Azopt: adverse event reports filed with FDA

3,656

reports as suspect product

0% of all reports · about 164 a year

40

reports, 12 months to June 2026

58 in the 12 months before

37.5%

marked serious by the reporter

40.1% across the class

1.4%

record death among outcomes, as reported

52 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 Azopt reports recording the termmedian drug in carbonic anhydrase inhibitor

1. Treatment failurethe treatment did not work36.4%1,332
2. Drug ineffectivethe medicine did not work as expected8%293
3. Hypersensitivityan allergic-type reaction5%182
4. Eye irritationeye irritation4.9%178
5. Intraocular pressure increasedraised pressure in the eye4.8%175
6. Glaucomaraised pressure in the eye4%147
7. Visual impairmentreduced vision3.7%134
8. Vision blurredblurred vision3.6%130
9. Eye paineye pain3.3%122
10. Ocular hyperaemiaa red eye3.2%118
11. Dyspnoeashortness of breath3%109
12. Cataractclouding of the eye lens2.5%92
13. Blindnessloss of sight2%74
14. Off label useused for a purpose or in a way not on the label2%72
15. Dizzinesslight-headedness or unsteadiness1.9%71
16. Headachehead pain1.9%69
17. Toxic epidermal necrolysisa severe skin reaction with peeling1.8%67
18. Drug hypersensitivityan allergic-type reaction to a medicine1.6%60
19. Dry eyedry eye1.6%59
20. Eye pruritus1.6%57
21. Haemoglobin decreasedlow haemoglobin1.6%57
22. Asthmaasthma1.5%54
23. Malaisegeneral feeling of being unwell1.4%53
24. Visual acuity reducedreduced sharpness of vision1.3%49
25. Fatiguetiredness1.3%48
26. Hypertensionhigh blood pressure1.3%48
27. Rash papular1.2%45
28. Rash erythematousa red rash1.2%44
29. Foreign body sensation in eyes1.1%41
30. Blindness unilateral1.1%40

Top 30 of 385 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. 72.6% 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 3,656 reports.

Drugs most often listed in the same reports

Other products listed in reports where Azopt is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

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 Azopt as a suspect or interacting product; reports listing it only as a concomitant medication (3,040) 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.