{"id":"macrogol","rwe":[{"pmid":"30694626","year":"2006","title":"Polyethylene Glycol.","finding":"","journal":"","studyType":"Clinical Study"},{"pmid":"41646193","year":"2026","title":"Real-world landscape of drug-related ocular injuries: a retrospective pharmacovigilance study.","finding":"","journal":"Frontiers in pharmacology","studyType":"Clinical Study"},{"pmid":"41555343","year":"2026","title":"Clinical and radiographic outcomes of lesion sterilization and tissue repair in primary molars: the role of patient cooperation in a retrospective study.","finding":"","journal":"BMC oral health","studyType":"Clinical Study"},{"pmid":"41331736","year":"2025","title":"Length of the Adult Human Colon in Health and Constipation Measured Using Magnetic Resonance Imaging.","finding":"","journal":"Neurogastroenterology and motility","studyType":"Clinical Study"},{"pmid":"40995714","year":"2025","title":"Human Stem Cells of Apical Papilla Viability Following the Removal of Triple Antibiotic Paste in a 3D Root Canal Culture Model.","finding":"","journal":"European endodontic journal","studyType":"Clinical Study"}],"_fda":{"id":"4526ca58-f032-31ad-e063-6394a90a7bae","set_id":"0a5b2121-928f-8f49-e063-6394a90a8aaf","openfda":{"nui":["N0000010288","N0000175811","N0000009871"],"upc":["0041100600554"],"unii":["G2M7P15E5P"],"route":["ORAL"],"rxcui":["876193","876195"],"spl_id":["4526ca58-f032-31ad-e063-6394a90a7bae"],"brand_name":["MiraLAX Orange Flavor"],"spl_set_id":["0a5b2121-928f-8f49-e063-6394a90a8aaf"],"package_ndc":["11523-0122-2","11523-0122-1"],"product_ndc":["11523-0122"],"generic_name":["POLYETHYLENE GLYCOL 3350"],"product_type":["HUMAN OTC DRUG"],"pharm_class_pe":["Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"],"substance_name":["POLYETHYLENE GLYCOL 3350"],"pharm_class_epc":["Osmotic Laxative [EPC]"],"pharm_class_moa":["Osmotic Activity [MoA]"],"manufacturer_name":["Bayer HealthCare LLC."],"application_number":["ANDA090685"],"is_original_packager":[true]},"purpose":["Purpose Osmotic Laxative"],"version":"3","stop_use":["Stop use and ask a doctor if you have rectal bleeding or you nausea, bloating or cramping or abdominal pain gets worse. These may be signs of a serious condition. you get diarrhea you need to use a laxative for longer than 1 week"],"warnings":["Warnings Allergy alert Do not use if you are allergic to polyethylene glycol Do not use if you have kidney disease, except under the advice and supervision of a doctor Ask a doctor before use if you have nausea, vomiting or abdominal pain a sudden change in bowel habits that lasts over 2 weeks irritable bowel syndrome Ask a doctor of pharmacist before use if you are taking a prescription drug When using this product you may have loose, watery, more frequent stools Stop use and ask a doctor if you have rectal bleeding or you nausea, bloating or cramping or abdominal pain gets worse. These may be signs of a serious condition. you get diarrhea you need to use a laxative for longer than 1 week If pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away(1-800-222-1222)."],"questions":["Questions or comments? 1-800-MiraLAX (1-800-647-2529)"],"ask_doctor":["Ask a doctor before use if you have nausea, vomiting or abdominal pain a sudden change in bowel habits that lasts over 2 weeks irritable bowel syndrome"],"do_not_use":["Do not use if you have kidney disease, except under the advice and supervision of a doctor"],"when_using":["When using this product you may have loose, watery, more frequent stools"],"effective_time":"20251204","active_ingredient":["Active ingredient (in each dose) Polyethylene Glycol 3350, 17 g (cap filled to line)"],"inactive_ingredient":["Inactive ingredients natural and artificial orange flavor, sucralose"],"storage_and_handling":["Other information store at 20°-25°C (68°-77°F) tamper-evident: do not use if printed foil seal under cap is missing, open or broken"],"indications_and_usage":["Use relieves occasional constipation (irregularity) generally produces a bowel movement in 1 to 3 days"],"ask_doctor_or_pharmacist":["Ask a doctor of pharmacist before use if you are taking a prescription drug"],"spl_unclassified_section":["Drug Facts"],"dosage_and_administration":["Directions (Bottle Only) do not take more than directed unless advised by your doctor the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line (white section in cap) adults and children 17 years of age and older: use once a day fill to top of white section in cap which is marked to indicate the correct dose (17 g) stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink do not combine with starch-based thickeners used for difficulty swallowing ensure that the powder is fully dissolved before drinking do not drink if there are any clumps do not use more than 7 days children 16 years of age or under: ask a doctor"],"spl_product_data_elements":["MiraLAX Orange Flavor Polyethylene Glycol 3350 SUCRALOSE POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 White or almost white solid with a waxy or paraffin-like appearance"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"keep_out_of_reach_of_children":["Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away(1-800-222-1222)."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 7 Dose Bottle MiraLAX ® Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative Relieves Occasional Constipation/Irregularity Softens Stool Grit-Free Powder Sugar-Free & Dye-Free ORANGE FLAVOR 7 ONCE-DAILY DOSES NET WT 4.1 OZ (119 g) Bayer PDP PDP MiraLAX Orange 7 dose Front Label"]},"tags":[{"label":"Osmotic Laxative","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"A06AD15","category":"atc"},{"label":"Ophthalmic","category":"route"},{"label":"Topical","category":"route"},{"label":"Cream","category":"form"},{"label":"Gel","category":"form"},{"label":"Liquid","category":"form"},{"label":"Active","category":"status"},{"label":"Constipation","category":"indication"},{"label":"Incomplete passage of stool","category":"indication"},{"label":"Red eye","category":"indication"},{"label":"Tear film insufficiency","category":"indication"},{"label":"Braintree","category":"company"},{"label":"Approved 1980s","category":"decade"},{"label":"Gastrointestinal Agents","category":"pharmacology"},{"label":"Laxatives","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"llr":655.544,"date":"","count":1485,"signal":"Constipation","source":"DrugCentral FAERS","actionTaken":"Reported 1,485 times (LLR=656)"},{"llr":354.722,"date":"","count":301,"signal":"Macular degeneration","source":"DrugCentral FAERS","actionTaken":"Reported 301 times (LLR=355)"},{"llr":350.375,"date":"","count":230,"signal":"Infective pulmonary exacerbation of cystic fibrosis","source":"DrugCentral FAERS","actionTaken":"Reported 230 times (LLR=350)"},{"llr":294.261,"date":"","count":16,"signal":"Contraindicated product administered","source":"DrugCentral FAERS","actionTaken":"Reported 16 times (LLR=294)"},{"llr":283.98,"date":"","count":895,"signal":"Febrile neutropenia","source":"DrugCentral FAERS","actionTaken":"Reported 895 times (LLR=284)"},{"llr":254.049,"date":"","count":8,"signal":"Synovitis","source":"DrugCentral FAERS","actionTaken":"Reported 8 times (LLR=254)"},{"llr":250.043,"date":"","count":6,"signal":"Pemphigus","source":"DrugCentral FAERS","actionTaken":"Reported 6 times (LLR=250)"},{"llr":235.119,"date":"","count":22,"signal":"Systemic lupus erythematosus","source":"DrugCentral FAERS","actionTaken":"Reported 22 times (LLR=235)"},{"llr":227.363,"date":"","count":43,"signal":"Treatment failure","source":"DrugCentral FAERS","actionTaken":"Reported 43 times (LLR=227)"},{"llr":219.754,"date":"","count":140,"signal":"Appendicolith","source":"DrugCentral FAERS","actionTaken":"Reported 140 times (LLR=220)"},{"llr":214.648,"date":"","count":6,"signal":"Hand deformity","source":"DrugCentral FAERS","actionTaken":"Reported 6 times (LLR=215)"},{"llr":209.129,"date":"","count":78,"signal":"Rheumatoid arthritis","source":"DrugCentral FAERS","actionTaken":"Reported 78 times (LLR=209)"},{"llr":202.03,"date":"","count":1181,"signal":"Abdominal pain","source":"DrugCentral FAERS","actionTaken":"Reported 1,181 times (LLR=202)"},{"llr":195.27,"date":"","count":1260,"signal":"Drug ineffective","source":"DrugCentral FAERS","actionTaken":"Reported 1,260 times (LLR=195)"},{"llr":185.803,"date":"","count":520,"signal":"Abdominal distension","source":"DrugCentral FAERS","actionTaken":"Reported 520 times (LLR=186)"}],"commonSideEffects":[],"contraindications":["Acute nephropathy","Acute vomiting","Angle-closure glaucoma","Anuria","Appendicitis","At risk for aspiration","Chronic heart failure","Complete atrioventricular block","Congenital myotonia, autosomal dominant form","Diabetes mellitus","Disorder of cardiovascular system","Edema","Eye infection","Familial hyperkalemic periodic paralysis","Gastric retention","Gastrointestinal obstruction","Gastrointestinal perforation","Gastrointestinal ulcer","Gastroparesis","Hyperchloremia","Hyperglycemia","Hyperkalemia","Hypertensive disorder","Hyperthyroidism","Hypocalcemia"],"specialPopulations":{"Pregnancy":"Category C. Animal reproductive studies have not been performed with Polyethylene Glycol 3350, NF. It is also not known whether Polyethylene Glycol 3350, NF can cause fetal harm when administered to pregnant woman, or can affect reproductive capacity. Polyethylene Glycol 3350, NF should only be administered to pregnant woman if clearly needed.","Geriatric use":"There is no evidence for special considerations when Polyethylene Glycol3350 NF is administered to elderly patients. In geriatric nursing home patients higherincidence of diarrhea occurred at the recommended 17 dose. If diarrhea occursPolyethylene Glycol 3350 NF should be discontinued.","Paediatric use":"Safety and effectiveness in pediatric patients has not been established."}},"trials":[],"aliases":[],"company":"Braintree","patents":[{"source":"FDA Orange Book via DrugCentral","expires":"2033-09-10","territory":"US","patentNumber":"10016504"},{"source":"FDA Orange Book via DrugCentral","expires":"2033-09-10","territory":"US","patentNumber":"10918723"},{"source":"FDA Orange Book via DrugCentral","expires":"2033-09-10","territory":"US","patentNumber":"8999313"},{"source":"FDA Orange Book via DrugCentral","expires":"2033-09-10","territory":"US","patentNumber":"9326969"},{"source":"FDA Orange Book via DrugCentral","expires":"2033-09-10","territory":"US","patentNumber":"9707297"},{"source":"FDA Orange Book via DrugCentral","expires":"2032-08-11","territory":"US","patentNumber":"9592252"},{"source":"FDA Orange Book via DrugCentral","expires":"2032-03-25","territory":"US","patentNumber":"10646512"},{"source":"FDA Orange Book via DrugCentral","expires":"2032-03-09","territory":"US","patentNumber":"10780112"},{"source":"FDA Orange Book via DrugCentral","expires":"2032-03-09","territory":"US","patentNumber":"10792306"},{"source":"FDA Orange Book via DrugCentral","expires":"2032-03-09","territory":"US","patentNumber":"11529368"},{"source":"FDA Orange Book via DrugCentral","expires":"2024-09-01","territory":"US","patentNumber":"7169381"},{"source":"FDA Orange Book via DrugCentral","expires":"2024-09-01","territory":"US","patentNumber":"7658914"}],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=Macrogol","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:05:20.313776+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange 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(EPC)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:05:18.128882+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:05:18.128907+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:05:18.128913+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1201478/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:05:26.914578+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA090685","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:05:18.128915+00:00"}},"allNames":"miralax","offLabel":[],"synonyms":["polyethylene glycol","polyethylene glycol 3350","polyethylene glycol 400","polyethylene glycol 300","macrogol","macrogol 4000"],"timeline":[{"date":"1984-07-13","type":"positive","source":"DrugCentral","milestone":"FDA approval (Braintree)"},{"date":"2018-09-21","type":"positive","source":"DrugCentral","milestone":"PMDA approval (EA Pharma Co., Ltd.)"}],"approvals":[{"date":"1984-07-13","orphan":false,"company":"BRAINTREE","regulator":"FDA"},{"date":"2018-09-21","orphan":false,"company":"EA Pharma Co., Ltd.","regulator":"PMDA"}],"brandName":"Miralax","ecosystem":[{"indication":"Constipation","otherDrugs":[{"name":"bisacodyl","slug":"bisacodyl","company":"Braintree"},{"name":"cholic acid","slug":"cholic-acid","company":"Rtrx"},{"name":"docusate sodium","slug":"docusate-sodium","company":""},{"name":"glycerol","slug":"glycerol","company":"B Braun"}],"globalPrevalence":1120000000},{"indication":"Incomplete passage of stool","otherDrugs":[{"name":"bisacodyl","slug":"bisacodyl","company":"Braintree"},{"name":"cholic acid","slug":"cholic-acid","company":"Rtrx"},{"name":"homatropine","slug":"homatropine","company":""},{"name":"magnesium carbonate","slug":"magnesium-carbonate","company":"United Guardian"}],"globalPrevalence":null},{"indication":"Red eye","otherDrugs":[{"name":"antazoline","slug":"antazoline","company":"Novartis"},{"name":"crospovidone","slug":"crospovidone","company":""},{"name":"naphazoline","slug":"naphazoline","company":"Novartis"},{"name":"oxymetazoline","slug":"oxymetazoline","company":"Bayer Healthcare Llc"}],"globalPrevalence":null},{"indication":"Tear film insufficiency","otherDrugs":[{"name":"ciclosporin","slug":"ciclosporin","company":"Novartis"},{"name":"crospovidone","slug":"crospovidone","company":""},{"name":"lifitegrast","slug":"lifitegrast","company":"Shire Dev Llc"},{"name":"lutein","slug":"lutein","company":""}],"globalPrevalence":null}],"mechanism":{"novelty":"Follow-on","moaClass":"Osmotic Activity","modality":"Small Molecule","drugClass":"Osmotic Laxative [EPC]","explanation":"","oneSentence":"","technicalDetail":"Miralax is an osmotic laxative that works by increasing the osmotic pressure in the intestines, which draws water into the lumen and softens the stool, making it easier to pass."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Macrogol","title":"Macrogol","extract":"Macrogol is the international nonproprietary name used for polyethylene glycol (PEG) as a medication ingredient. It is usually followed by a number indicating the average molecular weight, indicating the length of the polymer of the specific molecule in use. Macrogol is used as a laxative to treat constipation in children and adults. It is taken by mouth. Benefits usually occur within three days. It is also used as an excipient. It is also used to clear the bowels before a colonoscopy, when the onset of the laxative effect is more rapid, typically within an hour."},"commercial":{"launchDate":"1984","_launchSource":"DrugCentral (FDA 1984-07-13, BRAINTREE)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4253","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=Macrogol","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Macrogol","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Macrogol","fields":["history","overview"],"source":"Wikipedia"}],"_enrichedAt":"2026-03-30T15:00:51.174419","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:05:29.072730+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"magnesium carbonate","drugSlug":"magnesium-carbonate","fdaApproval":"1990-10-02","relationship":"same-class"},{"drugName":"magnesium oxide","drugSlug":"magnesium-oxide","fdaApproval":"1982-06-22","relationship":"same-class"},{"drugName":"magnesium sulfate","drugSlug":"magnesium-sulfate","fdaApproval":"1981-10-06","genericCount":12,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"lactulose","drugSlug":"lactulose","fdaApproval":"1976-03-25","genericCount":24,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"lactitol","drugSlug":"lactitol","fdaApproval":"2020-02-12","patentExpiry":"May 12, 2037","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"sodium sulfate","drugSlug":"sodium-sulfate","fdaApproval":"1986-04-30","relationship":"same-class"},{"drugName":"mannitol","drugSlug":"mannitol","fdaApproval":"1964-06-08","genericCount":6,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"sodium phosphate","drugSlug":"sodium-phosphate","fdaApproval":"1983-05-10","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"sorbitol","drugSlug":"sorbitol","fdaApproval":"1971-08-20","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"magnesium citrate","drugSlug":"magnesium-citrate","fdaApproval":"","relationship":"same-class"}],"genericName":"macrogol","indications":{"approved":[{"name":"Constipation","source":"DrugCentral","snomedId":14760008,"regulator":"FDA","eligibility":"adults and children 6 years of age and older","usPrevalence":null,"globalPrevalence":1120000000,"prevalenceMethod":"curated","prevalenceSource":"Am J Gastroenterol, 2011 (PMID:21606976)"},{"name":"Incomplete passage of stool","source":"DrugCentral","snomedId":249515001,"regulator":"FDA"},{"name":"Red eye","source":"DrugCentral","snomedId":75705005,"regulator":"FDA"},{"name":"Tear film insufficiency","source":"DrugCentral","snomedId":46152009,"regulator":"FDA"}],"offLabel":[{"name":"Keratoconjunctivitis sicca","source":"DrugCentral","drugName":"Macrogol","evidenceCount":4,"evidenceLevel":"emerging"}],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"magnesium-carbonate","brandName":"magnesium carbonate","genericName":"magnesium carbonate","approvalYear":"1990","relationship":"same-class"},{"drugId":"magnesium-oxide","brandName":"magnesium oxide","genericName":"magnesium oxide","approvalYear":"1982","relationship":"same-class"},{"drugId":"magnesium-sulfate","brandName":"magnesium sulfate","genericName":"magnesium sulfate","approvalYear":"1981","relationship":"same-class"},{"drugId":"lactulose","brandName":"lactulose","genericName":"lactulose","approvalYear":"1976","relationship":"same-class"},{"drugId":"lactitol","brandName":"lactitol","genericName":"lactitol","approvalYear":"2020","relationship":"same-class"},{"drugId":"sodium-sulfate","brandName":"sodium sulfate","genericName":"sodium sulfate","approvalYear":"1986","relationship":"same-class"},{"drugId":"mannitol","brandName":"mannitol","genericName":"mannitol","approvalYear":"1964","relationship":"same-class"},{"drugId":"sodium-phosphate","brandName":"sodium phosphate","genericName":"sodium phosphate","approvalYear":"1983","relationship":"same-class"},{"drugId":"sorbitol","brandName":"sorbitol","genericName":"sorbitol","approvalYear":"1971","relationship":"same-class"},{"drugId":"magnesium-citrate","brandName":"magnesium citrate","genericName":"magnesium 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Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL)","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2025-05-30","conditions":["B Acute Lymphoblastic Leukemia"],"enrollment":222,"completionDate":"2030-12-01"},{"nctId":"NCT03654170","phase":"PHASE1","title":"A Study in Healthy Men to Find Out How BI 425809 is Taken up and Handled by the Body","status":"COMPLETED","sponsor":"Boehringer Ingelheim","startDate":"2018-09-11","conditions":["Healthy"],"enrollment":6,"completionDate":"2018-11-12"},{"nctId":"NCT04123795","phase":"PHASE3","title":"A Study to Evaluate the Pharmacokinetics, Safety, and Effectiveness of Certolizumab Pegol in Children With Moderate to Severe Chronic Plaque Psoriasis","status":"ACTIVE_NOT_RECRUITING","sponsor":"UCB Biopharma 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