{"id":"docusate-sodium","rwe":[{"pmid":"41689811","year":"2026","title":"Compounded Semaglutide and Tirzepatide Products Use Unique Formulations but Efficacy and Safety Largely Unknown.","finding":"","journal":"The Annals of pharmacotherapy","studyType":"Clinical Study"},{"pmid":"41664145","year":"2026","title":"Using laxative to recover intestinal function could improve the survival outcome for patients with cardiac arrest: a retrospective cohort study from MIMIC-IV database.","finding":"","journal":"Journal of intensive care","studyType":"Clinical Study"},{"pmid":"41636377","year":"2026","title":"Competitive solvation of p-nitroaniline by water, diethyl sulfoxide, n-heptane, and AOT micelles.","finding":"","journal":"Physical chemistry chemical physics : PCCP","studyType":"Clinical Study"},{"pmid":"41310171","year":"2025","title":"High-throughput in vitro screening and in silico analysis for Zika virus inhibitor identification.","finding":"","journal":"Scientific reports","studyType":"Clinical Study"},{"pmid":"40976069","year":"2025","title":"Fouling mitigation for cellulose triacetate and thin-film composite forward osmosis membranes for seawater desalination by sodium metasilicate sol-gel.","finding":"","journal":"The Science of the total environment","studyType":"Clinical Study"}],"tags":[{"label":"docusate sodium","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"A06AA02","category":"atc"},{"label":"Oral","category":"route"},{"label":"Capsule","category":"form"},{"label":"Active","category":"status"},{"label":"Breastfeeding (mother)","category":"indication"},{"label":"Constipation","category":"indication"},{"label":"Iron deficiency anemia","category":"indication"},{"label":"Megaloblastic anemia due to folate deficiency","category":"indication"},{"label":"Pregnancy, function","category":"indication"},{"label":"Surface-Active Agents","category":"pharmacology"}],"phase":"discontinued","safety":{"safetySignals":[{"llr":629.077,"date":"","count":1153,"signal":"Drug ineffective","source":"DrugCentral FAERS","actionTaken":"Reported 1,153 times (LLR=629)"},{"llr":624.161,"date":"","count":1746,"signal":"Constipation","source":"DrugCentral FAERS","actionTaken":"Reported 1,746 times (LLR=624)"},{"llr":335.202,"date":"","count":22,"signal":"Systemic lupus erythematosus","source":"DrugCentral FAERS","actionTaken":"Reported 22 times (LLR=335)"},{"llr":334.452,"date":"","count":8,"signal":"Pemphigus","source":"DrugCentral FAERS","actionTaken":"Reported 8 times (LLR=334)"},{"llr":318.64,"date":"","count":17,"signal":"Synovitis","source":"DrugCentral FAERS","actionTaken":"Reported 17 times (LLR=319)"},{"llr":298.881,"date":"","count":5,"signal":"Hand deformity","source":"DrugCentral FAERS","actionTaken":"Reported 5 times (LLR=299)"},{"llr":240.286,"date":"","count":67,"signal":"Completed suicide","source":"DrugCentral FAERS","actionTaken":"Reported 67 times (LLR=240)"},{"llr":225.564,"date":"","count":455,"signal":"Pneumonia aspiration","source":"DrugCentral FAERS","actionTaken":"Reported 455 times (LLR=226)"},{"llr":214.463,"date":"","count":81,"signal":"Maternal exposure during pregnancy","source":"DrugCentral FAERS","actionTaken":"Reported 81 times (LLR=214)"},{"llr":214.149,"date":"","count":50,"signal":"Glossodynia","source":"DrugCentral FAERS","actionTaken":"Reported 50 times (LLR=214)"},{"llr":212.508,"date":"","count":439,"signal":"Plasma cell myeloma","source":"DrugCentral FAERS","actionTaken":"Reported 439 times (LLR=213)"},{"llr":207.536,"date":"","count":111,"signal":"Contraindicated product administered","source":"DrugCentral FAERS","actionTaken":"Reported 111 times (LLR=208)"},{"llr":193.322,"date":"","count":134,"signal":"Arthropathy","source":"DrugCentral FAERS","actionTaken":"Reported 134 times (LLR=193)"},{"llr":191.334,"date":"","count":1160,"signal":"Urinary tract infection","source":"DrugCentral FAERS","actionTaken":"Reported 1,160 times (LLR=191)"},{"llr":189.146,"date":"","count":100,"signal":"Therapeutic product effect decreased","source":"DrugCentral FAERS","actionTaken":"Reported 100 times (LLR=189)"}],"commonSideEffects":[{"effect":"Constipation","drugRate":"LLR 624","severity":"serious"},{"effect":"Systemic lupus erythematosus","drugRate":"LLR 335","severity":"common"},{"effect":"Pemphigus","drugRate":"LLR 334","severity":"common"},{"effect":"Synovitis","drugRate":"LLR 319","severity":"common"},{"effect":"Hand deformity","drugRate":"LLR 299","severity":"common"},{"effect":"Completed suicide","drugRate":"LLR 240","severity":"common"},{"effect":"Pneumonia aspiration","drugRate":"LLR 226","severity":"common"},{"effect":"Maternal exposure during pregnancy","drugRate":"LLR 214","severity":"common"},{"effect":"Glossodynia","drugRate":"LLR 214","severity":"common"},{"effect":"Plasma cell myeloma","drugRate":"LLR 213","severity":"common"},{"effect":"Contraindicated product administered","drugRate":"LLR 208","severity":"common"},{"effect":"Arthropathy","drugRate":"LLR 193","severity":"common"},{"effect":"Urinary tract infection","drugRate":"LLR 191","severity":"common"},{"effect":"Therapeutic product effect decreased","drugRate":"LLR 189","severity":"common"}],"contraindications":["Anemia due to enzyme deficiency","Appendicitis","Atrophic gastritis","Bleeding hemorrhoids","Disorder of mucous membrane","Diverticular disease","Gastrectomy","Gastroenteritis","Gastrointestinal obstruction","Hb SS disease","Hemochromatosis","Hemolytic anemia","Hemosiderosis","Hypokalemia","Incontinence of feces","Leber's optic atrophy","Peptic ulcer","Primary hyperoxaluria","Repeated Blood Transfusions","Ulcerative colitis","Urinary incontinence"],"specialPopulations":{"Pregnancy":"If pregnant or breast-feeding,. ask health professional before use."}},"trials":[],"aliases":[],"patents":[],"pricing":[],"allNames":"docusate","offLabel":[],"synonyms":["docusate","dioctyl sulfosuccinate","dioctyl sulfosuccinic acid","docusate sodium","docusate calcium","dioctyl disodium sulfosuccinate"],"timeline":[],"aiSummary":"Docusate sodium is a small molecule drug in the docusate class, used to treat various conditions including constipation, breastfeeding difficulties, and iron deficiency anemia. It is a stool softener that works by increasing the amount of water in the stool, making it easier to pass. The commercial status of docusate sodium is not specified, but it is likely available as a generic medication. Key safety considerations include potential interactions with other medications and gastrointestinal side effects. Docusate sodium is often used in conjunction with other treatments to address underlying conditions.","approvals":[{"date":"","orphan":false,"company":"","regulator":"FDA"}],"brandName":"Docusate","ecosystem":[{"indication":"Breastfeeding (mother)","otherDrugs":[{"name":"ascorbic acid","slug":"ascorbic-acid","company":""},{"name":"calcium phosphate","slug":"calcium-phosphate","company":""},{"name":"doconexent","slug":"doconexent","company":""},{"name":"eicosapentaenoic acid","slug":"eicosapentaenoic-acid","company":""}],"globalPrevalence":null},{"indication":"Constipation","otherDrugs":[{"name":"bisacodyl","slug":"bisacodyl","company":"Braintree"},{"name":"cholic acid","slug":"cholic-acid","company":"Rtrx"},{"name":"glycerol","slug":"glycerol","company":"B Braun"},{"name":"homatropine","slug":"homatropine","company":""}],"globalPrevalence":null},{"indication":"Iron deficiency anemia","otherDrugs":[{"name":"cyanocobalamin","slug":"cyanocobalamin","company":""},{"name":"ferric carboxymaltose","slug":"ferric-carboxymaltose","company":"Luitpold"},{"name":"ferric citrate","slug":"ferric-citrate","company":"Keryx Biopharms"},{"name":"ferric derisomaltose","slug":"ferric-derisomaltose","company":"Pharmacosmos As"}],"globalPrevalence":null},{"indication":"Megaloblastic anemia due to folate deficiency","otherDrugs":[{"name":"cyanocobalamin","slug":"cyanocobalamin","company":""},{"name":"ferrous fumarate","slug":"ferrous-fumarate","company":"Gd Searle Llc"},{"name":"ferrous sulfate","slug":"ferrous-sulfate","company":"Lederle"},{"name":"folic acid","slug":"folic-acid","company":"Lederle"}],"globalPrevalence":null},{"indication":"Pregnancy, function","otherDrugs":[{"name":"calcium phosphate","slug":"calcium-phosphate","company":""},{"name":"doconexent","slug":"doconexent","company":""},{"name":"eicosapentaenoic acid","slug":"eicosapentaenoic-acid","company":""},{"name":"ferrous fumarate","slug":"ferrous-fumarate","company":"Gd Searle Llc"}],"globalPrevalence":null}],"mechanism":{"modality":"Small Molecule","drugClass":"docusate sodium","explanation":"Imagine your stool as a mixture of solid and liquid. Docusate sodium helps to make the solid parts of the stool dissolve in water, making it softer and easier to pass. This is especially helpful for people who have trouble going to the bathroom or have constipation.","oneSentence":"Docusate sodium works by increasing the solubility of bile salts in the gut, allowing more water to be absorbed into the stool.","technicalDetail":"Docusate sodium increases the solubility of bile salts in the intestinal lumen, which in turn increases the absorption of water into the stool, resulting in softer and more easily passable feces."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/941","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=DOCUSATE%20SODIUM","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=DOCUSATE SODIUM","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T10:48:42.345399","biosimilars":[],"competitors":[],"genericName":"docusate sodium","indications":{"approved":[{"name":"Breastfeeding (mother)","source":"DrugCentral","snomedId":413712001,"regulator":"FDA","eligibility":"no information available"},{"name":"Constipation","source":"DrugCentral","snomedId":14760008,"regulator":"FDA","eligibility":"no specific eligibility criteria"},{"name":"Iron deficiency anemia","source":"DrugCentral","snomedId":87522002,"regulator":"FDA","eligibility":"no specific eligibility criteria"},{"name":"Megaloblastic anemia due to folate deficiency","source":"DrugCentral","snomedId":85649008,"regulator":"FDA","eligibility":"no specific eligibility criteria"},{"name":"Pregnancy, function","source":"DrugCentral","snomedId":289908002,"regulator":"FDA"}],"offLabel":[{"name":"Incomplete passage of stool","source":"DrugCentral","drugName":"DOCUSATE SODIUM"},{"name":"Prevention of Fetal Neural Tube Defects during Pregnancy","source":"DrugCentral","drugName":"DOCUSATE SODIUM","evidenceCount":0,"evidenceLevel":"emerging"}],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT04930237","phase":"","title":"RELISTOR's Effects on Opioid-Induced Constipation","status":"WITHDRAWN","sponsor":"Methodist Health System","startDate":"2021-07-01","conditions":["OIC"],"enrollment":0,"completionDate":"2022-04-22"},{"nctId":"NCT07328880","phase":"NA","title":"4-L Split-dose Polyethylene Glycol and Bisacodyl and Docusate Sodium Regimen Versus 2-L Split-dose Polyethylene Glycol Plus Oral Simethicone Regimen for Bowel Preparation Before Colonoscopy","status":"RECRUITING","sponsor":"Tanta University","startDate":"2025-04-01","conditions":["Colonoscopy Preparation"],"enrollment":450,"completionDate":"2026-04-26"},{"nctId":"NCT05215236","phase":"NA","title":"Opiate Sparing Protocol Randomized Controlled Trial in Open Distal Radius Fracture Repair","status":"COMPLETED","sponsor":"Campbell Clinic","startDate":"2022-03-01","conditions":["Distal Radius Fracture"],"enrollment":72,"completionDate":"2025-06-30"},{"nctId":"NCT00001337","phase":"PHASE2","title":"Dose-Adjusted EPOCH Chemotherapy and Rituximab (CD20+) in Previously Untreated Aggressive Non-Hodgkin's Lymphoma","status":"COMPLETED","sponsor":"National Cancer Institute (NCI)","startDate":"1993-05-08","conditions":["Diffuse Large B-Cell Lymphoma (DLBCL)","Primary Mediastinal Large B-cell Lymphoma","Burkitt Lymphoma","Anaplastic Large-Cell Lymphoma","Gray Zone Lymphoma"],"enrollment":348,"completionDate":"2024-05-24"},{"nctId":"NCT04696965","phase":"NA","title":"Appropriate Inhaler Use of Tiotropium As Add-on Therapy in Symptomatic Asthma","status":"COMPLETED","sponsor":"Chang Gung Memorial Hospital","startDate":"2021-03-04","conditions":["Asthma"],"enrollment":48,"completionDate":"2023-11-20"},{"nctId":"NCT05423249","phase":"NA","title":"Treatment of Non-Anemic Iron Deficiency in Pregnancy","status":"COMPLETED","sponsor":"Stony Brook University","startDate":"2022-08-12","conditions":["Non-anemic Iron Deficiency"],"enrollment":150,"completionDate":"2024-11-15"},{"nctId":"NCT03342157","phase":"PHASE2","title":"Docusate/Senna for the Treatment of Diabetic Gastroparesis","status":"TERMINATED","sponsor":"Wake Forest University Health Sciences","startDate":"2018-04-02","conditions":["Diabetic Gastroparesis"],"enrollment":2,"completionDate":"2018-08-17"},{"nctId":"NCT06561035","phase":"PHASE3","title":"ACL-R Opioid Sparing Study","status":"ENROLLING_BY_INVITATION","sponsor":"Campbell Clinic","startDate":"2024-09-01","conditions":["Anterior Cruciate Ligament Injuries"],"enrollment":56,"completionDate":"2026-06"},{"nctId":"NCT01156129","phase":"PHASE1","title":"Interventions to Decrease the Impact of Post-OPerative Ileus After Liver Transplant or Resection Surgery","status":"COMPLETED","sponsor":"University of 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