Drugs › Carbonic anhydrase inhibitor
Brand name · Dorzolamide hydrochloride and timolol maleate
Cosopt: adverse event reports filed with FDA
1,347 reports list it as a suspect or interacting product, 2004–2026. Class: Carbonic anhydrase inhibitor. Also reported as Cosopt /01419801/, Cosopt Ophthalmic Solution.
- 1,347
- reports as suspect product
- 0% of all reports · about 60 a year
- 30
- reports, 12 months to June 2026
- 35 in the 12 months before
- 66.9%
- marked serious by the reporter
- 40.1% across the class
- 3.2%
- record death among outcomes, as reported
- 43 reports · not verified by FDA
Between January 2004 and April 2026, 1,347 adverse event reports received by FDA list the brand name Cosopt (dorzolamide hydrochloride and timolol maleate) as a suspect or interacting product. Reports that mention it only as a concomitant medication (3,967) are left out of every figure here.
In the 12 months to June 2026, 30 reports listed it, down 14% from 35 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 60 reports a year and 0% of the 20,646,523 reports in the database, and 6.9% 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 reactions recorded most often are eye irritation (11.3%), drug ineffective (10.8%) and ocular hyperaemia (7%). A report can list several reactions, so shares add to more than 100%; 372 different terms appear across these reports. Eye irritation is recorded in 11.3% of these reports, a larger share than in the median carbonic anhydrase inhibitor drug (4.7%).
66.9% of the reports are marked serious by the reporter (40.1% across the class); 3.2% record death among the outcomes and 24.9% record hospitalisation, as reported. 35.8% of the reports came from consumers, and the largest patient age group is 75 and over (24.4%). 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 Cosopt reports recording the termmedian drug in carbonic anhydrase inhibitor
- Eye irritationeye irritation11.3%152
- Drug ineffectivethe medicine did not work as expected10.8%145
- Ocular hyperaemiaa red eye7%94
- Intraocular pressure increasedraised pressure in the eye6.8%92
- Eye paineye pain5.6%76
- Treatment failurethe treatment did not work4.7%63
- Dyspnoeashortness of breath4.4%59
- Bradycardiaslow heart rate3.9%52
- Vision blurredblurred vision3.8%51
- Eye pruritus3.6%49
- Glaucomaraised pressure in the eye3.3%44
- Product quality issuea problem with the product itself3%41
- Visual acuity reducedreduced sharpness of vision2.9%39
- Hypersensitivityan allergic-type reaction2.8%38
- Drug hypersensitivityan allergic-type reaction to a medicine2.6%35
- Cataractclouding of the eye lens2.4%33
- Falla fall2.4%33
- Painpain, site not specified2.4%32
- Condition aggravatedthe condition being treated got worse2.1%28
- Syncopefainting2.1%28
- Gait disturbancedifficulty walking2%27
- Off label useused for a purpose or in a way not on the label2%27
- Dizzinesslight-headedness or unsteadiness1.9%26
- Drug dose omissiona dose was missed1.9%25
- Headachehead pain1.9%25
- Visual impairmentreduced vision1.9%25
- Sciatica1.8%24
- Fatiguetiredness1.7%23
- Hand deformity1.7%23
Top 30 of 372 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. 49.1% 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 | 467 | 34.7% |
| Intraocular pressure increased | 62 | 4.6% |
| Open angle glaucoma | 49 | 3.6% |
| Intraocular pressure test abnormal | 8 | 0.6% |
| Age-related macular degeneration | 7 | 0.5% |
| Intraocular pressure test | 7 | 0.5% |
The indication field is filled in by the reporter and is often blank; shares are of all 1,347 reports.
In context
| Measure | Cosopt | Carbonic anhydrase inhibitor | All reports |
|---|---|---|---|
| Reports as suspect product | 1,347 | 19,384 | 20,646,523 |
| Share of that pool | — | 6.9% | 0% |
| Reports, latest 12 months | 30 | — | 1,332,454 |
| Marked serious | 66.9% | 40.1% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 32 | 49 | 91 |
| Hospitalisation recorded, per 1,000 reports | 249 | 115 | 213 |
| Consumer-filed share | 35.8% | 52.8% | 45.8% |
| Top term, share of reports | Eye irritation 11.3% | median 4.7% | 0.3% |
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% |
| Brinzolamide | generic | 886 | 66 | 73% |
| Dorzolamide hydrochloride | generic | 692 | 72 | 32.2% |
| 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 Cosopt reports
How many adverse event reports has FDA received for Cosopt?
1,347 reports list Cosopt as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 30 of them arrived in the latest 12 months. Another 3,967 list it only as a concomitant medication.
What reactions are recorded in Cosopt reports?
eye irritation (11.3%), drug ineffective (10.8%), ocular hyperaemia (7%), intraocular pressure increased (6.8%) and eye pain (5.6%). 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 Cosopt was responsible.
How serious are the reports?
66.9% are marked serious by the reporter. Among the outcomes recorded, 3.2% of reports include death and 24.9% 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 (35.8%), physician (25.8%) and other health professional (15.9%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Cosopt rising?
30 reports in the 12 months to June 2026, down 14% from 35 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 Cosopt 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 Cosopt?
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 Cosopt as a suspect or interacting product; reports listing it only as a concomitant medication (3,967) 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.