Drug · FAERS side-effect profile with label screen
Timolol Maleate side effects: what 9,846 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Betimol
openFDA label
Who reports
9,846 reports · 51% serious · 582 with death outcome · 60% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Betimol ® 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 Betimol ® (timolol ophthalmic solution), 0.25% and 0.5%, is a non-selective beta-adrenergic antagonist for ophthalmic use.
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 1Labeled (related wording) 9Likely indication confounding 5Reporting / coding artifact 4Not in label — unassessed 21
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. 1,013 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 |
|---|---|---|---|---|---|---|
| Trabeculectomy | 10 | 256.1 132.9–493.6ROR 256.4 · χ² 2,043 / p <1e-300 | 159.5 EB05 92.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Corneal deposits | 43 | 132.0 97.1–179.5ROR 132.6 · χ² 5,138 / p <1e-300 | 117.9 EB05 91.2 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=39 · ♀ 36% (drug 60%) | no trial data cached |
| Anterior chamber disorder | 10 | 95.0 50.4–179.0ROR 95.1 · χ² 802 / p 8e-177 | 77.9 EB05 45.2 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Glaucoma surgery | 10 | 86.8 46.1–163.3ROR 86.9 · χ² 734 / p 6e-162 | 72.3 EB05 42.0 · IC025 +3.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=9 | no trial data cached |
| Hypotony of eye | 14 | 73.7 43.3–125.5ROR 73.8 · χ² 901 / p 3e-198 | 65.2 EB05 41.3 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Intraocular pressure test abnormal | 22 | 68.3 44.7–104.4ROR 68.5 · χ² 1,349 / p 1e-295 | 62.8 EB05 43.7 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious n=13 | no trial data cached |
| Choroidal detachment | 17 | 67.4 41.6–109.1ROR 67.5 · χ² 1,013 / p 1e-222 | 61.0 EB05 40.4 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Intraocular pressure increased (raised eye pressure) | 316 | 53.7 48.1–59.9ROR 55.5 · χ² 15,896 / p <1e-300 | 52.2 EB05 47.6 · IC025 +5.4 3/3 methods agree | Likely indication confounding term in indications | serious PRR 59.1 | no trial data cached |
| Reaction to preservatives | 20 | 53.4 34.3–83.2ROR 53.5 · χ² 953 / p 1e-209 | 49.8 EB05 34.0 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Growth of eyelashes | 19 | 52.0 33.0–82.0ROR 52.1 · χ² 879 / p 2e-193 | 48.5 EB05 32.8 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Eyelid pain | 46 | 51.7 38.6–69.2ROR 51.9 · χ² 2,182 / p <1e-300 | 49.5 EB05 38.6 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious n=5 · 87% consumer | no trial data cached |
| Hyphaema | 12 | 49.8 28.1–88.3ROR 49.9 · χ² 514 / p 4e-114 | 45.4 EB05 27.7 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Intraocular pressure decreased | 12 | 49.1 27.7–87.0ROR 49.2 · χ² 507 / p 2e-112 | 44.8 EB05 27.3 · IC025 +3.1 3/3 methods agree | Likely indication confounding term in indications | serious n=5 | no trial data cached |
| Product dropper issue | 17 | 46.4 28.7–74.9ROR 46.4 · χ² 695 / p 2e-153 | 43.3 EB05 28.7 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Toxic anterior segment syndrome | 23 | 45.9 30.4–69.4ROR 46.0 · χ² 945 / p 7e-208 | 43.5 EB05 30.5 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 26% (drug 60%) · 100% clinician | no trial data cached |
| Periorbital pain | 16 | 43.3 26.4–71.0ROR 43.4 · χ² 607 / p 2e-134 | 40.6 EB05 26.5 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Iris adhesions | 10 | 42.9 23.0–80.3ROR 43.0 · χ² 361 / p 7e-81 | 39.2 EB05 22.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Choroidal effusion | 15 | 40.7 24.4–67.8ROR 40.8 · χ² 532 / p 7e-118 | 38.2 EB05 24.6 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Treatment failure | 1,014 | 26.6 25.1–28.2ROR 29.6 · χ² 24,763 / p <1e-300 | 26.3 EB05 25.0 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious PRR 2.0 · 79% consumer | no trial data cached |
| Instillation site irritation | 13 | 24.8 14.4–42.9ROR 24.8 · χ² 271 / p 4e-61 | 23.7 EB05 14.6 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Foreign body sensation in eyes | 70 | 24.1 19.1–30.5ROR 24.3 · χ² 1,512 / p <1e-300 | 23.7 EB05 19.4 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious n=9 · 75% consumer | no trial data cached |
| Superficial injury of eye | 12 | 24.1 13.7–42.6ROR 24.1 · χ² 241 / p 2e-54 | 22.9 EB05 13.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Glaucoma | 215 | 24.0 21.0–27.4ROR 24.5 · χ² 4,670 / p <1e-300 | 23.7 EB05 21.2 · IC025 +4.3 3/3 methods agree | Likely indication confounding term in indications | serious PRR 27.1 | no trial data cached |
| Eyelid irritation | 27 | 23.6 16.2–34.5ROR 23.7 · χ² 556 / p 3e-123 | 23.0 EB05 16.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=8 · 85% consumer | no trial data cached |
| Corneal oedema | 23 | 22.0 14.6–33.2ROR 22.1 · χ² 437 / p 3e-97 | 21.5 EB05 15.0 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious n=20 | no trial data cached |
| Ocular hypertension | 19 | 21.3 13.6–33.5ROR 21.4 · χ² 344 / p 4e-77 | 20.7 EB05 13.9 · IC025 +3.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=18 | no trial data cached |
| Conjunctivitis allergic | 14 | 20.6 12.1–34.8ROR 20.6 · χ² 239 / p 3e-54 | 19.7 EB05 12.1 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious n=5 | no trial data cached |
| Conjunctival hyperaemia | 34 | 20.5 14.6–28.7ROR 20.5 · χ² 605 / p 7e-134 | 20.1 EB05 15.0 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Eye pain | 524 | 20.4 18.7–22.2ROR 21.5 · χ² 9,573 / p <1e-300 | 20.2 EB05 18.8 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.1 · 79% consumer | no trial data cached |
| Sick sinus syndrome | 11 | 20.3 11.2–36.7ROR 20.3 · χ² 181 / p 1e-41 | 19.1 EB05 10.7 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Corneal disorder | 20 | 19.8 12.7–30.7ROR 19.8 · χ² 335 / p 4e-75 | 19.2 EB05 13.0 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious n=18 | no trial data cached |
| Eyelid margin crusting | 25 | 19.0 12.9–28.2ROR 19.1 · χ² 406 / p 1e-90 | 18.6 EB05 13.1 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Erythema of eyelid | 46 | 18.5 13.8–24.7ROR 18.6 · χ² 736 / p 2e-162 | 18.2 EB05 14.1 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious n=6 · ♀ 88% (drug 60%) · 78% consumer | no trial data cached |
| Eye irritation | 479 | 18.4 16.9–20.1ROR 19.3 · χ² 7,837 / p <1e-300 | 18.3 EB05 16.9 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 21.7 · 74% consumer | no trial data cached |
| Product container issue | 72 | 18.3 14.6–23.1ROR 18.5 · χ² 1,153 / p 4e-253 | 18.1 EB05 14.8 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious n=10 · 76% consumer | no trial data cached |
| Eyelids pruritus | 25 | 17.5 11.8–26.0ROR 17.6 · χ² 370 / p 9e-83 | 17.1 EB05 12.0 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | ♀ 88% (drug 60%) | no trial data cached |
| Abnormal sensation in eye | 34 | 17.1 12.2–23.9ROR 17.1 · χ² 494 / p 8e-110 | 16.7 EB05 12.4 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious n=12 | no trial data cached |
| Ocular discomfort | 86 | 17.0 13.8–21.0ROR 17.1 · χ² 1,268 / p 4e-278 | 16.8 EB05 14.0 · IC025 +3.6 3/3 methods agree | Labeled (related wording) related wording | serious n=15 · 81% consumer | no trial data cached |
| Eyelid disorder | 18 | 16.8 10.6–26.7ROR 16.8 · χ² 249 / p 2e-56 | 16.1 EB05 10.4 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious n=11 | no trial data cached |
| Eye pruritus | 218 | 14.2 12.4–16.2ROR 14.5 · χ² 2,641 / p <1e-300 | 14.0 EB05 12.5 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 15.5 · 75% 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 |
|---|---|---|---|---|---|---|
| Treatment failure | 1,014 | 26.6 25.1–28.2ROR 29.6 · χ² 24,763 / p <1e-300 | 26.3 EB05 25.0 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious PRR 2.0 · 79% consumer | no trial data cached |
| Drug ineffective (drug did not work) | 695 | 1.1 1.0–1.2ROR 1.1 · χ² 10 / p 8e-4 | 1.1 EB05 1.1 · IC025 +0.0 | Reporting / coding artifact | serious PRR 1.6 | no trial data cached |
| Fatigue (tiredness) | 524 | 1.4 1.3–1.6ROR 1.5 · χ² 72 / p 1e-17 | 1.4 EB05 1.3 · IC025 +0.4 | Labeled (related wording) related wording | serious PRR 1.8 | no trial data cached |
| Eye pain | 524 | 20.4 18.7–22.2ROR 21.5 · χ² 9,573 / p <1e-300 | 20.2 EB05 18.8 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.1 · 79% consumer | no trial data cached |
| Eye irritation | 479 | 18.4 16.9–20.1ROR 19.3 · χ² 7,837 / p <1e-300 | 18.3 EB05 16.9 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 21.7 · 74% consumer | no trial data cached |
| Dizziness | 380 | 1.6 1.5–1.8ROR 1.7 · χ² 93 / p 3e-22 | 1.6 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 2.1 | no trial data cached |
| Nausea | 353 | 1.0 0.9–1.1ROR 1.0 · χ² 1 / p 0.183 | 1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.3 | no trial data cached |
| Diarrhoea (diarrhea) | 353 | 1.2 1.1–1.3ROR 1.2 · χ² 9 / p 0.002 | 1.2 EB05 1.1 · IC025 +0.0 | Labeled adverse reaction exact term | serious PRR 1.4 | no trial data cached |
| Vision blurred (blurred vision) | 345 | 5.4 4.9–6.0ROR 5.5 · χ² 1,233 / p 2e-270 | 5.3 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.3 | no trial data cached |
| Dyspnoea (shortness of breath) | 327 | 1.2 1.1–1.4ROR 1.2 · χ² 14 / p 8e-5 | 1.2 EB05 1.1 · IC025 +0.1 | Labeled adverse reaction exact term | serious PRR 1.5 | no trial data cached |
| Headache | 324 | 1.1 1.0–1.2ROR 1.1 · χ² 3 / p 0.041 | 1.1 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.3 | no trial data cached |
| Intraocular pressure increased (raised eye pressure) | 316 | 53.7 48.1–59.9ROR 55.5 · χ² 15,896 / p <1e-300 | 52.2 EB05 47.6 · IC025 +5.4 3/3 methods agree | Likely indication confounding term in indications | serious PRR 59.1 | no trial data cached |
| Ocular hyperaemia | 305 | 14.0 12.5–15.6ROR 14.4 · χ² 3,648 / p <1e-300 | 13.9 EB05 12.6 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 12.6 · 70% consumer | no trial data cached |
| Off label use (used outside approved label) | 303 | 0.7 0.7–0.8ROR 0.7 · χ² 28 / p 7e-8 | 0.7 EB05 0.7 · IC025 -0.6 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.9 | no trial data cached |
| Fall | 283 | 1.8 1.6–2.0ROR 1.8 · χ² 104 / p 1e-24 | 1.8 EB05 1.6 · IC025 +0.7 | Not in label — unassessed | serious PRR 2.2 | 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.
- Corneal deposits — n=43, PRR 132.0
- Reaction to preservatives — n=20, PRR 53.4
- Toxic anterior segment syndrome — n=23, PRR 45.9
- Eyelid irritation — n=27, PRR 23.6
- Conjunctival hyperaemia — n=34, PRR 20.5
- Eyelid margin crusting — n=25, PRR 19.0
- Eye irritation — n=479, PRR 18.4
- Eyelids pruritus — n=25, PRR 17.5
- Eye pruritus — n=218, PRR 14.2
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?
In FDA FAERS, the most frequently co-reported reaction terms for Timolol are fatigue, eye pain, eye irritation, dizziness, nausea, diarrhoea. 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 have an FDA boxed warning?
No. The FDA label retrieved for Timolol has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Timolol 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 3ae775f4-340c-4bf4-aa49-8a31daba0f8b, effective 20250627; matched on
openfda.generic_name.exact:"TIMOLOL") - 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, 1,053 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.