Drug · FAERS side-effect profile with label screen
Dorzolamide and Timolol side effects: what 7,858 FDA adverse event reports show
Drug class
Carbonic anhydrase inhibitor
FDA label, Indications wording of the closest related product
Label matched
Dorzolamide (Dorzolamide Hydrochloride)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
7,858 reports · 55% serious · 650 with death outcome · 60% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Dorzolamide hydrochloride ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Dorzolamide hydrochloride ophthalmic solution is a carbonic anhydrase inhibitor indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. (1)
FDA label, Indications and Usage
What it is
Dorzolamide hydrochloride ophthalmic solution, is a carbonic anhydrase inhibitor formulated for topical ophthalmic use. Dorzolamide hydrochloride is described chemically as: (4 S-trans )-4-(ethylamino)-5,6-dihydro-6methyl-4 H -thieno[2,3- b ]thiopyran-2-sulfonamide 7,7-dioxide monohydrochloride.
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 2Labeled (related wording) 7Likely indication confounding 5Reporting / coding artifact 2Not 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. 973 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 |
|---|---|---|---|---|---|---|
| Glaucoma surgery | 22 | 251.8 162.7–389.7ROR 252.5 · χ² 4,789 / p <1e-300 | 191.8 EB05 133.5 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious n=18 | no trial data cached |
| Eye burns | 34 | 161.3 114.1–227.8ROR 162.0 · χ² 4,953 / p <1e-300 | 140.2 EB05 104.9 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | 73% consumer | no trial data cached |
| Intraocular pressure test abnormal | 32 | 126.5 88.8–180.2ROR 127.0 · χ² 3,682 / p <1e-300 | 112.8 EB05 83.6 · IC025 +4.8 3/3 methods agree | Reporting / coding artifact | serious n=23 | no trial data cached |
| Intraocular pressure increased (raised eye pressure) | 364 | 77.8 70.3–86.2ROR 81.6 · χ² 26,762 / p <1e-300 | 75.4 EB05 69.1 · IC025 +5.9 3/3 methods agree | Likely indication confounding term in indications | serious PRR 74.9 | no trial data cached |
| Intraocular pressure decreased | 15 | 77.4 46.4–129.3ROR 77.6 · χ² 1,026 / p 2e-225 | 68.9 EB05 44.3 · IC025 +3.6 3/3 methods agree | Likely indication confounding term in indications | serious n=8 | no trial data cached |
| Open angle glaucoma | 15 | 66.8 40.0–111.5ROR 66.9 · χ² 885 / p 8e-195 | 60.4 EB05 38.9 · IC025 +3.5 3/3 methods agree | Likely indication confounding term in indications | serious n=15 | no trial data cached |
| Choroidal detachment | 12 | 59.0 33.3–104.6ROR 59.1 · χ² 614 / p 7e-136 | 53.2 EB05 32.4 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious n=12 | no trial data cached |
| Superficial injury of eye | 21 | 53.4 34.7–82.1ROR 53.5 · χ² 1,007 / p 3e-221 | 50.1 EB05 34.6 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Hyphaema | 10 | 51.8 27.7–96.9ROR 51.9 · χ² 440 / p 5e-98 | 46.6 EB05 27.1 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Corneal opacity | 24 | 47.9 32.0–71.7ROR 48.1 · χ² 1,038 / p 6e-228 | 45.5 EB05 32.2 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=22 | no trial data cached |
| Reaction to preservatives | 14 | 46.5 27.4–78.9ROR 46.6 · χ² 569 / p 5e-126 | 43.2 EB05 27.4 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Colitis microscopic | 79 | 45.7 36.6–57.0ROR 46.1 · χ² 3,350 / p <1e-300 | 44.5 EB05 36.8 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=79 · ♀ 100% (drug 60%) | no trial data cached |
| Growth of eyelashes | 13 | 44.3 25.6–76.6ROR 44.3 · χ² 499 / p 8e-111 | 41.1 EB05 25.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=6 | no trial data cached |
| Eyelid skin dryness | 19 | 44.1 28.0–69.3ROR 44.2 · χ² 745 / p 3e-164 | 41.7 EB05 28.2 · IC025 +3.6 3/3 methods agree | Labeled (related wording) related wording | – | no trial data cached |
| Eyelid margin crusting | 44 | 42.3 31.4–56.9ROR 42.5 · χ² 1,706 / p <1e-300 | 41.0 EB05 31.8 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=7 · 71% consumer | no trial data cached |
| Eyelid exfoliation | 12 | 41.3 23.4–73.1ROR 41.4 · χ² 426 / p 5e-95 | 38.4 EB05 23.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Product dropper issue | 12 | 40.8 23.1–72.1ROR 40.8 · χ² 420 / p 1e-93 | 37.9 EB05 23.1 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious n=6 | no trial data cached |
| Glaucoma | 278 | 39.1 34.8–43.9ROR 40.4 · χ² 10,129 / p <1e-300 | 38.4 EB05 34.8 · IC025 +5.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 40.9 | no trial data cached |
| Corneal transplant | 11 | 38.7 21.4–70.2ROR 38.8 · χ² 362 / p 5e-81 | 36.0 EB05 21.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Eye injury | 43 | 38.7 28.6–52.2ROR 38.9 · χ² 1,518 / p <1e-300 | 37.5 EB05 29.0 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=8 · 80% consumer | no trial data cached |
| Eye irritation | 788 | 38.3 35.8–40.9ROR 42.4 · χ² 28,215 / p <1e-300 | 37.7 EB05 35.5 · IC025 +5.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 26.4 · 71% consumer | no trial data cached |
| Ocular hyperaemia | 644 | 37.3 34.6–40.2ROR 40.5 · χ² 22,440 / p <1e-300 | 36.7 EB05 34.4 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 16.8 · 72% consumer | no trial data cached |
| Periorbital pain | 11 | 37.1 20.5–67.2ROR 37.1 · χ² 346 / p 2e-77 | 34.6 EB05 20.6 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Blepharitis | 49 | 33.5 25.3–44.4ROR 33.7 · χ² 1,495 / p <1e-300 | 32.7 EB05 25.7 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=22 | no trial data cached |
| Foreign body sensation in eyes | 75 | 32.4 25.9–40.7ROR 32.7 · χ² 2,227 / p <1e-300 | 31.8 EB05 26.2 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=13 · 81% consumer | no trial data cached |
| Eye pruritus | 394 | 32.3 29.3–35.5ROR 33.9 · χ² 11,781 / p <1e-300 | 31.8 EB05 29.3 · IC025 +4.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.8 · 77% consumer | no trial data cached |
| Eyelid irritation | 29 | 31.8 22.1–45.8ROR 31.9 · χ² 825 / p 1e-181 | 30.9 EB05 22.5 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious n=3 | no trial data cached |
| Corneal abrasion | 15 | 29.6 17.8–49.3ROR 29.7 · χ² 383 / p 2e-85 | 28.4 EB05 18.2 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Eyelid pain | 21 | 29.2 19.0–44.8ROR 29.3 · χ² 538 / p 3e-119 | 28.2 EB05 19.5 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | – | no trial data cached |
| Corneal oedema | 23 | 27.6 18.3–41.6ROR 27.7 · χ² 558 / p 1e-123 | 26.8 EB05 18.8 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious n=19 | no trial data cached |
| Eyelids pruritus | 31 | 27.3 19.2–38.8ROR 27.4 · χ² 751 / p 1e-165 | 26.6 EB05 19.6 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | 84% consumer | no trial data cached |
| Eye discharge | 102 | 26.9 22.2–32.7ROR 27.2 · χ² 2,494 / p <1e-300 | 26.5 EB05 22.5 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=23 | no trial data cached |
| Ocular hypertension | 19 | 26.7 17.0–42.0ROR 26.8 · χ² 441 / p 4e-98 | 25.8 EB05 17.5 · IC025 +3.2 3/3 methods agree | Likely indication confounding term in indications | serious n=17 | no trial data cached |
| Erythema of eyelid | 50 | 25.2 19.1–33.2ROR 25.3 · χ² 1,127 / p 3e-247 | 24.8 EB05 19.5 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=15 · 70% consumer | no trial data cached |
| Eye pain | 482 | 23.5 21.5–25.6ROR 25.0 · χ² 10,291 / p <1e-300 | 23.3 EB05 21.6 · IC025 +4.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.2 | no trial data cached |
| Eye allergy | 11 | 19.2 10.6–34.8ROR 19.2 · χ² 171 / p 2e-39 | 18.0 EB05 9.9 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=5 | no trial data cached |
| Lacrimation increased | 208 | 18.7 16.3–21.4ROR 19.2 · χ² 3,448 / p <1e-300 | 18.5 EB05 16.5 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 · 73% consumer | no trial data cached |
| Eye swelling | 251 | 18.2 16.1–20.6ROR 18.8 · χ² 4,050 / p <1e-300 | 18.1 EB05 16.3 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 · 75% consumer | no trial data cached |
| Cytomegalovirus chorioretinitis | 13 | 18.1 10.5–31.2ROR 18.1 · χ² 192 / p 6e-44 | 17.1 EB05 10.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Swelling of eyelid | 41 | 18.0 13.3–24.5ROR 18.1 · χ² 639 / p 3e-141 | 17.8 EB05 13.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | 83% 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 |
|---|---|---|---|---|---|---|
| Eye irritation | 788 | 38.3 35.8–40.9ROR 42.4 · χ² 28,215 / p <1e-300 | 37.7 EB05 35.5 · IC025 +5.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 26.4 · 71% consumer | no trial data cached |
| Ocular hyperaemia | 644 | 37.3 34.6–40.2ROR 40.5 · χ² 22,440 / p <1e-300 | 36.7 EB05 34.4 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 16.8 · 72% consumer | no trial data cached |
| Drug ineffective (drug did not work) | 589 | 1.2 1.1–1.3ROR 1.2 · χ² 20 / p 5e-6 | 1.2 EB05 1.1 · IC025 +0.1 | Reporting / coding artifact | serious PRR 1.9 | no trial data cached |
| Eye pain | 482 | 23.5 21.5–25.6ROR 25.0 · χ² 10,291 / p <1e-300 | 23.3 EB05 21.6 · IC025 +4.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.2 | no trial data cached |
| Eye pruritus | 394 | 32.3 29.3–35.5ROR 33.9 · χ² 11,781 / p <1e-300 | 31.8 EB05 29.3 · IC025 +4.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.8 · 77% consumer | no trial data cached |
| Intraocular pressure increased (raised eye pressure) | 364 | 77.8 70.3–86.2ROR 81.6 · χ² 26,762 / p <1e-300 | 75.4 EB05 69.1 · IC025 +5.9 3/3 methods agree | Likely indication confounding term in indications | serious PRR 74.9 | no trial data cached |
| Death | 338 | 1.0 0.9–1.2ROR 1.0 · χ² 1 / p 0.201 | 1.0 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction | serious PRR 1.1 | no trial data cached |
| Vision blurred (blurred vision) | 329 | 6.4 5.8–7.2ROR 6.7 · χ² 1,513 / p <1e-300 | 6.4 EB05 5.8 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.3 | no trial data cached |
| Glaucoma | 278 | 39.1 34.8–43.9ROR 40.4 · χ² 10,129 / p <1e-300 | 38.4 EB05 34.8 · IC025 +5.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 40.9 | no trial data cached |
| Fatigue (tiredness) | 274 | 0.9 0.8–1.1ROR 0.9 · χ² 1 / p 0.161 | 0.9 EB05 0.9 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.2 | no trial data cached |
| Dyspnoea (shortness of breath) | 263 | 1.2 1.1–1.4ROR 1.2 · χ² 12 / p 2e-4 | 1.2 EB05 1.1 · IC025 +0.1 | Labeled adverse reaction exact term | serious PRR 1.3 | no trial data cached |
| Eye swelling | 251 | 18.2 16.1–20.6ROR 18.8 · χ² 4,050 / p <1e-300 | 18.1 EB05 16.3 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 · 75% consumer | no trial data cached |
| Off label use (used outside approved label) | 249 | 0.8 0.7–0.9ROR 0.8 · χ² 18 / p 9e-6 | 0.8 EB05 0.7 · IC025 -0.6 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.0 | no trial data cached |
| Headache | 228 | 1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.342 | 1.0 EB05 0.9 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.3 | no trial data cached |
| Hypersensitivity (allergic reaction) | 217 | 3.1 2.7–3.6ROR 3.2 · χ² 314 / p 1e-70 | 3.1 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.1 | 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.
- Eye burns — n=34, PRR 161.3
- Superficial injury of eye — n=21, PRR 53.4
- Corneal opacity — n=24, PRR 47.9
- Colitis microscopic — n=79, PRR 45.7
- Eyelid margin crusting — n=44, PRR 42.3
- Eye injury — n=43, PRR 38.7
- Ocular hyperaemia — n=644, PRR 37.3
- Blepharitis — n=49, PRR 33.5
- Foreign body sensation in eyes — n=75, PRR 32.4
- Eyelids pruritus — n=31, PRR 27.3
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 Dorzolamide and Timolol?
In FDA FAERS, the most frequently co-reported reaction terms for Dorzolamide and Timolol are eye irritation, ocular hyperaemia, eye pain, eye pruritus, intraocular pressure increased, vision blurred. 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 Dorzolamide and Timolol have an FDA boxed warning?
No. The FDA label retrieved for Dorzolamide and Timolol has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Dorzolamide and 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 462a61b2-1ec6-4d18-bc6b-fc03e027caa0, effective 20241004; matched on
openfda.generic_name.exact:"DORZOLAMIDE") - 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, 1,013 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.