Drug · FAERS side-effect profile with label screen
Standardized Senna Concentrate side effects: what 12,509 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Geri-Kot
openFDA label
Who reports
12,509 reports · 85% serious · 2,123 with death outcome · 59% 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
Lab value / disease marker 5No label text to screen 35
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). 1,116 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 |
|---|---|---|---|---|---|---|
| Cestode infection | 19 | 615.9 363.8–1,042.7ROR 616.8 · calibrated p 2e-13 ✓ | 309.2 EB05 209.2 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=19 | no trial data cached |
| Temperature regulation disorder | 359 | 330.1 295.1–369.2ROR 339.8 · calibrated p 3e-12 ✓ | 271.3 EB05 248.6 · IC025 +7.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=359 · ♀ 100% (drug 59%) | no trial data cached |
| Bronchopulmonary aspergillosis allergic | 93 | 189.3 152.9–234.5ROR 190.8 · calibrated p 9e-10 ✓ | 164.3 EB05 138.1 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=93 · ♀ 92% (drug 59%) | no trial data cached |
| Oesophageal spasm | 113 | 109.5 90.6–132.4ROR 110.5 · calibrated p 7e-8 ✓ | 101.0 EB05 86.4 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=113 · ♀ 100% (drug 59%) | no trial data cached |
| Food allergy | 452 | 106.7 97.2–117.1ROR 110.7 · calibrated p 6e-8 ✓ | 99.9 EB05 92.4 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=452 · ♀ 100% (drug 59%) | no trial data cached |
| Blood uric acid decreased | 28 | 102.2 69.8–149.6ROR 102.4 · calibrated p 2e-7 ✓ | 90.5 EB05 65.7 · IC025 +4.5 3/3 methods agree | Lab value / disease marker | serious n=28 · ♀ 100% (drug 59%) · 100% clinician | no trial data cached |
| Radiation associated pain | 12 | 101.2 56.5–181.3ROR 101.3 · calibrated p 8e-7 ✓ | 83.2 EB05 50.7 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | no trial data cached |
| Total lung capacity decreased | 85 | 93.9 75.5–116.8ROR 94.6 · calibrated p 2e-7 ✓ | 87.2 EB05 72.8 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=84 · ♀ 100% (drug 59%) | no trial data cached |
| Eosinophil percentage increased | 27 | 87.5 59.5–128.8ROR 87.7 · calibrated p 8e-7 ✓ | 78.7 EB05 56.8 · IC025 +4.4 3/3 methods agree | Lab value / disease marker | serious n=27 · ♀ 100% (drug 59%) · 100% clinician | no trial data cached |
| Magnesium deficiency | 21 | 79.1 51.1–122.5ROR 79.2 · calibrated p 2e-6 ✓ | 70.9 EB05 48.9 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=21 | no trial data cached |
| Foetal death | 224 | 75.7 66.3–86.4ROR 77.0 · calibrated p 8e-7 ✓ | 72.0 EB05 64.4 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=224 · ♀ 100% (drug 59%) · 94% clinician | no trial data cached |
| Lung opacity | 89 | 60.0 48.6–74.1ROR 60.4 · calibrated p 5e-6 ✓ | 57.3 EB05 48.0 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=89 · ♀ 100% (drug 59%) | no trial data cached |
| Pneumococcal infection | 20 | 59.1 37.9–92.4ROR 59.2 · calibrated p 1e-5 ✓ | 54.3 EB05 37.1 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=20 | no trial data cached |
| Coeliac disease | 322 | 56.8 50.9–63.4ROR 58.3 · calibrated p 5e-6 ✓ | 54.8 EB05 50.0 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 46.2 · ♀ 100% (drug 59%) | no trial data cached |
| Lichen sclerosus | 22 | 56.7 37.1–86.8ROR 56.8 · calibrated p 1e-5 ✓ | 52.5 EB05 36.6 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=22 · 100% clinician | no trial data cached |
| Immunodeficiency | 468 | 55.0 50.2–60.2ROR 57.1 · calibrated p 6e-6 ✓ | 53.1 EB05 49.2 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 39.0 · ♀ 98% (drug 59%) | no trial data cached |
| Dyspnoea paroxysmal nocturnal | 23 | 53.9 35.6–81.7ROR 54.0 · calibrated p 2e-5 ✓ | 50.2 EB05 35.2 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=23 | no trial data cached |
| Oesophageal pain | 118 | 51.7 43.0–62.0ROR 52.1 · calibrated p 1e-5 ✓ | 49.7 EB05 42.7 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=118 · ♀ 100% (drug 59%) | no trial data cached |
| Bursitis | 341 | 48.7 43.8–54.2ROR 50.1 · calibrated p 1e-5 ✓ | 47.3 EB05 43.2 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 37.6 · ♀ 98% (drug 59%) | no trial data cached |
| Dental restoration failure | 20 | 47.8 30.6–74.5ROR 47.9 · calibrated p 4e-5 ✓ | 44.6 EB05 30.5 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=20 | no trial data cached |
| Lymphoedema | 167 | 41.5 35.7–48.4ROR 42.1 · calibrated p 4e-5 ✓ | 40.4 EB05 35.5 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=165 · ♀ 100% (drug 59%) | no trial data cached |
| Central obesity | 17 | 39.8 24.6–64.4ROR 39.9 · calibrated p 1e-4 ✓ | 37.4 EB05 24.7 · 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 |
| Pleuritic pain | 63 | 39.0 30.4–50.0ROR 39.1 · calibrated p 8e-5 ✓ | 37.7 EB05 30.5 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=63 · ♀ 86% (drug 59%) | no trial data cached |
| Lip pruritus | 19 | 38.8 24.6–61.2ROR 38.9 · calibrated p 1e-4 ✓ | 36.7 EB05 24.8 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=19 | no trial data cached |
| Obstructive sleep apnoea syndrome | 29 | 35.5 24.6–51.3ROR 35.6 · calibrated p 2e-4 ✓ | 34.1 EB05 24.9 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=29 · ♀ 100% (drug 59%) | no trial data cached |
| Bladder irritation | 13 | 35.2 20.3–60.9ROR 35.2 · calibrated p 3e-4 ✓ | 33.0 EB05 20.5 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | no trial data cached |
| Prescribed overdose | 350 | 30.9 27.8–34.3ROR 31.7 · calibrated p 2e-4 ✓ | 30.3 EB05 27.7 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 34.6 · ♀ 98% (drug 59%) · 91% clinician | no trial data cached |
| Rales | 101 | 29.7 24.4–36.1ROR 29.9 · calibrated p 3e-4 ✓ | 29.0 EB05 24.6 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=101 · ♀ 93% (drug 59%) | no trial data cached |
| Thyroxine increased | 12 | 29.0 16.4–51.3ROR 29.0 · calibrated p 8e-4 ✓ | 27.4 EB05 16.6 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious n=12 | no trial data cached |
| Nasal discharge discolouration | 21 | 25.9 16.8–39.8ROR 25.9 · calibrated p 1e-3 ✓ | 25.0 EB05 17.2 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=21 | no trial data cached |
| Wound drainage | 12 | 25.5 14.4–45.1ROR 25.5 · calibrated p 0.001 ✓ | 24.2 EB05 14.5 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Bronchiectasis | 99 | 25.3 20.7–30.8ROR 25.5 · calibrated p 7e-4 ✓ | 24.8 EB05 21.0 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=99 · ♀ 95% (drug 59%) | no trial data cached |
| Premenstrual syndrome | 19 | 23.7 15.0–37.2ROR 23.7 · calibrated p 0.002 ✓ | 22.8 EB05 15.4 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=19 | no trial data cached |
| Sputum discoloured | 124 | 22.3 18.7–26.6ROR 22.5 · calibrated p 0.001 ✓ | 21.9 EB05 18.9 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.4 | no trial data cached |
| Upper respiratory tract infection (cold/sinus infection) | 566 | 20.8 19.2–22.6ROR 21.7 · calibrated p 0.001 ✓ | 20.5 EB05 19.2 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 23.4 · ♀ 95% (drug 59%) | no trial data cached |
| Blood creatinine decreased | 38 | 20.6 15.0–28.3ROR 20.6 · calibrated p 0.002 ✓ | 20.2 EB05 15.3 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious n=38 · ♀ 84% (drug 59%) | no trial data cached |
| Chronic kidney disease-mineral and bone disorder | 13 | 20.5 11.9–35.4ROR 20.5 · calibrated p 0.003 ✓ | 19.5 EB05 11.7 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=13 | no trial data cached |
| Blood calcium increased | 106 | 20.5 16.9–24.8ROR 20.6 · calibrated p 0.002 ✓ | 20.2 EB05 17.1 · IC025 +3.9 3/3 methods agree | Lab value / disease marker | serious n=106 · ♀ 91% (drug 59%) | no trial data cached |
| Fluid retention | 581 | 19.4 17.9–21.0ROR 20.3 · calibrated p 0.002 ✓ | 19.1 EB05 17.9 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.8 · ♀ 94% (drug 59%) | no trial data cached |
| Failure to thrive | 57 | 18.5 14.3–24.0ROR 18.6 · calibrated p 0.003 ✓ | 18.2 EB05 14.6 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=57 | 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) | 1,759 | 3.8 3.6–4.0ROR 4.3 · calibrated p 0.333 | 3.8 EB05 3.6 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.3 | no trial data cached |
| Constipation | 1,342 | 10.5 9.9–11.0ROR 11.6 · calibrated p 0.019 ✓ | 10.4 EB05 9.9 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.2 | no trial data cached |
| Pain | 1,313 | 3.6 3.4–3.8ROR 3.9 · calibrated p 0.400 | 3.6 EB05 3.4 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.6 | no trial data cached |
| Headache | 1,151 | 3.1 2.9–3.3ROR 3.3 · calibrated p 0.538 | 3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.0 · ♀ 84% (drug 59%) | no trial data cached |
| Nausea | 1,144 | 2.4 2.3–2.6ROR 2.6 · calibrated p 0.781 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.7 | no trial data cached |
| Off label use (used outside approved label) | 1,036 | 2.0 1.9–2.1ROR 2.1 · calibrated p 0.994 | 2.0 EB05 1.9 · IC025 +0.9 | Reporting / coding artifact | serious PRR 2.3 | no trial data cached |
| Diarrhoea (diarrhea) | 1,007 | 2.6 2.5–2.8ROR 2.8 · calibrated p 0.706 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.7 | no trial data cached |
| Dyspnoea (shortness of breath) | 953 | 2.8 2.7–3.0ROR 3.0 · calibrated p 0.634 | 2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.5 | no trial data cached |
| Pyrexia (fever) | 936 | 4.5 4.3–4.8ROR 4.8 · calibrated p 0.254 | 4.5 EB05 4.3 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.8 | no trial data cached |
| Pneumonia (lung infection) | 931 | 4.8 4.5–5.1ROR 5.1 · calibrated p 0.219 | 4.8 EB05 4.6 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.4 | no trial data cached |
| Drug ineffective (drug did not work) | 881 | 1.1 1.1–1.2ROR 1.1 · calibrated p 0.394 | 1.1 EB05 1.1 · IC025 +0.1 | Reporting / coding artifact | serious PRR 1.8 | no trial data cached |
| Vomiting | 836 | 3.0 2.8–3.2ROR 3.1 · calibrated p 0.584 | 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 2.8 | no trial data cached |
| Death | 827 | 1.6 1.5–1.7ROR 1.7 · calibrated p 0.740 | 1.6 EB05 1.5 · IC025 +0.6 | Outcome field, not a reaction | serious PRR 1.1 | no trial data cached |
| Asthenia (weakness) | 825 | 3.7 3.4–3.9ROR 3.9 · calibrated p 0.402 | 3.7 EB05 3.5 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.3 | no trial data cached |
| Back pain | 779 | 5.6 5.3–6.0ROR 5.9 · calibrated p 0.154 | 5.6 EB05 5.3 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.0 | 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 Standardized Senna Concentrate?
In FDA FAERS, the most frequently co-reported reaction terms for Standardized Senna Concentrate are fatigue, constipation, pain, headache, nausea, diarrhoea. 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 Standardized Senna Concentrate have an FDA boxed warning?
No. The FDA label retrieved for Standardized Senna Concentrate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Standardized Senna Concentrate 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 13d8f467-0a7f-4773-ad5f-1666f14cb84f, effective 20250627; matched on
openfda.generic_name.exact:"STANDARDIZED SENNA CONCENTRATE") - 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, 1,156 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.