Drug · FAERS side-effect profile with label screen
Sennosides A and B side effects: what 1,587 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Senna Syrup
openFDA label
Who reports
1,587 reports · 92% serious · 325 with death outcome · 51% female
openFDA FAERS counts, all years, deduplication not applied
Used for
• relieves occasional constipation (irregularity) • generally causes 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 3Lab value / disease marker 2No label text to screen 35
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. 73 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 |
|---|---|---|---|---|---|---|
| Vasculitis | 62 | 70.6 55.3–90.2ROR 73.4 · χ² 4,164 / p <1e-300 | 68.8 EB05 55.6 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 47.1 | no trial data cached |
| Obstructive airways disorder | 42 | 49.9 37.0–67.2ROR 51.2 · χ² 1,956 / p <1e-300 | 48.7 EB05 37.5 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.2 · ♀ 14% (drug 51%) | no trial data cached |
| Coeliac disease | 33 | 44.5 31.8–62.5ROR 45.5 · χ² 1,357 / p 2e-297 | 43.4 EB05 32.3 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 34.5 · ♀ 100% (drug 51%) · 100% clinician | no trial data cached |
| Immunodeficiency | 47 | 42.3 31.9–56.0ROR 43.5 · χ² 1,848 / p <1e-300 | 41.5 EB05 32.4 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 28.6 · ♀ 100% (drug 51%) · 98% clinician | no trial data cached |
| Full blood count abnormal | 33 | 41.5 29.6–58.1ROR 42.3 · χ² 1,259 / p 4e-276 | 40.4 EB05 30.1 · IC025 +4.1 3/3 methods agree | Lab value / disease marker | serious PRR 34.2 · ♀ 11% (drug 51%) | no trial data cached |
| Bursitis | 35 | 38.4 27.7–53.3ROR 39.3 · χ² 1,235 / p 7e-271 | 37.6 EB05 28.2 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 28.1 · ♀ 100% (drug 51%) · 100% clinician | no trial data cached |
| Subarachnoid haemorrhage | 27 | 35.0 24.1–50.9ROR 35.6 · χ² 856 / p 2e-188 | 34.1 EB05 24.6 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 21.8 · ♀ 95% (drug 51%) | no trial data cached |
| Haemoptysis | 70 | 33.1 26.4–41.7ROR 34.6 · χ² 2,148 / p <1e-300 | 32.8 EB05 26.8 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 23.2 · ♀ 11% (drug 51%) | no trial data cached |
| Myocardial ischaemia | 28 | 32.3 22.4–46.6ROR 32.9 · χ² 817 / p 7e-180 | 31.6 EB05 22.9 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.1 · ♀ 0% (drug 51%) · 96% clinician | no trial data cached |
| Prescribed overdose | 46 | 31.5 23.7–41.8ROR 32.4 · χ² 1,324 / p 3e-290 | 31.0 EB05 24.2 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 33.4 · ♀ 98% (drug 51%) · 98% clinician | no trial data cached |
| Pulmonary fibrosis | 45 | 31.2 23.4–41.6ROR 32.0 · χ² 1,282 / p 5e-281 | 30.7 EB05 23.9 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.6 · ♀ 15% (drug 51%) | no trial data cached |
| Cardiomegaly | 29 | 30.9 21.6–44.4ROR 31.5 · χ² 809 / p 3e-178 | 30.3 EB05 22.1 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.8 · ♀ 7% (drug 51%) · 96% clinician | no trial data cached |
| Sleep disorder due to a general medical condition | 37 | 30.3 22.0–41.6ROR 31.0 · χ² 1,017 / p 2e-223 | 29.8 EB05 22.6 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 37.3 · ♀ 0% (drug 51%) | no trial data cached |
| Pneumonia aspiration | 49 | 26.0 19.7–34.3ROR 26.8 · χ² 1,153 / p 6e-253 | 25.7 EB05 20.2 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.9 · 94% clinician | no trial data cached |
| Ventricular tachycardia | 32 | 25.5 18.1–36.0ROR 26.0 · χ² 729 / p 6e-161 | 25.2 EB05 18.7 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.0 · ♀ 89% (drug 51%) | no trial data cached |
| Anosmia (loss of smell) | 26 | 23.7 16.2–34.7ROR 24.1 · χ² 543 / p 3e-120 | 23.3 EB05 16.7 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=26 · ♀ 95% (drug 51%) | no trial data cached |
| Arteriosclerosis | 16 | 22.4 13.8–36.6ROR 22.7 · χ² 306 / p 7e-69 | 21.8 EB05 14.1 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.4 | no trial data cached |
| Drug level increased | 27 | 21.6 14.8–31.3ROR 21.9 · χ² 508 / p 7e-113 | 21.2 EB05 15.3 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 14.9 · ♀ 4% (drug 51%) · 96% clinician | no trial data cached |
| Pericarditis | 26 | 20.6 14.1–30.2ROR 21.0 · χ² 466 / p 1e-103 | 20.3 EB05 14.5 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.0 · ♀ 100% (drug 51%) | no trial data cached |
| Decreased immune responsiveness | 15 | 20.3 12.3–33.6ROR 20.5 · χ² 256 / p 7e-58 | 19.6 EB05 12.3 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.7 | no trial data cached |
| Contraindicated product administered | 42 | 18.4 13.7–24.8ROR 18.9 · χ² 674 / p 6e-149 | 18.2 EB05 14.0 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 13.9 · ♀ 97% (drug 51%) · 100% clinician | no trial data cached |
| Nodule | 17 | 17.2 10.7–27.6ROR 17.4 · χ² 244 / p 3e-55 | 16.6 EB05 10.6 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.6 | no trial data cached |
| Body temperature decreased | 12 | 16.0 9.1–28.1ROR 16.1 · χ² 154 / p 1e-35 | 14.8 EB05 8.1 · IC025 +2.3 3/3 methods agree | Lab value / disease marker | serious PRR 11.1 | no trial data cached |
| Ascites | 35 | 15.7 11.3–21.8ROR 16.1 · χ² 468 / p 4e-104 | 15.5 EB05 11.5 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.9 · ♀ 19% (drug 51%) · 97% clinician | no trial data cached |
| Productive cough (cough with phlegm) | 56 | 15.6 12.1–20.2ROR 16.2 · χ² 754 / p 3e-166 | 15.5 EB05 12.3 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.5 · ♀ 17% (drug 51%) | no trial data cached |
| Hypothyroidism | 37 | 15.4 11.2–21.1ROR 15.7 · χ² 483 / p 3e-107 | 15.1 EB05 11.3 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.5 · ♀ 6% (drug 51%) | no trial data cached |
| Febrile neutropenia | 76 | 15.2 12.2–18.9ROR 15.9 · χ² 994 / p 2e-218 | 15.1 EB05 12.4 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.4 · 93% clinician | no trial data cached |
| Muscle twitching | 26 | 14.9 10.2–21.8ROR 15.1 · χ² 323 / p 2e-72 | 14.5 EB05 10.1 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.4 · ♀ 100% (drug 51%) | no trial data cached |
| Infusion related reaction (reaction during infusion) | 71 | 14.2 11.3–17.8ROR 14.8 · χ² 860 / p 2e-189 | 14.1 EB05 11.5 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.2 · ♀ 94% (drug 51%) · 99% clinician | no trial data cached |
| Upper respiratory tract infection (cold/sinus infection) | 49 | 14.0 10.7–18.5ROR 14.4 · χ² 581 / p 1e-128 | 13.8 EB05 10.8 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.6 · ♀ 98% (drug 51%) · 94% clinician | no trial data cached |
| Cytokine release syndrome | 20 | 13.9 9.0–21.4ROR 14.0 · χ² 226 / p 2e-51 | 13.2 EB05 8.5 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.7 · 100% clinician | no trial data cached |
| Diplopia (double vision) | 27 | 13.7 9.4–20.0ROR 14.0 · χ² 306 / p 7e-69 | 13.3 EB05 9.3 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.7 · ♀ 91% (drug 51%) | no trial data cached |
| Aspiration | 11 | 13.4 7.4–24.2ROR 13.5 · χ² 114 / p 6e-27 | 11.7 EB05 6.1 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.6 | no trial data cached |
| Rash erythematous | 45 | 12.7 9.5–16.9ROR 13.0 · χ² 474 / p 2e-105 | 12.4 EB05 9.5 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.1 · ♀ 91% (drug 51%) · 98% clinician | no trial data cached |
| Pain of skin | 25 | 12.2 8.3–18.1ROR 12.4 · χ² 247 / p 6e-56 | 11.6 EB05 7.9 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 29.1 · ♀ 100% (drug 51%) | no trial data cached |
| Fluid retention | 47 | 12.2 9.2–16.2ROR 12.6 · χ² 474 / p 3e-105 | 11.9 EB05 9.2 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.6 · ♀ 94% (drug 51%) · 98% clinician | no trial data cached |
| Exposure during pregnancy | 56 | 11.9 9.2–15.4ROR 12.3 · χ² 549 / p 8e-122 | 11.6 EB05 9.2 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 11.0 · ♀ 100% (drug 51%) · 98% clinician | no trial data cached |
| Oesophageal carcinoma | 27 | 11.9 8.2–17.3ROR 12.1 · χ² 258 / p 2e-58 | 11.3 EB05 7.8 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.4 · ♀ 0% (drug 51%) · 96% clinician | no trial data cached |
| Pleural effusion | 54 | 11.7 9.0–15.2ROR 12.1 · χ² 520 / p 3e-115 | 11.4 EB05 9.0 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.5 · ♀ 31% (drug 51%) · 91% clinician | no trial data cached |
| Cognitive disorder | 41 | 11.6 8.6–15.8ROR 11.9 · χ² 389 / p 7e-87 | 11.3 EB05 8.5 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.9 · ♀ 91% (drug 51%) | 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 |
|---|---|---|---|---|---|---|
| Constipation | 142 | 8.7 7.4–10.1ROR 9.4 · χ² 965 / p 3e-212 | 8.5 EB05 7.4 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.0 · ♀ 73% (drug 51%) | no trial data cached |
| Asthma | 85 | 10.0 8.1–12.3ROR 10.5 · χ² 684 / p 4e-151 | 9.8 EB05 8.1 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.8 | no trial data cached |
| Hyperhidrosis (excessive sweating) | 82 | 8.4 6.8–10.4ROR 8.8 · χ² 530 / p 1e-117 | 8.1 EB05 6.7 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.3 · ♀ 98% (drug 51%) · 91% clinician | no trial data cached |
| Febrile neutropenia | 76 | 15.2 12.2–18.9ROR 15.9 · χ² 994 / p 2e-218 | 15.1 EB05 12.4 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.4 · 93% clinician | no trial data cached |
| Intentional product misuse | 72 | 11.0 8.7–13.7ROR 11.4 · χ² 643 / p 3e-142 | 10.7 EB05 8.7 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 15.5 · ♀ 98% (drug 51%) · 92% clinician | no trial data cached |
| Infusion related reaction (reaction during infusion) | 71 | 14.2 11.3–17.8ROR 14.8 · χ² 860 / p 2e-189 | 14.1 EB05 11.5 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.2 · ♀ 94% (drug 51%) · 99% clinician | no trial data cached |
| Haemoptysis | 70 | 33.1 26.4–41.7ROR 34.6 · χ² 2,148 / p <1e-300 | 32.8 EB05 26.8 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 23.2 · ♀ 11% (drug 51%) | no trial data cached |
| Overdose | 64 | 3.9 3.1–5.0ROR 4.0 · χ² 137 / p 7e-32 | 3.8 EB05 3.1 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 3.1 · ♀ 84% (drug 51%) | no trial data cached |
| Vasculitis | 62 | 70.6 55.3–90.2ROR 73.4 · χ² 4,164 / p <1e-300 | 68.8 EB05 55.6 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 47.1 | no trial data cached |
| Thrombocytopenia (low platelets) | 60 | 7.1 5.5–9.1ROR 7.3 · χ² 310 / p 9e-70 | 6.8 EB05 5.4 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.6 · ♀ 79% (drug 51%) · 97% clinician | no trial data cached |
| Exposure during pregnancy | 56 | 11.9 9.2–15.4ROR 12.3 · χ² 549 / p 8e-122 | 11.6 EB05 9.2 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 11.0 · ♀ 100% (drug 51%) · 98% clinician | no trial data cached |
| Productive cough (cough with phlegm) | 56 | 15.6 12.1–20.2ROR 16.2 · χ² 754 / p 3e-166 | 15.5 EB05 12.3 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.5 · ♀ 17% (drug 51%) | no trial data cached |
| Pleural effusion | 54 | 11.7 9.0–15.2ROR 12.1 · χ² 520 / p 3e-115 | 11.4 EB05 9.0 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.5 · ♀ 31% (drug 51%) · 91% clinician | no trial data cached |
| Renal impairment | 52 | 8.2 6.3–10.7ROR 8.5 · χ² 323 / p 1e-72 | 7.8 EB05 6.1 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.3 · ♀ 26% (drug 51%) · 94% clinician | no trial data cached |
| Joint swelling | 51 | 5.6 4.3–7.3ROR 5.7 · χ² 189 / p 3e-43 | 5.3 EB05 4.2 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.0 · ♀ 98% (drug 51%) · 94% clinician | 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 A and B?
In FDA FAERS, the most frequently co-reported reaction terms for Sennosides A and B are constipation, asthma, hyperhidrosis, febrile neutropenia, infusion related reaction, haemoptysis. 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 A and B have an FDA boxed warning?
No. The FDA label retrieved for Sennosides A and B has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Sennosides A and B 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 cfc6ab2f-5376-46fc-ac58-7dedd7010006, effective 20241220; matched on
openfda.generic_name.exact:"SENNOSIDES A AND B") - 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, 113 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.