Drug · FAERS side-effect profile with label screen
Senna side effects: what 20,946 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Onelax Senna
openFDA label
Who reports
20,946 reports · 84% serious · 3,190 with death outcome · 54% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Directions take preferably at bedtime or as directed by a doctor. Shake Well Before Using.
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 10No label text to screen 30
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). 1,148 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 |
|---|---|---|---|---|---|---|
| Musculoskeletal toxicity | 17 | 101.6 61.7–167.4ROR 101.7 · calibrated p 5e-7 ✓ | 83.8 EB05 55.4 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=17 | no trial data cached |
| Capillaritis | 23 | 93.8 61.1–143.8ROR 93.9 · calibrated p 6e-7 ✓ | 80.2 EB05 56.3 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=23 · ♀ 0% (drug 54%) | no trial data cached |
| Soft tissue mass | 31 | 72.0 50.0–103.6ROR 72.1 · calibrated p 3e-6 ✓ | 64.6 EB05 47.7 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=31 · ♀ 0% (drug 54%) · 100% clinician | no trial data cached |
| Chest wall mass | 17 | 70.2 42.9–114.7ROR 70.2 · calibrated p 5e-6 ✓ | 61.3 EB05 40.5 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=17 | no trial data cached |
| Postmortem blood drug level increased | 23 | 67.7 44.4–103.3ROR 67.8 · calibrated p 5e-6 ✓ | 60.4 EB05 42.4 · IC025 +4.1 3/3 methods agree | Lab value / disease marker | serious n=23 · 100% clinician | no trial data cached |
| Total lung capacity abnormal | 21 | 58.4 37.6–90.6ROR 58.4 · calibrated p 1e-5 ✓ | 52.7 EB05 36.3 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=21 · ♀ 0% (drug 54%) | no trial data cached |
| Pulmonary vasculitis | 26 | 51.7 34.9–76.7ROR 51.8 · calibrated p 2e-5 ✓ | 47.6 EB05 34.1 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=26 · ♀ 0% (drug 54%) | no trial data cached |
| Scan abnormal | 17 | 48.3 29.7–78.6ROR 48.4 · calibrated p 5e-5 ✓ | 44.0 EB05 29.1 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious n=17 | no trial data cached |
| Mite allergy | 29 | 47.6 32.8–69.1ROR 47.7 · calibrated p 3e-5 ✓ | 44.2 EB05 32.3 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=29 · ♀ 0% (drug 54%) | no trial data cached |
| Spirometry abnormal | 26 | 46.3 31.3–68.6ROR 46.4 · calibrated p 4e-5 ✓ | 43.0 EB05 30.8 · IC025 +4.0 3/3 methods agree | Lab value / disease marker | serious n=26 · ♀ 0% (drug 54%) | no trial data cached |
| Clostridium test positive | 92 | 44.0 35.8–54.2ROR 44.2 · calibrated p 3e-5 ✓ | 41.9 EB05 35.2 · IC025 +4.8 3/3 methods agree | Lab value / disease marker | serious n=91 · 100% clinician | no trial data cached |
| Immunisation | 18 | 43.3 27.0–69.4ROR 43.3 · calibrated p 8e-5 ✓ | 39.9 EB05 26.7 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=18 | no trial data cached |
| Oesophageal perforation | 32 | 40.0 28.1–57.0ROR 40.1 · calibrated p 8e-5 ✓ | 37.7 EB05 28.0 · IC025 +4.0 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 data cached |
| Temperature regulation disorder | 82 | 39.0 31.3–48.6ROR 39.1 · calibrated p 7e-5 ✓ | 37.2 EB05 31.0 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=82 · ♀ 100% (drug 54%) · 91% clinician | no trial data cached |
| Blood albumin abnormal | 18 | 36.4 22.7–58.2ROR 36.4 · calibrated p 2e-4 ✓ | 34.0 EB05 22.7 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious n=18 | no trial data cached |
| Mycotic allergy | 29 | 35.6 24.6–51.6ROR 35.7 · calibrated p 2e-4 ✓ | 33.7 EB05 24.6 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=29 · ♀ 0% (drug 54%) | no trial data cached |
| Antineutrophil cytoplasmic antibody positive | 24 | 34.1 22.7–51.2ROR 34.1 · calibrated p 2e-4 ✓ | 32.2 EB05 22.8 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious n=24 · ♀ 0% (drug 54%) | no trial data cached |
| Cardiospasm | 18 | 33.3 20.8–53.3ROR 33.3 · calibrated p 3e-4 ✓ | 31.3 EB05 20.9 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=18 | no trial data cached |
| Dust allergy | 30 | 32.1 22.3–46.2ROR 32.1 · calibrated p 3e-4 ✓ | 30.6 EB05 22.5 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=30 · ♀ 0% (drug 54%) | no trial data cached |
| Multimorbidity | 33 | 28.1 19.9–39.7ROR 28.2 · calibrated p 5e-4 ✓ | 27.0 EB05 20.1 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=33 · ♀ 0% (drug 54%) · 100% clinician | no trial data cached |
| Palmoplantar keratoderma | 19 | 27.1 17.2–42.7ROR 27.1 · calibrated p 8e-4 ✓ | 25.8 EB05 17.4 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=18 | no trial data cached |
| Superinfection | 38 | 26.0 18.8–35.8ROR 26.0 · calibrated p 7e-4 ✓ | 25.0 EB05 19.0 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=38 · ♀ 25% (drug 54%) · 100% clinician | no trial data cached |
| Blood alkaline phosphatase abnormal | 21 | 24.0 15.6–37.0ROR 24.0 · calibrated p 0.001 ✓ | 23.0 EB05 15.8 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious n=21 · 100% clinician | no trial data cached |
| Glomerular filtration rate increased | 19 | 23.9 15.2–37.7ROR 24.0 · calibrated p 0.001 ✓ | 22.9 EB05 15.4 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious n=19 | no trial data cached |
| Neuritis | 32 | 21.2 15.0–30.1ROR 21.3 · calibrated p 0.002 ✓ | 20.6 EB05 15.2 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=32 · ♀ 0% (drug 54%) | no trial data cached |
| Chronic kidney disease-mineral and bone disorder | 22 | 20.9 13.7–31.8ROR 20.9 · calibrated p 0.002 ✓ | 20.1 EB05 13.9 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=22 | no trial data cached |
| Conjunctivitis allergic | 28 | 19.5 13.4–28.3ROR 19.5 · calibrated p 0.003 ✓ | 18.9 EB05 13.6 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=28 · ♀ 0% (drug 54%) | no trial data cached |
| Lung consolidation | 53 | 19.2 14.6–25.2ROR 19.2 · calibrated p 0.003 ✓ | 18.7 EB05 14.8 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=53 · ♀ 24% (drug 54%) · 100% clinician | no trial data cached |
| Intestinal pseudo-obstruction | 15 | 17.7 10.6–29.5ROR 17.7 · calibrated p 0.006 ✓ | 16.7 EB05 10.2 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=15 | no trial data cached |
| Neutropenic sepsis | 122 | 17.3 14.5–20.7ROR 17.4 · calibrated p 0.004 ✓ | 17.0 EB05 14.6 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.7 · 100% clinician | no trial data cached |
| Cleft palate | 31 | 16.3 11.4–23.2ROR 16.3 · calibrated p 0.006 ✓ | 15.8 EB05 11.5 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=31 · 100% clinician | no trial data cached |
| Pleuritic pain | 44 | 16.1 12.0–21.7ROR 16.2 · calibrated p 0.006 ✓ | 15.7 EB05 12.1 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=44 | no trial data cached |
| Blood bilirubin abnormal | 19 | 15.2 9.7–23.9ROR 15.2 · calibrated p 0.010 ✓ | 14.4 EB05 9.3 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious n=19 | no trial data cached |
| Eosinophilic granulomatosis with polyangiitis | 30 | 15.1 10.5–21.6ROR 15.1 · calibrated p 0.009 ✓ | 14.6 EB05 10.5 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=30 · ♀ 0% (drug 54%) | no trial data cached |
| Monocyte count decreased | 18 | 15.1 9.5–24.0ROR 15.1 · calibrated p 0.010 ✓ | 14.2 EB05 9.0 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious n=18 | no trial data cached |
| Nephrogenic anaemia | 69 | 15.0 11.8–19.0ROR 15.0 · calibrated p 0.008 ✓ | 14.7 EB05 11.9 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=69 | no trial data cached |
| Food allergy | 111 | 14.9 12.4–18.0ROR 15.0 · calibrated p 0.007 ✓ | 14.6 EB05 12.5 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=109 · ♀ 100% (drug 54%) · 94% clinician | no trial data cached |
| Perirectal abscess | 16 | 14.5 8.9–23.8ROR 14.5 · calibrated p 0.012 ✓ | 13.5 EB05 8.1 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=16 | no trial data cached |
| Transplant failure | 32 | 13.3 9.4–18.8ROR 13.3 · calibrated p 0.014 ✓ | 12.7 EB05 9.2 · IC025 +2.9 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 data cached |
| Excessive eye blinking | 19 | 13.0 8.3–20.5ROR 13.0 · calibrated p 0.017 ✓ | 12.0 EB05 7.6 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=17 | 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 |
|---|---|---|---|---|---|---|
| Nausea | 1,445 | 1.8 1.7–1.9ROR 1.9 · calibrated p 0.886 | 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 data cached |
| Fatigue (tiredness) | 1,426 | 1.8 1.7–1.9ROR 1.9 · calibrated p 0.888 | 1.8 EB05 1.8 · IC025 +0.8 | No label text to screen label has no adverse-reaction text | serious PRR 1.8 | no trial data cached |
| Constipation | 1,201 | 5.6 5.3–5.9ROR 5.9 · calibrated p 0.160 | 5.5 EB05 5.3 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.5 | no trial data cached |
| Dyspnoea (shortness of breath) | 1,122 | 2.0 1.9–2.1ROR 2.0 · calibrated p 0.967 | 2.0 EB05 1.9 · IC025 +0.9 | No label text to screen label has no adverse-reaction text | serious PRR 1.7 | no trial data cached |
| Diarrhoea (diarrhea) | 1,109 | 1.7 1.6–1.8ROR 1.8 · calibrated p 0.810 | 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 data cached |
| Death | 1,085 | 1.3 1.2–1.3ROR 1.3 · calibrated p 0.491 | 1.3 EB05 1.2 · IC025 +0.2 | Outcome field, not a reaction | serious PRR 0.9 | no trial data cached |
| Vomiting | 1,023 | 2.2 2.1–2.3ROR 2.2 · calibrated p 0.928 | 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 2.0 | no trial data cached |
| Pneumonia (lung infection) | 968 | 3.0 2.8–3.2ROR 3.1 · calibrated p 0.595 | 3.0 EB05 2.8 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.1 | no trial data cached |
| Fall | 920 | 2.8 2.6–3.0ROR 2.9 · calibrated p 0.675 | 2.8 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 data cached |
| Pyrexia (fever) | 890 | 2.6 2.4–2.7ROR 2.6 · calibrated p 0.753 | 2.6 EB05 2.4 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.1 | no trial data cached |
| Headache | 868 | 1.4 1.3–1.5ROR 1.4 · calibrated p 0.579 | 1.4 EB05 1.3 · IC025 +0.4 | No label text to screen label has no adverse-reaction text | serious PRR 1.6 · ♀ 80% (drug 54%) | no trial data cached |
| Pain | 853 | 1.4 1.3–1.5ROR 1.4 · calibrated p 0.579 | 1.4 EB05 1.3 · IC025 +0.4 | No label text to screen label has no adverse-reaction text | serious PRR 1.3 | no trial data cached |
| Asthenia (weakness) | 785 | 2.1 2.0–2.2ROR 2.1 · calibrated p 0.985 | 2.1 EB05 2.0 · IC025 +0.9 | No label text to screen label has no adverse-reaction text | serious PRR 1.8 | no trial data cached |
| Off label use (used outside approved label) | 779 | 0.9 0.8–1.0ROR 0.9 · calibrated p 0.240 | 0.9 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.9 | no trial data cached |
| Dizziness | 744 | 1.5 1.4–1.6ROR 1.5 · calibrated p 0.651 | 1.5 EB05 1.4 · IC025 +0.5 | No label text to screen label has no adverse-reaction text | serious PRR 1.6 | 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 Senna?
In FDA FAERS, the most frequently co-reported reaction terms for Senna are nausea, fatigue, constipation, dyspnoea, diarrhoea, vomiting. 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 Senna have an FDA boxed warning?
No. The FDA label retrieved for Senna has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Senna 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 27fa8f54-ed84-4afd-8da3-8754da48643b, effective 20260901; matched on
openfda.generic_name.exact:"SENNA") - 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, 1,188 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 2026-10-14. 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.