docusate
Brand names: Colace
Docusate is a stool softener. It helps relieve constipation by making stools easier to pass.
Drug Pricing (NADAC)
Brand Price
$0.30/unit
Generic Price
$0.05/unit
Generic Savings
83%
Generic Available
Yes (0 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Docusate treats occasional constipation, also known as irregularity.
Common side effects
Diarrhea, Abdominal pain
Key warnings
There are no boxed warnings for docusate.
How It Works
Docusate works by increasing the amount of water in your stool. This makes the stool softer and easier to pass. It helps relieve constipation without causing strong contractions in your intestines.
How to Take It
Take docusate preferably at bedtime, or as your doctor tells you. Adults and children 12 and older should start with 2 tablets once a day. Do not take more than 4 tablets twice a day. Children 6 to under 12 should start with 1 tablet once a day, and no more than 2 tablets twice a day.
Pregnancy & Breastfeeding
If you are pregnant or breastfeeding, ask a doctor before using this medicine. It is important to discuss the risks and benefits with your doctor.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
Storage
Store docusate at room temperature (77ºF), but it's okay if it's between 59°-86°F.
Side Effects (from patient reports)
Based on 33,960 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 55,963 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 1998–2025.
Total Reports
55,963
Death-Related Reports
7,296
Hospitalization Reports
24,530
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | FATIGUE | 4,644 |
| 2 | NAUSEA | 4,456 |
| 3 | DYSPNOEA | 3,476 |
| 4 | DIARRHOEA | 3,423 |
| 5 | CONSTIPATION | 3,392 |
| 6 | PAIN | 3,134 |
| 7 | DEATH | 3,053 |
| 8 | VOMITING | 2,841 |
| 9 | ASTHENIA | 2,778 |
| 10 | FALL | 2,756 |
| 11 | PNEUMONIA | 2,645 |
| 12 | HEADACHE | 2,454 |
| 13 | OFF LABEL USE | 2,401 |
| 14 | DIZZINESS | 2,314 |
| 15 | DRUG INEFFECTIVE | 2,303 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
There are no boxed warnings for docusate.
Common Questions
How long does docusate take to work?
Can I take docusate every day?
Can children take docusate?
What should I do if docusate doesn't work?
Can I take docusate with other medicines?
How many milligrams of calcium are in each tablet?
How many milligrams of sodium are in each tablet?
What do I do if the safety seal is broken?
What is the maximum dosage for adults?
Should I take this medicine with food?
What are the common side effects of docusate?
What drug class is docusate?
Is there a generic version of docusate?
Is docusate safe during pregnancy?
Related Medications in Stool Softener
Other drugs grouped near docusate — same-class peers and common alternatives.
alosetron
Lotronex
Alosetron (Lotronex) is a medicine for women with severe diarrhea-predominant irritable bowel syndrome (IBS).
Compare with docusate →
aprepitant
Emend
Aprepitant (Emend) is a medicine that helps prevent nausea and vomiting.
Compare with docusate →
bisacodyl
Dulcolax
Bisacodyl is a medicine that helps you have a bowel movement.
Compare with docusate →
bismuth subsalicylate
Pepto-Bismol
Bismuth subsalicylate (Pepto-Bismol) is a medicine that can treat diarrhea and upset stomach.
Compare with docusate →
cimetidine
Tagamet
Cimetidine (Tagamet) reduces stomach acid.
Compare with docusate →
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What the FDA Data Shows for docusate
The FDA label for docusate (sold under brand names such as Colace) classifies it as an over-the-counter product in the Stool Softener class. Docusate treats occasional constipation, also known as irregularity. Official labeling lists 2 commonly reported side effects, including Diarrhea, Abdominal pain.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 33,960 voluntary reports. Interaction data is drawn directly from FDA-approved prescribing information. NADAC pricing from CMS shows a generic unit cost of $0.05 versus $0.30 for the brand — a 83% generic savings.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: October 21, 2023
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages