Drug · FAERS side-effect profile with label screen

Carboxymethylcellulose, Glycerin and Polysorbate 80 side effects: what 613 FDA adverse event reports show

Carboxymethylcellulose Sodium, Glycerin, Polysorbate 80 · 33 reaction terms · 813 drug–reaction co-reports · data 2026-09-14

Drug class

Non-Standardized Chemical Allergen

FDA label (Established Pharmacologic Class) of the closest related product

Label matched

Carboxymethylcellulose Sodium, Glycerin, Polysorbate 80 (Refresh Optive Advanced)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

613 reports · 36% serious · 8 with death outcome · 80% 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 19 strongest signals

Reporting / coding artifact 4No label text to screen 15

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.
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. 14 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Eye discharge	27	90.6 62.6–131.1ROR 94.8 · χ² 2,300 / p <1e-300	85.1 EB05 61.4 · IC025 +4.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=5 · 89% consumer	no trial data cached
Eye irritation	144	88.6 76.8–102.2ROR 115.5 · χ² 12,383 / p <1e-300	87.4 EB05 76.0 · IC025 +5.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 140.5 · 88% consumer	no trial data cached
Eye pain	119	73.9 62.8–86.8ROR 91.4 · χ² 8,485 / p <1e-300	72.9 EB05 62.5 · IC025 +5.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 40.8 · 89% consumer	no trial data cached
Ocular discomfort	22	69.4 46.0–104.7ROR 72.0 · χ² 1,414 / p <1e-300	65.5 EB05 45.6 · IC025 +4.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=2 · 91% consumer	no trial data cached
Photophobia (light sensitivity)	32	58.7 41.9–82.3ROR 61.9 · χ² 1,757 / p <1e-300	56.7 EB05 42.1 · IC025 +4.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 37.6	no trial data cached
Dry eye	61	43.1 34.0–54.7ROR 47.8 · χ² 2,470 / p <1e-300	42.5 EB05 34.3 · IC025 +4.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 73.2 · 85% consumer	no trial data cached
Macular degeneration	15	43.1 26.1–71.1ROR 44.2 · χ² 575 / p 2e-127	41.0 EB05 26.4 · IC025 +3.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 73.5	no trial data cached
Cataract	61	35.2 27.8–44.7ROR 39.0 · χ² 1,997 / p <1e-300	34.8 EB05 28.1 · IC025 +4.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 52.3 · 92% consumer	no trial data cached
Lacrimation increased	30	34.4 24.2–48.7ROR 36.1 · χ² 940 / p 1e-206	33.7 EB05 24.7 · IC025 +3.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 28.3 · 87% consumer	no trial data cached
Ocular hyperaemia	45	33.0 24.9–43.7ROR 35.5 · χ² 1,365 / p 4e-299	32.5 EB05 25.3 · IC025 +4.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 20.4 · 89% consumer	no trial data cached
Incorrect product storage	11	28.3 15.7–50.8ROR 28.7 · χ² 262 / p 2e-59	27.0 EB05 15.9 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious n=1	no trial data cached
Eye disorder	19	19.8 12.7–30.9ROR 20.4 · χ² 322 / p 3e-72	19.4 EB05 12.9 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 33.7	no trial data cached
Eye pruritus	19	19.7 12.7–30.7ROR 20.3 · χ² 320 / p 9e-72	19.3 EB05 12.9 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 36.6	no trial data cached
Vision blurred (blurred vision)	60	15.0 11.8–19.1ROR 16.6 · χ² 777 / p 3e-171	14.9 EB05 11.9 · IC025 +3.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 13.6 · 81% consumer	no trial data cached
Eye swelling	13	12.0 7.0–20.6ROR 12.3 · χ² 121 / p 2e-28	10.5 EB05 5.9 · IC025 +2.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 6.2	no trial data cached
Expired product administered	10	10.3 5.6–19.1ROR 10.5 · χ² 75 / p 2e-18	8.2 EB05 4.4 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious n=4	no trial data cached
Visual acuity reduced	10	10.2 5.5–18.9ROR 10.4 · χ² 74 / p 3e-18	8.1 EB05 4.3 · IC025 +1.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 8.7	no trial data cached
Inappropriate schedule of drug administration	14	6.6 4.0–11.1ROR 6.8 · χ² 62 / p 2e-15	5.6 EB05 3.5 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 5.2	no trial data cached
Product storage error	11	4.3 2.4–7.8ROR 4.4 · χ² 25 / p 3e-7	3.8 EB05 2.3 · IC025 +0.9 3/3 methods agree	Reporting / coding artifact	serious PRR 20.2	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
Eye irritation	144	88.6 76.8–102.2ROR 115.5 · χ² 12,383 / p <1e-300	87.4 EB05 76.0 · IC025 +5.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 140.5 · 88% consumer	no trial data cached
Eye pain	119	73.9 62.8–86.8ROR 91.4 · χ² 8,485 / p <1e-300	72.9 EB05 62.5 · IC025 +5.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 40.8 · 89% consumer	no trial data cached
Cataract	61	35.2 27.8–44.7ROR 39.0 · χ² 1,997 / p <1e-300	34.8 EB05 28.1 · IC025 +4.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 52.3 · 92% consumer	no trial data cached
Dry eye	61	43.1 34.0–54.7ROR 47.8 · χ² 2,470 / p <1e-300	42.5 EB05 34.3 · IC025 +4.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 73.2 · 85% consumer	no trial data cached
Vision blurred (blurred vision)	60	15.0 11.8–19.1ROR 16.6 · χ² 777 / p 3e-171	14.9 EB05 11.9 · IC025 +3.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 13.6 · 81% consumer	no trial data cached
Ocular hyperaemia	45	33.0 24.9–43.7ROR 35.5 · χ² 1,365 / p 4e-299	32.5 EB05 25.3 · IC025 +4.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 20.4 · 89% consumer	no trial data cached
Photophobia (light sensitivity)	32	58.7 41.9–82.3ROR 61.9 · χ² 1,757 / p <1e-300	56.7 EB05 42.1 · IC025 +4.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 37.6	no trial data cached
Lacrimation increased	30	34.4 24.2–48.7ROR 36.1 · χ² 940 / p 1e-206	33.7 EB05 24.7 · IC025 +3.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 28.3 · 87% consumer	no trial data cached
Eye discharge	27	90.6 62.6–131.1ROR 94.8 · χ² 2,300 / p <1e-300	85.1 EB05 61.4 · IC025 +4.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=5 · 89% consumer	no trial data cached
Ocular discomfort	22	69.4 46.0–104.7ROR 72.0 · χ² 1,414 / p <1e-300	65.5 EB05 45.6 · IC025 +4.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=2 · 91% consumer	no trial data cached
Eye pruritus	19	19.7 12.7–30.7ROR 20.3 · χ² 320 / p 9e-72	19.3 EB05 12.9 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 36.6	no trial data cached
Eye disorder	19	19.8 12.7–30.9ROR 20.4 · χ² 322 / p 3e-72	19.4 EB05 12.9 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 33.7	no trial data cached
Macular degeneration	15	43.1 26.1–71.1ROR 44.2 · χ² 575 / p 2e-127	41.0 EB05 26.4 · IC025 +3.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 73.5	no trial data cached
Inappropriate schedule of drug administration	14	6.6 4.0–11.1ROR 6.8 · χ² 62 / p 2e-15	5.6 EB05 3.5 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 5.2	no trial data cached
Eye swelling	13	12.0 7.0–20.6ROR 12.3 · χ² 121 / p 2e-28	10.5 EB05 5.9 · IC025 +2.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 6.2	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?

In FDA FAERS, the most frequently co-reported reaction terms for Carboxymethylcellulose are eye irritation, eye pain, cataract, dry eye, vision blurred, ocular hyperaemia. 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 have an FDA boxed warning?

No. The FDA label retrieved for Carboxymethylcellulose has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Carboxymethylcellulose 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 ebd0839e-2e1d-4e0e-986c-19f1f5c76358, effective 20220915; matched on openfda.generic_name.exact:"CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80")
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, field patient.drug.openfda.generic_name.exact, 33 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.