Dorzolamide and Timolol Preservative Free side effects: what 517 FDA adverse event reports show
Drug class
Carbonic anhydrase inhibitor
Label matched
Dorzolamide (Dorzolamide Hydrochloride)
Who reports
517 reports · 65% serious · 10 with death outcome · 68% female
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)
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.
Boxed warning
None in the current label
Causality screen of the 23 strongest signals
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.
- 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.
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. 7 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Glaucoma | 92 | 194.6 161.6–234.3ROR 236.5 · χ² 17,456 / p <1e-300 | 186.2 EB05 156.4 · IC025 +6.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 183.8 · ♀ 94% (drug 68%) | no trial data cached |
| Hand deformity | 61 | 190.0 150.0–240.6ROR 215.2 · χ² 11,232 / p <1e-300 | 178.6 EB05 144.0 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious PRR 181.1 · ♀ 100% (drug 68%) | no trial data cached |
| Sciatica | 66 | 169.5 135.2–212.4ROR 194.1 · χ² 10,848 / p <1e-300 | 161.0 EB05 130.9 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious PRR 199.8 · ♀ 100% (drug 68%) | no trial data cached |
| Synovitis | 72 | 162.4 131.0–201.4ROR 188.6 · χ² 11,355 / p <1e-300 | 155.2 EB05 127.4 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 149.2 · ♀ 100% (drug 68%) | no trial data cached |
| Skin reaction | 50 | 144.6 111.1–188.3ROR 160.0 · χ² 6,969 / p <1e-300 | 136.7 EB05 107.8 · IC025 +5.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 215.8 · ♀ 100% (drug 68%) | no trial data cached |
| Thyroid disorder | 51 | 134.6 103.7–174.8ROR 149.3 · χ² 6,614 / p <1e-300 | 127.9 EB05 101.0 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 164.0 · ♀ 100% (drug 68%) | no trial data cached |
| Diverticulitis | 75 | 110.4 89.5–136.1ROR 128.9 · χ² 8,008 / p <1e-300 | 107.1 EB05 88.3 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 103.0 · ♀ 100% (drug 68%) | no trial data cached |
| Deformity | 21 | 91.1 59.9–138.5ROR 94.9 · χ² 1,778 / p <1e-300 | 84.1 EB05 58.1 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 91.6 | no trial data cached |
| Contraindicated product administered | 46 | 61.9 47.0–81.6ROR 67.9 · χ² 2,697 / p <1e-300 | 60.4 EB05 47.1 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious PRR 67.8 · ♀ 100% (drug 68%) · 96% clinician | no trial data cached |
| C-reactive protein increased | 51 | 57.0 43.9–73.9ROR 63.1 · χ² 2,749 / p <1e-300 | 55.8 EB05 44.1 · IC025 +4.7 3/3 methods agree | Lab value / disease marker | serious PRR 52.1 · ♀ 98% (drug 68%) | no trial data cached |
| Product packaging quantity issue | 14 | 52.1 31.1–87.3ROR 53.5 · χ² 651 / p 8e-144 | 48.8 EB05 30.9 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious n=1 | no trial data cached |
| Treatment failure | 92 | 45.5 37.8–54.8ROR 55.1 · χ² 3,972 / p <1e-300 | 45.1 EB05 37.9 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious PRR 71.1 · ♀ 94% (drug 68%) | no trial data cached |
| Bronchitis | 77 | 42.0 34.2–51.6ROR 49.2 · χ² 3,050 / p <1e-300 | 41.6 EB05 34.3 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 56.7 · ♀ 100% (drug 68%) | no trial data cached |
| Intraocular pressure increased (raised eye pressure) | 12 | 37.9 21.7–66.4ROR 38.8 · χ² 395 / p 3e-88 | 35.9 EB05 21.9 · IC025 +3.0 3/3 methods agree | Likely indication confounding term in indications | serious PRR 37.1 | no trial data cached |
| Injection site reaction | 60 | 35.5 28.0–45.0ROR 40.0 · χ² 1,982 / p <1e-300 | 35.1 EB05 28.3 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 161.5 · ♀ 100% (drug 68%) | no trial data cached |
| Eye irritation | 46 | 33.5 25.4–44.1ROR 36.7 · χ² 1,420 / p <1e-300 | 33.1 EB05 25.8 · IC025 +4.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 35.2 · 84% consumer | no trial data cached |
| Drug intolerance | 78 | 32.9 26.8–40.4ROR 38.6 · χ² 2,389 / p <1e-300 | 32.6 EB05 27.0 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious PRR 47.2 · ♀ 100% (drug 68%) | no trial data cached |
| Hepatic enzyme increased | 51 | 30.5 23.5–39.5ROR 33.7 · χ² 1,427 / p <1e-300 | 30.1 EB05 23.8 · IC025 +4.1 3/3 methods agree | Lab value / disease marker | serious PRR 38.0 · ♀ 100% (drug 68%) | no trial data cached |
| Rheumatoid arthritis | 66 | 23.7 18.9–29.7ROR 27.0 · χ² 1,418 / p <1e-300 | 23.5 EB05 19.1 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 25.5 · ♀ 98% (drug 68%) | no trial data cached |
| Eye pain | 29 | 21.3 15.0–30.3ROR 22.5 · χ² 542 / p 3e-120 | 21.0 EB05 15.3 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.5 · 70% consumer | no trial data cached |
| Mobility decreased | 35 | 19.8 14.4–27.3ROR 21.2 · χ² 609 / p 1e-134 | 19.6 EB05 14.7 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 25.8 · ♀ 100% (drug 68%) | no trial data cached |
| Ocular hyperaemia | 22 | 19.1 12.7–28.8ROR 19.9 · χ² 360 / p 1e-80 | 18.7 EB05 12.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 15.7 | no trial data cached |
| Product substitution issue | 19 | 13.4 8.6–20.8ROR 13.9 · χ² 206 / p 5e-47 | 12.6 EB05 8.0 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 11.9 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 | 92 | 45.5 37.8–54.8ROR 55.1 · χ² 3,972 / p <1e-300 | 45.1 EB05 37.9 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious PRR 71.1 · ♀ 94% (drug 68%) | no trial data cached |
| Glaucoma | 92 | 194.6 161.6–234.3ROR 236.5 · χ² 17,456 / p <1e-300 | 186.2 EB05 156.4 · IC025 +6.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 183.8 · ♀ 94% (drug 68%) | no trial data cached |
| Drug intolerance | 78 | 32.9 26.8–40.4ROR 38.6 · χ² 2,389 / p <1e-300 | 32.6 EB05 27.0 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious PRR 47.2 · ♀ 100% (drug 68%) | no trial data cached |
| Bronchitis | 77 | 42.0 34.2–51.6ROR 49.2 · χ² 3,050 / p <1e-300 | 41.6 EB05 34.3 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 56.7 · ♀ 100% (drug 68%) | no trial data cached |
| Diverticulitis | 75 | 110.4 89.5–136.1ROR 128.9 · χ² 8,008 / p <1e-300 | 107.1 EB05 88.3 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 103.0 · ♀ 100% (drug 68%) | no trial data cached |
| Synovitis | 72 | 162.4 131.0–201.4ROR 188.6 · χ² 11,355 / p <1e-300 | 155.2 EB05 127.4 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 149.2 · ♀ 100% (drug 68%) | no trial data cached |
| Rheumatoid arthritis | 66 | 23.7 18.9–29.7ROR 27.0 · χ² 1,418 / p <1e-300 | 23.5 EB05 19.1 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 25.5 · ♀ 98% (drug 68%) | no trial data cached |
| Sciatica | 66 | 169.5 135.2–212.4ROR 194.1 · χ² 10,848 / p <1e-300 | 161.0 EB05 130.9 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious PRR 199.8 · ♀ 100% (drug 68%) | no trial data cached |
| Hand deformity | 61 | 190.0 150.0–240.6ROR 215.2 · χ² 11,232 / p <1e-300 | 178.6 EB05 144.0 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious PRR 181.1 · ♀ 100% (drug 68%) | no trial data cached |
| Injection site reaction | 60 | 35.5 28.0–45.0ROR 40.0 · χ² 1,982 / p <1e-300 | 35.1 EB05 28.3 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 161.5 · ♀ 100% (drug 68%) | no trial data cached |
| Hepatic enzyme increased | 51 | 30.5 23.5–39.5ROR 33.7 · χ² 1,427 / p <1e-300 | 30.1 EB05 23.8 · IC025 +4.1 3/3 methods agree | Lab value / disease marker | serious PRR 38.0 · ♀ 100% (drug 68%) | no trial data cached |
| C-reactive protein increased | 51 | 57.0 43.9–73.9ROR 63.1 · χ² 2,749 / p <1e-300 | 55.8 EB05 44.1 · IC025 +4.7 3/3 methods agree | Lab value / disease marker | serious PRR 52.1 · ♀ 98% (drug 68%) | no trial data cached |
| Thyroid disorder | 51 | 134.6 103.7–174.8ROR 149.3 · χ² 6,614 / p <1e-300 | 127.9 EB05 101.0 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 164.0 · ♀ 100% (drug 68%) | no trial data cached |
| Skin reaction | 50 | 144.6 111.1–188.3ROR 160.0 · χ² 6,969 / p <1e-300 | 136.7 EB05 107.8 · IC025 +5.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 215.8 · ♀ 100% (drug 68%) | no trial data cached |
| Eye irritation | 46 | 33.5 25.4–44.1ROR 36.7 · χ² 1,420 / p <1e-300 | 33.1 EB05 25.8 · IC025 +4.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 35.2 · 84% 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.
- Hand deformity — n=61, PRR 190.0
- Sciatica — n=66, PRR 169.5
- Synovitis — n=72, PRR 162.4
- Thyroid disorder — n=51, PRR 134.6
- Diverticulitis — n=75, PRR 110.4
- Deformity — n=21, PRR 91.1
- Bronchitis — n=77, PRR 42.0
- Injection site reaction — n=60, PRR 35.5
- Rheumatoid arthritis — n=66, PRR 23.7
- Mobility decreased — n=35, PRR 19.8
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 Preservative Free?
In FDA FAERS, the most frequently co-reported reaction terms for Dorzolamide and Timolol Preservative Free are glaucoma, bronchitis, diverticulitis, synovitis, rheumatoid arthritis, sciatica. 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 Preservative Free have an FDA boxed warning?
No. The FDA label retrieved for Dorzolamide and Timolol Preservative Free has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Dorzolamide and Timolol Preservative Free 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, 30 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.