Drug · FAERS side-effect profile with label screen
Bisacodyl Suppositories side effects: what 12,866 FDA adverse event reports show
Brand names
Bisacodyl
openFDA label
Who reports
12,866 reports · 88% serious · 2,302 with death outcome · 56% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Directions - tear off one suppository from the strip - peel apart the wrapper - continue peeling apart to almost the full length of the suppository - gently remove the suppository from the wrapper - lie on your side and push suppository, with pointed e.
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. 1,141 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 | 3,674.5 1,511.9–8,930.2ROR 3,679.0 · χ² 16,782 / p <1e-300 | 477.3 EB05 311.5 · 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 | 186 | 2,577.7 2,045.5–3,248.3ROR 2,615.5 · χ² 183,028 / p <1e-300 | 898.4 EB05 795.1 · IC025 +7.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=186 · ♀ 100% (drug 56%) | no trial arm names this drug |
| Appendicolith | 197 | 1,779.2 1,453.8–2,177.3ROR 1,806.8 · χ² 165,341 / p <1e-300 | 780.5 EB05 693.2 · IC025 +7.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=197 · ♀ 0% (drug 56%) · 96% clinician | no trial arm names this drug |
| Antacid therapy | 61 | 1,690.7 1,180.7–2,421.0ROR 1,698.8 · χ² 49,387 / p <1e-300 | 654.2 EB05 527.6 · IC025 +6.3 3/3 methods agree | Reporting / coding artifact | serious n=61 · ♀ 0% (drug 56%) · 100% clinician | no trial arm names this drug |
| Sleep disorder therapy | 89 | 1,506.0 1,128.5–2,009.9ROR 1,516.5 · χ² 68,338 / p <1e-300 | 665.9 EB05 557.7 · IC025 +6.8 3/3 methods agree | Reporting / coding artifact | serious n=89 · ♀ 0% (drug 56%) · 100% clinician | no trial arm names this drug |
| Total lung capacity increased | 100 | 945.6 739.1–1,209.9ROR 953.0 · χ² 58,821 / p <1e-300 | 534.5 EB05 452.2 · IC025 +6.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=100 · ♀ 100% (drug 56%) · 94% clinician | no trial arm names this drug |
| Analgesic therapy | 87 | 647.5 505.1–830.0ROR 651.9 · χ² 39,574 / p <1e-300 | 419.1 EB05 350.3 · IC025 +6.6 3/3 methods agree | Reporting / coding artifact | serious n=87 · ♀ 0% (drug 56%) · 97% clinician | no trial arm names this drug |
| Drug therapy | 83 | 572.7 446.0–735.3ROR 576.4 · χ² 34,504 / p <1e-300 | 384.9 EB05 320.3 · IC025 +6.5 3/3 methods agree | Reporting / coding artifact | serious n=83 · ♀ 0% (drug 56%) · 100% clinician | no trial arm names this drug |
| Congenital hiatus hernia | 55 | 539.1 397.4–731.3ROR 541.4 · χ² 21,722 / p <1e-300 | 354.1 EB05 282.3 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=55 · ♀ 0% (drug 56%) · 100% clinician | no trial arm names this drug |
| Malignant melanoma stage 0 | 44 | 523.9 373.0–736.0ROR 525.7 · χ² 16,928 / p <1e-300 | 337.3 EB05 261.7 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=44 · ♀ 0% (drug 56%) · 100% clinician | no trial arm names this drug |
| Anticoagulant therapy | 58 | 431.7 323.2–576.5ROR 433.6 · χ² 19,307 / p <1e-300 | 306.1 EB05 245.5 · IC025 +6.0 3/3 methods agree | Reporting / coding artifact | serious n=58 · ♀ 0% (drug 56%) · 100% clinician | no trial arm names this drug |
| Asthma-chronic obstructive pulmonary disease overlap syndrome | 100 | 388.3 312.3–482.7ROR 391.3 · χ² 30,804 / p <1e-300 | 295.3 EB05 249.8 · IC025 +6.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=100 · ♀ 100% (drug 56%) · 94% clinician | no trial arm names this drug |
| Victim of child abuse | 42 | 334.2 239.8–465.8ROR 335.3 · χ² 11,278 / p <1e-300 | 246.0 EB05 189.6 · IC025 +5.5 3/3 methods agree | Reporting / coding artifact | serious n=42 · ♀ 0% (drug 56%) · 90% clinician | no trial arm names this drug |
| Child abuse | 38 | 292.3 207.0–412.8ROR 293.1 · χ² 9,089 / p <1e-300 | 220.2 EB05 167.4 · IC025 +5.3 3/3 methods agree | Reporting / coding artifact | serious n=38 · ♀ 0% (drug 56%) | no trial arm names this drug |
| Bacteroides infection | 39 | 288.9 205.6–406.1ROR 289.8 · χ² 9,243 / p <1e-300 | 218.9 EB05 167.1 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=39 · ♀ 0% (drug 56%) · 100% clinician | no trial arm names this drug |
| Ivth nerve paralysis | 34 | 287.7 199.8–414.2ROR 288.4 · χ² 7,997 / p <1e-300 | 214.8 EB05 160.8 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=34 · ♀ 0% (drug 56%) · 100% clinician | no trial arm names this drug |
| Epidural lipomatosis | 52 | 286.3 213.2–384.3ROR 287.4 · χ² 12,307 / p <1e-300 | 223.3 EB05 176.8 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=52 · ♀ 0% (drug 56%) · 90% clinician | no trial arm names this drug |
| Cerebral hypoperfusion | 66 | 274.2 211.3–355.7ROR 275.6 · χ² 15,113 / p <1e-300 | 219.5 EB05 178.6 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=66 · ♀ 0% (drug 56%) | no trial arm names this drug |
| Sedation complication | 302 | 224.1 199.0–252.5ROR 229.5 · χ² 58,690 / p <1e-300 | 194.4 EB05 176.7 · IC025 +7.0 3/3 methods agree | Reporting / coding artifact | serious n=302 · ♀ 100% (drug 56%) | no trial arm names this drug |
| Capillaritis | 32 | 220.8 152.6–319.3ROR 221.3 · χ² 5,964 / p <1e-300 | 174.2 EB05 129.2 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=32 · ♀ 0% (drug 56%) | no trial arm names this drug |
| Female genital tract fistula | 196 | 209.6 180.8–243.0ROR 212.9 · χ² 35,821 / p <1e-300 | 182.3 EB05 161.9 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=196 · ♀ 100% (drug 56%) | no trial arm names this drug |
| Multiple drug therapy | 79 | 208.2 164.8–263.0ROR 209.5 · χ² 14,239 / p <1e-300 | 176.6 EB05 146.3 · IC025 +6.0 3/3 methods agree | Reporting / coding artifact | serious n=79 · ♀ 100% (drug 56%) | no trial arm names this drug |
| Bronchopulmonary aspergillosis allergic | 101 | 201.9 164.3–248.2ROR 203.5 · χ² 17,764 / p <1e-300 | 173.7 EB05 147.1 · 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 | 180.8 122.4–267.1ROR 181.2 · χ² 4,340 / p <1e-300 | 146.5 EB05 106.4 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=28 · ♀ 0% (drug 56%) | no trial arm names this drug |
| Total lung capacity abnormal | 37 | 175.5 125.0–246.2ROR 176.0 · χ² 5,630 / p <1e-300 | 146.5 EB05 111.0 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=37 · ♀ 0% (drug 56%) | no trial arm names this drug |
| Pulmonary vasculitis | 41 | 137.0 99.7–188.4ROR 137.5 · χ² 4,977 / p <1e-300 | 119.4 EB05 91.8 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=41 · ♀ 0% (drug 56%) | no trial arm names this drug |
| Radiculopathy | 198 | 132.3 114.6–152.8ROR 134.4 · χ² 23,729 / p <1e-300 | 121.0 EB05 107.5 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=198 · ♀ 100% (drug 56%) | no trial arm names this drug |
| Cerebellar stroke | 28 | 131.6 89.6–193.4ROR 131.9 · χ² 3,235 / p <1e-300 | 112.6 EB05 81.7 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=28 · ♀ 0% (drug 56%) | no trial arm names this drug |
| Colonic pseudo-obstruction | 20 | 124.1 78.8–195.6ROR 124.3 · χ² 2,155 / p <1e-300 | 104.1 EB05 71.2 · IC025 +4.2 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 | 282 | 122.7 108.8–138.3ROR 125.4 · χ² 31,516 / p <1e-300 | 113.2 EB05 102.5 · IC025 +6.4 3/3 methods agree | Lab value / disease marker | serious n=282 · ♀ 100% (drug 56%) | no trial arm names this drug |
| Proctitis | 192 | 119.8 103.6–138.6ROR 121.6 · χ² 20,946 / p <1e-300 | 110.4 EB05 97.9 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=192 · ♀ 100% (drug 56%) | no trial arm names this drug |
| Chronic sinusitis | 256 | 119.6 105.4–135.6ROR 122.0 · χ² 27,910 / p <1e-300 | 110.5 EB05 99.6 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=255 · ♀ 100% (drug 56%) | no trial arm names this drug |
| Creatinine renal clearance increased | 50 | 116.2 87.2–154.7ROR 116.6 · χ² 5,217 / p <1e-300 | 104.2 EB05 82.1 · IC025 +5.2 3/3 methods agree | Lab value / disease marker | serious n=50 · ♀ 100% (drug 56%) · 100% clinician | no trial arm names this drug |
| Spirometry abnormal | 39 | 115.9 83.8–160.3ROR 116.2 · χ² 4,037 / p <1e-300 | 102.8 EB05 78.5 · IC025 +5.0 3/3 methods agree | Lab value / disease marker | serious n=39 · ♀ 0% (drug 56%) | no trial arm names this drug |
| Macular degeneration | 787 | 115.3 107.5–123.7ROR 122.7 · χ² 83,138 / p <1e-300 | 107.4 EB05 101.2 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 75.8 · ♀ 100% (drug 56%) | no trial arm names this drug |
| Mite allergy | 42 | 114.8 84.0–157.0ROR 115.2 · χ² 4,318 / p <1e-300 | 102.4 EB05 78.9 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=42 · ♀ 0% (drug 56%) | no trial arm names this drug |
| Hyperphosphataemia | 125 | 102.2 85.3–122.3ROR 103.2 · χ² 11,679 / p <1e-300 | 94.8 EB05 81.6 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=125 · ♀ 0% (drug 56%) · 100% clinician | no trial arm names this drug |
| Antineutrophil cytoplasmic antibody positive | 42 | 99.7 73.1–136.1ROR 100.1 · χ² 3,773 / p <1e-300 | 90.2 EB05 69.6 · IC025 +5.0 3/3 methods agree | Lab value / disease marker | serious n=42 · ♀ 0% (drug 56%) | no trial arm names this drug |
| Blood phosphorus increased | 149 | 94.3 80.0–111.1ROR 95.4 · χ² 12,901 / p <1e-300 | 88.1 EB05 76.9 · IC025 +5.8 3/3 methods agree | Lab value / disease marker | serious n=148 · ♀ 0% (drug 56%) · 96% clinician | no trial arm names this drug |
| Total lung capacity decreased | 82 | 87.9 70.5–109.8ROR 88.5 · χ² 6,601 / p <1e-300 | 81.9 EB05 68.1 · 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 Suppositories only as a background or rescue medication (NCT02481219, NCT03197922); 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 | 1,456 | 11.0 10.5–11.6ROR 12.3 · χ² 13,325 / p <1e-300 | 11.0 EB05 10.5 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.8 | no trial arm names this drug |
| Nausea | 1,344 | 2.8 2.6–2.9ROR 3.0 · χ² 1,587 / p <1e-300 | 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 3.2 | no trial arm names this drug |
| Drug ineffective (drug did not work) | 1,311 | 1.6 1.5–1.7ROR 1.7 · χ² 334 / p 6e-75 | 1.6 EB05 1.6 · IC025 +0.6 | Reporting / coding artifact | serious PRR 2.8 | no trial arm names this drug |
| Off label use (used outside approved label) | 1,128 | 2.1 2.0–2.2ROR 2.2 · χ² 694 / p 3e-153 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 2.4 | no trial arm names this drug |
| Pain | 1,088 | 2.9 2.7–3.1ROR 3.1 · χ² 1,377 / p <1e-300 | 2.9 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 | 976 | 3.4 3.2–3.6ROR 3.6 · χ² 1,684 / p <1e-300 | 3.4 EB05 3.2 · IC025 +1.7 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 |
| Fall | 825 | 4.1 3.8–4.3ROR 4.3 · χ² 1,920 / p <1e-300 | 4.0 EB05 3.8 · IC025 +1.9 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) | 822 | 2.4 2.2–2.5ROR 2.5 · χ² 667 / p 2e-147 | 2.4 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 |
| Pneumonia (lung infection) | 798 | 4.0 3.8–4.3ROR 4.2 · χ² 1,840 / p <1e-300 | 4.0 EB05 3.8 · IC025 +1.9 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 |
| Macular degeneration | 787 | 115.3 107.5–123.7ROR 122.7 · χ² 83,138 / p <1e-300 | 107.4 EB05 101.2 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 75.8 · ♀ 100% (drug 56%) | no trial arm names this drug |
| Pyrexia (fever) | 760 | 3.6 3.3–3.8ROR 3.7 · χ² 1,434 / p <1e-300 | 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 2.9 | no trial arm names this drug |
| Death | 752 | 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 | 749 | 5.3 4.9–5.6ROR 5.5 · χ² 2,604 / p <1e-300 | 5.2 EB05 4.9 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.4 | no trial arm names this drug |
| Fatigue (tiredness) | 717 | 1.5 1.4–1.6ROR 1.5 · χ² 126 / p 2e-29 | 1.5 EB05 1.4 · IC025 +0.5 | No label text to screen label has no adverse-reaction text | serious PRR 1.5 | no trial arm names this drug |
| Hypotension (low blood pressure) | 691 | 5.6 5.2–6.1ROR 5.9 · χ² 2,649 / p <1e-300 | 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 4.2 | 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 Suppositories?
In FDA FAERS, the most frequently co-reported reaction terms for Bisacodyl Suppositories are constipation, nausea, pain, vomiting, fall, 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 Bisacodyl Suppositories have an FDA boxed warning?
No. The FDA label retrieved for Bisacodyl Suppositories has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Bisacodyl Suppositories 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 6f0aefc9-cd5f-4bdd-89c2-b6a80558987c, effective 20250124; matched on
openfda.generic_name.exact:"BISACODYL SUPPOSITORIES") - 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, 1,181 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 SUPPOSITORIES, 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.