Overview
Docusate, or dioctyl sulfosuccinate, is a stool softener indicated for the treatment of constipation. Docusate acts by increasing the amount of water the stool absorbs in the gut, making the stool softer and easier to pass . Docusate can be orally or rectally administered. Docusate is on the World Health Organization's List of Essential Medicines. However the effectiveness of docusate in treating constipation remains unclear, as several studies report docusate to be no more effective than placebo for increasing the frequency of stool or stool softening . Recently there has been pressure to stop prescribing docusate as it has been identified as an ineffective medicine. Additionally, it does not appear to lessen symptoms associated with constipation such as abdominal cramps. Still docusate is available in over-the-counter products as a common laxative.
Background
Docusate, or dioctyl sulfosuccinate, is a stool softener indicated for the treatment of constipation. Docusate acts by increasing the amount of water the stool absorbs in the gut, making the stool softer and easier to pass . Docusate can be orally or rectally administered. Docusate is on the World Health Organization's List of Essential Medicines. However the effectiveness of docusate in treating constipation remains unclear, as several studies report docusate to be no more effective than placebo for increasing the frequency of stool or stool softening . Recently there has been pressure to stop prescribing docusate as it has been identified as an ineffective medicine. Additionally, it does not appear to lessen symptoms associated with constipation such as abdominal cramps. Still docusate is available in over-the-counter products as a common laxative.
Indication
Indicated for the treatment of constipation associated with dry, hard stools or opioid induced constipation. Though recently, pressure has been building to end the use of docusate over concerns of efficacy.
Associated Conditions
- Constipation
- Occasional Constipation
Research Report
Docusate: A Critical Re-evaluation of a Ubiquitous Laxative
I. Introduction: The Docusate Paradox
Docusate is a stool-softening laxative that is widely utilized for the prevention and treatment of occasional constipation.[1] First introduced in the 1950s, its long history of use and broad availability in numerous over-the-counter (OTC) formulations have cemented its status as one of the most commonly prescribed agents for this indication, particularly within the inpatient hospital setting.[2] This ubiquity, however, stands in stark contrast to a substantial and growing body of clinical evidence that questions its efficacy.
This report addresses a central paradox in modern pharmacotherapy: the profound disconnect between docusate's pervasive clinical use and the data from numerous clinical trials and systematic reviews that demonstrate its lack of efficacy when compared to placebo.[5] This paradox is not a new discovery; for decades, studies have failed to show a meaningful benefit for docusate in softening stool or increasing the frequency of bowel movements.[5] Yet, its prescription remains a common practice, a phenomenon that can be described as a form of "medical dogma." The persistence of docusate use appears to be a classic example of clinical inertia, where a treatment is continued out of tradition and a perception of safety rather than a foundation of proven benefit, fitting the description of a "Thing We Do For No Reason".[5]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2022/06/21 | Not Applicable | Completed | |||
2021/06/18 | N/A | Withdrawn | |||
2020/05/08 | Phase 2 | Completed | |||
2019/01/11 | Phase 4 | Completed | |||
2018/05/14 | Phase 4 | Terminated | |||
2016/11/30 | Phase 4 | Terminated | |||
2013/06/18 | Phase 4 | Completed | Oslo University Hospital | ||
2011/11/18 | Phase 3 | Completed | |||
2010/01/07 | Not Applicable | Completed | |||
2009/05/14 | Not Applicable | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Geri-Care Pharmaceutical Corp | 57896-458 | ORAL | 50 mg in 1 1 | 3/24/2025 | |
MISSION PHARMACAL COMPANY | 0178-0812 | ORAL | 50 mg in 1 1 | 5/3/2010 | |
Mission Pharmacal Company | 0178-0813 | ORAL | 55 mg in 1 1 | 1/5/2024 | |
Mission Pharmacal Company | 0178-0089 | ORAL | 50 mg in 1 1 | 1/8/2024 | |
Bryant Ranch Prepack | 71335-1181 | ORAL | 50 mg in 1 1 | 4/29/2025 | |
STRATEGIC SOURCING SERVICES LLC | 49348-167 | ORAL | 100 mg in 1 1 | 3/3/2025 | |
Atlantis Consumer Healthcare, Inc. | 67618-110 | ORAL | 50 mg in 1 1 | 4/17/2025 | |
Avion Pharmaceuticals, LLC | 75854-316 | ORAL | 200 mg in 1 1 | 1/7/2021 | |
Meijer, Inc. | 79481-0555 | ORAL | 50 mg in 1 1 | 3/24/2025 | |
McKesson Corporation | 63739-478 | ORAL | 100 mg in 1 1 | 4/22/2025 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Docusate Sodium Tablets | 国药准字H20080620 | 化学药品 | 片剂 | 3/24/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
WYRUTIN HAEMORRHOID CAP | N/A | N/A | N/A | 3/17/1981 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
COLOXYL 50 docusate sodium 50mg film coated tablet bottle | 133299 | Medicine | A | 11/28/2006 | |
COLAXSEN film coated tablets bottle | 218552 | Medicine | A | 12/13/2013 | |
APOHEALTH Laxative with Softener sennosides (as sennoside B) 8mg and docusate sodium 50mg film coated tablet bottle | 229304 | Medicine | A | 10/14/2014 | |
CHEMISTS' OWN NATURAL LAXATIVE WITH SOFTENER tablet blister pack | 90442 | Medicine | A | 8/12/2002 | |
AdMed Docu/Senna tablets bottle | 372287 | Medicine | A | 8/5/2021 | |
SOLAX WITH SENNA tablet bottle | 456395 | Medicine | A | 7/25/2024 | |
Coloxyl with senna tablets - HK | 337361 | Medicine | A | 6/2/2020 | |
TERRYWHITE CHEMMART SENNALAX film coated tablet bottle | 309394 | Medicine | A | 9/18/2018 | |
PHARMACY ACTION COLOX-SENNA tablet bottle | 384165 | Medicine | A | 2/17/2022 | |
AMCAL SENNA-COL film coated tablet bottle (new formulation) | 231508 | Medicine | A | 12/5/2014 |