conditions":"Chronic Hemodialysis (ESRD)","enrollment":17}],"_emaApprovals":[],"_faersSignals":[],"_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":["Apresoline","Isordil"],"phase":"marketed","status":"active","brandName":"Hydralazine/Isorsorbide Dinitrate","genericName":"Hydralazine/Isorsorbide Dinitrate","companyName":"Brigham and Women's Hospital","companyId":"brigham-and-women-s-hospital","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Hydralazine relaxes blood vessel smooth muscle while isosorbide dinitrate provides nitric oxide to dilate vessels, together reducing cardiac afterload and preload to improve heart function. Used for Heart failure in self-identified Black patients, Heart failure with reduced ejection fraction.","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1953-01-15T00:00:00.000Z","mah":"NOVARTIS","brand_name_local":"APRESOLINE","application_number":"NDA008303"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1959-11-09T00:00:00.000Z","mah":"BAUSCH","brand_name_local":"ISORDIL","application_number":"NDA012093"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1980-12-12T00:00:00.000Z","mah":"WYETH AYERST","brand_name_local":"ISORDIL","application_number":"NDA012882"}],"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}