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 →
NADAC price trail: DOCUSATE CAL 240 MG SOFTGEL
Same CMS presentation as the headline generic unit price above (2 effective dates). Adjacent % compares consecutive NADAC releases for this description only, not a patient out-of-pocket quote. Latest step: -10.2% vs prior release.
| Effective | NADAC / unit | vs prior | NDCs |
|---|---|---|---|
| April 17, 2024 | $0.0579/EA | - | 2 |
| December 18, 2024 | $0.0520/EA | -10.2% | 3 |
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.
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
- Fatigue
Fatigue
4,644 reports
- Nausea
Nausea
4,456 reports
- Dyspnoea
Dyspnoea
3,476 reports
- Diarrhoea
Diarrhoea
3,423 reports
- Constipation
Constipation
3,392 reports
- Pain
Pain
3,134 reports
- Death
Death
3,053 reports
- Vomiting
Vomiting
2,841 reports
- Asthenia
Asthenia
2,778 reports
- Fall
Fall
2,756 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) 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?
What pregnancy or breastfeeding source fields are listed for docusate?
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 →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for docusate: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 55,963.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 13.04%.
- ondansetron Δ 0.05 pts · 103,354 reports · 5-HT3 Receptor Antagonist (Antiemetic) 12.99%death share
- paroxetine Δ 0.05 pts · 32,666 reports · Selective Serotonin Reuptake Inhibitor (SSRI) 13.09%death share
- zoledronic acid Δ 0.05 pts · 38,197 reports · Bisphosphonate (IV) 13.09%death share
- febuxostat Δ 0.08 pts · 16,005 reports · Xanthine Oxidase Inhibitor 13.11%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Pain Relievers Compared
NSAIDs vs acetaminophen, which OTC pain reliever to use
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: October 21, 2023
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
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 from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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