{"id":"paroxetine-hydrochloride-hydrate","safety":{"commonSideEffects":[{"rate":"15-25","effect":"Nausea"},{"rate":"10-20","effect":"Headache"},{"rate":"10-20","effect":"Sexual dysfunction"},{"rate":"10-15","effect":"Insomnia"},{"rate":"10-15","effect":"Somnolence"},{"rate":"5-10","effect":"Tremor"},{"rate":"5-10","effect":"Diarrhea"},{"rate":"5-10","effect":"Sweating"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"Paroxetine is a selective serotonin reuptake inhibitor (SSRI) that blocks the serotonin transporter protein, preventing the reabsorption of serotonin from the synaptic cleft back into presynaptic neurons. This increases serotonin concentration in the synapse, enhancing neurotransmission and improving mood regulation. The hydrochloride hydrate formulation is the salt form used for oral pharmaceutical administration.","oneSentence":"Paroxetine selectively inhibits the reuptake of serotonin at the neuronal synapse, increasing serotonin availability in the brain.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:50:58.030Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Major depressive disorder"},{"name":"Generalized anxiety disorder"},{"name":"Panic disorder"},{"name":"Obsessive-compulsive disorder"},{"name":"Post-traumatic stress disorder"},{"name":"Social anxiety disorder"}]},"trialDetails":[{"nctId":"NCT00557622","phase":"PHASE2","title":"Clinical Evaluation of BRL29060A (Paroxetine Hydrochloride Hydrate) in Posttraumatic Stress Disorder (PTSD)","status":"TERMINATED","sponsor":"GlaxoSmithKline","startDate":"2008-01-25","conditions":"Post-Traumatic Stress Disorder, Stress Disorders, Post-Traumatic","enrollment":5},{"nctId":"NCT02374567","phase":"PHASE3","title":"Pharmacovigilance in Gerontopsychiatric Patients","status":"TERMINATED","sponsor":"Hannover Medical School","startDate":"2015-01","conditions":"Dementia, Depression, Schizophrenia","enrollment":407},{"nctId":"NCT00839397","phase":"PHASE3","title":"BRL29060A (Paroxetine Hydrochloride Hydrate) in Posttraumatic Stress Disorder","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2002-05","conditions":"Post-Traumatic Stress Disorder","enrollment":52},{"nctId":"NCT00318669","phase":"PHASE3","title":"Social Anxiety Disorder Study Of Paroxetine","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2005-12","conditions":"Social Phobia","enrollment":390},{"nctId":"NCT00264654","phase":"PHASE3","title":"Long-term Study Of Paroxetine in Women and Men","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2005-10","conditions":"Social Phobia","enrollment":50}],"_emaApprovals":[],"_faersSignals":[],"_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":["BRL29060A"],"phase":"phase_3","status":"active","brandName":"paroxetine hydrochloride hydrate","genericName":"paroxetine hydrochloride hydrate","companyName":"GlaxoSmithKline","companyId":"gsk","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Paroxetine selectively inhibits the reuptake of serotonin at the neuronal synapse, increasing serotonin availability in the brain. Used for Major depressive disorder, Generalized anxiety disorder, Panic disorder.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}