{"id":"loperamide-simethicone","safety":{"commonSideEffects":[{"rate":null,"effect":"Constipation"},{"rate":null,"effect":"Abdominal pain"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Dizziness"}]},"_chembl":{"chemblId":"CHEMBL1707","moleculeType":"Small molecule","molecularWeight":"513.51"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Loperamide is a mu-opioid receptor agonist that decreases intestinal peristalsis and increases absorption of water and electrolytes, thereby reducing diarrhea. Simethicone is a silicone-based antifoaming agent that breaks up gas bubbles in the gastrointestinal tract, reducing abdominal discomfort and bloating. Together, they provide dual symptomatic relief for diarrhea accompanied by gas-related discomfort.","oneSentence":"Loperamide-simethicone combines an antimotility agent that slows intestinal movement with an anti-gas agent that reduces bloating and flatulence.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:52:53.234Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Acute diarrhea with associated gas, bloating, and abdominal discomfort"}]},"trialDetails":[{"nctId":"NCT04186936","phase":"PHASE1","title":"A Study of Combination Caplet With Loperamide Hydrochloride and Simethicone, and Imodium Express Tablets-lyophilizate Coadministered With Espumisan Capsule in Healthy Volunteers","status":"COMPLETED","sponsor":"McNeil AB","startDate":"2019-12-05","conditions":"Healthy","enrollment":48},{"nctId":"NCT02217982","phase":"PHASE4","title":"Pilot Study to Assess Dimethyl Fumarate Related GI Symptom Mitigation","status":"TERMINATED","sponsor":"Rocky Mountain MS Research Group, LLC","startDate":"2014-07","conditions":"Relapsing Remitting Multiple Sclerosis","enrollment":5},{"nctId":"NCT02340481","phase":"PHASE3","title":"Efficacy and Safety Study of Loperamide Hydrochloride/Simethicone Chewable Tablet in Treatment of Acute Diarrhea With Abdominal Discomfort and Flatulence","status":"COMPLETED","sponsor":"Xian-Janssen Pharmaceutical Ltd.","startDate":"2005-07","conditions":"Diarrhea","enrollment":217},{"nctId":"NCT00807326","phase":"PHASE4","title":"A Comparison of Three Medications to Treat Diarrhea in Adults.","status":"COMPLETED","sponsor":"McNeil AB","startDate":"2008-11","conditions":"Diarrhea","enrollment":415},{"nctId":"NCT00685607","phase":"PHASE4","title":"Study to Determine the Best Way to Measure How Quickly the Drug Can Give Relief From Sudden Diarrhea","status":"COMPLETED","sponsor":"Johnson & Johnson Consumer and Personal Products Worldwide","startDate":"2008-10","conditions":"Diarrhea","enrollment":45},{"nctId":"NCT00778115","phase":"NA","title":"Bioequivalence Study of Loperamide Hydrochloride 2 mg and Simethicone 125 mg Tablet Under Fasting Conditions","status":"COMPLETED","sponsor":"Ranbaxy Laboratories Limited","startDate":"2004-11","conditions":"Healthy","enrollment":26}],"_emaApprovals":[],"_faersSignals":[{"count":12,"reaction":"DRUG INEFFECTIVE"},{"count":11,"reaction":"INTENTIONAL PRODUCT USE ISSUE"},{"count":4,"reaction":"OFF LABEL USE"},{"count":4,"reaction":"WRONG TECHNIQUE IN PRODUCT USAGE PROCESS"},{"count":2,"reaction":"CEREBROVASCULAR ACCIDENT"},{"count":2,"reaction":"CHOKING"},{"count":2,"reaction":"CONSTIPATION"},{"count":2,"reaction":"DIZZINESS"},{"count":2,"reaction":"DRUG INEFFECTIVE FOR UNAPPROVED INDICATION"},{"count":2,"reaction":"DRUG INTERACTION"}],"_approvalHistory":[],"publicationCount":4,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Imodium"],"phase":"marketed","status":"active","brandName":"loperamide-simethicone","genericName":"loperamide-simethicone","companyName":"Johnson & Johnson Consumer and Personal Products Worldwide","companyId":"johnson-johnson-consumer-and-personal-products-worldwide","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Loperamide-simethicone combines an antimotility agent that slows intestinal movement with an anti-gas agent that reduces bloating and flatulence. Used for Acute diarrhea with associated gas, bloating, and abdominal discomfort.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}