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Colace (docusate sodium)
Docusate (Colace) is one of the most commonly prescribed stool softeners despite limited evidence of efficacy. Available OTC and generically. Many guidelines now prefer osmotic laxatives like polyethylene glycol.
At a glance
| Generic name | docusate sodium |
|---|---|
| Also known as | Colace, Dulcolax Stool Softener, DSS |
| Sponsor | Generic (multiple manufacturers) |
| Drug class | Stool softener (surfactant laxative) |
| Target | N/A (surfactant mechanism) |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
| First approval | 1955-01-01 (United States) |
Approved indications
- Breastfeeding (mother)
- Constipation
- Iron deficiency anemia
- Megaloblastic anemia due to folate deficiency
- Pregnancy, function
Common side effects
Key clinical trials
- Comparative Study Between Using a 4-L Split-dose Polyethylene Glycol and Bisacodyl + Docusate Sodium Regimen Versus a 2-L Split-dose Polyethylene Glycol Plus Oral Simethicone Regimen Versus Convention (NA)
- Comparing the Efficacy of 14-day Therapy Doxycycline With Bismuth Subsalicylate Versus Levofloxacin With Tinidazole on Rate of Eradication of Helicobacter Pylori Infected Patients on Syrian Population (Phase 4)
- Effect of Whole Body Vibration on Balance in Post Menopause Diabetic Women (NA)
- Opiate Sparing Pain Management Protocol After Anterior Cruciate Ligament Reconstruction Surgery (Phase 3)
- UARK 98-036, A Phase II Trial of Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide in Patients With Smoldering/Indolent Myeloma (Phase 2)
- Dose-Adjusted EPOCH Chemotherapy and Rituximab (CD20+) in Adults and Children With Previously Untreated Patients With Aggressive Non-Hodgkin's Lymphoma (Phase 2)
- Reduction of Postoperative Gastrointestinal Dysmotility Following Total Laparoscopic Hysterectomy: a Randomized Control Trial. (Phase 4)
- Double-Blind Randomized Controlled Trial of MiraLAX Versus Placebo to Prevent Constipation Following Urogynecologic Surgery in Women Receiving Routine Docusate Sodium (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |