{"id":"meclozine","rwe":[{"pmid":"41802703","year":"2026","title":"Metoclopramide Use in Nausea and Vomiting of Pregnancy and Risk of Depressive Symptoms as an Adverse Drug Reaction in the Netherlands: a Disproportionality Analysis in a National Spontaneous Reporting Database.","finding":"","journal":"Journal of the Academy of Consultation-Liaison Psychiatry","studyType":"Clinical Study"},{"pmid":"39514089","year":"2025","title":"Meclozine and growth hormone ameliorate bone length and quality in experimental models of achondroplasia.","finding":"","journal":"Journal of bone and mineral metabolism","studyType":"Clinical Study"},{"pmid":"38544920","year":"2024","title":"Long-term oral meclozine administration improves survival rate and spinal canal stenosis during postnatal growth in a mouse model of achondroplasia in both sexes.","finding":"","journal":"JBMR plus","studyType":"Clinical Study"},{"pmid":"36927417","year":"2023","title":"Activated FGFR3 suppresses bone regeneration and bone mineralization in an ovariectomized mouse model.","finding":"","journal":"BMC musculoskeletal disorders","studyType":"Clinical Study"},{"pmid":"36569439","year":"2023","title":"Meclozine ameliorates bone mineralization and growth plate structure in a mouse model of X‑linked hypophosphatemia.","finding":"","journal":"Experimental and therapeutic medicine","studyType":"Clinical Study"}],"tags":[{"label":"Antiemetic","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Nuclear receptor subfamily 1 group I member 3","category":"target"},{"label":"NR1I3","category":"gene"},{"label":"HPN","category":"gene"},{"label":"HRH1","category":"gene"},{"label":"R06AE05","category":"atc"},{"label":"Oral","category":"route"},{"label":"Film","category":"form"},{"label":"Liquid","category":"form"},{"label":"Tablet","category":"form"},{"label":"Active","category":"status"},{"label":"Motion sickness","category":"indication"},{"label":"Prevention of Motion Sickness","category":"indication"},{"label":"Vertigo","category":"indication"},{"label":"Citron Pharma Llc","category":"company"},{"label":"Approved 1950s","category":"decade"},{"label":"Anti-Allergic Agents","category":"pharmacology"},{"label":"Antiemetics","category":"pharmacology"},{"label":"Central Nervous System Agents","category":"pharmacology"},{"label":"Cholinergic Agents","category":"pharmacology"},{"label":"Cholinergic Antagonists","category":"pharmacology"},{"label":"Gastrointestinal Agents","category":"pharmacology"},{"label":"Histamine Agents","category":"pharmacology"},{"label":"Histamine Antagonists","category":"pharmacology"},{"label":"Histamine H1 Antagonists","category":"pharmacology"},{"label":"Neurotransmitter Agents","category":"pharmacology"},{"label":"Peripheral Nervous System Agents","category":"pharmacology"}],"phase":"marketed","safety":{"safetySignals":[{"llr":235.761,"date":"","count":207,"signal":"Vertigo","source":"DrugCentral FAERS","actionTaken":"Reported 207 times (LLR=236)"},{"llr":168.192,"date":"","count":530,"signal":"Dizziness","source":"DrugCentral FAERS","actionTaken":"Reported 530 times (LLR=168)"},{"llr":98.489,"date":"","count":416,"signal":"Fall","source":"DrugCentral FAERS","actionTaken":"Reported 416 times (LLR=98)"},{"llr":69.472,"date":"","count":176,"signal":"Cerebrovascular accident","source":"DrugCentral FAERS","actionTaken":"Reported 176 times (LLR=69)"},{"llr":68.265,"date":"","count":270,"signal":"Drug ineffective","source":"DrugCentral FAERS","actionTaken":"Reported 270 times (LLR=68)"},{"llr":67.913,"date":"","count":89,"signal":"Multiple sclerosis relapse","source":"DrugCentral FAERS","actionTaken":"Reported 89 times (LLR=68)"},{"llr":66.296,"date":"","count":16,"signal":"Narcotic bowel syndrome","source":"DrugCentral FAERS","actionTaken":"Reported 16 times (LLR=66)"},{"llr":64.74,"date":"","count":197,"signal":"Off label use","source":"DrugCentral FAERS","actionTaken":"Reported 197 times (LLR=65)"},{"llr":63.253,"date":"","count":7,"signal":"Treatment failure","source":"DrugCentral FAERS","actionTaken":"Reported 7 times (LLR=63)"},{"llr":60.276,"date":"","count":194,"signal":"Completed suicide","source":"DrugCentral FAERS","actionTaken":"Reported 194 times (LLR=60)"},{"llr":53.687,"date":"","count":11,"signal":"Contraindicated product administered","source":"DrugCentral FAERS","actionTaken":"Reported 11 times (LLR=54)"},{"llr":52.423,"date":"","count":5,"signal":"Synovitis","source":"DrugCentral FAERS","actionTaken":"Reported 5 times (LLR=52)"},{"llr":49.119,"date":"","count":55,"signal":"Multiple sclerosis","source":"DrugCentral FAERS","actionTaken":"Reported 55 times (LLR=49)"},{"llr":45.432,"date":"","count":78,"signal":"Transient ischaemic attack","source":"DrugCentral FAERS","actionTaken":"Reported 78 times (LLR=45)"},{"llr":43.883,"date":"","count":112,"signal":"Migraine","source":"DrugCentral FAERS","actionTaken":"Reported 112 times (LLR=44)"}],"commonSideEffects":[],"contraindications":["Angle-closure glaucoma","Benign prostatic hyperplasia","Bladder outflow obstruction","Chronic idiopathic constipation","Pyloric obstruction","Retention of urine"],"specialPopulations":{"Pregnancy":"Pregnancy Category B. Reproduction studies in rats have shown cleft palates at 25 to 50 times the human dose. Epidemiological studies in pregnant women, however, do not indicate that Meclizine Hydrochloride, USP increases the risk of abnormalities when administered during pregnancy. Despite the animal findings, it would appear that the possibility of fetal harm is remote. Nevertheless, Meclizine Hydrochloride, USP or any other medication, should be used during pregnancy only if clinically indicated.","Geriatric use":"In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.","Paediatric use":"Clinical studies establishing safety and effectiveness in children under 12 years of age have not been done; therefore, usage is not recommended in children under 12 years of age unless directed by doctor."}},"trials":[],"aliases":[],"company":"Citron Pharma Llc","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=meclozine","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:10:11.583090+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Meclozine","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T01:10:20.768468+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T01:10:19.532591+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=meclozine","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T01:10:20.180871+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1623/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:10:20.645038+00:00"}},"allNames":"antivert","offLabel":[],"synonyms":["meclizine","meclizine hydrochloride","meclozine","meclozine dihydrochloride","meclizine HCl"],"timeline":[{"date":"1957-02-14","type":"positive","source":"DrugCentral","milestone":"FDA approval (Citron Pharma Llc)"}],"approvals":[{"date":"1957-02-14","orphan":false,"company":"CITRON PHARMA LLC","regulator":"FDA"}],"brandName":"Antivert","ecosystem":[{"indication":"Motion sickness","otherDrugs":[{"name":"buclizine","slug":"buclizine","company":"Stuart Pharms"},{"name":"cyclizine","slug":"cyclizine","company":"Glaxosmithkline"},{"name":"dimenhydrinate","slug":"dimenhydrinate","company":"Alra"},{"name":"scopolamine","slug":"scopolamine","company":"Novartis"}],"globalPrevalence":null},{"indication":"Prevention of Motion Sickness","otherDrugs":[{"name":"dimenhydrinate","slug":"dimenhydrinate","company":"Alra"},{"name":"scopolamine","slug":"scopolamine","company":"Novartis"}],"globalPrevalence":null},{"indication":"Vertigo","otherDrugs":[{"name":"dimenhydrinate","slug":"dimenhydrinate","company":"Alra"},{"name":"diphenidol","slug":"diphenidol","company":""}],"globalPrevalence":null}],"mechanism":{"target":"Nuclear receptor subfamily 1 group I member 3","novelty":"Follow-on","targets":[{"gene":"NR1I3","source":"DrugCentral","target":"Nuclear receptor subfamily 1 group I member 3","protein":"Nuclear receptor subfamily 1 group I member 3"},{"gene":"HPN","source":"DrugCentral","target":"Serine protease hepsin","protein":"Serine protease hepsin"},{"gene":"HRH1","source":"DrugCentral","target":"Histamine H1 receptor","protein":"Histamine H1 receptor"}],"modality":"Small Molecule","drugClass":"Antiemetic","explanation":"","oneSentence":"","technicalDetail":"Antivert (meclozine) acts as a competitive antagonist at the 5-HT3 receptor, a subtype of serotonin receptor, which plays a crucial role in the regulation of nausea and vomiting."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Meclizine","title":"Meclizine","extract":"Meclizine, sold under the brand name Bonine, among others, is an antihistamine used to treat motion sickness and dizziness (vertigo). It is taken by mouth. Effects generally begin in an hour and last for up to a day.","wiki_society_and_culture":"== Society and culture ==\n=== Brand names ===\nMeclizine is an international nonproprietary name.\n\nIt is sold under the brand names Bonine, Bonamine, Antivert, Postafen, Sea Legs, and Dramamine II (Less Drowsy Formulation). Emesafene is a combination of meclizine (1/3) and pyridoxine (2/3). In Canada, Antivert Tab was a combination of meclizine and nicotinic acid."},"commercial":{"launchDate":"1957","_launchSource":"DrugCentral (FDA 1957-02-14, CITRON PHARMA LLC)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/1649","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=meclozine","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=meclozine","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Meclizine","fields":["history","overview"],"source":"Wikipedia"}],"_enrichedAt":"2026-03-30T15:01:25.840079","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:10:22.725351+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"buclizine","drugSlug":"buclizine","fdaApproval":"","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"cyclizine","drugSlug":"cyclizine","fdaApproval":"","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"chlorcyclizine","drugSlug":"chlorcyclizine","fdaApproval":"","relationship":"same-class"},{"drugName":"cetirizine","drugSlug":"cetirizine","fdaApproval":"1995-12-08","patentExpiry":"Sep 15, 2030","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"levocetirizine","drugSlug":"levocetirizine","fdaApproval":"2007-05-25","patentExpiry":"Oct 16, 2027","patentStatus":"Patent protected","relationship":"same-class"}],"genericName":"meclozine","indications":{"approved":[{"name":"Motion sickness","source":"DrugCentral","snomedId":37031009,"regulator":"FDA","eligibility":"all ages"},{"name":"Prevention of Motion Sickness","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Vertigo","source":"DrugCentral","snomedId":399153001,"regulator":"FDA"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"buclizine","brandName":"buclizine","genericName":"buclizine","approvalYear":"","relationship":"same-class"},{"drugId":"cyclizine","brandName":"cyclizine","genericName":"cyclizine","approvalYear":"","relationship":"same-class"},{"drugId":"chlorcyclizine","brandName":"chlorcyclizine","genericName":"chlorcyclizine","approvalYear":"","relationship":"same-class"},{"drugId":"cetirizine","brandName":"cetirizine","genericName":"cetirizine","approvalYear":"1995","relationship":"same-class"},{"drugId":"levocetirizine","brandName":"levocetirizine","genericName":"levocetirizine","approvalYear":"2007","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT03270839","phase":"PHASE4","title":"Motion Sickness Medications and Vestibular Time Constant","status":"COMPLETED","sponsor":"Medical Corps, Israel Defense Force","startDate":"2017-06-01","conditions":["Drug Reaction"],"enrollment":54,"completionDate":"2020-01-01"},{"nctId":"NCT03253289","phase":"PHASE1","title":"Meclizine for Hepatocellular Carcinoma","status":"COMPLETED","sponsor":"Tannaz Armaghnay","startDate":"2017-10-13","conditions":["Carcinoma, Hepatocellular"],"enrollment":13,"completionDate":"2023-03-28"},{"nctId":"NCT05852730","phase":"PHASE2","title":"Combination of Intranasal Scopolamine and Sensory Augmentation to Mitigate G-transition Induced Motion Sickness and Enhance Sensorimotor Performance","status":"RECRUITING","sponsor":"Repurposed Therapeutics, Inc.","startDate":"2021-08-10","conditions":["Motion Sickness, Space","Motion Simulation","Parabolic Flight"],"enrollment":80,"completionDate":"2026-09"},{"nctId":"NCT02112578","phase":"PHASE3","title":"Non Inferiority of Meclin® (Meclizine Chlorhydrate) Versus Dramin® (Dimenhydrinate) in Control of Acute Vertigo Symptoms From Peripheral Origin","status":"COMPLETED","sponsor":"Apsen Farmaceutica S.A.","startDate":"2016-11-01","conditions":["Vertigo, Peripheral"],"enrollment":292,"completionDate":"2017-12-01"},{"nctId":"NCT04564144","phase":"PHASE1,PHASE2","title":"Evaluation of Meclizine Orodispersible Tablet Pharmacokinetic in Human Volunteers","status":"UNKNOWN","sponsor":"Mansoura University","startDate":"2020-06-01","conditions":["Emesis"],"enrollment":6,"completionDate":"2020-12-01"},{"nctId":"NCT04482985","phase":"PHASE4","title":"Meclizine Plasma Levels in Responders and Non-responders","status":"UNKNOWN","sponsor":"Medical Corps, Israel Defense Force","startDate":"2020-09-01","conditions":["Seasickness","Meclizine"],"enrollment":50,"completionDate":"2021-09-01"},{"nctId":"NCT02625181","phase":"NA","title":"Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis","status":"COMPLETED","sponsor":"Vanderbilt University","startDate":"2016-07","conditions":["Postoperative Nausea and Vomiting"],"enrollment":27034,"completionDate":"2017-11-30"},{"nctId":"NCT00641797","phase":"NA","title":"Treating Benign Paroxysmal Positional Vertigo (BPPV) in ED Patients","status":"COMPLETED","sponsor":"Lehigh Valley Hospital","startDate":"2006-11","conditions":["Benign Paroxysmal Positional Vertigo"],"enrollment":26,"completionDate":"2013-11"},{"nctId":"NCT01443858","phase":"PHASE2","title":"Meclizine as a Potential Smoking Cessation Treatment","status":"COMPLETED","sponsor":"Duke University","startDate":"2011-08","conditions":["Smoking Cessation"],"enrollment":146,"completionDate":"2013-07"},{"nctId":"NCT01537471","phase":"PHASE1","title":"The Effects of Antihistamines on Pre-Pulse Inhibition","status":"COMPLETED","sponsor":"Duke University","startDate":"2012-01","conditions":["Healthy"],"enrollment":117,"completionDate":"2012-09"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Oral","formulation":"Film, Liquid, Tablet","formulations":[{"form":"FILM, SOLUBLE","route":"ORAL","productName":"NAUS-EASE"},{"form":"FILM, SOLUBLE","route":"ORAL","productName":"Zentrip"},{"form":"LIQUID","route":"ORAL","productName":"NOVOMINSYRUP"},{"form":"TABLET","route":"ORAL","productName":"MECLIZINE"},{"form":"TABLET","route":"ORAL","productName":"MECLIZINE HYDROCHLORIDE"},{"form":"TABLET","route":"ORAL","productName":"Meclizine Hydrochloride"},{"form":"TABLET","route":"ORAL","productName":"Meclizine Hydrocloride"},{"form":"TABLET","route":"ORAL","productName":"Meclizine hydrochloride"},{"form":"TABLET","route":"ORAL","productName":"NAUS-EASE"},{"form":"TABLET","route":"ORAL","productName":"Antivert"},{"form":"TABLET","route":"ORAL","productName":"Meclizine Hydrochloride"},{"form":"TABLET","route":"ORAL","productName":"MECLIZINE HYDROCHLORIDE"},{"form":"TABLET","route":"ORAL","productName":"Meclizine Hydrochloride"},{"form":"TABLET","route":"ORAL","productName":"DRAMAMINE - N"},{"form":"TABLET","route":"ORAL","productName":"Dramamine Less Drowsy"}]},"crossReferences":{"NUI":"N0000147898","MMSL":"1696","NDDF":"003400","UNII":"3L5TQ84570","VUID":"4019809","CHEBI":"CHEBI:6709","VANDF":"4017843","INN_ID":"204","RXNORM":"6676","UMLSCUI":"C0025039","chemblId":"CHEMBL1623","ChEMBL_ID":"CHEMBL1623","KEGG_DRUG":"D01317","DRUGBANK_ID":"DB00737","PUBCHEM_CID":"4034","SNOMEDCT_US":"372879002","IUPHAR_LIGAND_ID":"2757","SECONDARY_CAS_RN":"31884-77-2","MESH_DESCRIPTOR_UI":"D008468"},"formularyStatus":[],"originalProduct":{"form":"TABLET","route":"ORAL","company":"Casper Pharma LLC","brandName":"Antivert","isOriginal":true,"marketingStatus":"NDA"},"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"1957-","companyName":"Citron Pharma Llc","relationship":"Original Developer"}],"publicationCount":58,"therapeuticAreas":["Other"],"atcClassification":{"source":"DrugCentral","atcCode":"R06AE05","allCodes":["R06AE05","R06AE55"]},"biosimilarFilings":[],"originalDeveloper":"Citron Pharma Llc","recentPublications":[{"date":"2026 Mar 7","pmid":"41802703","title":"Metoclopramide Use in Nausea and Vomiting of Pregnancy and Risk of Depressive Symptoms as an Adverse Drug Reaction in the Netherlands: a Disproportionality Analysis in a National Spontaneous Reporting Database.","journal":"Journal of the Academy of Consultation-Liaison Psychiatry"},{"date":"2025 Mar","pmid":"39514089","title":"Meclozine and growth hormone ameliorate bone length and quality in experimental models of achondroplasia.","journal":"Journal of bone and mineral metabolism"},{"date":"2024 Apr","pmid":"38544920","title":"Long-term oral meclozine administration improves survival rate and spinal canal stenosis during postnatal growth in a mouse model of achondroplasia in both sexes.","journal":"JBMR plus"},{"date":"2023 Mar 16","pmid":"36927417","title":"Activated FGFR3 suppresses bone regeneration and bone mineralization in an ovariectomized mouse model.","journal":"BMC musculoskeletal disorders"},{"date":"2023 Jan","pmid":"36569439","title":"Meclozine ameliorates bone mineralization and growth plate structure in a mouse model of X‑linked hypophosphatemia.","journal":"Experimental and therapeutic medicine"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"active","companyName":"Citron Pharma Llc","companyId":"citron-pharma-llc","modality":"Small Molecule","firstApprovalDate":"1957","aiSummary":"","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1957-02-14T00:00:00.000Z","mah":"CITRON PHARMA LLC","brand_name_local":null,"application_number":""},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:10:22.725351+00:00","fieldsConflicting":2,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}