Drug · FAERS side-effect profile with label screen

Docusate - Sennosides side effects: what 51,178 FDA adverse event reports show

Docusate Sodium - Sennosides · 1,203 reaction terms · 154,968 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Docusate Sodium 100Mg (Docusate Sodium)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

51,178 reports · 78% serious · 6,762 with death outcome · 54% 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

Lab value / disease marker 1No label text to screen 39

What the badges mean

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). 1,163 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Salpingo-oophorectomy unilateral	47	488.6 334.5–713.7ROR 489.3 · calibrated p 5e-13 ✓	250.1 EB05 195.6 · IC025 +5.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Carbuncle	35	92.5 64.9–131.7ROR 92.6 · calibrated p 4e-7 ✓	77.7 EB05 58.4 · IC025 +4.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Sinusitis fungal	54	48.1 36.5–63.4ROR 48.2 · calibrated p 2e-5 ✓	44.2 EB05 35.1 · IC025 +4.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Monoclonal immunoglobulin present	43	38.9 28.6–52.9ROR 39.0 · calibrated p 9e-5 ✓	36.2 EB05 28.0 · IC025 +4.2 3/3 methods agree	Lab value / disease marker	–	no trial arm names this drug
Chronic kidney disease-mineral and bone disorder	59	37.9 29.2–49.3ROR 38.0 · calibrated p 9e-5 ✓	35.5 EB05 28.5 · IC025 +4.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Wrist deformity	33	36.7 25.9–52.2ROR 36.8 · calibrated p 1e-4 ✓	34.2 EB05 25.5 · IC025 +4.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Hyperparathyroidism secondary	110	29.7 24.5–35.9ROR 29.8 · calibrated p 3e-4 ✓	28.3 EB05 24.1 · IC025 +4.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Nephrogenic anaemia	182	26.5 22.8–30.7ROR 26.6 · calibrated p 5e-4 ✓	25.4 EB05 22.5 · IC025 +4.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Female genital tract fistula	58	22.8 17.5–29.6ROR 22.8 · calibrated p 0.001 ✓	21.9 EB05 17.6 · IC025 +3.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Sputum increased	63	20.1 15.6–25.8ROR 20.1 · calibrated p 0.002 ✓	19.4 EB05 15.7 · IC025 +3.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Diastolic dysfunction	88	19.1 15.4–23.6ROR 19.1 · calibrated p 0.003 ✓	18.5 EB05 15.5 · IC025 +3.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Chronic sinusitis	105	18.8 15.5–22.9ROR 18.9 · calibrated p 0.003 ✓	18.3 EB05 15.5 · IC025 +3.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Left atrial dilatation	34	17.8 12.6–25.0ROR 17.8 · calibrated p 0.004 ✓	17.1 EB05 12.7 · IC025 +3.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Hypothalamo-pituitary disorder	37	17.2 12.4–23.8ROR 17.2 · calibrated p 0.005 ✓	16.6 EB05 12.5 · IC025 +3.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Osteosclerosis	40	17.0 12.4–23.3ROR 17.0 · calibrated p 0.005 ✓	16.4 EB05 12.5 · IC025 +3.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Failure to thrive	118	15.1 12.6–18.2ROR 15.2 · calibrated p 0.007 ✓	14.8 EB05 12.6 · IC025 +3.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Kyphosis	39	14.7 10.7–20.2ROR 14.7 · calibrated p 0.009 ✓	14.1 EB05 10.6 · IC025 +3.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Respiratory symptom	59	14.1 10.9–18.2ROR 14.1 · calibrated p 0.010 ✓	13.6 EB05 10.9 · IC025 +3.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Atelectasis	200	13.8 12.0–15.8ROR 13.8 · calibrated p 0.010 ✓	13.5 EB05 11.9 · IC025 +3.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Tricuspid valve incompetence	158	13.3 11.4–15.6ROR 13.4 · calibrated p 0.011 ✓	13.0 EB05 11.4 · IC025 +3.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Aortic arteriosclerosis	51	13.2 10.0–17.4ROR 13.2 · calibrated p 0.013 ✓	12.7 EB05 9.9 · IC025 +3.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Osteolysis	40	13.0 9.5–17.8ROR 13.0 · calibrated p 0.014 ✓	12.4 EB05 9.4 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Embolism venous	59	12.9 10.0–16.8ROR 13.0 · calibrated p 0.014 ✓	12.5 EB05 10.0 · IC025 +3.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Haemorrhagic anaemia	85	12.7 10.2–15.7ROR 12.7 · calibrated p 0.014 ✓	12.3 EB05 10.2 · IC025 +3.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Neurogenic bladder	39	12.3 8.9–16.8ROR 12.3 · calibrated p 0.018 ✓	11.7 EB05 8.7 · IC025 +2.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Diverticulum	130	12.0 10.1–14.3ROR 12.0 · calibrated p 0.017 ✓	11.7 EB05 10.1 · IC025 +3.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Bone lesion	63	11.6 9.0–14.9ROR 11.6 · calibrated p 0.021 ✓	11.2 EB05 8.9 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Dyslipidaemia	87	11.4 9.2–14.1ROR 11.4 · calibrated p 0.022 ✓	11.0 EB05 9.1 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Fibrosis	52	11.2 8.5–14.8ROR 11.2 · calibrated p 0.024 ✓	10.7 EB05 8.4 · IC025 +2.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Wound infection staphylococcal	29	11.1 7.7–16.0ROR 11.1 · calibrated p 0.027 ✓	10.3 EB05 7.2 · IC025 +2.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Lumbar spinal stenosis	48	10.9 8.2–14.5ROR 10.9 · calibrated p 0.027 ✓	10.3 EB05 8.0 · IC025 +2.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Rebound acid hypersecretion	50	10.8 8.2–14.3ROR 10.8 · calibrated p 0.027 ✓	10.3 EB05 8.0 · IC025 +2.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Cervical spinal stenosis	28	10.7 7.4–15.6ROR 10.8 · calibrated p 0.030 ✓	9.9 EB05 6.9 · IC025 +2.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Lobar pneumonia	30	10.6 7.4–15.2ROR 10.6 · calibrated p 0.031 ✓	9.8 EB05 7.0 · IC025 +2.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Essential hypertension	41	10.5 7.7–14.3ROR 10.5 · calibrated p 0.031 ✓	9.9 EB05 7.4 · IC025 +2.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Pathological fracture	80	10.5 8.4–13.0ROR 10.5 · calibrated p 0.029 ✓	10.1 EB05 8.3 · IC025 +2.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Hiatus hernia	192	9.8 8.5–11.3ROR 9.9 · calibrated p 0.035 ✓	9.6 EB05 8.5 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Metabolic encephalopathy	44	9.7 7.2–13.1ROR 9.7 · calibrated p 0.039 ✓	9.1 EB05 7.0 · IC025 +2.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Renal failure chronic	112	9.5 7.9–11.5ROR 9.5 · calibrated p 0.039 ✓	9.2 EB05 7.8 · IC025 +2.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Ischaemic cardiomyopathy	44	9.4 7.0–12.7ROR 9.4 · calibrated p 0.044 ✓	8.8 EB05 6.7 · IC025 +2.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug

Trial evidence (ClinicalTrials.gov)

ClinicalTrials.gov returned results-bearing trials mentioning Docusate - Sennosides 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
Fatigue (tiredness)	2,857	2.4 2.3–2.5ROR 2.5 · calibrated p 0.792	2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Nausea	2,600	2.2 2.1–2.2ROR 2.3 · calibrated p 0.921	2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Diarrhoea (diarrhea)	2,013	2.1 2.0–2.1ROR 2.1 · calibrated p 0.991	2.0 EB05 2.0 · IC025 +1.0	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Dyspnoea (shortness of breath)	1,962	2.3 2.2–2.4ROR 2.4 · calibrated p 0.876	2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Constipation	1,928	5.9 5.6–6.1ROR 6.2 · calibrated p 0.139	5.8 EB05 5.6 · IC025 +2.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Death	1,823	1.4 1.3–1.4ROR 1.4 · calibrated p 0.581	1.4 EB05 1.3 · IC025 +0.4	Outcome field, not a reaction	–	no trial arm names this drug
Pain	1,790	1.9 1.8–2.0ROR 2.0 · calibrated p 0.922	1.9 EB05 1.8 · IC025 +0.9	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Asthenia (weakness)	1,676	2.9 2.8–3.1ROR 3.0 · calibrated p 0.616	2.9 EB05 2.8 · IC025 +1.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Fall	1,617	3.2 3.0–3.3ROR 3.3 · calibrated p 0.534	3.2 EB05 3.1 · IC025 +1.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Pneumonia (lung infection)	1,538	3.1 3.0–3.3ROR 3.2 · calibrated p 0.556	3.1 EB05 3.0 · IC025 +1.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Vomiting	1,517	2.1 2.0–2.2ROR 2.2 · calibrated p 0.963	2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Headache	1,379	1.4 1.4–1.5ROR 1.5 · calibrated p 0.616	1.4 EB05 1.4 · IC025 +0.4	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Dizziness	1,281	1.7 1.6–1.8ROR 1.7 · calibrated p 0.778	1.7 EB05 1.6 · IC025 +0.7	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Off label use (used outside approved label)	1,235	0.9 0.9–1.0ROR 0.9 · calibrated p 0.261	0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	–	no trial arm names this drug
Drug ineffective (drug did not work)	1,206	0.6 0.6–0.6ROR 0.6 · calibrated p 0.078	0.6 EB05 0.6 · IC025 -0.8 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	–	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 - Sennosides?

In FDA FAERS, the most frequently co-reported reaction terms for Docusate - Sennosides are fatigue, nausea, diarrhoea, dyspnoea, constipation, 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 - Sennosides have an FDA boxed warning?

No. The FDA label retrieved for Docusate - Sennosides has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Docusate - Sennosides 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 025e03e0-e273-47ed-87f7-98e388abe047, effective 20260305; matched on openfda.generic_name:"DOCUSATE")
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, field patient.drug.openfda.generic_name.exact, 1,203 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 - SENNOSIDES, 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.