{"id":"dicycloverine","rwe":[{"pmid":"30000514","year":"2006","title":"Dicyclomine.","finding":"","journal":"","studyType":"Clinical Study"},{"pmid":"36373155","year":"2022","title":"Toxicity Management in the Era of Changing Treatment Paradigms for Locally Advanced Rectal Cancer.","finding":"","journal":"Current colorectal cancer reports","studyType":"Clinical Study"},{"pmid":"25738989","year":"2015","title":"A predictive in vitro model of the impact of drugs with anticholinergic properties on human neuronal and astrocytic systems.","finding":"","journal":"PloS one","studyType":"Clinical Study"},{"pmid":"16636723","year":"2006","title":"Gateways to clinical trials.","finding":"","journal":"Methods and findings in experimental and clinical pharmacology","studyType":"Clinical Study"},{"pmid":"15087360","year":"2004","title":"Dicycloverine for persistent crying in babies: beware recommending dicycloverine treatment in babies.","finding":"","journal":"BMJ (Clinical research ed.)","studyType":"Clinical Study"}],"tags":[{"label":"Anticholinergic","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Muscarinic acetylcholine receptor M4","category":"target"},{"label":"CHRM4","category":"gene"},{"label":"CHRM1","category":"gene"},{"label":"CHRM3","category":"gene"},{"label":"A03AA07","category":"atc"},{"label":"Oral","category":"route"},{"label":"Intramuscular","category":"route"},{"label":"Capsule","category":"form"},{"label":"Injection","category":"form"},{"label":"Solution","category":"form"},{"label":"Syrup","category":"form"},{"label":"Active","category":"status"},{"label":"Irritable bowel syndrome","category":"indication"},{"label":"Forest Labs Inc","category":"company"},{"label":"Approved 1950s","category":"decade"},{"label":"Cholinergic Agents","category":"pharmacology"},{"label":"Cholinergic Antagonists","category":"pharmacology"},{"label":"Muscarinic Antagonists","category":"pharmacology"},{"label":"Neurotransmitter Agents","category":"pharmacology"},{"label":"Parasympatholytics","category":"pharmacology"},{"label":"Peripheral Nervous System Agents","category":"pharmacology"}],"phase":"marketed","safety":{"safetySignals":[{"llr":228.283,"date":"","count":101,"signal":"Cholecystitis chronic","source":"DrugCentral FAERS","actionTaken":"Reported 101 times (LLR=228)"},{"llr":133.521,"date":"","count":47,"signal":"Biliary dyskinesia","source":"DrugCentral FAERS","actionTaken":"Reported 47 times (LLR=134)"},{"llr":118.33,"date":"","count":408,"signal":"Abdominal pain","source":"DrugCentral FAERS","actionTaken":"Reported 408 times (LLR=118)"},{"llr":112.761,"date":"","count":314,"signal":"Anxiety","source":"DrugCentral FAERS","actionTaken":"Reported 314 times (LLR=113)"},{"llr":90.186,"date":"","count":75,"signal":"Gallbladder disorder","source":"DrugCentral FAERS","actionTaken":"Reported 75 times (LLR=90)"},{"llr":79.594,"date":"","count":5,"signal":"Contraindicated product administered","source":"DrugCentral FAERS","actionTaken":"Reported 5 times (LLR=80)"},{"llr":75.636,"date":"","count":684,"signal":"Diarrhoea","source":"DrugCentral FAERS","actionTaken":"Reported 684 times (LLR=76)"},{"llr":62.548,"date":"","count":700,"signal":"Nausea","source":"DrugCentral FAERS","actionTaken":"Reported 700 times (LLR=63)"},{"llr":61.505,"date":"","count":5,"signal":"Synovitis","source":"DrugCentral FAERS","actionTaken":"Reported 5 times (LLR=62)"},{"llr":58.592,"date":"","count":234,"signal":"Abdominal pain upper","source":"DrugCentral FAERS","actionTaken":"Reported 234 times (LLR=59)"},{"llr":56.216,"date":"","count":235,"signal":"Depression","source":"DrugCentral FAERS","actionTaken":"Reported 235 times (LLR=56)"},{"llr":53.954,"date":"","count":6,"signal":"Glossodynia","source":"DrugCentral FAERS","actionTaken":"Reported 6 times (LLR=54)"},{"llr":53.506,"date":"","count":22,"signal":"Vulvovaginal burning sensation","source":"DrugCentral FAERS","actionTaken":"Reported 22 times (LLR=54)"},{"llr":52.274,"date":"","count":262,"signal":"Product dose omission issue","source":"DrugCentral FAERS","actionTaken":"Reported 262 times (LLR=52)"},{"llr":49.955,"date":"","count":30,"signal":"General physical health deterioration","source":"DrugCentral FAERS","actionTaken":"Reported 30 times (LLR=50)"}],"commonSideEffects":[],"contraindications":["Achalasia of esophagus","Alcoholism","Anemia","Angle-closure glaucoma","Atony of colon","Autonomic dysreflexia","Benign prostatic hyperplasia","Bladder outflow obstruction","Bleeding","Brain damage","Breastfeeding (mother)","Chronic heart failure","Chronic lung disease","Complete trisomy 21 syndrome","Depressive disorder","Disease of liver","Disorder of coronary artery","Disturbance of salivary secretion","Drug AND/OR toxin-induced diarrhea","Dyspnea","Fever greater than 100.4 Fahrenheit","Gastric ulcer","Gastrointestinal obstruction","Hepatic coma","Hepatic encephalopathy"],"specialPopulations":{"Pregnancy":"Adequate and well-controlled studies have not been conducted with dicyclomine in pregnant women at the recommended doses of 80 mg/day to 160 mg/day. However, epidemiologic studies did not show an increased risk of structural malformations among babies born to women who took products containing dicyclomine hydrochloride at doses up to 40 mg/day during the first trimester of pregnancy. Reproduction studies have been performed in rats and rabbits at doses up to 33 times the maximum recommended human dose based on 160 mg/day (3 mg/kg) and have revealed no evidence of harm to the fetus due to dicyclomine. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.","Geriatric use":"Clinical studies of dicyclomine hydrochloride did not include sufficient time of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. 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 diseases or other drug therapy.","Paediatric use":"Dicyclomine is contraindicated in infants less than months of age. Safety and effectiveness in pediatric patients have not been established.","Hepatic impairment":"Dicyclomine hydrochloride should be administered with caution in patients with hepatic impairment."}},"trials":[],"aliases":[],"company":"Forest Labs Inc","patents":[],"pricing":[],"_fixedAt":"2026-03-30T16:53:18.340825","_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=dicycloverine","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:45:33.747990+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:45:39.028283+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=dicycloverine","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:45:39.369131+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1123/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:45:40.142985+00:00"}},"allNames":"bentyl","offLabel":[],"synonyms":["dicymine","dicycloverine hydrochloride","dicycloverine","dicyclomine","dicycloverin","dicyclomine hydrochloride","dicyclomine HCl"],"timeline":[{"date":"1950-05-11","type":"positive","source":"DrugCentral","milestone":"FDA approval (Forest Labs Inc)"}],"aiSummary":"Bentyl (dicycloverine) is a small molecule anticholinergic medication originally developed by Forest Labs Inc and currently owned by the same company. It targets the muscarinic acetylcholine receptor M4 and is FDA approved for the treatment of irritable bowel syndrome. Bentyl works by blocking the action of acetylcholine, a neurotransmitter that stimulates muscle contractions in the gastrointestinal tract. As an off-patent medication, Bentyl is likely available in generic forms. Key safety considerations include potential anticholinergic side effects such as dry mouth and constipation.","approvals":[{"date":"1950-05-11","orphan":false,"company":"FOREST LABS INC","regulator":"FDA"}],"brandName":"Bentyl","ecosystem":[{"indication":"Irritable bowel syndrome","otherDrugs":[{"name":"chlordiazepoxide","slug":"chlordiazepoxide","company":"Valeant Pharm Intl"},{"name":"clidinium","slug":"clidinium","company":"Roche"},{"name":"homatropine","slug":"homatropine","company":""},{"name":"linaclotide","slug":"linaclotide","company":"Forest Labs Llc"}],"globalPrevalence":null}],"mechanism":{"target":"Histamine H2 receptor","novelty":"First-in-class","targets":[{"gene":"HRH2","source":"DrugCentral","target":"Histamine H2 receptor","protein":"Histamine H2 receptor","isPrimary":true,"activityType":"Ki","activityValue":5.796},{"gene":"CHRM4","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M4","protein":"Muscarinic acetylcholine receptor 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M2"},{"gene":"DRD3","source":"DrugCentral","target":"D(3) dopamine receptor","protein":"D(3) dopamine receptor"},{"gene":"HTR2B","source":"DrugCentral","target":"5-hydroxytryptamine receptor 2B","protein":"5-hydroxytryptamine receptor 2B"}],"moaClass":"Cholinergic Antagonists","modality":"Small Molecule","drugClass":"Anticholinergic","explanation":"","oneSentence":"","technicalDetail":"Bentyl (dicycloverine) is a competitive antagonist of the muscarinic acetylcholine receptor M4, which is involved in the regulation of gastrointestinal smooth muscle contractions."},"commercial":{"launchDate":"1950","_launchSource":"DrugCentral (FDA 1950-05-11, FOREST LABS 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