{"id":"im-risperidone","safety":{"commonSideEffects":[{"rate":"10-20","effect":"Injection site pain or reaction"},{"rate":"15-25","effect":"Extrapyramidal symptoms (tremor, rigidity, akathisia)"},{"rate":"10-15","effect":"Weight gain"},{"rate":"20-30","effect":"Prolactin elevation"},{"rate":"10-15","effect":"Sedation"},{"rate":"5-10","effect":"Orthostatic hypotension"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Risperidone antagonizes dopamine D2 receptors in mesolimbic and mesocortical pathways, reducing positive symptoms of psychosis, while also blocking serotonin 5-HT2A receptors which may enhance antipsychotic efficacy and reduce extrapyramidal side effects. The intramuscular depot formulation provides sustained drug release over weeks, improving medication adherence in patients with schizophrenia and other psychotic disorders.","oneSentence":"IM risperidone is an intramuscular long-acting formulation of the atypical antipsychotic risperidone, which blocks dopamine D2 and serotonin 5-HT2A receptors in the brain.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:15:37.108Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Schizophrenia"},{"name":"Schizoaffective disorder"},{"name":"Bipolar disorder maintenance treatment"}]},"trialDetails":[{"nctId":"NCT06276361","phase":"PHASE1","title":"Pharmacokinetics, Safety and Tolerability of Different Formulations and Dose Strengths of Quarterly Risperidone (QUAR) in Patients With Schizophrenia","status":"COMPLETED","sponsor":"Rovi Pharmaceuticals Laboratories","startDate":"2023-09-26","conditions":"Schizophrenia","enrollment":58},{"nctId":"NCT04940039","phase":"PHASE4","title":"A Study to Assess the Treatment of Schizophrenia With Paliperidone Palmitate in Rwandan Healthcare Settings","status":"COMPLETED","sponsor":"Janssen-Cilag International NV","startDate":"2021-07-22","conditions":"Schizophrenia","enrollment":93},{"nctId":"NCT02237417","phase":"PHASE4","title":"Impact of Aripiprazole Once Monthly Medications on Changes in Brain Structure and Metabolism","status":"COMPLETED","sponsor":"University of Utah","startDate":"2014-09-01","conditions":"Schizophrenia","enrollment":47},{"nctId":"NCT02411526","phase":"PHASE1","title":"Safety and PK Trial With Injectable ZX003 (Risperidone-SABER®) Compared to Risperdal® Consta® in Stable Schizophrenia","status":"COMPLETED","sponsor":"Zogenix, Inc.","startDate":"2015-02","conditions":"Schizophrenia, Schizoaffective 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in Schizophrenia","status":"COMPLETED","sponsor":"Rovi Pharmaceuticals Laboratories","startDate":"2014-03","conditions":"Schizophrenia","enrollment":70},{"nctId":"NCT01150448","phase":"PHASE1","title":"A Safety and Pharmacokinetic Study of Paliperidone Palmitate in Patients With Schizophrenia","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2007-09","conditions":"Schizophrenia","enrollment":212},{"nctId":"NCT00132314","phase":"PHASE3","title":"Long-Acting Injectable Risperidone in the Treatment of Schizophrenia","status":"COMPLETED","sponsor":"US Department of Veterans Affairs","startDate":"2006-09","conditions":"Schizoaffective Disorder, Schizophrenia","enrollment":382},{"nctId":"NCT00132678","phase":"PHASE3","title":"A Study of the Safety and Efficacy of Injectable Risperidone in the Prevention of Bipolar Mood Episodes","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2005-02","conditions":"Bipolar Disorder","enrollment":559},{"nctId":"NCT00094926","phase":"PHASE3","title":"A Study of Effectiveness and Safety of Risperdal CONSTA Added to Usual Treatment in Patients With Bipolar Disorder Who Have Frequent Mood Episodes.","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2004-05","conditions":"Bipolar Disorder","enrollment":275},{"nctId":"NCT00249171","phase":"PHASE4","title":"A Study of Risperidone in Combination With Lorazepam Compared With Standard Therapy for Emergency Treatment of Schizophrenic Patients","status":"COMPLETED","sponsor":"Janssen Pharmaceutica N.V., Belgium","startDate":"2001-06","conditions":"Schizophrenia, Psychotic Disorders, Emergency Treatment","enrollment":226},{"nctId":"NCT00859872","phase":"PHASE4","title":"Efficacy and Safety of Risperidone Oral Solution Combination Clonazepam Versus Haloperidol Intramuscular (IM) Injection for Treatment of Acute Psychotic Agitation in Schizophrenia","status":"COMPLETED","sponsor":"Central South University","startDate":"2008-08","conditions":"Schizophrenia","enrollment":198}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":190,"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":"IM risperidone","genericName":"IM risperidone","companyName":"US Department of Veterans Affairs","companyId":"us-department-of-veterans-affairs","modality":"Small molecule","firstApprovalDate":"","aiSummary":"IM risperidone is an intramuscular long-acting formulation of the atypical antipsychotic risperidone, which blocks dopamine D2 and serotonin 5-HT2A receptors in the brain. Used for Schizophrenia, Schizoaffective disorder, Bipolar disorder maintenance treatment.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}