{"id":"generic-budesonide-formoterol-fumarate-dihydrate","safety":{"commonSideEffects":[{"rate":null,"effect":"Tremor"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Nervousness/anxiety"},{"rate":null,"effect":"Palpitations"},{"rate":null,"effect":"Oral candidiasis"},{"rate":null,"effect":"Dysphonia"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Budesonide is an inhaled corticosteroid that suppresses inflammatory responses in the airways by binding glucocorticoid receptors, reducing mucus production and airway edema. Formoterol is a long-acting beta-2 adrenergic agonist (LABA) that binds beta-2 receptors on airway smooth muscle, causing bronchodilation and improved airflow. Together, they provide both anti-inflammatory and bronchodilatory effects for sustained asthma and COPD control.","oneSentence":"Budesonide/formoterol combines a corticosteroid that reduces airway inflammation with a long-acting beta-2 agonist that relaxes airway smooth muscle.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:13:58.119Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Asthma maintenance therapy"},{"name":"Chronic obstructive pulmonary disease (COPD) maintenance therapy"}]},"trialDetails":[{"nctId":"NCT03015259","phase":"PHASE3","title":"Randomized, Placebo-controlled, Multi-dose, Study Comparing Budesonide/Formoterol to Symbicort® in Asthmatic Patients","status":"COMPLETED","sponsor":"Kindeva Drug Delivery","startDate":"2016-12-29","conditions":"Asthma","enrollment":1762},{"nctId":"NCT02495168","phase":"PHASE3","title":"Randomized, Placebo-Controlled, Multidose, Study Comparing Generic Budesonide/Formoterol Fumarate Dihydrate to Symbicort® in Asthmatic Participants","status":"COMPLETED","sponsor":"Actavis Inc.","startDate":"2017-01-13","conditions":"Asthma","enrollment":1714}],"_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":[],"phase":"phase_3","status":"active","brandName":"Generic Budesonide/Formoterol Fumarate Dihydrate","genericName":"Generic Budesonide/Formoterol Fumarate Dihydrate","companyName":"Actavis Inc.","companyId":"actavis-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Budesonide/formoterol combines a corticosteroid that reduces airway inflammation with a long-acting beta-2 agonist that relaxes airway smooth muscle. Used for Asthma maintenance therapy, Chronic obstructive pulmonary disease (COPD) maintenance therapy.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}