{"id":"adhansia-xr","safety":{"commonSideEffects":[{"rate":"20-30","effect":"Decreased appetite"},{"rate":"15-25","effect":"Insomnia"},{"rate":"10-20","effect":"Headache"},{"rate":"10-15","effect":"Irritability"},{"rate":"5-10","effect":"Nausea"},{"rate":"5-10","effect":"Dizziness"},{"rate":"5-10","effect":"Abdominal pain"},{"rate":"5-10","effect":"Fatigue"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The amphetamine component works as a sympathomimetic amine that increases the release and blocks the reuptake of dopamine and norepinephrine in the central nervous system. The guanfacine component is an alpha-2A adrenergic agonist that enhances prefrontal cortex function and reduces noradrenergic activity in other brain regions. Together, these mechanisms address multiple neurotransmitter systems implicated in ADHD pathophysiology.","oneSentence":"Adhansia XR is a combination of amphetamine salts and guanfacine that increases dopamine and norepinephrine activity while also activating alpha-2A adrenergic receptors to improve attention and reduce hyperactivity and impulsivity.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:19:09.896Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Attention-deficit/hyperactivity disorder (ADHD) in children and adolescents aged 6 years and older"}]},"trialDetails":[{"nctId":"NCT07300956","phase":"PHASE4","title":"Treating Young Children With Attention Deficit Hyperactivity Disorder","status":"NOT_YET_RECRUITING","sponsor":"Children's Hospital Medical Center, Cincinnati","startDate":"2026-02","conditions":"Attention-Deficit/Hyperactivity Disorder (ADHD)","enrollment":370},{"nctId":"NCT05916339","phase":"PHASE4","title":"AWARE: Management of ADHD in Autism Spectrum Disorder","status":"RECRUITING","sponsor":"Daniel Coury","startDate":"2023-10-01","conditions":"ADHD, Autism Spectrum Disorder","enrollment":500},{"nctId":"NCT04419272","phase":"PHASE4","title":"Methylphenidate for the Treatment of Epilepsy-related Cognitive Deficits","status":"RECRUITING","sponsor":"VA Office of Research and Development","startDate":"2023-08-14","conditions":"Epilepsy","enrollment":226},{"nctId":"NCT04987762","phase":"PHASE4","title":"Safety and Tolerability Study of Adhansia XR® Extended-Release Capsules in Children","status":"TERMINATED","sponsor":"Purdue Pharma LP","startDate":"2021-08-03","conditions":"Attention Deficit/Hyperactivity Disorder","enrollment":103},{"nctId":"NCT04507204","phase":"PHASE4","title":"Real-World Evidence of Duration of Effect of Adhansia XR (Extended-Release) for Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD)","status":"TERMINATED","sponsor":"Purdue Pharma LP","startDate":"2020-07-30","conditions":"Attention-Deficit/Hyperactivity Disorder","enrollment":267},{"nctId":"NCT04152629","phase":"PHASE4","title":"Real World Evidence of the Efficacy and Safety of FOQUEST","status":"COMPLETED","sponsor":"Purdue Pharma, Canada","startDate":"2019-09-19","conditions":"Attention Deficit-Hyperactivity Disorder","enrollment":257}],"_emaApprovals":[],"_faersSignals":[{"count":14,"reaction":"DRUG INEFFECTIVE"},{"count":6,"reaction":"ANGER"},{"count":6,"reaction":"HEADACHE"},{"count":6,"reaction":"INSOMNIA"},{"count":5,"reaction":"UNEVALUABLE EVENT"},{"count":3,"reaction":"ABDOMINAL PAIN UPPER"},{"count":3,"reaction":"AGGRESSION"},{"count":3,"reaction":"FEELING ABNORMAL"},{"count":3,"reaction":"OFF LABEL USE"},{"count":2,"reaction":"AGITATION"}],"_approvalHistory":[],"publicationCount":3,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Methylphenidate hydrochloride (HCl) extended release"],"phase":"marketed","status":"active","brandName":"Adhansia XR","genericName":"Adhansia XR","companyName":"Purdue Pharma LP","companyId":"purdue-pharma-lp","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Adhansia XR is a combination of amphetamine salts and guanfacine that increases dopamine and norepinephrine activity while also activating alpha-2A adrenergic receptors to improve attention and reduce hyperactivity and impulsivity. Used for Attention-deficit/hyperactivity disorder (ADHD) in children and adolescents aged 6 years and older.","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2019-02-27T00:00:00.000Z","mah":"PURDUE PHARMA LP","brand_name_local":"ADHANSIA XR","application_number":"NDA212038"}],"trialStats":{"total":2,"withResults":2},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}