Drug · FAERS side-effect profile with label screen
Sennosides side effects: what 29,701 FDA adverse event reports show
Drug class
Not stated in label
Who reports
29,701 reports · 84% serious · 4,515 with death outcome · 54% female
openFDA FAERS counts, all years, deduplication not applied
Used for
relieves occasional constipation (irregularity) generally produces bowel movement in 6 to 12 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 2Lab value / disease marker 8No label text to screen 30
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). 1,153 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 |
|---|---|---|---|---|---|---|
| Pulmonary vasculitis | 160 | 307.4 255.3–370.1ROR 309.0 · calibrated p 1e-11 ✓ | 208.2 EB05 182.5 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=160 · ♀ 0% (drug 54%) | no trial arm names this drug |
| Total lung capacity abnormal | 98 | 245.1 194.8–308.5ROR 246.0 · calibrated p 1e-10 ✓ | 175.4 EB05 148.1 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=98 · ♀ 0% (drug 54%) | no trial arm names this drug |
| Capillaritis | 57 | 190.6 142.2–255.4ROR 190.9 · calibrated p 1e-9 ✓ | 142.7 EB05 114.2 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=57 · ♀ 0% (drug 54%) | no trial arm names this drug |
| Burkholderia test positive | 21 | 143.2 89.5–229.0ROR 143.3 · calibrated p 4e-8 ✓ | 107.5 EB05 74.2 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious n=21 · 100% clinician | no trial arm names this drug |
| Spirometry abnormal | 91 | 129.4 103.5–161.8ROR 129.8 · calibrated p 2e-8 ✓ | 106.9 EB05 89.7 · IC025 +5.8 3/3 methods agree | Lab value / disease marker | serious n=90 · ♀ 0% (drug 54%) | no trial arm names this drug |
| Mite allergy | 92 | 118.9 95.4–148.3ROR 119.3 · calibrated p 4e-8 ✓ | 99.6 EB05 83.7 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=92 · ♀ 0% (drug 54%) | no trial arm names this drug |
| Temperature regulation disorder | 260 | 95.3 83.8–108.4ROR 96.1 · calibrated p 2e-7 ✓ | 83.4 EB05 75.3 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=260 · ♀ 100% (drug 54%) | no trial arm names this drug |
| Antineutrophil cytoplasmic antibody positive | 81 | 88.3 70.1–111.2ROR 88.5 · calibrated p 4e-7 ✓ | 77.1 EB05 64.0 · IC025 +5.4 3/3 methods agree | Lab value / disease marker | serious n=81 · ♀ 0% (drug 54%) | no trial arm names this drug |
| Mycotic allergy | 92 | 86.5 69.6–107.3ROR 86.7 · calibrated p 4e-7 ✓ | 75.8 EB05 63.7 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=92 · ♀ 0% (drug 54%) | no trial arm names this drug |
| Neuritis | 164 | 84.2 71.6–98.9ROR 84.6 · calibrated p 5e-7 ✓ | 74.6 EB05 65.5 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=164 · ♀ 0% (drug 54%) | no trial arm names this drug |
| Bronchopulmonary aspergillosis allergic | 94 | 80.6 65.1–99.8ROR 80.9 · calibrated p 7e-7 ✓ | 71.3 EB05 60.0 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=94 · ♀ 88% (drug 54%) | no trial arm names this drug |
| Dust allergy | 93 | 75.3 60.8–93.2ROR 75.5 · calibrated p 1e-6 ✓ | 67.1 EB05 56.4 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=93 · ♀ 0% (drug 54%) | no trial arm names this drug |
| Soft tissue mass | 32 | 52.5 36.6–75.2ROR 52.5 · calibrated p 2e-5 ✓ | 47.6 EB05 35.3 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=32 · ♀ 0% (drug 54%) · 100% clinician | no trial arm names this drug |
| Conjunctivitis allergic | 98 | 50.6 41.3–62.1ROR 50.8 · calibrated p 1e-5 ✓ | 46.9 EB05 39.6 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=98 · ♀ 0% (drug 54%) | no trial arm names this drug |
| Eosinophilic granulomatosis with polyangiitis | 132 | 49.3 41.4–58.8ROR 49.5 · calibrated p 2e-5 ✓ | 45.8 EB05 39.6 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=132 · ♀ 0% (drug 54%) | no trial arm names this drug |
| Postmortem blood drug level increased | 23 | 47.7 31.3–72.8ROR 47.8 · calibrated p 4e-5 ✓ | 43.3 EB05 30.4 · IC025 +3.8 3/3 methods agree | Lab value / disease marker | serious n=23 · 100% clinician | no trial arm names this drug |
| Respiratory symptom | 170 | 45.6 39.0–53.2ROR 45.8 · calibrated p 3e-5 ✓ | 42.6 EB05 37.5 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=170 · ♀ 0% (drug 54%) | no trial arm names this drug |
| Total lung capacity decreased | 86 | 40.0 32.2–49.7ROR 40.1 · calibrated p 6e-5 ✓ | 37.6 EB05 31.4 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=86 · ♀ 100% (drug 54%) | no trial arm names this drug |
| Food allergy | 349 | 34.1 30.7–38.0ROR 34.5 · calibrated p 1e-4 ✓ | 32.5 EB05 29.8 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=347 · ♀ 100% (drug 54%) · 90% clinician | no trial arm names this drug |
| Multiple drug therapy | 32 | 33.9 23.8–48.3ROR 33.9 · calibrated p 2e-4 ✓ | 31.8 EB05 23.6 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious n=32 · ♀ 100% (drug 54%) · 100% clinician | no trial arm names this drug |
| Creatinine renal clearance increased | 33 | 32.4 22.8–45.9ROR 32.4 · calibrated p 3e-4 ✓ | 30.5 EB05 22.7 · IC025 +3.8 3/3 methods agree | Lab value / disease marker | serious n=33 · ♀ 100% (drug 54%) · 100% clinician | no trial arm names this drug |
| Clostridium test positive | 94 | 31.7 25.8–39.0ROR 31.8 · calibrated p 2e-4 ✓ | 30.2 EB05 25.4 · IC025 +4.4 3/3 methods agree | Lab value / disease marker | serious n=93 · 100% clinician | no trial arm names this drug |
| Foetal death | 218 | 30.9 27.0–35.4ROR 31.2 · calibrated p 2e-4 ✓ | 29.6 EB05 26.4 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=218 · ♀ 100% (drug 54%) · 94% clinician | no trial arm names this drug |
| Oesophageal perforation | 32 | 28.2 19.8–40.2ROR 28.2 · calibrated p 5e-4 ✓ | 26.8 EB05 19.8 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=32 · ♀ 0% (drug 54%) · 100% clinician | no trial arm names this drug |
| Lung opacity | 94 | 26.7 21.7–32.8ROR 26.8 · calibrated p 5e-4 ✓ | 25.6 EB05 21.6 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=94 · ♀ 89% (drug 54%) | no trial arm names this drug |
| Pleuritic pain | 101 | 26.6 21.9–32.5ROR 26.7 · calibrated p 5e-4 ✓ | 25.6 EB05 21.7 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=101 · ♀ 78% (drug 54%) | no trial arm names this drug |
| Forced expiratory volume decreased | 100 | 25.8 21.1–31.4ROR 25.8 · calibrated p 6e-4 ✓ | 24.8 EB05 21.0 · IC025 +4.1 3/3 methods agree | Lab value / disease marker | serious n=100 · ♀ 0% (drug 54%) | no trial arm names this drug |
| Normochromic normocytic anaemia | 102 | 24.8 20.4–30.2ROR 24.9 · calibrated p 8e-4 ✓ | 23.9 EB05 20.2 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=102 · ♀ 0% (drug 54%) | no trial arm names this drug |
| Neurological symptom | 180 | 23.1 19.9–26.8ROR 23.2 · calibrated p 0.001 ✓ | 22.3 EB05 19.7 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=180 · ♀ 10% (drug 54%) | no trial arm names this drug |
| Pulmonary alveolar haemorrhage | 171 | 22.2 19.1–25.8ROR 22.3 · calibrated p 0.001 ✓ | 21.5 EB05 18.9 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=171 · ♀ 0% (drug 54%) | no trial arm names this drug |
| Palmoplantar keratoderma | 21 | 21.2 13.7–32.7ROR 21.2 · calibrated p 0.002 ✓ | 20.2 EB05 13.8 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=20 | no trial arm names this drug |
| Multimorbidity | 34 | 20.4 14.5–28.7ROR 20.5 · calibrated p 0.002 ✓ | 19.7 EB05 14.7 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=34 · ♀ 0% (drug 54%) · 100% clinician | no trial arm names this drug |
| Superinfection | 40 | 19.3 14.1–26.4ROR 19.3 · calibrated p 0.003 ✓ | 18.6 EB05 14.2 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=40 · ♀ 0% (drug 54%) · 100% clinician | no trial arm names this drug |
| Immunodeficiency | 372 | 18.3 16.5–20.2ROR 18.5 · calibrated p 0.003 ✓ | 17.8 EB05 16.3 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.3 · ♀ 96% (drug 54%) · 90% clinician | no trial arm names this drug |
| Chronic kidney disease-mineral and bone disorder | 27 | 18.1 12.4–26.6ROR 18.2 · calibrated p 0.004 ✓ | 17.4 EB05 12.4 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=27 | no trial arm names this drug |
| Obstructive airways disorder | 267 | 17.3 15.3–19.5ROR 17.4 · calibrated p 0.004 ✓ | 16.9 EB05 15.2 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.1 | no trial arm names this drug |
| Blood alkaline phosphatase abnormal | 21 | 16.9 11.0–26.1ROR 16.9 · calibrated p 0.006 ✓ | 16.1 EB05 10.8 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | serious n=21 · 100% clinician | no trial arm names this drug |
| Rales | 136 | 16.9 14.3–20.0ROR 17.0 · calibrated p 0.004 ✓ | 16.5 EB05 14.3 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=135 | no trial arm names this drug |
| Coeliac disease | 225 | 16.5 14.5–18.9ROR 16.7 · calibrated p 0.005 ✓ | 16.1 EB05 14.4 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.9 · ♀ 100% (drug 54%) | no trial arm names this drug |
| Sedation complication | 56 | 16.1 12.4–21.0ROR 16.2 · calibrated p 0.006 ✓ | 15.7 EB05 12.5 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious n=55 · ♀ 100% (drug 54%) | no trial arm names this drug |
Trial evidence (ClinicalTrials.gov)
ClinicalTrials.gov returned results-bearing trials mentioning Sennosides only as a background or rescue medication (NCT00001337, NCT02481219); 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) | 2,183 | 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 |
| Nausea | 2,035 | 1.8 1.7–1.9ROR 1.9 · calibrated p 0.878 | 1.8 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 |
| Constipation | 1,940 | 6.4 6.1–6.7ROR 6.8 · calibrated p 0.109 | 6.3 EB05 6.1 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.3 | no trial arm names this drug |
| Dyspnoea (shortness of breath) | 1,750 | 2.2 2.1–2.3ROR 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 | serious PRR 1.9 | no trial arm names this drug |
| Death | 1,590 | 1.3 1.2–1.4ROR 1.3 · calibrated p 0.522 | 1.3 EB05 1.3 · IC025 +0.3 | Outcome field, not a reaction | serious PRR 0.9 | no trial arm names this drug |
| Diarrhoea (diarrhea) | 1,531 | 1.7 1.6–1.8ROR 1.7 · calibrated p 0.781 | 1.7 EB05 1.6 · IC025 +0.7 | No label text to screen label has no adverse-reaction text | serious PRR 1.6 | no trial arm names this drug |
| Pain | 1,498 | 1.7 1.6–1.8ROR 1.8 · calibrated p 0.805 | 1.7 EB05 1.6 · IC025 +0.7 | No label text to screen label has no adverse-reaction text | serious PRR 1.7 · ♀ 74% (drug 54%) | no trial arm names this drug |
| Off label use (used outside approved label) | 1,439 | 1.2 1.1–1.2ROR 1.2 · calibrated p 0.426 | 1.2 EB05 1.1 · IC025 +0.1 | Reporting / coding artifact | serious PRR 1.2 | no trial arm names this drug |
| Pyrexia (fever) | 1,438 | 2.9 2.8–3.1ROR 3.0 · calibrated p 0.614 | 2.9 EB05 2.8 · 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 | 1,434 | 1.6 1.5–1.7ROR 1.6 · calibrated p 0.738 | 1.6 EB05 1.5 · IC025 +0.6 | No label text to screen label has no adverse-reaction text | serious PRR 2.0 · ♀ 82% (drug 54%) | no trial arm names this drug |
| Vomiting | 1,406 | 2.1 2.0–2.2ROR 2.2 · calibrated p 0.964 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 1.9 | no trial arm names this drug |
| Pneumonia (lung infection) | 1,396 | 3.1 2.9–3.2ROR 3.2 · calibrated p 0.577 | 3.0 EB05 2.9 · IC025 +1.5 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 |
| Fall | 1,288 | 2.7 2.6–2.9ROR 2.8 · calibrated p 0.688 | 2.7 EB05 2.6 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.1 | no trial arm names this drug |
| Asthenia (weakness) | 1,151 | 2.2 2.0–2.3ROR 2.2 · calibrated p 0.946 | 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 1.8 | no trial arm names this drug |
| Drug ineffective (drug did not work) | 1,072 | 0.6 0.5–0.6ROR 0.6 · calibrated p 0.068 | 0.6 EB05 0.5 · IC025 -0.9 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.8 | 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.
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 Sennosides?
In FDA FAERS, the most frequently co-reported reaction terms for Sennosides are fatigue, nausea, constipation, dyspnoea, 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 Sennosides have an FDA boxed warning?
No. The FDA label retrieved for Sennosides has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that 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 10dc8b4d-8136-44a5-a2ce-30295866cd3b, effective 20241223; matched on
openfda.generic_name.exact:"SENNOSIDES") - 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, 1,193 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
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.