Drugs › Carbonic anhydrase inhibitor
Generic name
Dorzolamide hydrochloride: adverse event reports filed with FDA
692 reports list it as a suspect or interacting product, 2004–2026. Class: Carbonic anhydrase inhibitor. Also reported as Dorzolamide Hcl Ophthalmic Solution.
- 692
- reports as suspect product
- 0% of all reports · about 32 a year
- 72
- reports, 12 months to June 2026
- 59 in the 12 months before
- 32.2%
- marked serious by the reporter
- 40.1% across the class
- 0.7%
- record death among outcomes, as reported
- 5 reports · not verified by FDA
692 adverse event reports received by FDA list dorzolamide hydrochloride, a generic name as a suspect or interacting product, from December 2004 to June 2026. A further 1,018 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 72 reports listed it, up 22% from 59 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 32 reports a year and 0% of the 20,646,523 reports in the database, and 3.6% of the reports for the carbonic anhydrase inhibitor class. How many people take it is not in the data, so a count is not a rate of occurrence.
The MedDRA terms listed most often are treatment failure (19.7%), eye irritation (11%) and drug ineffective (9.1%). A report can list several reactions, so shares add to more than 100%; 147 different terms appear across these reports. Treatment failure is recorded in 19.7% of these reports, a larger share than in the median carbonic anhydrase inhibitor drug (15.1%).
32.2% of the reports are marked serious by the reporter (40.1% across the class); 0.7% record death among the outcomes and 9.5% record hospitalisation, as reported. 70.2% of the reports came from consumers, and the largest patient age group is 75 and over (20.5%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Dorzolamide hydrochloride reports recording the termmedian drug in carbonic anhydrase inhibitor
- Treatment failurethe treatment did not work19.7%136
- Eye irritationeye irritation11%76
- Drug ineffectivethe medicine did not work as expected9.1%63
- Eye paineye pain7.8%54
- Ocular hyperaemiaa red eye5.3%37
- Vision blurredblurred vision5.1%35
- Intraocular pressure increasedraised pressure in the eye4.2%29
- Hypersensitivityan allergic-type reaction3.9%27
- Visual impairmentreduced vision3.8%26
- Eye pruritus3.5%24
- Product quality issuea problem with the product itself3.3%23
- Inappropriate schedule of product administrationthe product was taken at the wrong times3.2%22
- Dizzinesslight-headedness or unsteadiness2.7%19
- Off label useused for a purpose or in a way not on the label2.6%18
- Product container issuea problem with the container2.6%18
- Product dose omission issuea dose was missed2.6%18
- Dyspnoeashortness of breath2.3%16
- Glaucomaraised pressure in the eye1.9%13
- Drug hypersensitivityan allergic-type reaction to a medicine1.7%12
- Product storage errorthe product was stored wrongly1.7%12
- Fatiguetiredness1.6%11
- Acute kidney injurysudden loss of kidney function1.4%10
- Arrhythmia1.4%10
- Burning sensationa burning feeling1.4%10
- Ischaemic stroke1.4%10
- Product delivery mechanism issue1.4%10
- Condition aggravatedthe condition being treated got worse1.3%9
- Dysgeusiaaltered taste1.3%9
- Headachehead pain1.3%9
- Prescribed underdose1.3%9
Top 30 of 147 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 12 drugs in the carbonic anhydrase inhibitor class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 19,384 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 75% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Glaucoma | 157 | 22.7% |
| Open angle glaucoma | 25 | 3.6% |
| Intraocular pressure increased | 15 | 2.2% |
| Retinal detachment | 10 | 1.4% |
| Ocular hypertension | 3 | 0.4% |
| Angle closure glaucoma | 2 | 0.3% |
The indication field is filled in by the reporter and is often blank; shares are of all 692 reports.
In context
| Measure | Dorzolamide hydrochloride | Carbonic anhydrase inhibitor | All reports |
|---|---|---|---|
| Reports as suspect product | 692 | 19,384 | 20,646,523 |
| Share of that pool | — | 3.6% | 0% |
| Reports, latest 12 months | 72 | — | 1,332,454 |
| Marked serious | 32.2% | 40.1% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 7 | 49 | 91 |
| Hospitalisation recorded, per 1,000 reports | 95 | 115 | 213 |
| Consumer-filed share | 70.2% | 52.8% | 45.8% |
| Top term, share of reports | Treatment failure 19.7% | median 15.1% | 0.4% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the carbonic anhydrase inhibitor class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Azopt | brand | 3,656 | 40 | 37.5% |
| Simbrinza | brand | 2,953 | 64 | 33.9% |
| Acetazolamide | generic | 2,567 | 259 | 87.3% |
| Dorzolamide | generic | 2,073 | 75 | 18.2% |
| Cosopt Pf | brand | 1,880 | 12 | 19.7% |
| Keveyis | brand | 1,559 | 41 | 27.2% |
| Cosopt | brand | 1,347 | 30 | 66.9% |
| Brinzolamide | generic | 886 | 66 | 73% |
| Dorzolamide hcl | generic | 688 | 0 | 2.8% |
| Dorzolamide and Timolol | brand | 562 | 4 | 11.4% |
| Dorzolamide hydrochloride timolol maleate | generic | 521 | 103 | 25% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Dorzolamide hydrochloride reports
How many adverse event reports has FDA received for Dorzolamide hydrochloride?
692 reports list Dorzolamide hydrochloride as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 72 of them arrived in the latest 12 months. Another 1,018 list it only as a concomitant medication.
What reactions are recorded in Dorzolamide hydrochloride reports?
treatment failure (19.7%), eye irritation (11%), drug ineffective (9.1%), eye pain (7.8%) and ocular hyperaemia (5.3%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Dorzolamide hydrochloride was responsible.
How serious are the reports?
32.2% are marked serious by the reporter. Among the outcomes recorded, 0.7% of reports include death and 9.5% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (70.2%), other health professional (10.7%) and physician (10.5%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Dorzolamide hydrochloride rising?
72 reports in the 12 months to June 2026, up 22% from 59 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Dorzolamide hydrochloride was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Dorzolamide hydrochloride?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Dorzolamide hydrochloride as a suspect or interacting product; reports listing it only as a concomitant medication (1,018) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.