Drug · FAERS side-effect profile with label screen
Carboxymethylcellulose and Glycerin side effects: what 2,474 FDA adverse event reports show
Drug class
Non-Standardized Chemical Allergen
FDA label (Established Pharmacologic Class) of the closest related product
Label matched
Carboxymethylcellulose Sodium And Glycerin (Refresh Relieva Pf)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
2,474 reports · 26% serious · 22 with death outcome · 79% female
openFDA FAERS counts, all years, deduplication not applied
Used for
For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun. May be used as a protectant against further irritation.
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 36 strongest signals
Reporting / coding artifact 8Lab value / disease marker 1No label text to screen 27
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. 16 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 |
|---|---|---|---|---|---|---|
| Eye discharge | 106 | 88.9 73.7–107.2ROR 92.8 · χ² 9,028 / p <1e-300 | 86.6 EB05 73.6 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=8 · 88% consumer | no trial data cached |
| Eye irritation | 481 | 73.8 68.0–80.0ROR 91.3 · χ² 34,241 / p <1e-300 | 72.9 EB05 67.6 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 82.0 · 89% consumer | no trial data cached |
| Ocular discomfort | 68 | 53.4 42.2–67.6ROR 54.9 · χ² 3,424 / p <1e-300 | 52.3 EB05 42.7 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 · 90% consumer | no trial data cached |
| Eye pain | 315 | 48.6 43.8–53.9ROR 55.6 · χ² 14,597 / p <1e-300 | 48.2 EB05 43.9 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 23.2 · 89% consumer | no trial data cached |
| Ocular hyperaemia | 198 | 36.1 31.5–41.2ROR 39.1 · χ² 6,702 / p <1e-300 | 35.8 EB05 31.8 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.2 · 89% consumer | no trial data cached |
| Dry eye | 185 | 32.5 28.3–37.3ROR 35.0 · χ² 5,605 / p <1e-300 | 32.3 EB05 28.5 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 41.9 · 91% consumer | no trial data cached |
| Eye pruritus | 102 | 26.3 21.7–31.8ROR 27.4 · χ² 2,453 / p <1e-300 | 26.1 EB05 22.1 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.8 · 87% consumer | no trial data cached |
| Cataract | 172 | 24.6 21.3–28.5ROR 26.4 · χ² 3,879 / p <1e-300 | 24.5 EB05 21.6 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 56.9 · 97% consumer | no trial data cached |
| Eyelid oedema | 33 | 24.0 17.1–33.6ROR 24.3 · χ² 702 / p 6e-155 | 23.6 EB05 17.6 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | 79% consumer | no trial data cached |
| Lacrimation increased | 83 | 23.6 19.1–29.2ROR 24.4 · χ² 1,772 / p <1e-300 | 23.4 EB05 19.5 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.3 · 89% consumer | no trial data cached |
| Product use complaint | 41 | 22.5 16.6–30.5ROR 22.8 · χ² 818 / p 3e-180 | 22.2 EB05 17.1 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious n=16 · 100% consumer | no trial data cached |
| Macular degeneration | 31 | 22.1 15.6–31.4ROR 22.4 · χ² 602 / p 3e-133 | 21.8 EB05 16.0 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 53.6 · 100% consumer | no trial data cached |
| Photophobia (light sensitivity) | 46 | 20.9 15.7–27.9ROR 21.3 · χ² 852 / p 1e-187 | 20.7 EB05 16.2 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.3 · 89% consumer | no trial data cached |
| Eye disorder | 69 | 17.9 14.2–22.6ROR 18.4 · χ² 1,082 / p 1e-237 | 17.8 EB05 14.5 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 27.8 · 87% consumer | no trial data cached |
| Eye infection | 23 | 17.4 11.6–26.2ROR 17.6 · χ² 339 / p 5e-76 | 17.0 EB05 11.7 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=7 · 83% consumer | no trial data cached |
| Vision blurred (blurred vision) | 262 | 16.3 14.5–18.3ROR 18.1 · χ² 3,761 / p <1e-300 | 16.2 EB05 14.6 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.1 · 88% consumer | no trial data cached |
| Eye swelling | 62 | 14.2 11.1–18.2ROR 14.6 · χ² 750 / p 2e-165 | 14.1 EB05 11.3 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.6 · 92% consumer | no trial data cached |
| Vitreous floaters | 16 | 13.9 8.6–22.7ROR 14.0 · χ² 179 / p 3e-41 | 13.0 EB05 7.8 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=4 | no trial data cached |
| Expired product administered | 50 | 12.8 9.7–16.8ROR 13.0 · χ² 532 / p 6e-118 | 12.5 EB05 9.8 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious n=10 · 96% consumer | no trial data cached |
| Eyelid ptosis | 15 | 12.5 7.6–20.7ROR 12.6 · χ² 147 / p 3e-34 | 11.3 EB05 6.7 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=1 | no trial data cached |
| Glaucoma | 25 | 11.0 7.5–16.3ROR 11.1 · χ² 218 / p 2e-49 | 10.2 EB05 7.0 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.2 · 100% consumer | no trial data cached |
| Poor quality product administered | 12 | 10.0 5.7–17.5ROR 10.0 · χ² 88 / p 3e-21 | 8.2 EB05 4.7 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=2 | no trial data cached |
| Eye inflammation | 11 | 9.9 5.5–17.8ROR 9.9 · χ² 79 / p 3e-19 | 8.0 EB05 4.4 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Product packaging issue | 10 | 9.1 4.9–17.0ROR 9.2 · χ² 65 / p 5e-16 | 7.2 EB05 3.9 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious n=5 | no trial data cached |
| Intraocular pressure increased (raised eye pressure) | 12 | 7.9 4.5–13.9ROR 8.0 · χ² 66 / p 2e-16 | 6.4 EB05 3.8 · IC025 +1.7 3/3 methods agree | Lab value / disease marker | serious PRR 11.0 | no trial data cached |
| Visual acuity reduced | 28 | 7.1 4.9–10.3ROR 7.2 · χ² 141 / p 1e-32 | 6.4 EB05 4.6 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.4 · 82% consumer | no trial data cached |
| Visual impairment | 82 | 5.7 4.6–7.0ROR 5.8 · χ² 311 / p 7e-70 | 5.5 EB05 4.6 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.6 · 93% consumer | no trial data cached |
| Conjunctivitis | 11 | 5.1 2.8–9.2ROR 5.1 · χ² 32 / p 8e-9 | 4.3 EB05 2.6 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.6 | no trial data cached |
| Diplopia (double vision) | 15 | 4.9 3.0–8.1ROR 4.9 · χ² 43 / p 3e-11 | 4.3 EB05 2.8 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.0 | no trial data cached |
| Product administration error | 11 | 4.7 2.6–8.4ROR 4.7 · χ² 28 / p 5e-8 | 4.0 EB05 2.4 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Arthritis | 43 | 4.6 3.4–6.2ROR 4.7 · χ² 119 / p 5e-28 | 4.4 EB05 3.4 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.9 · 93% consumer | no trial data cached |
| Blindness | 18 | 3.7 2.4–5.9ROR 3.8 · χ² 34 / p 3e-9 | 3.5 EB05 2.3 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.7 | no trial data cached |
| Therapeutic response decreased | 25 | 3.5 2.4–5.2ROR 3.5 · χ² 43 / p 3e-11 | 3.3 EB05 2.4 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | 84% consumer | no trial data cached |
| Accidental overdose | 13 | 3.0 1.8–5.2ROR 3.0 · χ² 16 / p 4e-5 | 2.8 EB05 1.8 · IC025 +0.5 | Reporting / coding artifact | serious PRR 0.9 | no trial data cached |
| Wrong technique in product usage process | 55 | 2.3 1.8–3.0ROR 2.3 · χ² 40 / p 1e-10 | 2.3 EB05 1.8 · IC025 +0.7 | Reporting / coding artifact | serious PRR 5.1 · 93% consumer | no trial data cached |
| Inappropriate schedule of drug administration | 19 | 2.2 1.4–3.5ROR 2.2 · χ² 12 / p 3e-4 | 2.2 EB05 1.5 · IC025 +0.3 | Reporting / coding artifact | serious PRR 0.9 | 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 |
|---|---|---|---|---|---|---|
| Eye irritation | 481 | 73.8 68.0–80.0ROR 91.3 · χ² 34,241 / p <1e-300 | 72.9 EB05 67.6 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 82.0 · 89% consumer | no trial data cached |
| Eye pain | 315 | 48.6 43.8–53.9ROR 55.6 · χ² 14,597 / p <1e-300 | 48.2 EB05 43.9 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 23.2 · 89% consumer | no trial data cached |
| Vision blurred (blurred vision) | 262 | 16.3 14.5–18.3ROR 18.1 · χ² 3,761 / p <1e-300 | 16.2 EB05 14.6 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.1 · 88% consumer | no trial data cached |
| Ocular hyperaemia | 198 | 36.1 31.5–41.2ROR 39.1 · χ² 6,702 / p <1e-300 | 35.8 EB05 31.8 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.2 · 89% consumer | no trial data cached |
| Dry eye | 185 | 32.5 28.3–37.3ROR 35.0 · χ² 5,605 / p <1e-300 | 32.3 EB05 28.5 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 41.9 · 91% consumer | no trial data cached |
| Cataract | 172 | 24.6 21.3–28.5ROR 26.4 · χ² 3,879 / p <1e-300 | 24.5 EB05 21.6 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 56.9 · 97% consumer | no trial data cached |
| Eye discharge | 106 | 88.9 73.7–107.2ROR 92.8 · χ² 9,028 / p <1e-300 | 86.6 EB05 73.6 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=8 · 88% consumer | no trial data cached |
| Eye pruritus | 102 | 26.3 21.7–31.8ROR 27.4 · χ² 2,453 / p <1e-300 | 26.1 EB05 22.1 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.8 · 87% consumer | no trial data cached |
| Lacrimation increased | 83 | 23.6 19.1–29.2ROR 24.4 · χ² 1,772 / p <1e-300 | 23.4 EB05 19.5 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.3 · 89% consumer | no trial data cached |
| Visual impairment | 82 | 5.7 4.6–7.0ROR 5.8 · χ² 311 / p 7e-70 | 5.5 EB05 4.6 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.6 · 93% consumer | no trial data cached |
| Eye disorder | 69 | 17.9 14.2–22.6ROR 18.4 · χ² 1,082 / p 1e-237 | 17.8 EB05 14.5 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 27.8 · 87% consumer | no trial data cached |
| Ocular discomfort | 68 | 53.4 42.2–67.6ROR 54.9 · χ² 3,424 / p <1e-300 | 52.3 EB05 42.7 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 · 90% consumer | no trial data cached |
| Eye swelling | 62 | 14.2 11.1–18.2ROR 14.6 · χ² 750 / p 2e-165 | 14.1 EB05 11.3 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.6 · 92% consumer | no trial data cached |
| Wrong technique in product usage process | 55 | 2.3 1.8–3.0ROR 2.3 · χ² 40 / p 1e-10 | 2.3 EB05 1.8 · IC025 +0.7 | Reporting / coding artifact | serious PRR 5.1 · 93% consumer | no trial data cached |
| Expired product administered | 50 | 12.8 9.7–16.8ROR 13.0 · χ² 532 / p 6e-118 | 12.5 EB05 9.8 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious n=10 · 96% consumer | 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 Carboxymethylcellulose and Glycerin?
In FDA FAERS, the most frequently co-reported reaction terms for Carboxymethylcellulose and Glycerin are eye irritation, eye pain, vision blurred, ocular hyperaemia, dry eye, cataract. 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 Carboxymethylcellulose and Glycerin have an FDA boxed warning?
No. The FDA label retrieved for Carboxymethylcellulose and Glycerin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Carboxymethylcellulose and 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 d5d3df4a-a311-4f2d-9a24-edfec1a6c9f9, effective 20250822; matched on
openfda.generic_name.exact:"CARBOXYMETHYLCELLULOSE SODIUM AND 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, 52 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.