Drug · FAERS side-effect profile with label screen
Dorzolamide side effects: what 7,783 FDA adverse event reports show
Drug class
Carbonic anhydrase inhibitor
FDA label, Indications wording
Brand names
Dorzolamide Hydrochloride
openFDA label
Who reports
7,783 reports · 48% serious · 404 with death outcome · 55% 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 1Labeled (related wording) 4Likely indication confounding 2Reporting / coding artifact 5Not in label — unassessed 28
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. 371 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) | 220 | 46.9 41.2–53.5ROR 48.3 · χ² 9,681 / p <1e-300 | 46.0 EB05 41.1 · IC025 +5.2 3/3 methods agree | Likely indication confounding term in indications | serious PRR 52.4 | no trial data cached |
| Treatment failure | 1,371 | 45.7 43.6–48.0ROR 55.3 · χ² 59,178 / p <1e-300 | 45.0 EB05 43.0 · IC025 +5.4 3/3 methods agree | Reporting / coding artifact | serious PRR 2.9 · 81% consumer | no trial data cached |
| Glaucoma | 185 | 26.1 22.6–30.1ROR 26.7 · χ² 4,402 / p <1e-300 | 25.8 EB05 22.8 · IC025 +4.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 31.6 | no trial data cached |
| Impaired quality of life | 136 | 25.7 21.7–30.4ROR 26.1 · χ² 3,174 / p <1e-300 | 25.4 EB05 22.0 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 44.9 · ♀ 25% (drug 55%) | no trial data cached |
| Tubulointerstitial nephritis | 141 | 20.4 17.3–24.1ROR 20.8 · χ² 2,568 / p <1e-300 | 20.2 EB05 17.6 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 24.5 · ♀ 15% (drug 55%) · 92% clinician | no trial data cached |
| Impaired work ability | 140 | 17.7 15.0–20.9ROR 18.0 · χ² 2,176 / p <1e-300 | 17.5 EB05 15.2 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 27.1 · ♀ 17% (drug 55%) · 91% clinician | no trial data cached |
| Frequent bowel movements | 157 | 15.8 13.5–18.5ROR 16.1 · χ² 2,152 / p <1e-300 | 15.7 EB05 13.7 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 27.2 · ♀ 19% (drug 55%) | no trial data cached |
| Eye pain | 308 | 15.1 13.5–16.9ROR 15.7 · χ² 4,029 / p <1e-300 | 15.0 EB05 13.6 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.5 · 77% consumer | no trial data cached |
| Eye irritation | 292 | 14.2 12.7–15.9ROR 14.7 · χ² 3,554 / p <1e-300 | 14.1 EB05 12.8 · IC025 +3.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 18.0 · 72% consumer | no trial data cached |
| Swollen tongue | 154 | 13.3 11.4–15.6ROR 13.6 · χ² 1,738 / p <1e-300 | 13.2 EB05 11.5 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 21.5 · ♀ 22% (drug 55%) · 91% clinician | no trial data cached |
| Eye inflammation | 44 | 12.6 9.4–17.0ROR 12.7 · χ² 457 / p 1e-101 | 12.3 EB05 9.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=28 | no trial data cached |
| Ocular discomfort | 48 | 12.0 9.0–15.9ROR 12.0 · χ² 469 / p 3e-104 | 11.6 EB05 9.0 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious n=14 · 83% consumer | no trial data cached |
| Nightmare | 153 | 11.9 10.2–13.9ROR 12.1 · χ² 1,513 / p <1e-300 | 11.8 EB05 10.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 24.3 · ♀ 17% (drug 55%) | no trial data cached |
| Accidental overdose | 158 | 11.7 10.0–13.6ROR 11.9 · χ² 1,530 / p <1e-300 | 11.6 EB05 10.1 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 22.5 · ♀ 25% (drug 55%) | no trial data cached |
| Systemic lupus erythematosus | 142 | 10.9 9.2–12.8ROR 11.0 · χ² 1,257 / p 1e-275 | 10.7 EB05 9.3 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 13.4 · ♀ 16% (drug 55%) · 91% clinician | no trial data cached |
| Blindness unilateral | 54 | 10.4 7.9–13.5ROR 10.4 · χ² 446 / p 3e-99 | 10.0 EB05 7.8 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 12.8 · 72% consumer | no trial data cached |
| Eye discharge | 39 | 10.3 7.5–14.1ROR 10.4 · χ² 318 / p 2e-71 | 9.8 EB05 7.3 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=13 · 79% consumer | no trial data cached |
| Rectal haemorrhage | 163 | 10.2 8.8–11.9ROR 10.4 · χ² 1,344 / p 2e-294 | 10.1 EB05 8.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 12.9 · ♀ 21% (drug 55%) | no trial data cached |
| Ocular hyperaemia | 174 | 10.1 8.7–11.7ROR 10.3 · χ² 1,409 / p <1e-300 | 9.9 EB05 8.7 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 · 73% consumer | no trial data cached |
| Tinnitus (ringing in the ears) | 161 | 9.5 8.1–11.0ROR 9.6 · χ² 1,207 / p 9e-265 | 9.3 EB05 8.1 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 16.7 · ♀ 21% (drug 55%) | no trial data cached |
| Product packaging quantity issue | 36 | 8.9 6.4–12.3ROR 8.9 · χ² 244 / p 2e-55 | 8.3 EB05 6.2 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious n=7 · 78% consumer | no trial data cached |
| Loss of personal independence in daily activities | 156 | 8.9 7.6–10.4ROR 9.0 · χ² 1,079 / p 6e-237 | 8.7 EB05 7.6 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 13.3 · ♀ 22% (drug 55%) | no trial data cached |
| Colitis ulcerative | 145 | 8.8 7.5–10.3ROR 8.9 · χ² 991 / p 8e-218 | 8.6 EB05 7.5 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 11.3 · ♀ 16% (drug 55%) · 93% clinician | no trial data cached |
| Eye pruritus | 105 | 8.6 7.1–10.4ROR 8.7 · χ² 697 / p 8e-154 | 8.4 EB05 7.1 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.8 · 75% consumer | no trial data cached |
| Photophobia (light sensitivity) | 58 | 8.4 6.5–10.8ROR 8.4 · χ² 369 / p 1e-82 | 8.0 EB05 6.4 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.0 · 77% consumer | no trial data cached |
| Eczema | 152 | 8.2 7.0–9.6ROR 8.3 · χ² 947 / p 3e-208 | 8.0 EB05 7.0 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 28.2 · ♀ 16% (drug 55%) · 92% clinician | no trial data cached |
| Haematochezia (blood in stool) | 157 | 7.7 6.6–9.0ROR 7.8 · χ² 907 / p 1e-199 | 7.5 EB05 6.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.1 · ♀ 18% (drug 55%) · 90% clinician | no trial data cached |
| Lacrimation increased | 84 | 7.6 6.1–9.4ROR 7.7 · χ² 473 / p 3e-105 | 7.3 EB05 6.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 · 78% consumer | no trial data cached |
| Uveitis | 37 | 7.4 5.4–10.2ROR 7.4 · χ² 198 / p 3e-45 | 6.9 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 | no trial data cached |
| Vertigo (spinning dizziness) | 161 | 7.1 6.1–8.3ROR 7.3 · χ² 842 / p 2e-185 | 7.0 EB05 6.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 11.4 · ♀ 23% (drug 55%) | no trial data cached |
| Medication error | 144 | 7.0 6.0–8.2ROR 7.1 · χ² 735 / p 3e-162 | 6.9 EB05 6.0 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 13.5 · ♀ 17% (drug 55%) | no trial data cached |
| Eye infection | 28 | 6.7 4.7–9.8ROR 6.8 · χ² 131 / p 1e-30 | 6.1 EB05 4.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=13 · 71% consumer | no trial data cached |
| Dysgeusia (altered taste) | 179 | 6.5 5.6–7.5ROR 6.6 · χ² 823 / p 3e-181 | 6.4 EB05 5.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 18.0 · ♀ 32% (drug 55%) | no trial data cached |
| Deep vein thrombosis (leg blood clot) | 155 | 6.4 5.5–7.5ROR 6.5 · χ² 702 / p 5e-155 | 6.3 EB05 5.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 · ♀ 19% (drug 55%) · 92% clinician | no trial data cached |
| Stress | 170 | 6.4 5.5–7.4ROR 6.5 · χ² 767 / p 5e-169 | 6.3 EB05 5.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 12.1 · ♀ 24% (drug 55%) | no trial data cached |
| Vitreous floaters | 23 | 6.4 4.2–9.6ROR 6.4 · χ² 99 / p 1e-23 | 5.7 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Sciatica | 35 | 6.0 4.3–8.3ROR 6.0 · χ² 139 / p 2e-32 | 5.5 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 · ♀ 90% (drug 55%) | no trial data cached |
| Visual acuity reduced | 73 | 5.9 4.7–7.4ROR 5.9 · χ² 291 / p 2e-65 | 5.7 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Arthritis | 171 | 5.9 5.0–6.8ROR 6.0 · χ² 685 / p 3e-151 | 5.8 EB05 5.1 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 · ♀ 27% (drug 55%) | no trial data cached |
| Product use complaint | 31 | 5.4 3.8–7.7ROR 5.4 · χ² 107 / p 3e-25 | 5.0 EB05 3.7 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious n=16 · 81% 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 | 1,371 | 45.7 43.6–48.0ROR 55.3 · χ² 59,178 / p <1e-300 | 45.0 EB05 43.0 · IC025 +5.4 3/3 methods agree | Reporting / coding artifact | serious PRR 2.9 · 81% consumer | no trial data cached |
| Drug ineffective (drug did not work) | 732 | 1.5 1.4–1.6ROR 1.5 · χ² 129 / p 4e-30 | 1.5 EB05 1.4 · IC025 +0.5 | Reporting / coding artifact | serious PRR 2.6 | no trial data cached |
| Off label use (used outside approved label) | 511 | 1.6 1.5–1.7ROR 1.6 · χ² 115 / p 4e-27 | 1.6 EB05 1.5 · IC025 +0.5 | Reporting / coding artifact | serious PRR 2.5 | no trial data cached |
| Fatigue (tiredness) | 468 | 1.6 1.5–1.8ROR 1.7 · χ² 116 / p 3e-27 | 1.6 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 2.5 | no trial data cached |
| Headache | 374 | 1.6 1.5–1.8ROR 1.6 · χ² 88 / p 3e-21 | 1.6 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 2.7 | no trial data cached |
| Pain | 337 | 1.5 1.3–1.6ROR 1.5 · χ² 53 / p 2e-13 | 1.5 EB05 1.3 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 2.3 | no trial data cached |
| Eye pain | 308 | 15.1 13.5–16.9ROR 15.7 · χ² 4,029 / p <1e-300 | 15.0 EB05 13.6 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.5 · 77% consumer | no trial data cached |
| Eye irritation | 292 | 14.2 12.7–15.9ROR 14.7 · χ² 3,554 / p <1e-300 | 14.1 EB05 12.8 · IC025 +3.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 18.0 · 72% consumer | no trial data cached |
| Hypersensitivity (allergic reaction) | 277 | 4.0 3.6–4.5ROR 4.1 · χ² 633 / p 7e-140 | 4.0 EB05 3.6 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.6 · 73% consumer | no trial data cached |
| Rash | 270 | 1.7 1.5–1.9ROR 1.7 · χ² 75 / p 3e-18 | 1.7 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 3.5 · ♀ 30% (drug 55%) | no trial data cached |
| Pain in extremity | 264 | 2.4 2.1–2.7ROR 2.5 · χ² 219 / p 6e-50 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Condition aggravated | 259 | 2.3 2.1–2.6ROR 2.4 · χ² 194 / p 2e-44 | 2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 3.8 | no trial data cached |
| Weight decreased (weight loss) | 257 | 2.5 2.2–2.8ROR 2.5 · χ² 229 / p 5e-52 | 2.5 EB05 2.2 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 · ♀ 31% (drug 55%) | no trial data cached |
| Dizziness | 247 | 1.3 1.2–1.5ROR 1.3 · χ² 21 / p 2e-6 | 1.3 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Confusional state (confusion) | 242 | 4.0 3.6–4.6ROR 4.1 · χ² 552 / p 3e-122 | 4.0 EB05 3.6 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 · ♀ 34% (drug 55%) | 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.
- Impaired quality of life — n=136, PRR 25.7
- Tubulointerstitial nephritis — n=141, PRR 20.4
- Impaired work ability — n=140, PRR 17.7
- Frequent bowel movements — n=157, PRR 15.8
- Swollen tongue — n=154, PRR 13.3
- Eye inflammation — n=44, PRR 12.6
- Nightmare — n=153, PRR 11.9
- Systemic lupus erythematosus — n=142, PRR 10.9
- Blindness unilateral — n=54, PRR 10.4
- Eye discharge — n=39, PRR 10.3
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?
In FDA FAERS, the most frequently co-reported reaction terms for Dorzolamide are fatigue, headache, pain, eye pain, eye irritation, hypersensitivity. 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 have an FDA boxed warning?
No. The FDA label retrieved for Dorzolamide has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Dorzolamide 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, 411 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.