Sold as Colace, Doculase, Docusol, DOK, Enemeez and 5 more.
This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
C
Score breakdown (73/100)
Safety ×35%
A
Evidence ×25%
F
Regulatory ×15%
A
Money & lawsuits ×15%
A
Options ×10%
F
Safety: 100
Death share in reports is near or below the FAERS average (1.3x)
Evidence: 16
11 randomized trials and 2 systematic reviews/meta-analyses indexed in PubMed
On the WHO Model List of Essential Medicines (shown for context; no score effect)
No Cochrane review found (-5)
Only 31% of completed registered trials posted results (-15)
Regulatory history: 100
No recalls on record since 2016
Money & lawsuits: 100
Pharma paid doctors $0 tied to this drug last year: negligible
Not named in any pending federal MDL
Options: 40
No generic version approved: brand-only pricing (-30)
No same-class alternatives found: little leverage to switch (-30)
Independent reviews and post-approval warnings
WHO Essential Medicine
Listed on the WHO Model List of Essential Medicines: a global expert panel judged it among the medicines a health system should always have, on evidence of value, not marketing.
What the FDA label says
Approved uses
Uses • relieves occasional constipation (irregularity) • generally produces bowel movement in 12 to 72 hours
Contraindications
None listed.
Warnings and precautions
Warnings Do not use • if you are presently taking mineral oil, unless told to do so by a doctor Ask a doctor before use if you have • stomach pain • nausea • vomiting • noticed a sudden change in bowel habits that lasts over 2 weeks Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work. Stop use and ask a doctor if • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition. • you need to use a laxative for more than 1 week If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Adverse reactions (label)
Not available.
Source: FDA SPL label for Docusate Sodium (A-S Medication Solutions), effective 20241106.
Full label on DailyMed.
Side-effect reports sent to the FDA
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
63,394reports that mention this drug
63,323of those blame this drug, not another one the person was taking
71%of reports describe a serious outcome, such as a hospital stay (average for all drugs: 57%)
12.0%of reports include a death, from any cause (average for all drugs: 9.1%)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
Recalls and regulatory record
0recall actions on file
0 / 0brand / generic applications
0label changes since 2021
NoREMS program
Evidence base
11randomized trials (PubMed)
2systematic reviews
64registered trials
31%of completed trials posted results
12%terminated or withdrawn
14%industry-funded
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
Money and lawsuits
In 2024, drug companies reported $0 in payments to US physicians and hospitals tied to this drug across 0 transactions.
No pending federal MDL names this drug or its brands.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
Who takes it and what it costs
Not in the Medicare Part D spending file (typically hospital-administered or very new drugs).
Same-class alternatives
No same-class alternatives found in RxClass.
Questions to ask your prescriber
The most-reported problems in FDA's adverse event data are fatigue, nausea, diarrhoea, constipation. How would we recognize and handle those?
There is no generic. Is there an older generic in the same class that works as well for my situation?
What result are we expecting, by when, and what is the plan if it does not happen?
If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)