{"id":"betahistine","rwe":[],"tags":[{"label":"betahistine","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Histamine H3 receptor","category":"target"},{"label":"HRH3","category":"gene"},{"label":"N07CA01","category":"atc"},{"label":"Active","category":"status"},{"label":"Ménière's disease","category":"indication"},{"label":"Cardiovascular Agents","category":"pharmacology"},{"label":"Histamine Agents","category":"pharmacology"},{"label":"Histamine Agonists","category":"pharmacology"},{"label":"Neurotransmitter Agents","category":"pharmacology"},{"label":"Vasodilator Agents","category":"pharmacology"}],"phase":"phase_2","safety":{"safetySignals":[{"llr":125.248,"date":"","count":32,"signal":"Soft tissue mass","source":"DrugCentral FAERS","actionTaken":"Reported 32 times (LLR=125)"},{"llr":122.58,"date":"","count":33,"signal":"Oesophageal perforation","source":"DrugCentral FAERS","actionTaken":"Reported 33 times (LLR=123)"},{"llr":114.558,"date":"","count":152,"signal":"Hyponatraemia","source":"DrugCentral FAERS","actionTaken":"Reported 152 times (LLR=115)"},{"llr":114.026,"date":"","count":31,"signal":"Multimorbidity","source":"DrugCentral FAERS","actionTaken":"Reported 31 times (LLR=114)"},{"llr":113.616,"date":"","count":300,"signal":"Dizziness","source":"DrugCentral FAERS","actionTaken":"Reported 300 times (LLR=114)"},{"llr":107.655,"date":"","count":113,"signal":"Hypoglycaemia","source":"DrugCentral FAERS","actionTaken":"Reported 113 times (LLR=108)"},{"llr":105.009,"date":"","count":33,"signal":"Pituitary tumour benign","source":"DrugCentral FAERS","actionTaken":"Reported 33 times (LLR=105)"},{"llr":89.715,"date":"","count":258,"signal":"Fall","source":"DrugCentral FAERS","actionTaken":"Reported 258 times (LLR=90)"},{"llr":84.733,"date":"","count":32,"signal":"Superinfection","source":"DrugCentral FAERS","actionTaken":"Reported 32 times (LLR=85)"},{"llr":81.719,"date":"","count":33,"signal":"Transplant failure","source":"DrugCentral FAERS","actionTaken":"Reported 33 times (LLR=82)"},{"llr":80.939,"date":"","count":37,"signal":"Immunosuppressant drug level increased","source":"DrugCentral FAERS","actionTaken":"Reported 37 times (LLR=81)"},{"llr":80.056,"date":"","count":46,"signal":"Parkinsonism","source":"DrugCentral FAERS","actionTaken":"Reported 46 times (LLR=80)"},{"llr":76.512,"date":"","count":38,"signal":"Oesophageal carcinoma","source":"DrugCentral FAERS","actionTaken":"Reported 38 times (LLR=77)"},{"llr":71.564,"date":"","count":38,"signal":"Enthesopathy","source":"DrugCentral FAERS","actionTaken":"Reported 38 times (LLR=72)"},{"llr":70.6,"date":"","count":27,"signal":"Multiple drug therapy","source":"DrugCentral FAERS","actionTaken":"Reported 27 times (LLR=71)"}],"commonSideEffects":[{"effect":"Soft tissue mass","drugRate":"LLR 125","severity":"common"},{"effect":"Oesophageal perforation","drugRate":"LLR 123","severity":"common"},{"effect":"Hyponatraemia","drugRate":"LLR 115","severity":"common"},{"effect":"Multimorbidity","drugRate":"LLR 114","severity":"common"},{"effect":"Dizziness","drugRate":"LLR 114","severity":"common"},{"effect":"Hypoglycaemia","drugRate":"LLR 108","severity":"common"},{"effect":"Pituitary tumour benign","drugRate":"LLR 105","severity":"common"},{"effect":"Fall","drugRate":"LLR 90","severity":"common"},{"effect":"Superinfection","drugRate":"LLR 85","severity":"common"},{"effect":"Transplant failure","drugRate":"LLR 82","severity":"common"},{"effect":"Immunosuppressant drug level increased","drugRate":"LLR 81","severity":"common"},{"effect":"Parkinsonism","drugRate":"LLR 80","severity":"common"},{"effect":"Oesophageal carcinoma","drugRate":"LLR 77","severity":"common"},{"effect":"Enthesopathy","drugRate":"LLR 72","severity":"common"},{"effect":"Multiple drug therapy","drugRate":"LLR 71","severity":"common"}]},"trials":[],"aliases":[],"patents":[],"pricing":[],"allNames":"merislon","offLabel":[],"synonyms":["betahistine dihydrochloride","betahistine hydrochloride","betahistine methanesulfonate","betahistine dihydrobromide","betahistine","beta-histine","betahistine mesilate","merislon","betahistine mesylate"],"timeline":[],"brandName":"Merislon","ecosystem":[{"indication":"Ménière's disease","otherDrugs":[],"globalPrevalence":null}],"mechanism":{"target":"Histamine H3 receptor","targets":[{"gene":"HRH3","source":"DrugCentral","target":"Histamine H3 receptor","protein":"Histamine H3 receptor"}],"modality":"Small Molecule","drugClass":"betahistine","explanation":"Think of the histamine system like a thermostat in your body. When histamine levels get too high, it can cause problems like Ménière's disease. 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system."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/346","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=BETAHISTINE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=BETAHISTINE","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T08:56:47.704233","biosimilars":[],"competitors":[{"drugName":"ciprofloxacin","drugSlug":"ciprofloxacin","fdaApproval":"1987-10-22","patentExpiry":"Nov 27, 2038","patentStatus":"Patent protected","relationship":"same-target"},{"drugName":"clozapine","drugSlug":"clozapine","fdaApproval":"1989-09-26","patentExpiry":"May 1, 2028","patentStatus":"Patent 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for Meniere Disease","status":"RECRUITING","sponsor":"Beijing Tongren Hospital","startDate":"2021-05-01","conditions":["Meniere Disease"],"enrollment":324,"completionDate":"2024-10-20"},{"nctId":"NCT06001047","phase":"NA","title":"Head Acupuncture Treat Residual Symptoms After Canalith Repositioning Procedure for BPPV","status":"RECRUITING","sponsor":"Xi'an No.3 Hospital","startDate":"2023-11-01","conditions":["Benign Paroxysmal Positional Vertigo"],"enrollment":120,"completionDate":"2026-11-01"},{"nctId":"NCT03908567","phase":"PHASE2","title":"AM-125 in the Treatment of Acute Peripheral Vertigo Following Neurosurgery","status":"COMPLETED","sponsor":"Auris Medical AG","startDate":"2019-07-18","conditions":["Vestibular Vertigo"],"enrollment":124,"completionDate":"2022-03-28"},{"nctId":"NCT05938517","phase":"PHASE1","title":"Pharmacokinetic Profile of Betahistine With and Without Selegiline in Healthy Volunteers","status":"COMPLETED","sponsor":"Ludwig-Maximilians - University of 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synonyms BETAHISTINE DIHYDROCHLORIDE, BETAHISTINE HCL, BETAHISTINE HYDROCHLORIDE, and it has been studied in clinical trials for Meniere Disease, Vertigo, and Cervicogenic Dizziness. In one clinical trial, Merislon was compared to taVNS and MLS laser therapy in the treatment of Meniere Disease.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":3,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}