Drug · FAERS side-effect profile with label screen
Lubricant Eye Drops side effects: what 40 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Minidrops
openFDA label
Who reports
40 reports · 55% serious · 1 with death outcome · 74% female
openFDA FAERS counts, all years, deduplication not applied
Used for
AND USE SECTION USES FOR TEMPORARY RELIEF OF BURNING AND IRRITATION DUE TO DRYNESS OF THE EYE FOR USE AS A PROTECTANT AGAINST FURTHER IRRITATION OR TO RELIEVE DRYNESS OF THE EYE
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 3Lab value / disease marker 5No label text to screen 32
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. 71 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 pain | 346 | 51.4 46.6–56.7ROR 59.3 · χ² 16,991 / p <1e-300 | 51.0 EB05 46.6 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 45.9 | no trial data cached |
| Ocular discomfort | 56 | 42.3 32.6–54.8ROR 43.2 · χ² 2,205 / p <1e-300 | 41.5 EB05 33.2 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Eye irritation | 248 | 36.4 32.4–41.0ROR 40.2 · χ² 8,497 / p <1e-300 | 36.2 EB05 32.6 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 98.2 | no trial data cached |
| Photophobia (light sensitivity) | 72 | 31.6 25.1–39.7ROR 32.4 · χ² 2,094 / p <1e-300 | 31.2 EB05 25.6 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Product use complaint | 52 | 27.4 21.0–35.9ROR 28.0 · χ² 1,295 / p 5e-284 | 27.1 EB05 21.5 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Eye discharge | 30 | 24.0 16.8–34.3ROR 24.3 · χ² 637 / p 6e-141 | 23.6 EB05 17.3 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=1 | no trial data cached |
| Lacrimation increased | 86 | 23.5 19.1–29.0ROR 24.3 · χ² 1,831 / 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 | – | no trial data cached |
| Eye inflammation | 27 | 23.4 16.1–34.1ROR 23.6 · χ² 556 / p 4e-123 | 23.0 EB05 16.6 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Ocular hyperaemia | 121 | 21.2 17.8–25.2ROR 22.2 · χ² 2,305 / p <1e-300 | 21.1 EB05 18.1 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 103.6 | no trial data cached |
| Dry eye | 108 | 18.2 15.1–21.9ROR 19.0 · χ² 1,740 / p <1e-300 | 18.1 EB05 15.4 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Eye swelling | 73 | 16.1 12.9–20.2ROR 16.6 · χ² 1,021 / p 3e-224 | 16.0 EB05 13.1 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 31.4 | no trial data cached |
| Vitreous floaters | 17 | 14.3 8.9–22.9ROR 14.3 · χ² 196 / p 7e-45 | 13.4 EB05 8.3 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Impaired quality of life | 23 | 13.1 8.7–19.6ROR 13.2 · χ² 244 / p 3e-55 | 12.4 EB05 8.3 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Intraocular pressure increased (raised eye pressure) | 20 | 12.7 8.2–19.7ROR 12.8 · χ² 204 / p 1e-46 | 11.9 EB05 7.7 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | – | no trial data cached |
| Eye pruritus | 51 | 12.6 9.6–16.6ROR 12.9 · χ² 535 / p 1e-118 | 12.4 EB05 9.7 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Eye infection | 17 | 12.4 7.7–19.9ROR 12.5 · χ² 166 / p 2e-38 | 11.3 EB05 7.0 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=3 | no trial data cached |
| Eyelid oedema | 15 | 10.5 6.3–17.3ROR 10.5 · χ² 119 / p 5e-28 | 9.1 EB05 5.4 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Ear discomfort | 13 | 10.4 6.0–17.8ROR 10.4 · χ² 101 / p 5e-24 | 8.8 EB05 5.0 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Product administration error | 23 | 9.4 6.3–14.1ROR 9.5 · χ² 164 / p 6e-38 | 8.5 EB05 5.8 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Visual acuity reduced | 37 | 9.0 6.5–12.4ROR 9.1 · χ² 256 / p 6e-58 | 8.4 EB05 6.3 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Vision blurred (blurred vision) | 148 | 8.8 7.6–10.3ROR 9.3 · χ² 1,028 / p 9e-226 | 8.7 EB05 7.6 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.7 | no trial data cached |
| Neutrophil count increased | 11 | 8.7 4.8–15.8ROR 8.8 · χ² 68 / p 9e-17 | 7.0 EB05 4.0 · IC025 +1.7 3/3 methods agree | Lab value / disease marker | – | no trial data cached |
| Hospice care | 10 | 8.3 4.5–15.4ROR 8.3 · χ² 57 / p 2e-14 | 6.5 EB05 3.6 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Blood urea increased | 17 | 8.2 5.1–13.2ROR 8.3 · χ² 101 / p 5e-24 | 7.1 EB05 4.6 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | – | no trial data cached |
| Tinnitus (ringing in the ears) | 46 | 8.2 6.1–10.9ROR 8.3 · χ² 282 / p 1e-63 | 7.7 EB05 6.0 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Eyelid ptosis | 10 | 8.0 4.3–14.9ROR 8.1 · χ² 55 / p 7e-14 | 6.3 EB05 3.5 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Ear pain | 19 | 8.0 5.1–12.5ROR 8.0 · χ² 109 / p 8e-26 | 7.0 EB05 4.6 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Seasonal allergy | 12 | 6.9 3.9–12.2ROR 7.0 · χ² 55 / p 6e-14 | 5.7 EB05 3.4 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Discomfort | 46 | 6.2 4.6–8.2ROR 6.3 · χ² 196 / p 1e-44 | 5.9 EB05 4.6 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Haemorrhoids | 14 | 5.8 3.5–9.9ROR 5.9 · χ² 52 / p 4e-13 | 5.0 EB05 3.2 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Eye disorder | 23 | 5.7 3.8–8.6ROR 5.8 · χ² 85 / p 1e-20 | 5.2 EB05 3.6 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Cataract | 41 | 5.6 4.2–7.6ROR 5.7 · χ² 152 / p 3e-35 | 5.3 EB05 4.1 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Haematocrit decreased | 13 | 5.3 3.1–9.1ROR 5.3 · χ² 41 / p 6e-11 | 4.5 EB05 2.8 · IC025 +1.3 3/3 methods agree | Lab value / disease marker | – | no trial data cached |
| Blood alkaline phosphatase increased | 16 | 5.2 3.2–8.6ROR 5.3 · χ² 51 / p 5e-13 | 4.6 EB05 3.0 · IC025 +1.4 3/3 methods agree | Lab value / disease marker | – | no trial data cached |
| Device use issue | 11 | 5.2 2.9–9.4ROR 5.2 · χ² 33 / p 4e-9 | 4.3 EB05 2.6 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Sleep apnoea syndrome | 12 | 5.1 2.9–9.0ROR 5.1 · χ² 36 / p 1e-9 | 4.3 EB05 2.7 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Glaucoma | 12 | 5.1 2.9–8.9ROR 5.1 · χ² 35 / p 1e-9 | 4.3 EB05 2.7 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Diplopia (double vision) | 16 | 5.0 3.1–8.2ROR 5.1 · χ² 48 / p 3e-12 | 4.4 EB05 2.9 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Leukocytosis | 11 | 5.0 2.8–9.0ROR 5.0 · χ² 31 / p 1e-8 | 4.2 EB05 2.5 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Conjunctivitis | 10 | 4.4 2.4–8.2ROR 4.5 · χ² 23 / p 7e-7 | 3.8 EB05 2.2 · IC025 +0.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 55.4 | 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 pain | 346 | 51.4 46.6–56.7ROR 59.3 · χ² 16,991 / p <1e-300 | 51.0 EB05 46.6 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 45.9 | no trial data cached |
| Eye irritation | 248 | 36.4 32.4–41.0ROR 40.2 · χ² 8,497 / p <1e-300 | 36.2 EB05 32.6 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 98.2 | no trial data cached |
| Vision blurred (blurred vision) | 148 | 8.8 7.6–10.3ROR 9.3 · χ² 1,028 / p 9e-226 | 8.7 EB05 7.6 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.7 | no trial data cached |
| Ocular hyperaemia | 121 | 21.2 17.8–25.2ROR 22.2 · χ² 2,305 / p <1e-300 | 21.1 EB05 18.1 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 103.6 | no trial data cached |
| Dry eye | 108 | 18.2 15.1–21.9ROR 19.0 · χ² 1,740 / p <1e-300 | 18.1 EB05 15.4 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Lacrimation increased | 86 | 23.5 19.1–29.0ROR 24.3 · χ² 1,831 / 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 | – | no trial data cached |
| Eye swelling | 73 | 16.1 12.9–20.2ROR 16.6 · χ² 1,021 / p 3e-224 | 16.0 EB05 13.1 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 31.4 | no trial data cached |
| Photophobia (light sensitivity) | 72 | 31.6 25.1–39.7ROR 32.4 · χ² 2,094 / p <1e-300 | 31.2 EB05 25.6 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Visual impairment | 66 | 4.4 3.4–5.6ROR 4.5 · χ² 170 / p 5e-39 | 4.3 EB05 3.5 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.7 | no trial data cached |
| Emotional distress | 62 | 4.2 3.3–5.3ROR 4.2 · χ² 147 / p 5e-34 | 4.0 EB05 3.3 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Ocular discomfort | 56 | 42.3 32.6–54.8ROR 43.2 · χ² 2,205 / p <1e-300 | 41.5 EB05 33.2 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Wrong technique in product usage process | 55 | 2.2 1.7–2.9ROR 2.2 · χ² 36 / p 1e-9 | 2.2 EB05 1.8 · IC025 +0.7 | Reporting / coding artifact | – | no trial data cached |
| Product use complaint | 52 | 27.4 21.0–35.9ROR 28.0 · χ² 1,295 / p 5e-284 | 27.1 EB05 21.5 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Eye pruritus | 51 | 12.6 9.6–16.6ROR 12.9 · χ² 535 / p 1e-118 | 12.4 EB05 9.7 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Discomfort | 46 | 6.2 4.6–8.2ROR 6.3 · χ² 196 / p 1e-44 | 5.9 EB05 4.6 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | 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 Lubricant Eye Drops?
In FDA FAERS, the most frequently co-reported reaction terms for Lubricant Eye Drops are eye pain, eye irritation, vision blurred, ocular hyperaemia, dry eye, lacrimation increased. 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 Lubricant Eye Drops have an FDA boxed warning?
No. The FDA label retrieved for Lubricant Eye Drops has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Lubricant Eye Drops 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 c13c5f91-50df-471c-a7c9-1747a2ac1250, effective 20260203; matched on
openfda.generic_name.exact:"LUBRICANT EYE DROPS") - 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, 111 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.