Drug · FAERS side-effect profile with label screen
Glycerin Suppository side effects: what 2,600 FDA adverse event reports show
Drug class
Non-Standardized Chemical Allergen
FDA label (Established Pharmacologic Class) · compare the class
Brand names
Rite-Aid Glycerin Laxative
openFDA label
Who reports
2,600 reports · 93% serious · 368 with death outcome · 66% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Do not use Do not use laxative products for longer than 1 week unless directed by a doctor
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 1Lab value / disease marker 4No 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. 98 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 |
|---|---|---|---|---|---|---|
| Macular degeneration | 598 | 426.3 396.4–458.5ROR 553.3 · χ² 240,561 / p <1e-300 | 399.5 EB05 373.3 · IC025 +8.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 269.2 · ♀ 100% (drug 66%) | no trial data cached |
| Vaginal discharge | 154 | 125.6 107.6–146.5ROR 133.4 · χ² 18,621 / p <1e-300 | 121.8 EB05 106.5 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=154 · ♀ 100% (drug 66%) | no trial data cached |
| Paraesthesia oral | 212 | 120.7 106.0–137.5ROR 131.4 · χ² 24,698 / p <1e-300 | 117.7 EB05 105.0 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 129.7 · ♀ 100% (drug 66%) | no trial data cached |
| Blood calcium decreased | 164 | 119.0 102.5–138.1ROR 126.9 · χ² 18,794 / p <1e-300 | 115.7 EB05 101.6 · IC025 +6.2 3/3 methods agree | Lab value / disease marker | serious PRR 90.4 · ♀ 97% (drug 66%) · 90% clinician | no trial data cached |
| Oral candidiasis (oral thrush) | 157 | 98.5 84.6–114.7ROR 104.8 · χ² 14,881 / p <1e-300 | 96.2 EB05 84.2 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 83.5 · ♀ 99% (drug 66%) | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 165 | 77.0 66.4–89.3ROR 82.1 · χ² 12,190 / p <1e-300 | 75.6 EB05 66.4 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 53.2 · ♀ 97% (drug 66%) | no trial data cached |
| Procedural pain | 195 | 57.3 50.0–65.6ROR 61.8 · χ² 10,661 / p <1e-300 | 56.6 EB05 50.2 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 60.4 · ♀ 98% (drug 66%) | no trial data cached |
| Sedation | 156 | 48.5 41.7–56.6ROR 51.6 · χ² 7,182 / p <1e-300 | 48.0 EB05 42.0 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 41.0 · ♀ 100% (drug 66%) · 94% clinician | no trial data cached |
| Frequent bowel movements | 159 | 47.9 41.2–55.8ROR 51.0 · χ² 7,227 / p <1e-300 | 47.4 EB05 41.5 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 45.3 · ♀ 98% (drug 66%) | no trial data cached |
| Colitis | 170 | 36.6 31.6–42.3ROR 39.0 · χ² 5,828 / p <1e-300 | 36.3 EB05 31.9 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 24.0 · ♀ 99% (drug 66%) | no trial data cached |
| Depressed level of consciousness | 175 | 35.9 31.1–41.4ROR 38.4 · χ² 5,889 / p <1e-300 | 35.6 EB05 31.4 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.6 · ♀ 97% (drug 66%) · 91% clinician | no trial data cached |
| Rectal haemorrhage | 160 | 30.0 25.8–34.9ROR 31.9 · χ² 4,455 / p <1e-300 | 29.8 EB05 26.2 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.8 · ♀ 100% (drug 66%) | no trial data cached |
| Colitis ulcerative | 159 | 28.9 24.8–33.6ROR 30.7 · χ² 4,241 / p <1e-300 | 28.7 EB05 25.1 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.0 · ♀ 99% (drug 66%) | no trial data cached |
| Cognitive disorder | 165 | 28.7 24.8–33.3ROR 30.6 · χ² 4,378 / p <1e-300 | 28.5 EB05 25.1 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 24.6 · ♀ 99% (drug 66%) | no trial data cached |
| Infusion related reaction (reaction during infusion) | 214 | 26.2 23.0–29.8ROR 28.5 · χ² 5,163 / p <1e-300 | 26.1 EB05 23.3 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.2 · ♀ 95% (drug 66%) | no trial data cached |
| Therapeutic product effect incomplete | 228 | 26.1 23.0–29.5ROR 28.5 · χ² 5,476 / p <1e-300 | 26.0 EB05 23.2 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious PRR 30.2 · ♀ 99% (drug 66%) | no trial data cached |
| Haematochezia (blood in stool) | 167 | 24.5 21.2–28.4ROR 26.1 · χ² 3,741 / p <1e-300 | 24.4 EB05 21.4 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.6 · ♀ 97% (drug 66%) | no trial data cached |
| Mobility decreased | 171 | 19.3 16.7–22.3ROR 20.6 · χ² 2,952 / p <1e-300 | 19.2 EB05 16.9 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.3 · ♀ 97% (drug 66%) | no trial data cached |
| Bladder disorder | 21 | 17.1 11.1–26.1ROR 17.2 · χ² 301 / p 1e-67 | 16.6 EB05 11.2 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=21 | no trial data cached |
| Dyspepsia (indigestion) | 205 | 16.9 14.8–19.3ROR 18.2 · χ² 3,056 / p <1e-300 | 16.8 EB05 15.0 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.5 · ♀ 97% (drug 66%) | no trial data cached |
| Constipation | 444 | 16.6 15.2–18.0ROR 19.8 · χ² 6,538 / p <1e-300 | 16.5 EB05 15.3 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.8 · ♀ 88% (drug 66%) | no trial data cached |
| Neutrophil count increased | 21 | 16.5 10.8–25.3ROR 16.6 · χ² 290 / p 2e-65 | 16.0 EB05 10.8 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | serious PRR 11.2 · ♀ 38% (drug 66%) · 100% clinician | no trial data cached |
| Balance disorder | 171 | 16.0 13.8–18.4ROR 17.0 · χ² 2,388 / p <1e-300 | 15.9 EB05 14.0 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.7 · ♀ 97% (drug 66%) | no trial data cached |
| Pneumonia aspiration | 39 | 12.6 9.3–17.3ROR 12.8 · χ² 406 / p 1e-90 | 12.3 EB05 9.2 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.8 · ♀ 28% (drug 66%) | no trial data cached |
| Lymphocyte count decreased | 26 | 11.9 8.1–17.4ROR 12.0 · χ² 248 / p 4e-56 | 11.2 EB05 7.7 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious PRR 9.0 · ♀ 36% (drug 66%) · 96% clinician | no trial data cached |
| Metastases to central nervous system | 16 | 10.1 6.2–16.4ROR 10.1 · χ² 122 / p 1e-28 | 8.8 EB05 5.4 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.3 | no trial data cached |
| Ileus | 15 | 9.8 5.9–16.3ROR 9.9 · χ² 110 / p 4e-26 | 8.4 EB05 5.1 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.1 | no trial data cached |
| Anaemia (low red blood cells) | 231 | 9.8 8.6–11.1ROR 10.6 · χ² 1,825 / p <1e-300 | 9.7 EB05 8.7 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.6 | no trial data cached |
| Skin reaction | 17 | 9.8 6.1–15.7ROR 9.8 · χ² 125 / p 3e-29 | 8.5 EB05 5.4 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.2 | no trial data cached |
| Disseminated intravascular coagulation | 16 | 9.1 5.6–14.9ROR 9.2 · χ² 108 / p 1e-25 | 7.8 EB05 4.9 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.7 | no trial data cached |
| Urosepsis | 10 | 8.8 4.7–16.3ROR 8.8 · χ² 61 / p 3e-15 | 6.8 EB05 3.8 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.4 | no trial data cached |
| Abdominal pain | 246 | 8.5 7.6–9.6ROR 9.3 · χ² 1,647 / p <1e-300 | 8.4 EB05 7.6 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.0 · ♀ 89% (drug 66%) | no trial data cached |
| Dementia | 29 | 8.4 5.9–12.1ROR 8.5 · χ² 182 / p 9e-42 | 7.7 EB05 5.5 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.6 · ♀ 93% (drug 66%) | no trial data cached |
| Toxicity to various agents | 171 | 8.2 7.1–9.5ROR 8.7 · χ² 1,086 / p 2e-238 | 8.1 EB05 7.1 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.2 · ♀ 90% (drug 66%) · 95% clinician | no trial data cached |
| Erythema (skin redness) | 208 | 8.2 7.2–9.3ROR 8.8 · χ² 1,315 / p 3e-288 | 8.1 EB05 7.2 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.8 · ♀ 88% (drug 66%) | no trial data cached |
| Hypotension (low blood pressure) | 193 | 7.8 6.8–8.9ROR 8.3 · χ² 1,143 / p 7e-251 | 7.7 EB05 6.8 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.6 · ♀ 89% (drug 66%) | no trial data cached |
| Weight decreased (weight loss) | 268 | 7.8 6.9–8.7ROR 8.5 · χ² 1,589 / p <1e-300 | 7.7 EB05 6.9 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.2 · ♀ 91% (drug 66%) | no trial data cached |
| Blood pressure systolic increased | 18 | 7.4 4.7–11.8ROR 7.5 · χ² 94 / p 2e-22 | 6.4 EB05 4.2 · IC025 +1.9 3/3 methods agree | Lab value / disease marker | serious PRR 5.0 | no trial data cached |
| Gastrointestinal pain | 10 | 7.4 4.0–13.7ROR 7.4 · χ² 49 / p 1e-12 | 5.8 EB05 3.3 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.2 | no trial data cached |
| Skin infection | 10 | 7.2 3.9–13.4ROR 7.3 · χ² 48 / p 3e-12 | 5.7 EB05 3.2 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.2 | 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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 650 | 4.0 3.7–4.3ROR 5.0 · χ² 1,546 / p <1e-300 | 4.0 EB05 3.7 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 6.9 · ♀ 95% (drug 66%) | no trial data cached |
| Macular degeneration | 598 | 426.3 396.4–458.5ROR 553.3 · χ² 240,561 / p <1e-300 | 399.5 EB05 373.3 · IC025 +8.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 269.2 · ♀ 100% (drug 66%) | no trial data cached |
| Constipation | 444 | 16.6 15.2–18.0ROR 19.8 · χ² 6,538 / p <1e-300 | 16.5 EB05 15.3 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.8 · ♀ 88% (drug 66%) | no trial data cached |
| Pain | 401 | 5.3 4.8–5.8ROR 6.0 · χ² 1,420 / p <1e-300 | 5.2 EB05 4.8 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.1 · ♀ 96% (drug 66%) | no trial data cached |
| Pyrexia (fever) | 309 | 7.2 6.5–8.0ROR 8.0 · χ² 1,671 / p <1e-300 | 7.1 EB05 6.5 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.5 | no trial data cached |
| Malaise (feeling unwell) | 275 | 5.0 4.5–5.6ROR 5.5 · χ² 907 / p 1e-199 | 5.0 EB05 4.5 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.1 · ♀ 93% (drug 66%) | no trial data cached |
| Weight decreased (weight loss) | 268 | 7.8 6.9–8.7ROR 8.5 · χ² 1,589 / p <1e-300 | 7.7 EB05 6.9 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.2 · ♀ 91% (drug 66%) | no trial data cached |
| Abdominal pain | 246 | 8.5 7.6–9.6ROR 9.3 · χ² 1,647 / p <1e-300 | 8.4 EB05 7.6 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.0 · ♀ 89% (drug 66%) | no trial data cached |
| Anaemia (low red blood cells) | 231 | 9.8 8.6–11.1ROR 10.6 · χ² 1,825 / p <1e-300 | 9.7 EB05 8.7 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.6 | no trial data cached |
| Therapeutic product effect incomplete | 228 | 26.1 23.0–29.5ROR 28.5 · χ² 5,476 / p <1e-300 | 26.0 EB05 23.2 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious PRR 30.2 · ♀ 99% (drug 66%) | no trial data cached |
| Infusion related reaction (reaction during infusion) | 214 | 26.2 23.0–29.8ROR 28.5 · χ² 5,163 / p <1e-300 | 26.1 EB05 23.3 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.2 · ♀ 95% (drug 66%) | no trial data cached |
| Paraesthesia oral | 212 | 120.7 106.0–137.5ROR 131.4 · χ² 24,698 / p <1e-300 | 117.7 EB05 105.0 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 129.7 · ♀ 100% (drug 66%) | no trial data cached |
| Erythema (skin redness) | 208 | 8.2 7.2–9.3ROR 8.8 · χ² 1,315 / p 3e-288 | 8.1 EB05 7.2 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.8 · ♀ 88% (drug 66%) | no trial data cached |
| Fall | 205 | 5.0 4.4–5.7ROR 5.3 · χ² 657 / p 3e-145 | 4.9 EB05 4.4 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.7 · ♀ 89% (drug 66%) | no trial data cached |
| Dyspepsia (indigestion) | 205 | 16.9 14.8–19.3ROR 18.2 · χ² 3,056 / p <1e-300 | 16.8 EB05 15.0 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.5 · ♀ 97% (drug 66%) | 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 Glycerin Suppository?
In FDA FAERS, the most frequently co-reported reaction terms for Glycerin Suppository are macular degeneration, constipation, pain, pyrexia, malaise, weight decreased. 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 Glycerin Suppository have an FDA boxed warning?
No. The FDA label retrieved for Glycerin Suppository has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Glycerin Suppository 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 0fb8f488-3386-29b9-e063-6294a90a014c, effective 20260114; matched on
openfda.generic_name.exact:"GLYCERIN SUPPOSITORY") - 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, 138 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.