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Docusate

Generic Name
Docusate
Brand Names
Citranatal Harmony, Colace, Docusol, Docusol Plus, Dok, Dulcolax, Enemeez, Enemeez Plus, Ferralet 90, Laxacin, Pedia-lax Liquid, Peri-colace Reformulated Feb 2008, Phillips Stool Softener, Promolaxin, Senexon S, Senokot-S
Drug Type
Small Molecule
Chemical Formula
C20H38O7S
CAS Number
10041-19-7
Unique Ingredient Identifier
M7P27195AG

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

Published: Jun 19, 2025

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]

Continue reading the full research report

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
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