Drug · FAERS side-effect profile with label screen

Dorzolamide and Timolol Ophthalmic side effects: what 773 FDA adverse event reports show

Dorzolamide Hydrochloride And Timolol Maleate Ophthalmic Solution · 8 reaction terms · 526 drug–reaction co-reports · data 2026-09-14

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

773 reports · 19% serious · 11 with death outcome · 57% 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 7 strongest signals

Labeled (related wording) 2Likely indication confounding 1Reporting / coding artifact 2Not in label — unassessed 2

What the badges mean

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 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Treatment failure	416	138.2 129.4–147.6ROR 298.0 · χ² 56,449 / p <1e-300	136.6 EB05 126.0 · IC025 +6.7 3/3 methods agree	Reporting / coding artifact	serious PRR 9.5 · 81% consumer	no trial data cached
Product packaging quantity issue	17	42.3 26.4–67.7ROR 43.2 · χ² 644 / p 2e-142	40.5 EB05 26.8 · IC025 +3.5 3/3 methods agree	Reporting / coding artifact	serious n=2	no trial data cached
Intraocular pressure increased (raised eye pressure)	15	31.7 19.2–52.4ROR 32.3 · χ² 416 / p 1e-92	30.6 EB05 19.7 · IC025 +3.1 3/3 methods agree	Likely indication confounding term in indications	serious PRR 37.4	no trial data cached
Eye irritation	35	17.0 12.3–23.6ROR 17.8 · χ² 514 / p 5e-114	16.8 EB05 12.6 · IC025 +3.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 7.2 · 94% consumer	no trial data cached
Eye discharge	6	15.9 7.2–35.4ROR 16.1 · χ² 70 / p 3e-17	12.4 EB05 4.7 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious n=2	no trial data cached
Eye pain	29	14.3 10.0–20.4ROR 14.8 · χ² 345 / p 3e-77	13.9 EB05 9.9 · IC025 +2.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 10.2 · 93% consumer	no trial data cached
Hand deformity	5	10.4 4.3–24.8ROR 10.4 · χ² 33 / p 4e-9	6.6 EB05 2.7 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 33.7	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	416	138.2 129.4–147.6ROR 298.0 · χ² 56,449 / p <1e-300	136.6 EB05 126.0 · IC025 +6.7 3/3 methods agree	Reporting / coding artifact	serious PRR 9.5 · 81% consumer	no trial data cached
Eye irritation	35	17.0 12.3–23.6ROR 17.8 · χ² 514 / p 5e-114	16.8 EB05 12.6 · IC025 +3.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 7.2 · 94% consumer	no trial data cached
Eye pain	29	14.3 10.0–20.4ROR 14.8 · χ² 345 / p 3e-77	13.9 EB05 9.9 · IC025 +2.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 10.2 · 93% consumer	no trial data cached
Product packaging quantity issue	17	42.3 26.4–67.7ROR 43.2 · χ² 644 / p 2e-142	40.5 EB05 26.8 · IC025 +3.5 3/3 methods agree	Reporting / coding artifact	serious n=2	no trial data cached
Intraocular pressure increased (raised eye pressure)	15	31.7 19.2–52.4ROR 32.3 · χ² 416 / p 1e-92	30.6 EB05 19.7 · IC025 +3.1 3/3 methods agree	Likely indication confounding term in indications	serious PRR 37.4	no trial data cached
Eye discharge	6	15.9 7.2–35.4ROR 16.1 · χ² 70 / p 3e-17	12.4 EB05 4.7 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious n=2	no trial data cached
Hand deformity	5	10.4 4.3–24.8ROR 10.4 · χ² 33 / p 4e-9	6.6 EB05 2.7 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 33.7	no trial data cached
Deformity	3	8.7 2.8–26.9ROR 8.7 · χ² 13 / p 1e-4	4.6 EB05 1.7 · IC025 -0.0 PRR-only: not supported by EBGM or IC	Not in label — unassessed	serious PRR 29.7	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 Dorzolamide and Timolol Ophthalmic?

In FDA FAERS, the most frequently co-reported reaction terms for Dorzolamide and Timolol Ophthalmic are eye irritation, eye pain, intraocular pressure increased, eye discharge, hand deformity, deformity. 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 Ophthalmic have an FDA boxed warning?

No. The FDA label retrieved for Dorzolamide and Timolol Ophthalmic has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Dorzolamide and 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 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, field patient.drug.openfda.generic_name.exact, 8 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.