{"id":"dimenhydrinate","rwe":[{"pmid":"41628415","year":"2026","title":"Exogenous Sex Hormones and Postoperative Nausea and Vomiting Risk in Transgender Patients.","finding":"","journal":"Anesthesia and analgesia","studyType":"Clinical Study"},{"pmid":"41405074","year":"2025","title":"Acute Kounis Syndrome Induced by Tramadol: A Case Report.","finding":"","journal":"Journal of pain & palliative care pharmacotherapy","studyType":"Clinical Study"},{"pmid":"41327197","year":"2025","title":"Antiemetic use during pregnancy and child neurodevelopment: population-based birth cohort study.","finding":"","journal":"BMC medicine","studyType":"Clinical Study"},{"pmid":"41144537","year":"2025","title":"Development and characterisation of fast dispersible dimenhydrinate tablets: Compactional study and in-silico PBPK modeling.","finding":"","journal":"PloS one","studyType":"Clinical Study"},{"pmid":"41072313","year":"2025","title":"From waterways to the brain: Unraveling the environmental triggers of depression through PPCPs-gene network convergence.","finding":"","journal":"Ecotoxicology and environmental safety","studyType":"Clinical Study"}],"_fda":{"id":"766ba325-4972-4feb-8ef9-39c824bd8f7e","set_id":"00a327c6-6b86-4702-8c04-55c405c1404c","openfda":{"upc":["0635515997134"],"unii":["JB937PER5C"],"route":["ORAL"],"rxcui":["198603"],"spl_id":["766ba325-4972-4feb-8ef9-39c824bd8f7e"],"brand_name":["Motion Sickness Relief"],"spl_set_id":["00a327c6-6b86-4702-8c04-55c405c1404c"],"package_ndc":["83324-032-12","83324-032-24"],"product_ndc":["83324-032"],"generic_name":["DIMENHYDRINATE"],"product_type":["HUMAN OTC DRUG"],"substance_name":["DIMENHYDRINATE"],"manufacturer_name":["Chain Drug Marketing Association, Inc."],"application_number":["M009"],"is_original_packager":[true]},"purpose":["Purpose Antiemetic"],"version":"4","warnings":["Warnings Do not use for children under 2 years of age unless directed by a doctor. Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery avoid alcoholic beverages If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"questions":["Questions or comments? 1-800-426-9391"],"ask_doctor":["Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland"],"do_not_use":["Do not use for children under 2 years of age unless directed by a doctor."],"when_using":["When using this product marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery avoid alcoholic beverages"],"effective_time":"20250510","active_ingredient":["Active ingredient (in each tablet) Dimenhydrinate 50 mg"],"inactive_ingredient":["Inactive ingredients croscarmellose sodium, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid"],"storage_and_handling":["Other information each tablet contains: calcium 35 mg TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) protect from moisture see end flap for expiration date and lot number"],"indications_and_usage":["Uses for prevention and treatment of these symptoms associated with motion sickness: nausea vomiting dizziness"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers."],"dosage_and_administration":["Directions to prevent motion sickness, the first dose should be taken one-half to one hour before starting activity adults and children 12 years and over 1 to 2 tablets every 4-6 hours; do not exceed 8 tablets in 24 hours, or as directed by a doctor children 6 to under 12 years 1/2 to 1 tablet every 6-8 hours; do not exceed 3 tablets in 24 hours, or as directed by a doctor children 2 to under 6 years 1/2 tablet every 6-8 hours; do not exceed 1&1/2 tablets in 24 hours, or as directed by a doctor"],"spl_product_data_elements":["Motion Sickness Relief Dimenhydrinate DIMENHYDRINATE DIPHENHYDRAMINE 8-CHLOROTHEOPHYLLINE CROSCARMELLOSE SODIUM DIBASIC CALCIUM PHOSPHATE DIHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SILICON DIOXIDE STEARIC ACID 44;198"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"dosage_and_administration_table":["<table width=\"400px\"><col/><col/><tbody><tr><td styleCode=\" Botrule Toprule Lrule Rrule\">adults and children 12 years and over</td><td styleCode=\" Botrule Toprule Lrule Rrule\">1 to 2 tablets every 4-6 hours; do not exceed 8 tablets in 24 hours, or as directed by a doctor</td></tr><tr><td styleCode=\" Botrule Toprule Lrule Rrule\">children 6 to under 12 years</td><td styleCode=\" Botrule Toprule Lrule Rrule\">1/2 to 1 tablet every 6-8 hours; do not exceed 3 tablets in 24 hours, or as directed by a doctor</td></tr><tr><td styleCode=\" Botrule Toprule Lrule Rrule\">children 2 to under 6 years</td><td styleCode=\" Botrule Toprule Lrule Rrule\">1/2 tablet every 6-8 hours; do not exceed 1&amp;1/2 tablets in 24 hours, or as directed by a doctor</td></tr></tbody></table>"],"package_label_principal_display_panel":["Principal Display Panel NDC 83324-032-12 QC® QUALITY CHOICE *Compare to the Active Ingredient in Dramamine® Original Formula Motion Sickness Relief Original Formula Dimenhydrinate 50 mg | Antiemetic Prevents: Nausea, Vomiting & Dizziness for Children & Adults 12 Tablets actual size TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING *This product is not manufactured or distributed by Medtech Products Inc., owner of the registered trademark Dramamine® Original Formula. 50844 REV0518A19802 SATISFACTION GUARANTEED 100% QC Distributed by CDMA, Inc. Novi, MI 48375 www.qualitychoice.com Questions: 800-935-2362 Quality_Chocie_44-198 Quality_Chocie_44-198"]},"tags":[{"label":"dimenhydrinate","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Histamine H1 receptor","category":"target"},{"label":"HRH1","category":"gene"},{"label":"CHRM4","category":"gene"},{"label":"CHRM3","category":"gene"},{"label":"R06AA11","category":"atc"},{"label":"Intramuscular","category":"route"},{"label":"Oral","category":"route"},{"label":"Capsule","category":"form"},{"label":"Injection","category":"form"},{"label":"Syrup","category":"form"},{"label":"Tablet","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Established","category":"status"},{"label":"Motion sickness","category":"indication"},{"label":"Nausea","category":"indication"},{"label":"Nausea and vomiting","category":"indication"},{"label":"Prevention of Motion Sickness","category":"indication"},{"label":"Prevention of Nausea and Vomiting","category":"indication"},{"label":"Vertigo","category":"indication"},{"label":"Alra","category":"company"},{"label":"Approved 1970s","category":"decade"},{"label":"Antiemetics","category":"pharmacology"},{"label":"Central Nervous System Agents","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":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"2379 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"1768 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"1730 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"1516 reports"},{"date":"","signal":"VOMITING","source":"FDA FAERS","actionTaken":"1326 reports"},{"date":"","signal":"MALAISE","source":"FDA FAERS","actionTaken":"1168 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"1088 reports"},{"date":"","signal":"DIZZINESS","source":"FDA FAERS","actionTaken":"1084 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"1067 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"1064 reports"}],"commonSideEffects":[],"contraindications":["Acute coronary syndrome","Alcoholism","Angle-closure glaucoma","Arterial hemorrhage","Benign prostatic hyperplasia","Bladder outflow obstruction","Blood coagulation disorder","Chronic idiopathic constipation","Diabetes mellitus","Disease of liver","Disorder of coronary artery","Gout","Hyperglycemia","Hypertensive disorder","Hyperthyroidism","Hypophosphatemia","Liver function tests abnormal","Low blood pressure","Myocardial infarction","Ocular hypertension","Peptic ulcer","Pyloric obstruction","Retention of urine","Thrombocytopenic disorder"],"specialPopulations":{"Pregnancy":"There are no adequate and well-controlled studies in pregnant women. However, clinical studies in pregnant women have not indicated that dimenhydrinate increases the risk of abnormalities when administered in an"}},"trials":[],"aliases":[],"company":"Alra","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=DIMENHYDRINATE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:42:38.879017+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T01:42:57.500985+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T01:42:44.023670+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T01:42:38.007218+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=DIMENHYDRINATE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T01:42:44.426348+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:42:37.558997+00:00"},"indications.approved":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:42:51.142948+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:42:37.559019+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T01:42:46.054560+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Histamine H1 receptor antagonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:42:45.460433+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1200406/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:42:45.129228+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"M009","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:42:37.559023+00:00"}},"allNames":["dimenhydrinate","andramine","chloranautine","diamarin","diphenhydramine 8-chlorotheophyllinate","diphenhydrinate","dramamine","menhydrinate","theohydramine"],"offLabel":[],"synonyms":["dimenhydrinate","andramine","chloranautine","diamarin","diphenhydramine 8-chlorotheophyllinate","diphenhydrinate","dramamine","menhydrinate","theohydramine"],"timeline":[{"date":"1972-05-31","type":"positive","source":"DrugCentral","milestone":"FDA approval (Alra)"}],"aiSummary":"Dimenhydrinate, marketed by Alra, is an antihistamine primarily indicated for motion sickness, competing in a well-established class of drugs. Its key strength lies in its mechanism of action, effectively blocking histamine to alleviate nausea and vomiting, with a key composition patent expiring in 2028. The primary risk is the strong presence of off-patent competitors such as diphenhydramine and clemastine, which are widely available generics, potentially eroding market share.","approvals":[{"date":"1972-05-31","orphan":false,"company":"ALRA","regulator":"FDA"}],"brandName":"Dimenhydrinate","ecosystem":[{"indication":"Motion sickness","otherDrugs":[{"name":"buclizine","slug":"buclizine","company":"Stuart Pharms"},{"name":"cyclizine","slug":"cyclizine","company":"Glaxosmithkline"},{"name":"meclozine","slug":"meclozine","company":"Citron Pharma Llc"},{"name":"scopolamine","slug":"scopolamine","company":"Novartis"}],"globalPrevalence":null},{"indication":"Nausea","otherDrugs":[{"name":"promazine","slug":"promazine","company":""},{"name":"thiethylperazine","slug":"thiethylperazine","company":"Novartis"},{"name":"triflupromazine","slug":"triflupromazine","company":""},{"name":"trimethobenzamide","slug":"trimethobenzamide","company":"Par Sterile Products"}],"globalPrevalence":null},{"indication":"Nausea and vomiting","otherDrugs":[{"name":"chlorpromazine","slug":"chlorpromazine","company":"Glaxosmithkline"},{"name":"perphenazine","slug":"perphenazine","company":""},{"name":"prochlorperazine","slug":"prochlorperazine","company":"Glaxosmithkline"},{"name":"promazine","slug":"promazine","company":""}],"globalPrevalence":null},{"indication":"Prevention of Motion Sickness","otherDrugs":[{"name":"meclozine","slug":"meclozine","company":"Citron Pharma Llc"},{"name":"scopolamine","slug":"scopolamine","company":"Novartis"}],"globalPrevalence":null},{"indication":"Prevention of Nausea and Vomiting","otherDrugs":[],"globalPrevalence":null},{"indication":"Vertigo","otherDrugs":[{"name":"diphenidol","slug":"diphenidol","company":""},{"name":"meclozine","slug":"meclozine","company":"Citron Pharma Llc"}],"globalPrevalence":null},{"indication":"Vomiting","otherDrugs":[{"name":"promazine","slug":"promazine","company":""},{"name":"thiethylperazine","slug":"thiethylperazine","company":"Novartis"},{"name":"triflupromazine","slug":"triflupromazine","company":""},{"name":"trimethobenzamide","slug":"trimethobenzamide","company":"Par Sterile Products"}],"globalPrevalence":null}],"mechanism":{"target":"Histamine H1 receptor","novelty":"Follow-on","targets":[{"gene":"HRH1","source":"DrugCentral","target":"Histamine H1 receptor","protein":"Histamine H1 receptor"},{"gene":"CHRM4","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M4","protein":"Muscarinic acetylcholine receptor M4"},{"gene":"CHRM3","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M3","protein":"Muscarinic acetylcholine receptor M3"},{"gene":"CHRM1","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M1","protein":"Muscarinic acetylcholine receptor M1"},{"gene":"CHRM2","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M2","protein":"Muscarinic acetylcholine receptor M2"},{"gene":"HTR2A","source":"DrugCentral","target":"5-hydroxytryptamine receptor 2A","protein":"5-hydroxytryptamine receptor 2A"},{"gene":"CHRM5","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M5","protein":"Muscarinic acetylcholine receptor M5"},{"gene":"HTR2C","source":"DrugCentral","target":"5-hydroxytryptamine receptor 2C","protein":"5-hydroxytryptamine receptor 2C"},{"gene":"SIGMAR1","source":"DrugCentral","target":"Sigma non-opioid intracellular receptor 1","protein":"Sigma non-opioid intracellular receptor 1"},{"gene":"HTR2B","source":"DrugCentral","target":"5-hydroxytryptamine receptor 2B","protein":"5-hydroxytryptamine receptor 2B"}],"modality":"Small Molecule","drugClass":"dimenhydrinate","explanation":"","oneSentence":"","technicalDetail":"Dimenhydrinate is a competitive antagonist of the histamine H1 receptor, which is a G-protein coupled receptor that plays a key role in the regulation of nausea and vomiting. By blocking the action of histamine at this receptor, dimenhydrinate reduces the excitatory input to the vomiting center in the brain, leading to a decrease in nausea and vomiting."},"commercial":{"launchDate":"1972","_launchSource":"DrugCentral (FDA 1972-05-31, ALRA)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/901","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=DIMENHYDRINATE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=DIMENHYDRINATE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange 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