Drug · FAERS side-effect profile with label screen
Docusate 100Mg side effects: what 23,761 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Docusate Sodium 100Mg (Docusate Sodium 100Mg)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
23,761 reports · 76% serious · 3,078 with death outcome · 58% female
openFDA FAERS counts, all years, deduplication not applied
Used for
. Relieves occasional constipation (irregularity) . Generally produces bowel movement in 12 to 72 hours
FDA label, Indications and Usage
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Reporting / coding artifact 9Lab value / disease marker 3No label text to screen 28
What the badges mean
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only (and, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,144 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Antacid therapy | 47 | 567.5 393.1–819.5ROR 568.7 · calibrated p 9e-14 ✓ | 301.6 EB05 235.9 · IC025 +5.7 3/3 methods agree | Reporting / coding artifact | serious n=47 · ♀ 0% (drug 58%) · 100% clinician | no trial arm names this drug |
| Sleep disorder therapy | 68 | 509.7 377.9–687.3ROR 511.1 · calibrated p 1e-13 ✓ | 295.0 EB05 240.7 · IC025 +6.2 3/3 methods agree | Reporting / coding artifact | serious n=68 · ♀ 0% (drug 58%) · 100% clinician | no trial arm names this drug |
| Appendicolith | 99 | 311.9 248.0–392.2ROR 313.2 · calibrated p 1e-11 ✓ | 220.1 EB05 186.0 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=99 · ♀ 0% (drug 58%) · 100% clinician | no trial arm names this drug |
| Analgesic therapy | 71 | 266.1 204.0–347.0ROR 266.9 · calibrated p 6e-11 ✓ | 193.4 EB05 158.5 · IC025 +6.0 3/3 methods agree | Reporting / coding artifact | serious n=71 · ♀ 0% (drug 58%) · 100% clinician | no trial arm names this drug |
| Respiratory tract malformation | 29 | 252.1 166.8–381.1ROR 252.4 · calibrated p 3e-10 ✓ | 173.5 EB05 126.7 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=29 · ♀ 100% (drug 58%) · 100% clinician | no trial arm names this drug |
| Drug therapy | 71 | 252.0 193.5–328.0ROR 252.7 · calibrated p 1e-10 ✓ | 185.9 EB05 152.3 · IC025 +6.0 3/3 methods agree | Reporting / coding artifact | serious n=70 · ♀ 0% (drug 58%) · 100% clinician | no trial arm names this drug |
| Pulmonary malformation | 64 | 194.6 148.4–255.0ROR 195.1 · calibrated p 1e-9 ✓ | 152.0 EB05 123.3 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=64 · ♀ 100% (drug 58%) | no trial arm names this drug |
| Anticoagulant therapy | 49 | 189.3 139.0–257.8ROR 189.7 · calibrated p 1e-9 ✓ | 146.9 EB05 115.5 · IC025 +5.5 3/3 methods agree | Reporting / coding artifact | serious n=49 · ♀ 0% (drug 58%) · 100% clinician | no trial arm names this drug |
| Congenital hiatus hernia | 36 | 171.0 119.7–244.4ROR 171.3 · calibrated p 4e-9 ✓ | 133.1 EB05 100.5 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=36 · ♀ 0% (drug 58%) · 100% clinician | no trial arm names this drug |
| Malignant melanoma stage 0 | 28 | 161.2 107.7–241.3ROR 161.4 · calibrated p 9e-9 ✓ | 124.8 EB05 90.6 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=28 · ♀ 0% (drug 58%) · 100% clinician | no trial arm names this drug |
| Lung cyst | 42 | 105.5 76.6–145.3ROR 105.7 · calibrated p 1e-7 ✓ | 90.5 EB05 69.7 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=42 · ♀ 100% (drug 58%) | no trial arm names this drug |
| Bacteroides infection | 23 | 85.8 55.9–131.7ROR 85.9 · calibrated p 1e-6 ✓ | 73.6 EB05 51.7 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=23 · ♀ 0% (drug 58%) · 100% clinician | no trial arm names this drug |
| Colonic pseudo-obstruction | 22 | 74.4 48.2–115.0ROR 74.5 · calibrated p 3e-6 ✓ | 64.9 EB05 45.2 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=22 | no trial arm names this drug |
| Cardiospasm | 42 | 71.7 52.4–98.2ROR 71.9 · calibrated p 2e-6 ✓ | 64.5 EB05 49.7 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=42 · ♀ 100% (drug 58%) | no trial arm names this drug |
| Immunisation | 28 | 60.9 41.5–89.3ROR 60.9 · calibrated p 8e-6 ✓ | 54.9 EB05 39.9 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=28 · ♀ 100% (drug 58%) | no trial arm names this drug |
| Anal inflammation | 39 | 57.7 41.7–79.7ROR 57.8 · calibrated p 9e-6 ✓ | 52.8 EB05 40.3 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=39 · ♀ 0% (drug 58%) · 100% clinician | no trial arm names this drug |
| Palmoplantar keratoderma | 43 | 56.0 41.1–76.2ROR 56.1 · calibrated p 1e-5 ✓ | 51.5 EB05 39.8 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=43 · ♀ 100% (drug 58%) | no trial arm names this drug |
| Multiple drug therapy | 40 | 53.6 38.9–73.7ROR 53.7 · calibrated p 1e-5 ✓ | 49.4 EB05 37.8 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious n=40 · ♀ 100% (drug 58%) · 100% clinician | no trial arm names this drug |
| Lactation disorder | 26 | 49.6 33.4–73.6ROR 49.6 · calibrated p 3e-5 ✓ | 45.5 EB05 32.6 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=26 · ♀ 100% (drug 58%) | no trial arm names this drug |
| Sars-cov-2 test negative | 34 | 46.1 32.7–65.1ROR 46.2 · calibrated p 4e-5 ✓ | 42.9 EB05 32.1 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious n=34 · ♀ 0% (drug 58%) · 100% clinician | no trial arm names this drug |
| Creatinine renal clearance increased | 37 | 45.6 32.8–63.5ROR 45.7 · calibrated p 4e-5 ✓ | 42.5 EB05 32.2 · IC025 +4.2 3/3 methods agree | Lab value / disease marker | serious n=37 · ♀ 100% (drug 58%) · 100% clinician | no trial arm names this drug |
| Hyperphosphataemia | 100 | 43.6 35.7–53.3ROR 43.8 · calibrated p 4e-5 ✓ | 41.3 EB05 34.9 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=100 · ♀ 12% (drug 58%) · 100% clinician | no trial arm names this drug |
| Bronchopulmonary aspergillosis allergic | 33 | 32.9 23.2–46.6ROR 32.9 · calibrated p 2e-4 ✓ | 31.2 EB05 23.3 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=33 · ♀ 0% (drug 58%) · 100% clinician | no trial arm names this drug |
| Blood phosphorus increased | 89 | 29.7 24.1–36.7ROR 29.9 · calibrated p 3e-4 ✓ | 28.6 EB05 24.0 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious n=86 · ♀ 16% (drug 58%) · 100% clinician | no trial arm names this drug |
| Total lung capacity decreased | 44 | 24.9 18.4–33.6ROR 24.9 · calibrated p 9e-4 ✓ | 24.0 EB05 18.6 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=43 · ♀ 0% (drug 58%) · 100% clinician | no trial arm names this drug |
| Chronic kidney disease-mineral and bone disorder | 29 | 24.4 16.9–35.3ROR 24.4 · calibrated p 0.001 ✓ | 23.4 EB05 17.1 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=29 | no trial arm names this drug |
| Anti-neutrophil cytoplasmic antibody positive vasculitis | 56 | 20.7 15.9–27.0ROR 20.8 · calibrated p 0.002 ✓ | 20.1 EB05 16.1 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=56 · ♀ 100% (drug 58%) · 100% clinician | no trial arm names this drug |
| Iron deficiency | 101 | 20.5 16.8–24.9ROR 20.6 · calibrated p 0.002 ✓ | 20.0 EB05 16.9 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=99 · ♀ 24% (drug 58%) | no trial arm names this drug |
| Sedation complication | 56 | 20.2 15.5–26.3ROR 20.2 · calibrated p 0.002 ✓ | 19.6 EB05 15.7 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious n=56 · ♀ 100% (drug 58%) · 100% clinician | no trial arm names this drug |
| Atrial tachycardia | 45 | 19.2 14.3–25.8ROR 19.2 · calibrated p 0.003 ✓ | 18.7 EB05 14.5 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=45 · ♀ 100% (drug 58%) | no trial arm names this drug |
| Nephrogenic anaemia | 97 | 18.7 15.3–22.8ROR 18.7 · calibrated p 0.003 ✓ | 18.2 EB05 15.4 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=97 | no trial arm names this drug |
| Hyperparathyroidism secondary | 52 | 18.5 14.0–24.3ROR 18.5 · calibrated p 0.003 ✓ | 18.0 EB05 14.2 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=52 | no trial arm names this drug |
| Pruritus genital | 45 | 17.4 12.9–23.3ROR 17.4 · calibrated p 0.004 ✓ | 16.9 EB05 13.1 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=44 · ♀ 100% (drug 58%) | no trial arm names this drug |
| Lung opacity | 47 | 16.4 12.3–21.9ROR 16.4 · calibrated p 0.006 ✓ | 16.0 EB05 12.4 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=47 · ♀ 0% (drug 58%) · 100% clinician | no trial arm names this drug |
| Activated partial thromboplastin time prolonged | 92 | 16.2 13.2–20.0ROR 16.3 · calibrated p 0.005 ✓ | 15.9 EB05 13.3 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious n=89 · ♀ 20% (drug 58%) · 100% clinician | no trial arm names this drug |
| Hypophosphataemia | 129 | 15.8 13.2–18.7ROR 15.8 · calibrated p 0.006 ✓ | 15.4 EB05 13.3 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.2 · ♀ 22% (drug 58%) · 100% clinician | no trial arm names this drug |
| Aortic stenosis | 58 | 14.9 11.5–19.3ROR 15.0 · calibrated p 0.008 ✓ | 14.5 EB05 11.6 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=58 · ♀ 35% (drug 58%) | no trial arm names this drug |
| Pneumonia aspiration | 408 | 14.7 13.3–16.2ROR 14.9 · calibrated p 0.007 ✓ | 14.4 EB05 13.3 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.9 · ♀ 83% (drug 58%) | no trial arm names this drug |
| Pleuritic pain | 45 | 14.5 10.8–19.5ROR 14.6 · calibrated p 0.009 ✓ | 14.1 EB05 10.9 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=45 · ♀ 37% (drug 58%) · 100% clinician | no trial arm names this drug |
| Maternal exposure during breast feeding | 61 | 13.9 10.8–17.9ROR 14.0 · calibrated p 0.010 ✓ | 13.6 EB05 10.9 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious n=57 · ♀ 100% (drug 58%) | no trial arm names this drug |
Trial evidence (ClinicalTrials.gov)
ClinicalTrials.gov returned results-bearing trials mentioning Docusate 100Mg only as a background or rescue medication (NCT00001337, NCT02977286); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Nausea | 1,940 | 2.2 2.1–2.3ROR 2.3 · calibrated p 0.914 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.4 | no trial arm names this drug |
| Fatigue (tiredness) | 1,882 | 2.1 2.0–2.2ROR 2.2 · calibrated p 0.933 | 2.1 EB05 2.1 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.2 | no trial arm names this drug |
| Dyspnoea (shortness of breath) | 1,597 | 2.5 2.4–2.6ROR 2.6 · calibrated p 0.771 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.3 | no trial arm names this drug |
| Constipation | 1,510 | 6.2 5.9–6.5ROR 6.5 · calibrated p 0.119 | 6.1 EB05 5.9 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.2 | no trial arm names this drug |
| Diarrhoea (diarrhea) | 1,456 | 2.0 1.9–2.1ROR 2.1 · calibrated p 0.979 | 2.0 EB05 1.9 · IC025 +0.9 | No label text to screen label has no adverse-reaction text | serious PRR 2.0 | no trial arm names this drug |
| Pain | 1,380 | 2.0 1.9–2.1ROR 2.0 · calibrated p 0.966 | 2.0 EB05 1.9 · IC025 +0.9 | No label text to screen label has no adverse-reaction text | serious PRR 2.0 | no trial arm names this drug |
| Vomiting | 1,369 | 2.6 2.5–2.7ROR 2.7 · calibrated p 0.741 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.6 | no trial arm names this drug |
| Death | 1,220 | 1.2 1.2–1.3ROR 1.3 · calibrated p 0.483 | 1.2 EB05 1.2 · IC025 +0.2 | Outcome field, not a reaction | serious PRR 0.9 | no trial arm names this drug |
| Off label use (used outside approved label) | 1,219 | 1.2 1.2–1.3ROR 1.3 · calibrated p 0.476 | 1.2 EB05 1.2 · IC025 +0.2 | Reporting / coding artifact | serious PRR 1.3 | no trial arm names this drug |
| Fall | 1,159 | 3.1 2.9–3.3ROR 3.2 · calibrated p 0.568 | 3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.5 | no trial arm names this drug |
| Asthenia (weakness) | 1,147 | 2.7 2.5–2.9ROR 2.8 · calibrated p 0.702 | 2.7 EB05 2.6 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.5 | no trial arm names this drug |
| Pneumonia (lung infection) | 1,137 | 3.1 2.9–3.3ROR 3.2 · calibrated p 0.560 | 3.1 EB05 3.0 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.4 | no trial arm names this drug |
| Headache | 1,125 | 1.6 1.5–1.7ROR 1.6 · calibrated p 0.716 | 1.6 EB05 1.5 · IC025 +0.6 | No label text to screen label has no adverse-reaction text | serious PRR 1.8 | no trial arm names this drug |
| Drug ineffective (drug did not work) | 1,054 | 0.7 0.7–0.7ROR 0.7 · calibrated p 0.127 | 0.7 EB05 0.7 · IC025 -0.6 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.9 | no trial arm names this drug |
| Dizziness | 1,053 | 1.9 1.8–2.0ROR 1.9 · calibrated p 0.893 | 1.9 EB05 1.8 · IC025 +0.8 | No label text to screen label has no adverse-reaction text | serious PRR 1.9 | no trial arm names this drug |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
✓ A hand-written Bradford Hill causality assessment exists for this drug: Methotrexate Sodium ↔ Rheumatoid Arthritis.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Docusate 100Mg?
In FDA FAERS, the most frequently co-reported reaction terms for Docusate 100Mg are nausea, fatigue, dyspnoea, constipation, diarrhoea, pain. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Docusate 100Mg have an FDA boxed warning?
No. The FDA label retrieved for Docusate 100Mg has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Docusate 100Mg causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 44269b79-a5ad-f443-e063-6294a90a8473, effective 20260128; matched on
openfda.generic_name.exact:"DOCUSATE SODIUM 100MG") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,184 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
DOCUSATE 100MG, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.