Drugs › Carbonic anhydrase inhibitor
Generic name
Dorzolamide hcl: adverse event reports filed with FDA
688 reports list it as a suspect or interacting product, 2013–2021. Class: Carbonic anhydrase inhibitor.
- 688
- reports as suspect product
- 0% of all reports · about 51 a year
- 0
- reports, 12 months to June 2026
- 0 in the 12 months before
- 2.8%
- marked serious by the reporter
- 40.1% across the class
- 0%
- record death among outcomes, as reported
- 0 reports · not verified by FDA
Between January 2013 and May 2021, 688 adverse event reports received by FDA list dorzolamide hcl, a generic name as a suspect or interacting product. Reports that mention it only as a concomitant medication (384) are left out of every figure here.
In the 12 months to June 2026, 0 reports listed it, and none 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 51 reports a year and 0% of the 20,646,523 reports in the database, and 3.5% 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 (70.5%), drug ineffective (9.6%) and hypersensitivity (8.9%). A report can list several reactions, so shares add to more than 100%; 83 different terms appear across these reports. Treatment failure is recorded in 70.5% of these reports, a larger share than in the median carbonic anhydrase inhibitor drug (15.1%).
2.8% of the reports are marked serious by the reporter (40.1% across the class); 0% record death among the outcomes and 0% record hospitalisation, as reported. 76.3% of the reports came from consumers, and the largest patient age group is 75 and over (1.5%). 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
No report listing Dorzolamide hcl was received in the five years to June 2026; the latest was received in May 2021.
By year received
Reactions recorded in the reports
share of Dorzolamide hcl reports recording the termmedian drug in carbonic anhydrase inhibitor
- Treatment failurethe treatment did not work70.5%485
- Drug ineffectivethe medicine did not work as expected9.6%66
- Hypersensitivityan allergic-type reaction8.9%61
- Eye irritationeye irritation4.5%31
- Drug hypersensitivityan allergic-type reaction to a medicine3.8%26
- Intraocular pressure increasedraised pressure in the eye2.5%17
- Incorrect dose administeredthe wrong dose was given1.6%11
- Ocular hyperaemiaa red eye1.6%11
- Eye paineye pain1.3%9
- Vision blurredblurred vision1.3%9
- Eye allergy1%7
- Glaucomaraised pressure in the eye1%7
- Drug intolerancethe medicine was not tolerated0.7%5
- Eye pruritus0.7%5
- Product container issuea problem with the container0.7%5
- Product dropper issue0.7%5
- Dizzinesslight-headedness or unsteadiness0.6%4
- Burning sensationa burning feeling0.4%3
- Eye infection0.4%3
- Back painback pain0.3%2
- Blindnessloss of sight0.3%2
- Cardiac disorder0.3%2
- Drug administration errora mistake in giving the medicine0.3%2
- Dry skindry skin0.3%2
- Dyspnoeashortness of breath0.3%2
- Fatiguetiredness0.3%2
- Headachehead pain0.3%2
- Lacrimation increasedwatery eyes0.3%2
Top 30 of 83 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. 99.9% 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 | 21 | 3.1% |
| Intraocular pressure increased | 8 | 1.2% |
| Open angle glaucoma | 4 | 0.6% |
| Usher's syndrome | 2 | 0.3% |
The indication field is filled in by the reporter and is often blank; shares are of all 688 reports.
In context
| Measure | Dorzolamide hcl | Carbonic anhydrase inhibitor | All reports |
|---|---|---|---|
| Reports as suspect product | 688 | 19,384 | 20,646,523 |
| Share of that pool | — | 3.5% | 0% |
| Reports, latest 12 months | 0 | — | 1,332,454 |
| Marked serious | 2.8% | 40.1% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 0 | 49 | 91 |
| Hospitalisation recorded, per 1,000 reports | 0 | 115 | 213 |
| Consumer-filed share | 76.3% | 52.8% | 45.8% |
| Top term, share of reports | Treatment failure 70.5% | 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 hydrochloride | generic | 692 | 72 | 32.2% |
| 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 hcl reports
How many adverse event reports has FDA received for Dorzolamide hcl?
688 reports list Dorzolamide hcl as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 0 of them arrived in the latest 12 months. Another 384 list it only as a concomitant medication.
What reactions are recorded in Dorzolamide hcl reports?
treatment failure (70.5%), drug ineffective (9.6%), hypersensitivity (8.9%), eye irritation (4.5%) and drug hypersensitivity (3.8%). 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 hcl was responsible.
How serious are the reports?
2.8% are marked serious by the reporter. Among the outcomes recorded, 0% of reports include death and 0% 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 (76.3%), other health professional (13.4%) and physician (9.2%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Dorzolamide hcl rising?
0 reports in the 12 months to June 2026, and none 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 hcl 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 hcl?
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 hcl as a suspect or interacting product; reports listing it only as a concomitant medication (384) 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.