Drug · FAERS side-effect profile with label screen
Bisacodyl side effects: what 13,995 FDA adverse event reports show
Brand names
Laxative
openFDA label
Who reports
13,995 reports · 86% serious · 2,457 with death outcome · 57% female
openFDA FAERS counts, all years, deduplication not applied
Used for
for temporary relief of occasional constipation and irregularity this product 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
Reporting / coding artifact 9Lab value / disease marker 5No 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. 1,143 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 |
|---|---|---|---|---|---|---|
| Hypokinetic dysarthria | 16 | 3,377.8 1,389.8–8,209.3ROR 3,381.7 · χ² 15,426 / p <1e-300 | 460.2 EB05 300.3 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=16 | no trial arm names this drug |
| Vaginal flatulence | 188 | 2,437.1 1,932.3–3,073.6ROR 2,470.2 · χ² 171,892 / p <1e-300 | 841.1 EB05 744.9 · IC025 +7.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=188 · ♀ 100% (drug 57%) | no trial arm names this drug |
| Appendicolith | 198 | 1,653.1 1,350.7–2,023.3ROR 1,676.8 · χ² 153,531 / p <1e-300 | 725.6 EB05 644.7 · IC025 +7.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=198 · ♀ 0% (drug 57%) · 96% clinician | no trial arm names this drug |
| Antacid therapy | 61 | 1,554.2 1,085.3–2,225.7ROR 1,561.0 · χ² 45,395 / p <1e-300 | 611.7 EB05 493.3 · IC025 +6.3 3/3 methods agree | Reporting / coding artifact | serious n=61 · ♀ 0% (drug 57%) · 100% clinician | no trial arm names this drug |
| Sleep disorder therapy | 90 | 1,414.9 1,060.2–1,888.2ROR 1,424.1 · χ² 64,243 / p <1e-300 | 626.4 EB05 525.1 · IC025 +6.8 3/3 methods agree | Reporting / coding artifact | serious n=90 · ♀ 0% (drug 57%) · 100% clinician | no trial arm names this drug |
| Total lung capacity increased | 100 | 869.3 679.4–1,112.2ROR 875.5 · χ² 54,062 / p <1e-300 | 495.5 EB05 419.2 · IC025 +6.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=100 · ♀ 100% (drug 57%) · 94% clinician | no trial arm names this drug |
| Analgesic therapy | 88 | 604.9 472.3–774.7ROR 608.7 · χ² 37,217 / p <1e-300 | 392.7 EB05 328.5 · IC025 +6.6 3/3 methods agree | Reporting / coding artifact | serious n=88 · ♀ 0% (drug 57%) · 100% clinician | no trial arm names this drug |
| Drug therapy | 84 | 535.1 417.1–686.4ROR 538.3 · χ² 32,484 / p <1e-300 | 360.7 EB05 300.5 · IC025 +6.5 3/3 methods agree | Reporting / coding artifact | serious n=84 · ♀ 0% (drug 57%) · 100% clinician | no trial arm names this drug |
| Congenital hiatus hernia | 55 | 495.6 365.3–672.3ROR 497.6 · χ² 19,961 / p <1e-300 | 328.9 EB05 262.2 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=55 · ♀ 0% (drug 57%) · 100% clinician | no trial arm names this drug |
| Malignant melanoma stage 0 | 44 | 481.6 342.9–676.6ROR 483.2 · χ² 15,556 / p <1e-300 | 313.9 EB05 243.5 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=44 · ♀ 0% (drug 57%) · 100% clinician | no trial arm names this drug |
| Anticoagulant therapy | 58 | 396.8 297.1–530.0ROR 398.5 · χ² 17,741 / p <1e-300 | 283.7 EB05 227.6 · IC025 +6.0 3/3 methods agree | Reporting / coding artifact | serious n=58 · ♀ 0% (drug 57%) · 100% clinician | no trial arm names this drug |
| Asthma-chronic obstructive pulmonary disease overlap syndrome | 100 | 357.0 287.1–443.8ROR 359.5 · χ² 28,304 / p <1e-300 | 272.7 EB05 230.7 · IC025 +6.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=100 · ♀ 100% (drug 57%) · 94% clinician | no trial arm names this drug |
| Victim of child abuse | 42 | 307.3 220.5–428.2ROR 308.2 · χ² 10,362 / p <1e-300 | 228.2 EB05 175.9 · IC025 +5.5 3/3 methods agree | Reporting / coding artifact | serious n=42 · ♀ 0% (drug 57%) · 100% clinician | no trial arm names this drug |
| Child abuse | 39 | 277.1 196.9–389.9ROR 277.9 · χ² 8,803 / p <1e-300 | 209.6 EB05 160.0 · IC025 +5.4 3/3 methods agree | Reporting / coding artifact | serious n=39 · ♀ 0% (drug 57%) | no trial arm names this drug |
| Epidural lipomatosis | 53 | 269.2 200.9–360.5ROR 270.2 · χ² 11,752 / p <1e-300 | 210.6 EB05 167.2 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=53 · ♀ 0% (drug 57%) · 91% clinician | no trial arm names this drug |
| Bacteroides infection | 39 | 265.6 188.9–373.3ROR 266.3 · χ² 8,491 / p <1e-300 | 203.0 EB05 154.9 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=39 · ♀ 0% (drug 57%) · 100% clinician | no trial arm names this drug |
| Ivth nerve paralysis | 34 | 264.4 183.7–380.8ROR 265.1 · χ² 7,347 / p <1e-300 | 199.4 EB05 149.3 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=34 · ♀ 0% (drug 57%) · 100% clinician | no trial arm names this drug |
| Cerebral hypoperfusion | 66 | 252.0 194.2–327.0ROR 253.2 · χ² 13,884 / p <1e-300 | 202.9 EB05 165.0 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=66 · ♀ 0% (drug 57%) | no trial arm names this drug |
| Sedation complication | 303 | 206.8 183.6–233.0ROR 211.4 · χ² 54,269 / p <1e-300 | 179.5 EB05 163.2 · IC025 +6.9 3/3 methods agree | Reporting / coding artifact | serious n=303 · ♀ 100% (drug 57%) | no trial arm names this drug |
| Capillaritis | 32 | 203.0 140.3–293.6ROR 203.4 · χ² 5,478 / p <1e-300 | 161.5 EB05 119.8 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=32 · ♀ 0% (drug 57%) | no trial arm names this drug |
| Female genital tract fistula | 198 | 194.9 168.2–225.9ROR 197.7 · χ² 33,582 / p <1e-300 | 169.5 EB05 150.6 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=198 · ♀ 100% (drug 57%) | no trial arm names this drug |
| Multiple drug therapy | 79 | 191.4 151.5–241.8ROR 192.5 · χ² 13,079 / p <1e-300 | 162.9 EB05 134.9 · IC025 +6.0 3/3 methods agree | Reporting / coding artifact | serious n=79 · ♀ 100% (drug 57%) | no trial arm names this drug |
| Bronchopulmonary aspergillosis allergic | 101 | 185.6 151.0–228.2ROR 187.0 · χ² 16,315 / p <1e-300 | 160.1 EB05 135.6 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=101 | no trial arm names this drug |
| Binocular eye movement disorder | 28 | 166.2 112.5–245.5ROR 166.5 · χ² 3,985 / p <1e-300 | 135.8 EB05 98.6 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=28 · ♀ 0% (drug 57%) | no trial arm names this drug |
| Total lung capacity abnormal | 38 | 166.1 118.9–232.2ROR 166.6 · χ² 5,460 / p <1e-300 | 139.1 EB05 105.8 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=38 · ♀ 0% (drug 57%) | no trial arm names this drug |
| Pulmonary vasculitis | 42 | 129.3 94.4–177.2ROR 129.7 · χ² 4,800 / p <1e-300 | 113.0 EB05 87.1 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=42 · ♀ 0% (drug 57%) | no trial arm names this drug |
| Radiculopathy | 201 | 123.7 107.2–142.7ROR 125.4 · χ² 22,457 / p <1e-300 | 113.0 EB05 100.5 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=201 · ♀ 100% (drug 57%) | no trial arm names this drug |
| Cerebellar stroke | 28 | 121.0 82.3–177.8ROR 121.2 · χ² 2,970 / p <1e-300 | 104.1 EB05 75.6 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=28 · ♀ 0% (drug 57%) | no trial arm names this drug |
| Colonic pseudo-obstruction | 20 | 114.1 72.4–179.8ROR 114.3 · χ² 1,978 / p <1e-300 | 96.5 EB05 66.0 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=20 | no trial arm names this drug |
| Creatinine renal clearance decreased | 283 | 113.2 100.4–127.6ROR 115.5 · χ² 29,138 / p <1e-300 | 104.5 EB05 94.7 · IC025 +6.3 3/3 methods agree | Lab value / disease marker | serious n=283 · ♀ 100% (drug 57%) | no trial arm names this drug |
| Proctitis | 194 | 111.4 96.3–128.8ROR 112.9 · χ² 19,634 / p <1e-300 | 102.6 EB05 91.1 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=194 · ♀ 100% (drug 57%) | no trial arm names this drug |
| Chronic sinusitis | 258 | 110.8 97.8–125.6ROR 112.9 · χ² 26,025 / p <1e-300 | 102.4 EB05 92.3 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=257 · ♀ 100% (drug 57%) | no trial arm names this drug |
| Spirometry abnormal | 40 | 109.5 79.4–150.9ROR 109.8 · χ² 3,902 / p <1e-300 | 97.4 EB05 74.6 · IC025 +5.0 3/3 methods agree | Lab value / disease marker | serious n=40 · ♀ 0% (drug 57%) | no trial arm names this drug |
| Mite allergy | 43 | 108.3 79.5–147.5ROR 108.6 · χ² 4,158 / p <1e-300 | 96.7 EB05 74.8 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=43 · ♀ 0% (drug 57%) | no trial arm names this drug |
| Creatinine renal clearance increased | 50 | 106.8 80.2–142.2ROR 107.2 · χ² 4,788 / p <1e-300 | 96.1 EB05 75.7 · IC025 +5.2 3/3 methods agree | Lab value / disease marker | serious n=50 · ♀ 100% (drug 57%) · 100% clinician | no trial arm names this drug |
| Macular degeneration | 789 | 106.3 99.1–114.0ROR 112.6 · χ² 76,701 / p <1e-300 | 99.0 EB05 93.3 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 71.5 · ♀ 100% (drug 57%) | no trial arm names this drug |
| Hyperphosphataemia | 131 | 98.7 82.8–117.7ROR 99.6 · χ² 11,788 / p <1e-300 | 91.4 EB05 79.0 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=131 · ♀ 6% (drug 57%) · 100% clinician | no trial arm names this drug |
| Antineutrophil cytoplasmic antibody positive | 43 | 94.0 69.1–127.9ROR 94.3 · χ² 3,633 / p <1e-300 | 85.2 EB05 65.9 · IC025 +5.0 3/3 methods agree | Lab value / disease marker | serious n=43 · ♀ 0% (drug 57%) | no trial arm names this drug |
| Blood phosphorus increased | 150 | 87.3 74.1–102.8ROR 88.2 · χ² 11,999 / p <1e-300 | 81.6 EB05 71.2 · IC025 +5.8 3/3 methods agree | Lab value / disease marker | serious n=149 · ♀ 0% (drug 57%) · 96% clinician | no trial arm names this drug |
| Total lung capacity decreased | 82 | 80.8 64.8–100.9ROR 81.3 · χ² 6,055 / p <1e-300 | 75.4 EB05 62.7 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=82 | no trial arm names this drug |
Trial evidence (ClinicalTrials.gov)
ClinicalTrials.gov returned results-bearing trials mentioning Bisacodyl only as a background or rescue medication (NCT01982240, NCT01073930); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.
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 | 1,578 | 11.0 10.5–11.5ROR 12.3 · χ² 14,380 / p <1e-300 | 10.9 EB05 10.5 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.7 | no trial arm names this drug |
| Nausea | 1,443 | 2.7 2.6–2.9ROR 2.9 · χ² 1,657 / p <1e-300 | 2.7 EB05 2.6 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.2 | no trial arm names this drug |
| Drug ineffective (drug did not work) | 1,406 | 1.6 1.5–1.7ROR 1.7 · χ² 337 / p 1e-75 | 1.6 EB05 1.5 · IC025 +0.6 | Reporting / coding artifact | serious PRR 2.7 | no trial arm names this drug |
| Off label use (used outside approved label) | 1,175 | 2.0 1.9–2.1ROR 2.1 · χ² 639 / p 3e-141 | 2.0 EB05 1.9 · IC025 +0.9 | Reporting / coding artifact | serious PRR 2.3 | no trial arm names this drug |
| Pain | 1,149 | 2.8 2.7–3.0ROR 3.0 · χ² 1,367 / p 1e-299 | 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 2.8 | no trial arm names this drug |
| Vomiting | 1,049 | 3.4 3.2–3.6ROR 3.5 · χ² 1,770 / p <1e-300 | 3.3 EB05 3.2 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.1 | no trial arm names this drug |
| Dyspnoea (shortness of breath) | 868 | 2.3 2.2–2.5ROR 2.4 · χ² 654 / p 1e-144 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.0 | no trial arm names this drug |
| Fall | 867 | 3.9 3.7–4.2ROR 4.1 · χ² 1,905 / p <1e-300 | 3.9 EB05 3.7 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.0 | no trial arm names this drug |
| Pneumonia (lung infection) | 838 | 3.9 3.6–4.2ROR 4.1 · χ² 1,822 / p <1e-300 | 3.9 EB05 3.7 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.7 | no trial arm names this drug |
| Fatigue (tiredness) | 816 | 1.6 1.5–1.7ROR 1.6 · χ² 177 / p 1e-40 | 1.6 EB05 1.5 · IC025 +0.5 | No label text to screen label has no adverse-reaction text | serious PRR 1.5 | no trial arm names this drug |
| Death | 808 | 1.4 1.3–1.5ROR 1.4 · χ² 98 / p 2e-23 | 1.4 EB05 1.3 · IC025 +0.4 | Outcome field, not a reaction | serious PRR 0.9 | no trial arm names this drug |
| Abdominal pain | 801 | 5.2 4.8–5.5ROR 5.4 · χ² 2,717 / p <1e-300 | 5.1 EB05 4.9 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.3 | no trial arm names this drug |
| Macular degeneration | 789 | 106.3 99.1–114.0ROR 112.6 · χ² 76,701 / p <1e-300 | 99.0 EB05 93.3 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 71.5 · ♀ 100% (drug 57%) | no trial arm names this drug |
| Pyrexia (fever) | 787 | 3.4 3.2–3.7ROR 3.6 · χ² 1,359 / p 9e-298 | 3.4 EB05 3.2 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.8 | no trial arm names this drug |
| Hypotension (low blood pressure) | 710 | 5.3 5.0–5.7ROR 5.6 · χ² 2,507 / p <1e-300 | 5.3 EB05 5.0 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.0 | no trial arm names this drug |
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 Bisacodyl?
In FDA FAERS, the most frequently co-reported reaction terms for Bisacodyl are constipation, nausea, pain, vomiting, dyspnoea, fall. 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 Bisacodyl have an FDA boxed warning?
No. The FDA label retrieved for Bisacodyl has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Bisacodyl 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 02358772-6724-4f1a-b3d8-bc36e58b5cfc, effective 20250501; matched on
openfda.generic_name.exact:"BISACODYL") - 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, 1,183 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 - ClinicalTrials.gov API v2 (query
BISACODYL, results-bearing studies sorted by enrollment)
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.