Drug · FAERS side-effect profile with label screen
Glycerin side effects: what 5,454 FDA adverse event reports show
Drug class
Non-Standardized Chemical Allergen
FDA label (Established Pharmacologic Class) · compare the class
Who reports
5,454 reports · 71% serious · 598 with death outcome · 67% female
openFDA FAERS counts, all years, deduplication not applied
Used for
for relief of occasional constipation this product usually produces bowel movement in 1/4 to 1 hour
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 2Lab value / disease marker 5No label text to screen 33
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. 392 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 | 602 | 204.6 189.3–221.1ROR 229.8 · χ² 115,590 / p <1e-300 | 193.0 EB05 180.4 · IC025 +7.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 169.8 · ♀ 100% (drug 67%) | no trial data cached |
| Vaginal discharge | 154 | 59.8 51.1–70.0ROR 61.5 · χ² 8,718 / p <1e-300 | 58.5 EB05 51.2 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=154 · ♀ 100% (drug 67%) | no trial data cached |
| Paraesthesia oral | 218 | 59.2 51.9–67.5ROR 61.6 · χ² 12,232 / p <1e-300 | 58.0 EB05 51.8 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 82.9 · ♀ 100% (drug 67%) | no trial data cached |
| Blood calcium decreased | 166 | 57.4 49.4–66.7ROR 59.2 · χ² 9,010 / p <1e-300 | 56.2 EB05 49.4 · IC025 +5.3 3/3 methods agree | Lab value / disease marker | serious PRR 57.4 · ♀ 96% (drug 67%) · 90% clinician | no trial data cached |
| Oral candidiasis (oral thrush) | 158 | 47.2 40.5–55.1ROR 48.6 · χ² 7,023 / p <1e-300 | 46.4 EB05 40.7 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 52.3 · ♀ 99% (drug 67%) | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 169 | 37.6 32.4–43.6ROR 38.8 · χ² 5,928 / p <1e-300 | 37.1 EB05 32.6 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 34.1 · ♀ 97% (drug 67%) | no trial data cached |
| Eye pain | 397 | 27.8 25.3–30.6ROR 29.9 · χ² 10,193 / p <1e-300 | 27.6 EB05 25.4 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.4 · 80% consumer | no trial data cached |
| Procedural pain | 198 | 27.7 24.2–31.8ROR 28.7 · χ² 5,041 / p <1e-300 | 27.5 EB05 24.4 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 38.2 · ♀ 98% (drug 67%) | no trial data cached |
| Ocular discomfort | 68 | 24.2 19.1–30.7ROR 24.5 · χ² 1,482 / p <1e-300 | 23.9 EB05 19.5 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 · 73% consumer | no trial data cached |
| Sedation | 158 | 23.4 20.1–27.3ROR 24.1 · χ² 3,354 / p <1e-300 | 23.2 EB05 20.4 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.9 · ♀ 100% (drug 67%) · 92% clinician | no trial data cached |
| Frequent bowel movements | 162 | 23.3 20.0–27.1ROR 24.0 · χ² 3,416 / p <1e-300 | 23.1 EB05 20.3 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 28.9 · ♀ 98% (drug 67%) | no trial data cached |
| Eye irritation | 285 | 19.7 17.6–22.1ROR 20.8 · χ² 5,041 / p <1e-300 | 19.6 EB05 17.8 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.6 · 75% consumer | no trial data cached |
| Colitis | 181 | 18.6 16.1–21.4ROR 19.2 · χ² 2,980 / p <1e-300 | 18.4 EB05 16.3 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.9 · ♀ 98% (drug 67%) | no trial data cached |
| Depressed level of consciousness | 182 | 17.8 15.4–20.5ROR 18.4 · χ² 2,861 / p <1e-300 | 17.7 EB05 15.6 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.7 · ♀ 95% (drug 67%) · 91% clinician | no trial data cached |
| Photophobia (light sensitivity) | 85 | 17.6 14.2–21.7ROR 17.8 · χ² 1,307 / p 1e-286 | 17.4 EB05 14.5 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.1 · 72% consumer | no trial data cached |
| Product use complaint | 64 | 15.9 12.5–20.3ROR 16.1 · χ² 878 / p 3e-193 | 15.8 EB05 12.7 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious n=45 · 81% consumer | no trial data cached |
| Rectal haemorrhage | 168 | 15.0 13.0–17.5ROR 15.5 · χ² 2,183 / p <1e-300 | 14.9 EB05 13.1 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.0 · ♀ 97% (drug 67%) | no trial data cached |
| Cognitive disorder | 174 | 14.4 12.5–16.7ROR 14.9 · χ² 2,158 / p <1e-300 | 14.3 EB05 12.6 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.1 · ♀ 100% (drug 67%) | no trial data cached |
| Eye discharge | 37 | 14.0 10.1–19.3ROR 14.1 · χ² 431 / p 4e-96 | 13.6 EB05 10.2 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=9 | no trial data cached |
| Colitis ulcerative | 159 | 13.7 11.8–16.0ROR 14.1 · χ² 1,864 / p <1e-300 | 13.7 EB05 11.9 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.9 · ♀ 100% (drug 67%) | no trial data cached |
| Infusion related reaction (reaction during infusion) | 222 | 13.0 11.4–14.7ROR 13.5 · χ² 2,438 / p <1e-300 | 12.9 EB05 11.5 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.2 · ♀ 95% (drug 67%) | no trial data cached |
| Eye inflammation | 31 | 12.7 8.9–18.0ROR 12.7 · χ² 321 / p 5e-72 | 12.2 EB05 8.7 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 | no trial data cached |
| Therapeutic product effect incomplete | 231 | 12.6 11.1–14.3ROR 13.1 · χ² 2,454 / p <1e-300 | 12.5 EB05 11.2 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 19.0 · ♀ 99% (drug 67%) | no trial data cached |
| Lacrimation increased | 97 | 12.5 10.3–15.3ROR 12.7 · χ² 1,014 / p 6e-223 | 12.4 EB05 10.4 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.0 | no trial data cached |
| Haematochezia (blood in stool) | 176 | 12.3 10.6–14.2ROR 12.7 · χ² 1,817 / p <1e-300 | 12.2 EB05 10.8 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.9 · ♀ 94% (drug 67%) | no trial data cached |
| Neutrophil count increased | 32 | 12.0 8.5–17.0ROR 12.1 · χ² 311 / p 7e-70 | 11.5 EB05 8.3 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious PRR 10.3 · ♀ 47% (drug 67%) · 100% clinician | no trial data cached |
| Ocular hyperaemia | 137 | 11.3 9.6–13.3ROR 11.6 · χ² 1,275 / p 1e-279 | 11.2 EB05 9.7 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.1 · 73% consumer | no trial data cached |
| Dry eye | 132 | 10.5 8.9–12.4ROR 10.7 · χ² 1,124 / p 8e-247 | 10.3 EB05 8.9 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.7 · 72% consumer | no trial data cached |
| Mobility decreased | 178 | 9.6 8.3–11.1ROR 9.9 · χ² 1,360 / p 6e-298 | 9.4 EB05 8.3 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.4 · ♀ 94% (drug 67%) | no trial data cached |
| Vitreous floaters | 24 | 9.5 6.4–14.2ROR 9.5 · χ² 174 / p 6e-40 | 8.6 EB05 5.9 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=16 | no trial data cached |
| Constipation | 506 | 9.0 8.3–9.8ROR 9.8 · χ² 3,623 / p <1e-300 | 8.9 EB05 8.3 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.6 | no trial data cached |
| Dyspepsia (indigestion) | 221 | 8.7 7.6–9.9ROR 9.0 · χ² 1,497 / p <1e-300 | 8.6 EB05 7.6 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.9 · ♀ 94% (drug 67%) | no trial data cached |
| Balance disorder | 195 | 8.7 7.6–10.0ROR 9.0 · χ² 1,319 / p 4e-289 | 8.5 EB05 7.6 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.0 · ♀ 93% (drug 67%) | no trial data cached |
| Bladder disorder | 21 | 8.1 5.3–12.5ROR 8.2 · χ² 124 / p 4e-29 | 7.2 EB05 4.8 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=21 | no trial data cached |
| Eye swelling | 77 | 8.0 6.4–10.0ROR 8.1 · χ² 466 / p 1e-103 | 7.7 EB05 6.4 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.5 · 72% consumer | no trial data cached |
| Lymphocyte count decreased | 34 | 7.4 5.3–10.4ROR 7.4 · χ² 182 / p 1e-41 | 6.8 EB05 5.1 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious PRR 7.3 · ♀ 42% (drug 67%) · 94% clinician | no trial data cached |
| Pneumonia aspiration | 47 | 7.3 5.5–9.7ROR 7.3 · χ² 247 / p 5e-56 | 6.8 EB05 5.3 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.9 · ♀ 30% (drug 67%) | no trial data cached |
| Eye infection | 21 | 7.2 4.7–11.1ROR 7.2 · χ² 106 / p 4e-25 | 6.4 EB05 4.3 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=6 | no trial data cached |
| Blood urea increased | 31 | 7.1 5.0–10.1ROR 7.1 · χ² 156 / p 4e-36 | 6.5 EB05 4.8 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 6.2 | no trial data cached |
| Intraocular pressure increased (raised eye pressure) | 23 | 6.9 4.6–10.4ROR 6.9 · χ² 110 / p 5e-26 | 6.2 EB05 4.3 · IC025 +1.9 3/3 methods agree | Lab value / disease marker | serious PRR 5.0 | 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) | 817 | 2.4 2.2–2.5ROR 2.6 · χ² 700 / p 1e-154 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 4.6 · ♀ 90% (drug 67%) | no trial data cached |
| Macular degeneration | 602 | 204.6 189.3–221.1ROR 229.8 · χ² 115,590 / p <1e-300 | 193.0 EB05 180.4 · IC025 +7.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 169.8 · ♀ 100% (drug 67%) | no trial data cached |
| Pain | 537 | 3.4 3.1–3.6ROR 3.6 · χ² 912 / p 1e-200 | 3.3 EB05 3.1 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.1 · ♀ 89% (drug 67%) | no trial data cached |
| Constipation | 506 | 9.0 8.3–9.8ROR 9.8 · χ² 3,623 / p <1e-300 | 8.9 EB05 8.3 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.6 | no trial data cached |
| Off label use (used outside approved label) | 485 | 2.1 2.0–2.3ROR 2.3 · χ² 309 / p 1e-69 | 2.1 EB05 2.0 · IC025 +1.0 | Reporting / coding artifact | serious PRR 2.8 | no trial data cached |
| Nausea | 463 | 2.3 2.1–2.5ROR 2.4 · χ² 335 / p 4e-75 | 2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.2 | no trial data cached |
| Eye pain | 397 | 27.8 25.3–30.6ROR 29.9 · χ² 10,193 / p <1e-300 | 27.6 EB05 25.4 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.4 · 80% consumer | no trial data cached |
| Headache | 389 | 2.4 2.2–2.6ROR 2.5 · χ² 322 / p 2e-72 | 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 3.2 · ♀ 89% (drug 67%) | no trial data cached |
| Pyrexia (fever) | 371 | 4.1 3.7–4.5ROR 4.4 · χ² 888 / p 2e-195 | 4.1 EB05 3.8 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.1 | no trial data cached |
| Weight decreased (weight loss) | 343 | 4.7 4.3–5.2ROR 5.0 · χ² 1,017 / p 1e-223 | 4.7 EB05 4.3 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.4 | no trial data cached |
| Malaise (feeling unwell) | 340 | 3.0 2.7–3.3ROR 3.1 · χ² 453 / p 8e-101 | 3.0 EB05 2.7 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.8 · ♀ 88% (drug 67%) | no trial data cached |
| Fall | 302 | 3.5 3.1–3.9ROR 3.6 · χ² 543 / p 2e-120 | 3.5 EB05 3.2 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.2 | no trial data cached |
| Abdominal pain | 292 | 4.8 4.3–5.4ROR 5.0 · χ² 893 / p 2e-196 | 4.8 EB05 4.3 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.1 | no trial data cached |
| Eye irritation | 285 | 19.7 17.6–22.1ROR 20.8 · χ² 5,041 / p <1e-300 | 19.6 EB05 17.8 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.6 · 75% consumer | no trial data cached |
| Dyspnoea (shortness of breath) | 277 | 1.9 1.7–2.1ROR 1.9 · χ² 117 / p 1e-27 | 1.9 EB05 1.7 · IC025 +0.7 | No label text to screen label has no adverse-reaction text | serious PRR 1.9 | 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?
In FDA FAERS, the most frequently co-reported reaction terms for Glycerin are macular degeneration, pain, constipation, nausea, eye pain, headache. 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 have an FDA boxed warning?
No. The FDA label retrieved for Glycerin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Glycerin 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 03237ed2-265f-4acd-b504-d82b9263287c, effective 20241017; matched on
openfda.generic_name.exact:"GLYCERIN") - 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, 432 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.