Drug · FAERS side-effect profile with label screen
Dorzolamide Hydrochloride side effects: what 1,736 FDA adverse event reports show
Drug class
Carbonic anhydrase inhibitor
FDA label, Indications wording
Brand names
Dorzolamide Hydrochloride
openFDA label
Who reports
1,736 reports · 49% serious · 65 with death outcome · 56% 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 6Not in label — unassessed 27
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. 44 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) | 63 | 59.6 46.7–75.9ROR 61.8 · χ² 3,553 / p <1e-300 | 58.3 EB05 47.2 · IC025 +4.9 3/3 methods agree | Likely indication confounding term in indications | serious PRR 62.7 | no trial data cached |
| Impaired quality of life | 59 | 49.7 38.7–63.9ROR 51.4 · χ² 2,759 / p <1e-300 | 48.8 EB05 39.2 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 87.2 · ♀ 5% (drug 56%) · 95% clinician | no trial data cached |
| Tubulointerstitial nephritis | 67 | 43.4 34.3–54.9ROR 45.1 · χ² 2,723 / p <1e-300 | 42.7 EB05 34.8 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 51.4 · ♀ 0% (drug 56%) · 97% clinician | no trial data cached |
| Impaired work ability | 69 | 39.0 30.9–49.1ROR 40.6 · χ² 2,510 / p <1e-300 | 38.5 EB05 31.4 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 59.0 · ♀ 2% (drug 56%) · 94% clinician | no trial data cached |
| Frequent bowel movements | 72 | 32.4 25.8–40.6ROR 33.8 · χ² 2,157 / p <1e-300 | 32.1 EB05 26.3 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 57.5 · ♀ 0% (drug 56%) · 94% clinician | no trial data cached |
| Eye pain | 135 | 29.6 25.2–34.8ROR 32.0 · χ² 3,702 / p <1e-300 | 29.4 EB05 25.5 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.8 · 83% consumer | no trial data cached |
| Eye irritation | 129 | 28.0 23.7–33.1ROR 30.2 · χ² 3,334 / p <1e-300 | 27.8 EB05 24.0 · IC025 +4.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 32.0 · 79% consumer | no trial data cached |
| Glaucoma | 43 | 27.0 20.1–36.3ROR 27.7 · χ² 1,050 / p 1e-230 | 26.7 EB05 20.6 · IC025 +3.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 33.6 | no trial data cached |
| Swollen tongue | 69 | 26.7 21.2–33.7ROR 27.8 · χ² 1,681 / p <1e-300 | 26.5 EB05 21.6 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 43.0 · ♀ 2% (drug 56%) · 97% clinician | no trial data cached |
| Ocular discomfort | 22 | 24.5 16.2–37.1ROR 24.8 · χ² 472 / p 5e-105 | 24.0 EB05 16.7 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious n=2 · 91% consumer | no trial data cached |
| Accidental overdose | 73 | 24.2 19.3–30.3ROR 25.2 · χ² 1,598 / p <1e-300 | 24.0 EB05 19.7 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 45.8 · ♀ 8% (drug 56%) · 92% clinician | no trial data cached |
| Nightmare | 69 | 24.0 19.1–30.3ROR 25.0 · χ² 1,499 / p <1e-300 | 23.8 EB05 19.5 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 48.3 · ♀ 2% (drug 56%) · 96% clinician | no trial data cached |
| Systemic lupus erythematosus | 69 | 23.6 18.7–29.7ROR 24.5 · χ² 1,471 / p <1e-300 | 23.4 EB05 19.1 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 28.7 · ♀ 2% (drug 56%) · 96% clinician | no trial data cached |
| Treatment failure | 152 | 22.4 19.2–26.1ROR 24.5 · χ² 3,094 / p <1e-300 | 22.3 EB05 19.5 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious PRR 6.4 · 84% consumer | no trial data cached |
| Rectal haemorrhage | 79 | 22.2 17.9–27.5ROR 23.2 · χ² 1,576 / p <1e-300 | 22.0 EB05 18.2 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 28.1 · ♀ 9% (drug 56%) · 96% clinician | no trial data cached |
| Hand deformity | 22 | 20.3 13.4–30.8ROR 20.6 · χ² 385 / p 5e-86 | 19.9 EB05 13.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 26.2 | no trial data cached |
| Tinnitus (ringing in the ears) | 76 | 20.0 16.0–24.9ROR 20.8 · χ² 1,352 / p 3e-296 | 19.9 EB05 16.4 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 35.0 · ♀ 5% (drug 56%) · 91% clinician | no trial data cached |
| Product packaging quantity issue | 18 | 19.9 12.6–31.6ROR 20.1 · χ² 305 / p 1e-68 | 19.4 EB05 12.8 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious n=3 | no trial data cached |
| Colitis ulcerative | 71 | 19.3 15.3–24.2ROR 20.0 · χ² 1,211 / p 1e-265 | 19.1 EB05 15.7 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 24.5 · ♀ 0% (drug 56%) · 97% clinician | no trial data cached |
| Sciatica | 25 | 19.1 12.9–28.1ROR 19.3 · χ² 410 / p 2e-91 | 18.7 EB05 13.2 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 29.1 · ♀ 100% (drug 56%) | no trial data cached |
| Loss of personal independence in daily activities | 74 | 18.8 15.1–23.5ROR 19.6 · χ² 1,232 / p 3e-270 | 18.7 EB05 15.4 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 29.0 · ♀ 4% (drug 56%) · 95% clinician | no trial data cached |
| Ocular hyperaemia | 69 | 17.9 14.2–22.5ROR 18.6 · χ² 1,082 / p 1e-237 | 17.8 EB05 14.5 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 16.2 · 77% consumer | no trial data cached |
| Eye discharge | 15 | 17.8 10.7–29.4ROR 17.9 · χ² 221 / p 3e-50 | 17.1 EB05 10.5 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=4 | no trial data cached |
| Eczema | 73 | 17.6 14.0–22.0ROR 18.3 · χ² 1,124 / p 1e-246 | 17.4 EB05 14.3 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 60.0 · ♀ 6% (drug 56%) · 96% clinician | no trial data cached |
| Haematochezia (blood in stool) | 73 | 16.0 12.8–20.1ROR 16.7 · χ² 1,014 / p 7e-223 | 15.9 EB05 13.0 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 20.9 · ♀ 2% (drug 56%) · 96% clinician | no trial data cached |
| Medication error | 71 | 15.5 12.3–19.4ROR 16.1 · χ² 948 / p 2e-208 | 15.4 EB05 12.5 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 29.7 · ♀ 2% (drug 56%) · 96% clinician | no trial data cached |
| Eye pruritus | 39 | 14.3 10.5–19.5ROR 14.6 · χ² 470 / p 2e-104 | 14.0 EB05 10.6 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.3 · 89% consumer | no trial data cached |
| Vertigo (spinning dizziness) | 72 | 14.3 11.4–17.9ROR 14.9 · χ² 877 / p 4e-193 | 14.1 EB05 11.6 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 22.8 · ♀ 4% (drug 56%) · 92% clinician | no trial data cached |
| Deep vein thrombosis (leg blood clot) | 75 | 13.9 11.1–17.3ROR 14.5 · χ² 886 / p 6e-195 | 13.8 EB05 11.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 16.8 · ♀ 7% (drug 56%) · 95% clinician | no trial data cached |
| Dysgeusia (altered taste) | 83 | 13.4 10.9–16.6ROR 14.1 · χ² 945 / p 7e-208 | 13.3 EB05 11.0 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 37.6 · ♀ 22% (drug 56%) | no trial data cached |
| Stress | 78 | 13.1 10.6–16.3ROR 13.7 · χ² 863 / p 7e-190 | 13.0 EB05 10.7 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 24.8 · ♀ 7% (drug 56%) · 92% clinician | no trial data cached |
| Eye inflammation | 10 | 12.8 6.9–23.8ROR 12.9 · χ² 97 / p 3e-23 | 10.8 EB05 5.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=6 | no trial data cached |
| Vitreous floaters | 10 | 12.4 6.7–23.0ROR 12.5 · χ² 94 / p 2e-22 | 10.4 EB05 5.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Product use complaint | 15 | 11.7 7.1–19.4ROR 11.8 · χ² 136 / p 9e-32 | 10.4 EB05 6.2 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious n=7 | no trial data cached |
| Photophobia (light sensitivity) | 18 | 11.7 7.4–18.5ROR 11.8 · χ² 165 / p 5e-38 | 10.6 EB05 6.6 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 | no trial data cached |
| Arthritis | 73 | 11.2 8.9–14.0ROR 11.6 · χ² 670 / p 5e-148 | 11.0 EB05 8.9 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 20.4 · ♀ 6% (drug 56%) · 93% clinician | no trial data cached |
| Eye infection | 10 | 10.8 5.8–20.0ROR 10.8 · χ² 79 / p 3e-19 | 8.7 EB05 4.6 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=5 | no trial data cached |
| Intentional product use issue | 78 | 10.7 8.6–13.3ROR 11.2 · χ² 680 / p 3e-150 | 10.5 EB05 8.6 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 17.7 · ♀ 5% (drug 56%) · 91% clinician | no trial data cached |
| Blindness unilateral | 12 | 10.3 5.9–18.1ROR 10.4 · χ² 92 / p 5e-22 | 8.5 EB05 4.8 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 12.6 | no trial data cached |
| Migraine | 73 | 9.3 7.4–11.6ROR 9.7 · χ² 535 / p 1e-118 | 9.0 EB05 7.3 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 21.3 · ♀ 2% (drug 56%) · 93% clinician | 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 | 152 | 22.4 19.2–26.1ROR 24.5 · χ² 3,094 / p <1e-300 | 22.3 EB05 19.5 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious PRR 6.4 · 84% consumer | no trial data cached |
| Eye pain | 135 | 29.6 25.2–34.8ROR 32.0 · χ² 3,702 / p <1e-300 | 29.4 EB05 25.5 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.8 · 83% consumer | no trial data cached |
| Eye irritation | 129 | 28.0 23.7–33.1ROR 30.2 · χ² 3,334 / p <1e-300 | 27.8 EB05 24.0 · IC025 +4.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 32.0 · 79% consumer | no trial data cached |
| Product dose omission issue | 109 | 4.6 3.9–5.5ROR 4.9 · χ² 310 / p 1e-69 | 4.5 EB05 3.9 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 3.8 · 80% consumer | no trial data cached |
| Inappropriate schedule of product administration | 104 | 7.1 5.9–8.6ROR 7.5 · χ² 544 / p 1e-120 | 6.9 EB05 5.9 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 17.1 · ♀ 26% (drug 56%) | no trial data cached |
| Abdominal discomfort | 85 | 6.1 5.0–7.6ROR 6.4 · χ² 364 / p 2e-81 | 6.0 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 14.4 · ♀ 18% (drug 56%) | no trial data cached |
| Covid-19 | 84 | 5.7 4.7–7.1ROR 6.0 · χ² 326 / p 3e-73 | 5.6 EB05 4.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 · ♀ 14% (drug 56%) | no trial data cached |
| Palpitations (pounding heartbeat) | 83 | 8.6 6.9–10.6ROR 9.0 · χ² 550 / p 5e-122 | 8.3 EB05 6.9 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 14.8 · ♀ 21% (drug 56%) | no trial data cached |
| Dysgeusia (altered taste) | 83 | 13.4 10.9–16.6ROR 14.1 · χ² 945 / p 7e-208 | 13.3 EB05 11.0 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 37.6 · ♀ 22% (drug 56%) | no trial data cached |
| Cerebrovascular accident (stroke) | 79 | 5.6 4.5–7.0ROR 5.8 · χ² 297 / p 7e-67 | 5.4 EB05 4.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 · ♀ 8% (drug 56%) · 91% clinician | no trial data cached |
| Rectal haemorrhage | 79 | 22.2 17.9–27.5ROR 23.2 · χ² 1,576 / p <1e-300 | 22.0 EB05 18.2 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 28.1 · ♀ 9% (drug 56%) · 96% clinician | no trial data cached |
| Intentional product use issue | 78 | 10.7 8.6–13.3ROR 11.2 · χ² 680 / p 3e-150 | 10.5 EB05 8.6 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 17.7 · ♀ 5% (drug 56%) · 91% clinician | no trial data cached |
| Stress | 78 | 13.1 10.6–16.3ROR 13.7 · χ² 863 / p 7e-190 | 13.0 EB05 10.7 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 24.8 · ♀ 7% (drug 56%) · 92% clinician | no trial data cached |
| Tinnitus (ringing in the ears) | 76 | 20.0 16.0–24.9ROR 20.8 · χ² 1,352 / p 3e-296 | 19.9 EB05 16.4 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 35.0 · ♀ 5% (drug 56%) · 91% clinician | no trial data cached |
| Deep vein thrombosis (leg blood clot) | 75 | 13.9 11.1–17.3ROR 14.5 · χ² 886 / p 6e-195 | 13.8 EB05 11.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 16.8 · ♀ 7% (drug 56%) · 95% clinician | 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=59, PRR 49.7
- Tubulointerstitial nephritis — n=67, PRR 43.4
- Impaired work ability — n=69, PRR 39.0
- Frequent bowel movements — n=72, PRR 32.4
- Swollen tongue — n=69, PRR 26.7
- Nightmare — n=69, PRR 24.0
- Systemic lupus erythematosus — n=69, PRR 23.6
- Rectal haemorrhage — n=79, PRR 22.2
- Hand deformity — n=22, PRR 20.3
- Tinnitus — n=76, PRR 20.0
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 eye pain, eye irritation, abdominal discomfort, covid-19, palpitations, dysgeusia. 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, 84 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.