Dorzolamide hydrochloride timolol maleate: adverse event reports filed with FDA

521

reports as suspect product

0% of all reports · about 36 a year

103

reports, 12 months to June 2026

77 in the 12 months before

25%

marked serious by the reporter

40.1% across the class

0.2%

record death among outcomes, as reported

1 reports · not verified by FDA

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 timolol maleate reports recording the termmedian drug in carbonic anhydrase inhibitor

1. Eye irritationeye irritation13.8%72
2. Product container issuea problem with the container8.6%45
3. Drug ineffectivethe medicine did not work as expected8.4%44
4. Vision blurredblurred vision8.1%42
5. Ocular hyperaemiaa red eye6.9%36
6. Product dose omission issuea dose was missed6.3%33
7. Eye paineye pain6%31
8. Product quality issuea problem with the product itself6%31
9. No adverse eventno adverse event was reported3.5%18
10. Eye pruritus3.3%17
11. Intraocular pressure increasedraised pressure in the eye3.3%17
12. Product delivery mechanism issue3.3%17
13. Visual impairmentreduced vision3.1%16
14. Condition aggravatedthe condition being treated got worse2.9%15
15. Burning sensationa burning feeling2.7%14
16. Dysgeusiaaltered taste2.5%13
17. Dyspnoeashortness of breath2.5%13
18. Dizzinesslight-headedness or unsteadiness2.3%12
19. Lacrimation increasedwatery eyes2.3%12
20. Painpain, site not specified2.3%12
21. Eye swellinga swollen eye1.9%10
22. Headachehead pain1.9%10
23. Instillation site pain1.9%10
24. Product packaging quantity issue1.9%10
25. Liquid product physical issue1.7%9
26. Product packaging issuea problem with the packaging1.7%9
27. Product substitution issuea problem after switching products1.7%9
28. Product use issuea problem in how the product was used1.7%9
29. Rashskin rash1.7%9
30. Acute kidney injurysudden loss of kidney function1.5%8

Top 30 of 151 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

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 80.6% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 521 reports.

In context

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

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.

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 timolol maleate as a suspect or interacting product; reports listing it only as a concomitant medication (412) 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.