Drug · FAERS side-effect profile with label screen
Sennosides side effects: what 189 FDA adverse event reports show
Drug class
Not stated in label
Who reports
189 reports · 99% serious · 73 with death outcome · 48% 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 32 strongest signals
Reporting / coding artifact 5Lab value / disease marker 1No label text to screen 26
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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1 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 |
|---|---|---|---|---|---|---|
| Obstructive airways disorder | 62 | 619.7 504.9–760.6ROR 921.7 · χ² 37,488 / p <1e-300 | 517.3 EB05 418.0 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 370.9 · ♀ 0% (drug 48%) | no trial data cached |
| Vasculitis | 61 | 583.5 474.3–718.0ROR 861.1 · χ² 34,728 / p <1e-300 | 490.7 EB05 395.7 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 361.7 · ♀ 0% (drug 48%) | no trial data cached |
| Arteriosclerosis | 47 | 555.9 433.5–712.8ROR 739.5 · χ² 25,363 / p <1e-300 | 451.1 EB05 352.9 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 330.6 · ♀ 0% (drug 48%) | no trial data cached |
| Full blood count abnormal | 52 | 549.9 435.9–693.6ROR 758.2 · χ² 27,817 / p <1e-300 | 455.1 EB05 360.4 · IC025 +6.0 3/3 methods agree | Lab value / disease marker | serious PRR 420.6 · ♀ 0% (drug 48%) | no trial data cached |
| Nodule | 47 | 400.9 312.8–514.0ROR 533.3 · χ² 18,297 / p <1e-300 | 343.5 EB05 268.7 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 358.2 · ♀ 0% (drug 48%) | no trial data cached |
| Sleep disorder due to a general medical condition | 56 | 385.5 309.3–480.5ROR 547.4 · χ² 21,036 / p <1e-300 | 339.5 EB05 271.2 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 440.3 · ♀ 2% (drug 48%) | no trial data cached |
| Pulmonary fibrosis | 62 | 361.1 294.3–443.0ROR 536.8 · χ² 21,851 / p <1e-300 | 323.9 EB05 261.7 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 210.6 · ♀ 0% (drug 48%) | no trial data cached |
| Coeliac disease | 27 | 306.0 215.7–434.1ROR 356.8 · χ² 7,887 / p <1e-300 | 251.0 EB05 181.2 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 219.9 · ♀ 100% (drug 48%) · 93% clinician | no trial data cached |
| Immunodeficiency | 37 | 279.4 209.2–373.1ROR 347.1 · χ² 9,968 / p <1e-300 | 243.7 EB05 184.6 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 175.3 · ♀ 100% (drug 48%) · 95% clinician | no trial data cached |
| Bursitis | 27 | 248.8 175.4–353.0ROR 290.1 · χ² 6,408 / p <1e-300 | 211.3 EB05 152.5 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 169.1 · ♀ 100% (drug 48%) · 93% clinician | no trial data cached |
| Haemoptysis | 62 | 246.6 201.0–302.5ROR 366.5 · χ² 14,907 / p <1e-300 | 228.7 EB05 184.8 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 160.3 · ♀ 0% (drug 48%) | no trial data cached |
| Hypothyroidism | 57 | 198.9 160.1–247.2ROR 284.4 · χ² 11,026 / p <1e-300 | 186.3 EB05 149.1 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 126.5 · ♀ 2% (drug 48%) | no trial data cached |
| Prescribed overdose | 34 | 195.3 144.0–264.8ROR 237.9 · χ² 6,372 / p <1e-300 | 175.8 EB05 131.6 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 192.5 · ♀ 100% (drug 48%) · 97% clinician | no trial data cached |
| Hypoxia (low oxygen) | 48 | 152.1 119.1–194.2ROR 203.5 · χ² 7,055 / p <1e-300 | 143.3 EB05 112.4 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 89.4 · ♀ 3% (drug 48%) | no trial data cached |
| Lung disorder | 62 | 140.7 114.7–172.5ROR 208.8 · χ² 8,467 / p <1e-300 | 134.7 EB05 108.9 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 91.5 · ♀ 0% (drug 48%) | no trial data cached |
| Loss of personal independence in daily activities | 55 | 128.5 102.8–160.5ROR 180.8 · χ² 6,836 / p <1e-300 | 122.9 EB05 98.0 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 97.8 · ♀ 2% (drug 48%) | no trial data cached |
| Wheezing | 63 | 118.3 96.7–144.7ROR 176.9 · χ² 7,221 / p <1e-300 | 114.1 EB05 92.4 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 94.3 · ♀ 2% (drug 48%) | no trial data cached |
| Contraindicated product administered | 31 | 114.1 82.7–157.5ROR 136.3 · χ² 3,366 / p <1e-300 | 106.7 EB05 78.7 · IC025 +4.8 3/3 methods agree | Reporting / coding artifact | serious PRR 82.2 · ♀ 100% (drug 48%) · 94% clinician | no trial data cached |
| Productive cough (cough with phlegm) | 47 | 110.3 86.0–141.3ROR 146.4 · χ² 4,986 / p <1e-300 | 105.5 EB05 82.6 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 94.9 · ♀ 0% (drug 48%) | no trial data cached |
| Therapeutic product effect incomplete | 63 | 98.9 80.9–121.0ROR 147.9 · χ² 6,025 / p <1e-300 | 96.0 EB05 77.7 · IC025 +5.4 3/3 methods agree | Reporting / coding artifact | serious PRR 107.6 · ♀ 2% (drug 48%) | no trial data cached |
| Asthma | 91 | 90.1 77.7–104.5ROR 172.9 · χ² 7,969 / p <1e-300 | 88.4 EB05 74.2 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 73.3 | no trial data cached |
| Fluid retention | 33 | 72.1 52.8–98.3ROR 87.1 · χ² 2,246 / p <1e-300 | 69.2 EB05 51.6 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 58.0 · ♀ 100% (drug 48%) · 94% clinician | no trial data cached |
| Thrombosis | 48 | 66.0 51.7–84.3ROR 88.2 · χ² 3,020 / p <1e-300 | 64.4 EB05 50.5 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 39.6 · ♀ 0% (drug 48%) | no trial data cached |
| Infusion related reaction (reaction during infusion) | 37 | 62.2 46.6–83.0ROR 77.1 · χ² 2,172 / p <1e-300 | 60.3 EB05 45.7 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 45.4 · ♀ 100% (drug 48%) · 95% clinician | no trial data cached |
| Rash erythematous | 26 | 61.6 43.1–88.0ROR 71.3 · χ² 1,493 / p <1e-300 | 59.0 EB05 42.3 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 72.4 · ♀ 100% (drug 48%) · 96% clinician | no trial data cached |
| Exposure during pregnancy | 33 | 58.9 43.2–80.3ROR 71.2 · χ² 1,825 / p <1e-300 | 57.0 EB05 42.5 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious PRR 51.3 · ♀ 100% (drug 48%) · 97% clinician | no trial data cached |
| Pulmonary embolism (lung blood clot) | 47 | 54.6 42.6–70.0ROR 72.4 · χ² 2,432 / p <1e-300 | 53.5 EB05 41.9 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 31.8 · ♀ 0% (drug 48%) | no trial data cached |
| Intentional product misuse | 34 | 43.4 32.0–58.9ROR 52.8 · χ² 1,373 / p <1e-300 | 42.5 EB05 31.8 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 57.1 · ♀ 100% (drug 48%) · 94% clinician | no trial data cached |
| Treatment failure | 31 | 41.9 30.4–57.8ROR 49.9 · χ² 1,202 / p 1e-263 | 40.9 EB05 30.2 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious PRR 46.6 · ♀ 100% (drug 48%) · 97% clinician | no trial data cached |
| Skin exfoliation | 26 | 34.7 24.3–49.6ROR 40.1 · χ² 821 / p 7e-181 | 33.9 EB05 24.3 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 59.6 · ♀ 0% (drug 48%) | no trial data cached |
| Rheumatoid arthritis | 29 | 28.5 20.4–39.8ROR 33.4 · χ² 745 / p 2e-164 | 28.0 EB05 20.4 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.1 · ♀ 100% (drug 48%) · 93% clinician | no trial data cached |
| Psoriasis | 33 | 28.0 20.5–38.2ROR 33.7 · χ² 838 / p 2e-184 | 27.6 EB05 20.6 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 44.3 · ♀ 100% (drug 48%) · 94% clinician | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
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 |
|---|---|---|---|---|---|---|
| Asthma | 91 | 90.1 77.7–104.5ROR 172.9 · χ² 7,969 / p <1e-300 | 88.4 EB05 74.2 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 73.3 | no trial data cached |
| Therapeutic product effect incomplete | 63 | 98.9 80.9–121.0ROR 147.9 · χ² 6,025 / p <1e-300 | 96.0 EB05 77.7 · IC025 +5.4 3/3 methods agree | Reporting / coding artifact | serious PRR 107.6 · ♀ 2% (drug 48%) | no trial data cached |
| Wheezing | 63 | 118.3 96.7–144.7ROR 176.9 · χ² 7,221 / p <1e-300 | 114.1 EB05 92.4 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 94.3 · ♀ 2% (drug 48%) | no trial data cached |
| Lung disorder | 62 | 140.7 114.7–172.5ROR 208.8 · χ² 8,467 / p <1e-300 | 134.7 EB05 108.9 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 91.5 · ♀ 0% (drug 48%) | no trial data cached |
| Haemoptysis | 62 | 246.6 201.0–302.5ROR 366.5 · χ² 14,907 / p <1e-300 | 228.7 EB05 184.8 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 160.3 · ♀ 0% (drug 48%) | no trial data cached |
| Pulmonary fibrosis | 62 | 361.1 294.3–443.0ROR 536.8 · χ² 21,851 / p <1e-300 | 323.9 EB05 261.7 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 210.6 · ♀ 0% (drug 48%) | no trial data cached |
| Obstructive airways disorder | 62 | 619.7 504.9–760.6ROR 921.7 · χ² 37,488 / p <1e-300 | 517.3 EB05 418.0 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 370.9 · ♀ 0% (drug 48%) | no trial data cached |
| Vasculitis | 61 | 583.5 474.3–718.0ROR 861.1 · χ² 34,728 / p <1e-300 | 490.7 EB05 395.7 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 361.7 · ♀ 0% (drug 48%) | no trial data cached |
| Hypothyroidism | 57 | 198.9 160.1–247.2ROR 284.4 · χ² 11,026 / p <1e-300 | 186.3 EB05 149.1 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 126.5 · ♀ 2% (drug 48%) | no trial data cached |
| Sleep disorder due to a general medical condition | 56 | 385.5 309.3–480.5ROR 547.4 · χ² 21,036 / p <1e-300 | 339.5 EB05 271.2 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 440.3 · ♀ 2% (drug 48%) | no trial data cached |
| Loss of personal independence in daily activities | 55 | 128.5 102.8–160.5ROR 180.8 · χ² 6,836 / p <1e-300 | 122.9 EB05 98.0 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 97.8 · ♀ 2% (drug 48%) | no trial data cached |
| Full blood count abnormal | 52 | 549.9 435.9–693.6ROR 758.2 · χ² 27,817 / p <1e-300 | 455.1 EB05 360.4 · IC025 +6.0 3/3 methods agree | Lab value / disease marker | serious PRR 420.6 · ♀ 0% (drug 48%) | no trial data cached |
| Thrombosis | 48 | 66.0 51.7–84.3ROR 88.2 · χ² 3,020 / p <1e-300 | 64.4 EB05 50.5 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 39.6 · ♀ 0% (drug 48%) | no trial data cached |
| Hypoxia (low oxygen) | 48 | 152.1 119.1–194.2ROR 203.5 · χ² 7,055 / p <1e-300 | 143.3 EB05 112.4 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 89.4 · ♀ 3% (drug 48%) | no trial data cached |
| Pulmonary embolism (lung blood clot) | 47 | 54.6 42.6–70.0ROR 72.4 · χ² 2,432 / p <1e-300 | 53.5 EB05 41.9 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 31.8 · ♀ 0% (drug 48%) | no trial data cached |
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 asthma, wheezing, lung disorder, haemoptysis, pulmonary fibrosis, obstructive airways disorder. 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, 33 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
Page generated 2026-10-08. 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.