Drug · FAERS side-effect profile with label screen
Senna Leaf side effects: what 22,923 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Senna
openFDA label
Who reports
22,923 reports · 84% serious · 3,499 with death outcome · 55% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Relieves ketone breath Uses: See symptoms on front panel.
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 8No label text to screen 32
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). 1,153 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 |
|---|---|---|---|---|---|---|
| Temperature regulation disorder | 288 | 138.9 122.8–157.1ROR 140.6 · calibrated p 9e-9 ✓ | 119.5 EB05 108.4 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=288 · ♀ 100% (drug 55%) | no trial data cached |
| Capillaritis | 31 | 119.4 82.1–173.6ROR 119.6 · calibrated p 8e-8 ✓ | 99.2 EB05 73.2 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=31 · ♀ 0% (drug 55%) | no trial data cached |
| Total lung capacity abnormal | 42 | 113.3 82.2–156.2ROR 113.5 · calibrated p 9e-8 ✓ | 96.5 EB05 74.4 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=42 · ♀ 0% (drug 55%) | no trial data cached |
| Pulmonary vasculitis | 53 | 101.8 76.7–135.3ROR 102.1 · calibrated p 2e-7 ✓ | 88.8 EB05 70.5 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=53 · ♀ 0% (drug 55%) | no trial data cached |
| Musculoskeletal toxicity | 17 | 92.9 56.4–153.0ROR 92.9 · calibrated p 9e-7 ✓ | 77.2 EB05 51.1 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=17 | no trial data cached |
| Spirometry abnormal | 52 | 88.8 66.8–118.0ROR 89.0 · calibrated p 4e-7 ✓ | 78.6 EB05 62.3 · IC025 +5.1 3/3 methods agree | Lab value / disease marker | serious n=52 · ♀ 0% (drug 55%) | no trial data cached |
| Mite allergy | 55 | 86.2 65.4–113.6ROR 86.4 · calibrated p 5e-7 ✓ | 76.7 EB05 61.2 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=55 · ♀ 0% (drug 55%) | no trial data cached |
| Postmortem blood drug level increased | 26 | 70.6 47.4–105.2ROR 70.7 · calibrated p 3e-6 ✓ | 62.7 EB05 44.9 · IC025 +4.2 3/3 methods agree | Lab value / disease marker | serious n=26 · 100% clinician | no trial data cached |
| Soft tissue mass | 33 | 70.3 49.3–100.2ROR 70.4 · calibrated p 3e-6 ✓ | 63.0 EB05 47.0 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=33 · ♀ 0% (drug 55%) · 100% clinician | no trial data cached |
| Chest wall mass | 17 | 64.1 39.2–104.8ROR 64.2 · calibrated p 9e-6 ✓ | 56.3 EB05 37.2 · 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 |
| Mycotic allergy | 55 | 63.8 48.5–83.8ROR 63.9 · calibrated p 4e-6 ✓ | 58.5 EB05 46.6 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=55 · ♀ 0% (drug 55%) | no trial data cached |
| Antineutrophil cytoplasmic antibody positive | 45 | 60.2 44.5–81.3ROR 60.3 · calibrated p 6e-6 ✓ | 55.2 EB05 43.0 · IC025 +4.6 3/3 methods agree | Lab value / disease marker | serious n=45 · ♀ 0% (drug 55%) | no trial data cached |
| Bronchopulmonary aspergillosis allergic | 55 | 58.3 44.4–76.6ROR 58.5 · calibrated p 7e-6 ✓ | 53.9 EB05 42.9 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=55 · ♀ 84% (drug 55%) | no trial data cached |
| Dust allergy | 56 | 56.3 43.0–73.8ROR 56.5 · calibrated p 9e-6 ✓ | 52.2 EB05 41.7 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=56 · ♀ 0% (drug 55%) | no trial data cached |
| Food allergy | 404 | 51.6 46.7–57.0ROR 52.5 · calibrated p 1e-5 ✓ | 48.8 EB05 44.9 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=402 · ♀ 100% (drug 55%) · 91% clinician | no trial data cached |
| Immunisation | 20 | 44.2 28.2–69.2ROR 44.2 · calibrated p 7e-5 ✓ | 40.7 EB05 27.8 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=20 | no trial data cached |
| Scan abnormal | 17 | 44.2 27.1–71.8ROR 44.2 · calibrated p 7e-5 ✓ | 40.4 EB05 26.7 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious n=17 | no trial data cached |
| Foetal death | 238 | 44.0 38.6–50.0ROR 44.4 · calibrated p 3e-5 ✓ | 41.8 EB05 37.6 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=238 · ♀ 100% (drug 55%) · 93% clinician | no trial data cached |
| Clostridium test positive | 98 | 43.0 35.1–52.6ROR 43.2 · calibrated p 4e-5 ✓ | 40.8 EB05 34.4 · IC025 +4.8 3/3 methods agree | Lab value / disease marker | serious n=97 · 100% clinician | no trial data cached |
| Oesophageal perforation | 34 | 38.9 27.6–54.9ROR 39.0 · calibrated p 1e-4 ✓ | 36.7 EB05 27.4 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=34 · ♀ 0% (drug 55%) · 100% clinician | no trial data cached |
| Medical induction of coma | 17 | 38.4 23.6–62.4ROR 38.4 · calibrated p 2e-4 ✓ | 35.5 EB05 23.5 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=17 | no trial data cached |
| Cardiospasm | 22 | 37.5 24.5–57.4ROR 37.5 · calibrated p 1e-4 ✓ | 35.0 EB05 24.4 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=22 | no trial data cached |
| Neuritis | 58 | 35.8 27.5–46.5ROR 35.9 · calibrated p 1e-4 ✓ | 34.1 EB05 27.4 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=58 · ♀ 0% (drug 55%) | no trial data cached |
| Conjunctivitis allergic | 54 | 35.0 26.7–45.9ROR 35.1 · calibrated p 1e-4 ✓ | 33.4 EB05 26.6 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=54 · ♀ 0% (drug 55%) | no trial data cached |
| Blood albumin abnormal | 18 | 33.2 20.8–53.2ROR 33.3 · calibrated p 3e-4 ✓ | 31.1 EB05 20.8 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | serious n=18 | no trial data cached |
| Pneumococcal infection | 19 | 30.6 19.4–48.3ROR 30.6 · calibrated p 5e-4 ✓ | 28.8 EB05 19.5 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=19 | no trial data cached |
| Palmoplantar keratoderma | 23 | 30.1 19.9–45.6ROR 30.2 · calibrated p 4e-4 ✓ | 28.6 EB05 20.0 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=22 | no trial data cached |
| Total lung capacity decreased | 47 | 27.6 20.7–36.9ROR 27.7 · calibrated p 5e-4 ✓ | 26.6 EB05 20.8 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=47 · ♀ 100% (drug 55%) | no trial data cached |
| Immunodeficiency | 429 | 27.4 24.9–30.1ROR 27.9 · calibrated p 4e-4 ✓ | 26.6 EB05 24.6 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.8 · ♀ 96% (drug 55%) · 90% clinician | no trial data cached |
| Multimorbidity | 35 | 27.3 19.5–38.2ROR 27.3 · calibrated p 6e-4 ✓ | 26.2 EB05 19.7 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=35 · ♀ 0% (drug 55%) · 100% clinician | no trial data cached |
| Eosinophilic granulomatosis with polyangiitis | 57 | 26.5 20.4–34.5ROR 26.6 · calibrated p 6e-4 ✓ | 25.6 EB05 20.5 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=57 · ♀ 0% (drug 55%) | no trial data cached |
| Pleuritic pain | 77 | 26.1 20.8–32.7ROR 26.2 · calibrated p 6e-4 ✓ | 25.2 EB05 20.9 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=77 · ♀ 77% (drug 55%) | no trial data cached |
| Superinfection | 41 | 25.6 18.8–35.0ROR 25.7 · calibrated p 8e-4 ✓ | 24.7 EB05 19.0 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=41 · ♀ 26% (drug 55%) · 100% clinician | no trial data cached |
| Coeliac disease | 250 | 23.9 21.1–27.0ROR 24.1 · calibrated p 8e-4 ✓ | 23.2 EB05 20.9 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.9 · ♀ 100% (drug 55%) | no trial data cached |
| Blood alkaline phosphatase abnormal | 22 | 23.0 15.1–35.1ROR 23.0 · calibrated p 0.002 ✓ | 22.0 EB05 15.3 · 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 | 21.9 13.9–34.5ROR 21.9 · calibrated p 0.002 ✓ | 20.9 EB05 14.0 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious n=19 | no trial data cached |
| Bursitis | 270 | 20.9 18.5–23.6ROR 21.1 · calibrated p 0.002 ✓ | 20.4 EB05 18.5 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.4 · ♀ 97% (drug 55%) | no trial data cached |
| Respiratory symptom | 60 | 20.0 15.5–25.8ROR 20.0 · calibrated p 0.002 ✓ | 19.5 EB05 15.7 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=60 · ♀ 0% (drug 55%) | no trial data cached |
| Normochromic normocytic anaemia | 63 | 19.6 15.3–25.1ROR 19.6 · calibrated p 0.003 ✓ | 19.1 EB05 15.4 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=63 · ♀ 0% (drug 55%) | no trial data cached |
| Chronic kidney disease-mineral and bone disorder | 22 | 19.1 12.5–29.1ROR 19.1 · calibrated p 0.004 ✓ | 18.3 EB05 12.6 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=22 | 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 |
|---|---|---|---|---|---|---|
| Fatigue (tiredness) | 1,758 | 2.1 2.0–2.2ROR 2.2 · calibrated p 0.971 | 2.1 EB05 2.0 · IC025 +1.0 | No label text to screen label has no adverse-reaction text | serious PRR 2.1 | no trial data cached |
| Nausea | 1,565 | 1.8 1.7–1.9ROR 1.9 · calibrated p 0.874 | 1.8 EB05 1.7 · IC025 +0.8 | No label text to screen label has no adverse-reaction text | serious PRR 1.9 | no trial data cached |
| Constipation | 1,519 | 6.5 6.1–6.8ROR 6.8 · calibrated p 0.105 | 6.4 EB05 6.1 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.5 | no trial data cached |
| Headache | 1,253 | 1.8 1.7–1.9ROR 1.9 · calibrated p 0.876 | 1.8 EB05 1.7 · IC025 +0.8 | No label text to screen label has no adverse-reaction text | serious PRR 2.3 · ♀ 85% (drug 55%) | no trial data cached |
| Pain | 1,248 | 1.9 1.8–2.0ROR 1.9 · calibrated p 0.891 | 1.9 EB05 1.8 · IC025 +0.8 | No label text to screen label has no adverse-reaction text | serious PRR 1.8 · ♀ 76% (drug 55%) | no trial data cached |
| Off label use (used outside approved label) | 1,245 | 1.3 1.2–1.4ROR 1.3 · calibrated p 0.528 | 1.3 EB05 1.3 · IC025 +0.3 | Reporting / coding artifact | serious PRR 1.4 | no trial data cached |
| Dyspnoea (shortness of breath) | 1,245 | 2.0 1.9–2.1ROR 2.1 · calibrated p 0.983 | 2.0 EB05 1.9 · IC025 +0.9 | No label text to screen label has no adverse-reaction text | serious PRR 1.8 | no trial data cached |
| Pyrexia (fever) | 1,233 | 3.3 3.1–3.4ROR 3.4 · calibrated p 0.512 | 3.3 EB05 3.1 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.7 | no trial data cached |
| Death | 1,192 | 1.3 1.2–1.3ROR 1.3 · calibrated p 0.495 | 1.3 EB05 1.2 · IC025 +0.2 | Outcome field, not a reaction | serious PRR 0.9 | no trial data cached |
| Diarrhoea (diarrhea) | 1,186 | 1.7 1.6–1.8ROR 1.7 · calibrated p 0.784 | 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 |
| Vomiting | 1,100 | 2.1 2.0–2.3ROR 2.2 · calibrated p 0.949 | 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 data cached |
| Pneumonia (lung infection) | 1,072 | 3.0 2.9–3.2ROR 3.1 · calibrated p 0.583 | 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 data cached |
| Fall | 977 | 2.7 2.5–2.9ROR 2.8 · calibrated p 0.707 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.0 | no trial data cached |
| Rash | 930 | 2.0 1.8–2.1ROR 2.0 · calibrated p 0.946 | 2.0 EB05 1.9 · IC025 +0.9 | No label text to screen label has no adverse-reaction text | serious PRR 2.5 | no trial data cached |
| Asthenia (weakness) | 862 | 2.1 2.0–2.2ROR 2.1 · calibrated p 0.981 | 2.1 EB05 2.0 · IC025 +1.0 | No label text to screen label has no adverse-reaction text | serious PRR 1.8 | 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 Leaf?
In FDA FAERS, the most frequently co-reported reaction terms for Senna Leaf are fatigue, nausea, constipation, headache, pain, dyspnoea. 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 Leaf have an FDA boxed warning?
No. The FDA label retrieved for Senna Leaf has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Senna Leaf 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 3b8d8a9c-2be9-881c-e063-6294a90abd8e, effective 20250804; matched on
openfda.generic_name.exact:"SENNA LEAF") - 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
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.