Over-the-counter medication · Stool Softener
docusate
Also sold as Colace. Docusate treats occasional constipation, also known as irregularity.
Data updated 2026-05-15
- 55,963
- FDA reportsOften reported
- 83% less
- Generic vs brandHuge savings
- $0.30
- Brand price (NADAC)
What the data shows
docusate (Colace) is an over-the-counter Stool Softener, more reported than most tracked drugs (55,963 FDA reports), whose generic runs roughly half the brand price or less (83% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
docusate (Colace) is an over-the-counter Stool Softener. Docusate treats occasional constipation, also known as irregularity.
Docusate is a stool softener. It helps relieve constipation by making stools easier to pass.
Verify with FDA → · CMS NADAC pricing →
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
No specific warnings noted. Always follow your prescriber's instructions.
The sections below are summarized in plain English from docusate's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
This is a plain-language summary of docusate's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
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.
This is a plain-language summary of docusate's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
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.
This is a plain-language summary of docusate's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
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 55,963 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for docusate, by number of reports
- Tiredness
Tiredness
4,646 reports
- Feeling sick to your stomach
Feeling sick to your stomach
4,456 reports
- Difficulty breathing
Difficulty breathing
3,475 reports
- Loose stools
Loose stools
3,424 reports
- Difficulty having a bowel movement
Difficulty having a bowel movement
3,396 reports
- Aches
Aches
3,134 reports
- Death
Death
3,048 reports
- Throwing up
Throwing up
2,841 reports
- Weakness
Weakness
2,780 reports
- Fall
Fall
2,760 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for docusate each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where docusate sits
docusate has more FDA adverse-event reports than 75% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is docusate; the line is the median (50th percentile).
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
Reports Mentioning Death
7,296
13.0% of reports — not proof of cause
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 |
| 14 | DIZZINESS | 2,314 |
| 16 | BACK PAIN | 1,908 |
| 17 | PYREXIA | 1,878 |
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
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 55,963 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.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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