Drug · FAERS side-effect profile with label screen
Timolol Ophthalmic side effects: what 7,571 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Timolol Maleate Ophthalmic (Timolol Maleate)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
7,571 reports · 48% serious · 432 with death outcome · 59% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Timolol maleate ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
FDA label, Indications and Usage
What it is
DESCRIPTION Timolol maleate ophthalmic solution, USP is a non-selective beta-adrenergic receptor blocking agent.
FDA label, Description section
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
Labeled adverse reaction 3Labeled (related wording) 7Likely indication confounding 2Reporting / coding artifact 4Not in label — unassessed 24
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- 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.
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. 379 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 |
|---|---|---|---|---|---|---|
| Intraocular pressure increased (raised eye pressure) | 221 | 48.5 42.5–55.3ROR 49.9 · χ² 10,056 / p <1e-300 | 47.5 EB05 42.4 · IC025 +5.2 3/3 methods agree | Likely indication confounding term in indications | serious PRR 56.9 | no trial data cached |
| Treatment failure | 978 | 33.4 31.5–35.4ROR 38.2 · χ² 30,433 / p <1e-300 | 33.0 EB05 31.3 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious PRR 2.7 · 78% consumer | no trial data cached |
| Glaucoma | 153 | 22.2 18.9–25.9ROR 22.6 · χ² 3,047 / p <1e-300 | 21.9 EB05 19.2 · IC025 +4.1 3/3 methods agree | Likely indication confounding term in indications | serious PRR 26.9 | no trial data cached |
| Eye pain | 425 | 21.5 19.6–23.6ROR 22.7 · χ² 8,229 / p <1e-300 | 21.3 EB05 19.6 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.8 · 82% consumer | no trial data cached |
| Ocular discomfort | 66 | 16.9 13.3–21.5ROR 17.1 · χ² 967 / p 1e-212 | 16.7 EB05 13.6 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=10 · 86% consumer | no trial data cached |
| Eye irritation | 333 | 16.6 15.0–18.5ROR 17.3 · χ² 4,860 / p <1e-300 | 16.5 EB05 15.1 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 17.6 · 78% consumer | no trial data cached |
| Eye pruritus | 166 | 14.0 12.0–16.3ROR 14.3 · χ² 1,985 / p <1e-300 | 13.9 EB05 12.2 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.8 · 75% consumer | no trial data cached |
| Eye inflammation | 47 | 13.9 10.4–18.4ROR 13.9 · χ² 545 / p 6e-121 | 13.6 EB05 10.5 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=28 | no trial data cached |
| Ocular hyperaemia | 220 | 13.1 11.5–14.9ROR 13.5 · χ² 2,439 / p <1e-300 | 13.0 EB05 11.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 12.8 · 73% consumer | no trial data cached |
| Eye discharge | 47 | 12.8 9.6–17.0ROR 12.9 · χ² 497 / p 2e-110 | 12.5 EB05 9.6 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious n=9 · 87% consumer | no trial data cached |
| Lacrimation increased | 128 | 11.9 10.0–14.1ROR 12.1 · χ² 1,264 / p 3e-277 | 11.8 EB05 10.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 · 70% consumer | no trial data cached |
| Photophobia (light sensitivity) | 77 | 11.5 9.2–14.3ROR 11.6 · χ² 722 / p 2e-159 | 11.2 EB05 9.2 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 · 84% consumer | no trial data cached |
| Eye infection | 41 | 10.2 7.5–13.8ROR 10.2 · χ² 328 / p 1e-73 | 9.6 EB05 7.3 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious n=13 · 74% consumer | no trial data cached |
| Hand deformity | 33 | 7.0 5.0–9.8ROR 7.0 · χ² 163 / p 1e-37 | 6.4 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 · ♀ 100% (drug 59%) | no trial data cached |
| Visual acuity reduced | 83 | 6.9 5.5–8.5ROR 6.9 · χ² 411 / p 1e-91 | 6.6 EB05 5.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 | no trial data cached |
| Sciatica | 38 | 6.6 4.8–9.1ROR 6.7 · χ² 176 / p 2e-40 | 6.2 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 10.5 · ♀ 88% (drug 59%) | no trial data cached |
| Product use complaint | 35 | 6.3 4.5–8.7ROR 6.3 · χ² 149 / p 1e-34 | 5.8 EB05 4.4 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious n=10 · ♀ 82% (drug 59%) · 88% consumer | no trial data cached |
| Dry eye | 109 | 6.2 5.2–7.5ROR 6.3 · χ² 474 / p 2e-105 | 6.1 EB05 5.2 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.1 · ♀ 79% (drug 59%) · 79% consumer | no trial data cached |
| Sinus bradycardia | 21 | 6.0 3.9–9.2ROR 6.0 · χ² 83 / p 5e-20 | 5.4 EB05 3.7 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.5 | no trial data cached |
| Blindness unilateral | 30 | 5.9 4.1–8.4ROR 5.9 · χ² 117 / p 1e-27 | 5.4 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Eye swelling | 76 | 5.7 4.6–7.1ROR 5.7 · χ² 290 / p 3e-65 | 5.5 EB05 4.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 · 81% consumer | no trial data cached |
| Blindness | 78 | 5.3 4.3–6.6ROR 5.4 · χ² 269 / p 1e-60 | 5.1 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Eye disorder | 62 | 5.2 4.1–6.7ROR 5.3 · χ² 209 / p 1e-47 | 5.0 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Vision blurred (blurred vision) | 249 | 5.1 4.5–5.7ROR 5.2 · χ² 809 / p 2e-178 | 5.0 EB05 4.5 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.1 · 73% consumer | no trial data cached |
| Cataract | 102 | 4.8 3.9–5.8ROR 4.8 · χ² 300 / p 1e-67 | 4.7 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | no trial data cached |
| Product administration error | 32 | 4.4 3.1–6.3ROR 4.5 · χ² 82 / p 7e-20 | 4.2 EB05 3.1 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 2.5 · 78% consumer | no trial data cached |
| Eyelid ptosis | 16 | 4.4 2.7–7.1ROR 4.4 · χ² 38 / p 3e-10 | 3.9 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Eyelid oedema | 18 | 4.3 2.7–6.8ROR 4.3 · χ² 42 / p 5e-11 | 3.9 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Retinal detachment | 14 | 4.2 2.5–7.1ROR 4.2 · χ² 31 / p 1e-8 | 3.8 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Macular degeneration | 18 | 4.2 2.6–6.6ROR 4.2 · χ² 40 / p 1e-10 | 3.8 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Intervertebral disc degeneration | 14 | 4.2 2.5–7.0ROR 4.2 · χ² 31 / p 2e-8 | 3.7 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Heart rate decreased | 53 | 4.2 3.2–5.4ROR 4.2 · χ² 124 / p 4e-29 | 4.0 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.6 | no trial data cached |
| Eye haemorrhage | 20 | 4.1 2.7–6.4ROR 4.2 · χ² 45 / p 1e-11 | 3.8 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Uveitis | 20 | 4.1 2.6–6.4ROR 4.1 · χ² 44 / p 2e-11 | 3.8 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Body height decreased | 16 | 4.1 2.5–6.7ROR 4.1 · χ² 34 / p 2e-9 | 3.7 EB05 2.4 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Product packaging quantity issue | 16 | 4.1 2.5–6.6ROR 4.1 · χ² 34 / p 3e-9 | 3.7 EB05 2.4 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious n=6 | no trial data cached |
| Bradycardia (slow heart rate) | 77 | 4.0 3.2–5.0ROR 4.0 · χ² 172 / p 2e-39 | 3.9 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.9 | no trial data cached |
| Vitreous floaters | 14 | 4.0 2.4–6.7ROR 4.0 · χ² 28 / p 5e-8 | 3.6 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Deformity | 13 | 3.8 2.2–6.6ROR 3.8 · χ² 25 / p 4e-7 | 3.4 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Visual impairment | 169 | 3.8 3.3–4.4ROR 3.9 · χ² 349 / p 4e-78 | 3.8 EB05 3.3 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | 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 |
|---|---|---|---|---|---|---|
| Treatment failure | 978 | 33.4 31.5–35.4ROR 38.2 · χ² 30,433 / p <1e-300 | 33.0 EB05 31.3 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious PRR 2.7 · 78% consumer | no trial data cached |
| Drug ineffective (drug did not work) | 563 | 1.2 1.1–1.3ROR 1.2 · χ² 17 / p 2e-5 | 1.2 EB05 1.1 · IC025 +0.1 | Reporting / coding artifact | serious PRR 1.8 | no trial data cached |
| Eye pain | 425 | 21.5 19.6–23.6ROR 22.7 · χ² 8,229 / p <1e-300 | 21.3 EB05 19.6 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.8 · 82% consumer | no trial data cached |
| Fatigue (tiredness) | 400 | 1.4 1.3–1.6ROR 1.4 · χ² 52 / p 2e-13 | 1.4 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Eye irritation | 333 | 16.6 15.0–18.5ROR 17.3 · χ² 4,860 / p <1e-300 | 16.5 EB05 15.1 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 17.6 · 78% consumer | no trial data cached |
| Dizziness | 283 | 1.6 1.4–1.8ROR 1.6 · χ² 60 / p 5e-15 | 1.6 EB05 1.4 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 2.1 | no trial data cached |
| Vision blurred (blurred vision) | 249 | 5.1 4.5–5.7ROR 5.2 · χ² 809 / p 2e-178 | 5.0 EB05 4.5 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.1 · 73% consumer | no trial data cached |
| Death | 223 | 0.7 0.6–0.8ROR 0.7 · χ² 26 / p 2e-7 | 0.7 EB05 0.6 · IC025 -0.7 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction | serious PRR 0.9 | no trial data cached |
| Intraocular pressure increased (raised eye pressure) | 221 | 48.5 42.5–55.3ROR 49.9 · χ² 10,056 / p <1e-300 | 47.5 EB05 42.4 · IC025 +5.2 3/3 methods agree | Likely indication confounding term in indications | serious PRR 56.9 | no trial data cached |
| Ocular hyperaemia | 220 | 13.1 11.5–14.9ROR 13.5 · χ² 2,439 / p <1e-300 | 13.0 EB05 11.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 12.8 · 73% consumer | no trial data cached |
| Fall | 210 | 1.7 1.5–2.0ROR 1.8 · χ² 68 / p 1e-16 | 1.7 EB05 1.6 · IC025 +0.6 | Not in label — unassessed | serious PRR 2.2 | no trial data cached |
| Asthenia (weakness) | 195 | 1.4 1.3–1.6ROR 1.4 · χ² 26 / p 2e-7 | 1.4 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.9 | no trial data cached |
| Hypersensitivity (allergic reaction) | 179 | 2.7 2.3–3.1ROR 2.7 · χ² 188 / p 5e-43 | 2.7 EB05 2.3 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Visual impairment | 169 | 3.8 3.3–4.4ROR 3.9 · χ² 349 / p 4e-78 | 3.8 EB05 3.3 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Eye pruritus | 166 | 14.0 12.0–16.3ROR 14.3 · χ² 1,985 / p <1e-300 | 13.9 EB05 12.2 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.8 · 75% consumer | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Ocular discomfort — n=66, PRR 16.9
- Eye inflammation — n=47, PRR 13.9
- Ocular hyperaemia — n=220, PRR 13.1
- Lacrimation increased — n=128, PRR 11.9
- Photophobia — n=77, PRR 11.5
- Hand deformity — n=33, PRR 7.0
- Visual acuity reduced — n=83, PRR 6.9
- Sciatica — n=38, PRR 6.6
- Blindness unilateral — n=30, PRR 5.9
- Eye swelling — n=76, PRR 5.7
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 Timolol Ophthalmic?
In FDA FAERS, the most frequently co-reported reaction terms for Timolol Ophthalmic are eye pain, fatigue, eye irritation, dizziness, vision blurred, intraocular pressure 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 Timolol Ophthalmic have an FDA boxed warning?
No. The FDA label retrieved for Timolol Ophthalmic has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Timolol Ophthalmic 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 6c9f3971-8c07-4d3a-915d-76438baa2a0b, effective 20241003; matched on
openfda.generic_name.exact:"TIMOLOL MALEATE OPHTHALMIC") - 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, 419 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.