Drug · FAERS side-effect profile with label screen
Carboxymethylcellulose Sodium side effects: what 9,339 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Carboxymethylcellulose Sodium (Gentle Eyes Lubricant Eye Drops)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
9,339 reports · 54% serious · 351 with death outcome · 75% 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 40 strongest signals
Reporting / coding artifact 2No label text to screen 38
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. 1,010 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 |
|---|---|---|---|---|---|---|
| Vaginal flatulence | 165 | 2,666.2 2,127.7–3,341.1ROR 2,714.1 · χ² 198,216 / p <1e-300 | 1,060.0 EB05 931.0 · IC025 +7.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=165 · ♀ 100% (drug 75%) | no trial data cached |
| Periumbilical abscess | 12 | 510.9 272.8–956.7ROR 511.5 · χ² 4,556 / p <1e-300 | 250.2 EB05 152.5 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | no trial data cached |
| Nail bed inflammation | 37 | 295.7 210.0–416.5ROR 296.9 · χ² 9,328 / p <1e-300 | 230.1 EB05 174.3 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=35 · ♀ 100% (drug 75%) | no trial data cached |
| Female genital tract fistula | 167 | 241.3 206.0–282.7ROR 245.7 · χ² 35,825 / p <1e-300 | 212.4 EB05 186.7 · IC025 +6.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=167 · ♀ 100% (drug 75%) | no trial data cached |
| Macular degeneration | 896 | 182.6 171.1–194.8ROR 201.8 · χ² 149,381 / p <1e-300 | 168.1 EB05 159.1 · IC025 +7.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 194.0 · ♀ 99% (drug 75%) | no trial data cached |
| Catheter site abscess | 12 | 171.4 95.3–308.2ROR 171.6 · χ² 1,732 / p <1e-300 | 127.4 EB05 77.7 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | no trial data cached |
| Keratomileusis | 17 | 163.6 100.0–267.7ROR 163.9 · χ² 2,409 / p <1e-300 | 130.4 EB05 86.3 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=17 | no trial data cached |
| Radiculopathy | 169 | 153.7 131.7–179.4ROR 156.5 · χ² 23,836 / p <1e-300 | 141.5 EB05 124.5 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=169 · ♀ 98% (drug 75%) | no trial data cached |
| Periorbital pain | 51 | 152.4 114.8–202.2ROR 153.2 · χ² 7,034 / p <1e-300 | 135.5 EB05 107.1 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | 94% consumer | no trial data cached |
| Nasal mucosal disorder | 36 | 147.3 105.2–206.3ROR 147.9 · χ² 4,769 / p <1e-300 | 128.9 EB05 97.3 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=36 · ♀ 100% (drug 75%) | no trial data cached |
| Proctitis | 166 | 141.2 120.9–165.0ROR 143.8 · χ² 21,599 / p <1e-300 | 130.9 EB05 115.0 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=166 · ♀ 100% (drug 75%) | no trial data cached |
| Chronic sinusitis | 220 | 140.0 122.4–160.2ROR 143.4 · χ² 28,436 / p <1e-300 | 130.3 EB05 116.5 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=220 · ♀ 100% (drug 75%) | no trial data cached |
| Symblepharon | 12 | 107.6 60.3–191.9ROR 107.7 · χ² 1,109 / p 2e-243 | 88.6 EB05 54.0 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | no trial data cached |
| Eyelid pain | 88 | 106.6 86.2–131.9ROR 107.6 · χ² 8,685 / p <1e-300 | 99.6 EB05 83.3 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=6 · 94% consumer | no trial data cached |
| Scleral hyperaemia | 27 | 91.7 62.4–134.6ROR 91.9 · χ² 2,239 / p <1e-300 | 83.1 EB05 59.9 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Streptococcal sepsis | 42 | 81.8 60.2–111.3ROR 82.2 · χ² 3,157 / p <1e-300 | 76.3 EB05 58.8 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=42 · ♀ 100% (drug 75%) | no trial data cached |
| Intraocular lens implant | 17 | 79.7 49.2–129.3ROR 79.9 · χ² 1,201 / p 2e-263 | 71.1 EB05 47.0 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=17 | no trial data cached |
| Foreign body sensation in eyes | 212 | 78.9 68.9–90.3ROR 80.7 · χ² 15,672 / p <1e-300 | 75.7 EB05 67.5 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=48 · 85% consumer | no trial data cached |
| Corneal transplant | 25 | 75.4 50.6–112.3ROR 75.6 · χ² 1,704 / p <1e-300 | 69.3 EB05 49.3 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=22 · 92% consumer | no trial data cached |
| Vaginal lesion | 10 | 75.3 40.1–141.4ROR 75.4 · χ² 639 / p 3e-141 | 64.3 EB05 37.3 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | no trial data cached |
| Superficial injury of eye | 33 | 71.3 50.5–100.8ROR 71.6 · χ² 2,150 / p <1e-300 | 66.6 EB05 49.6 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=9 · 84% consumer | no trial data cached |
| Instillation site pruritus | 11 | 66.9 36.7–121.8ROR 67.0 · χ² 631 / p 2e-139 | 58.7 EB05 35.0 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Foreign body in eye | 25 | 60.9 40.9–90.5ROR 61.0 · χ² 1,375 / p <1e-300 | 56.8 EB05 40.5 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | no trial data cached |
| Meibomian gland dysfunction | 11 | 57.4 31.6–104.5ROR 57.5 · χ² 541 / p 6e-120 | 51.3 EB05 30.6 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | no trial data cached |
| Pseudomonal sepsis | 43 | 56.1 41.5–75.9ROR 56.4 · χ² 2,217 / p <1e-300 | 53.5 EB05 41.4 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=43 · ♀ 100% (drug 75%) | no trial data cached |
| Corneal abrasion | 30 | 50.4 35.1–72.4ROR 50.6 · χ² 1,373 / p <1e-300 | 47.9 EB05 35.2 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=16 · 83% consumer | no trial data cached |
| Lacrimation decreased | 10 | 48.4 25.9–90.6ROR 48.5 · χ² 409 / p 2e-91 | 43.8 EB05 25.4 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=7 | no trial data cached |
| Instillation site reaction | 23 | 47.8 31.6–72.2ROR 47.9 · χ² 986 / p 1e-216 | 45.1 EB05 31.7 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Product dropper issue | 16 | 45.9 28.0–75.3ROR 46.0 · χ² 646 / p 9e-143 | 42.9 EB05 28.0 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious n=5 | no trial data cached |
| Eyelid irritation | 49 | 45.6 34.4–60.4ROR 45.8 · χ² 2,050 / p <1e-300 | 44.0 EB05 34.6 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=4 · 82% consumer | no trial data cached |
| Instillation site erythema | 10 | 43.0 23.0–80.3ROR 43.0 · χ² 362 / p 5e-81 | 39.3 EB05 22.8 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Instillation site pain | 45 | 41.1 30.6–55.1ROR 41.3 · χ² 1,688 / p <1e-300 | 39.7 EB05 30.9 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | 77% consumer | no trial data cached |
| Eye pain | 954 | 39.4 37.1–41.9ROR 43.8 · χ² 35,172 / p <1e-300 | 38.7 EB05 36.7 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.6 · 88% consumer | no trial data cached |
| Endocrine ophthalmopathy | 14 | 38.6 22.8–65.5ROR 38.7 · χ² 468 / p 4e-104 | 36.3 EB05 23.0 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=14 | no trial data cached |
| Vaginal discharge | 167 | 37.9 32.6–44.1ROR 38.6 · χ² 5,870 / p <1e-300 | 37.2 EB05 32.7 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=166 · ♀ 100% (drug 75%) | no trial data cached |
| Eye operation | 74 | 37.3 29.7–46.9ROR 37.6 · χ² 2,535 / p <1e-300 | 36.4 EB05 29.9 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | serious n=74 · 89% consumer | no trial data cached |
| Eye irritation | 908 | 37.1 34.9–39.5ROR 41.0 · χ² 31,461 / p <1e-300 | 36.5 EB05 34.6 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 40.1 · 85% consumer | no trial data cached |
| Eye discharge | 164 | 36.6 31.4–42.7ROR 37.2 · χ² 5,555 / p <1e-300 | 35.9 EB05 31.5 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=51 · 83% consumer | no trial data cached |
| Paraesthesia oral | 223 | 35.4 31.0–40.3ROR 36.2 · χ² 7,300 / p <1e-300 | 34.7 EB05 31.1 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 66.5 · ♀ 100% (drug 75%) | no trial data cached |
| Ocular discomfort | 168 | 35.3 30.3–41.0ROR 35.9 · χ² 5,473 / p <1e-300 | 34.6 EB05 30.4 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=36 · 88% consumer | 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) | 1,395 | 2.4 2.3–2.5ROR 2.6 · χ² 1,188 / p 2e-260 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 5.1 | no trial data cached |
| Eye pain | 954 | 39.4 37.1–41.9ROR 43.8 · χ² 35,172 / p <1e-300 | 38.7 EB05 36.7 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.6 · 88% consumer | no trial data cached |
| Eye irritation | 908 | 37.1 34.9–39.5ROR 41.0 · χ² 31,461 / p <1e-300 | 36.5 EB05 34.6 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 40.1 · 85% consumer | no trial data cached |
| Macular degeneration | 896 | 182.6 171.1–194.8ROR 201.8 · χ² 149,381 / p <1e-300 | 168.1 EB05 159.1 · IC025 +7.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 194.0 · ♀ 99% (drug 75%) | no trial data cached |
| Off label use (used outside approved label) | 626 | 1.6 1.5–1.7ROR 1.7 · χ² 154 / p 1e-35 | 1.6 EB05 1.5 · IC025 +0.6 | Reporting / coding artifact | serious PRR 2.3 | no trial data cached |
| Nausea | 597 | 1.7 1.6–1.8ROR 1.7 · χ² 177 / p 9e-41 | 1.7 EB05 1.6 · IC025 +0.6 | No label text to screen label has no adverse-reaction text | serious PRR 2.7 | no trial data cached |
| Vision blurred (blurred vision) | 558 | 9.2 8.5–10.0ROR 9.7 · χ² 4,081 / p <1e-300 | 9.1 EB05 8.5 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.3 · 82% consumer | no trial data cached |
| Headache | 529 | 1.9 1.7–2.1ROR 2.0 · χ² 230 / p 3e-52 | 1.9 EB05 1.8 · IC025 +0.8 | No label text to screen label has no adverse-reaction text | serious PRR 2.5 | no trial data cached |
| Cataract | 515 | 19.7 18.1–21.4ROR 20.7 · χ² 9,044 / p <1e-300 | 19.5 EB05 18.1 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.2 · 93% consumer | no trial data cached |
| Pain | 464 | 1.7 1.5–1.9ROR 1.7 · χ² 135 / p 2e-31 | 1.7 EB05 1.6 · IC025 +0.6 | No label text to screen label has no adverse-reaction text | serious PRR 2.4 | no trial data cached |
| Dry eye | 452 | 21.1 19.3–23.1ROR 22.2 · χ² 8,585 / p <1e-300 | 20.9 EB05 19.4 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.4 · 80% consumer | no trial data cached |
| Ocular hyperaemia | 447 | 21.7 19.8–23.7ROR 22.7 · χ² 8,728 / p <1e-300 | 21.5 EB05 19.8 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.2 · 83% consumer | no trial data cached |
| Fatigue (tiredness) | 446 | 1.3 1.2–1.4ROR 1.3 · χ² 30 / p 3e-8 | 1.3 EB05 1.2 · IC025 +0.2 | No label text to screen label has no adverse-reaction text | serious PRR 1.6 | no trial data cached |
| Malaise (feeling unwell) | 411 | 2.1 1.9–2.3ROR 2.2 · χ² 240 / p 2e-54 | 2.1 EB05 1.9 · IC025 +0.9 | No label text to screen label has no adverse-reaction text | serious PRR 3.1 | no trial data cached |
| Weight decreased (weight loss) | 382 | 3.1 2.8–3.4ROR 3.2 · χ² 539 / p 1e-119 | 3.1 EB05 2.8 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.4 | 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 pain, eye irritation, macular degeneration, nausea, vision blurred, 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 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 13f99af6-b7d8-a092-e063-6394a90a5daa, effective 20251215; matched on
openfda.generic_name.exact:"CARBOXYMETHYLCELLULOSE SODIUM") - 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, 1,050 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.