Timoptic: adverse event reports filed with FDA

506

reports as suspect product

0% of all reports · about 23 a year

9

reports, 12 months to June 2026

8 in the 12 months before

51.8%

marked serious by the reporter

78.7% across the class

4.2%

record death among outcomes, as reported

21 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

Reactions recorded in the reports

share of Timoptic reports recording the termmedian drug in beta-adrenergic blocker

1. Eye irritationeye irritation10.9%55
2. Ocular hyperaemiaa red eye6.9%35
3. Drug ineffectivethe medicine did not work as expected6.5%33
4. Intraocular pressure increasedraised pressure in the eye6.1%31
5. Eye paineye pain5.7%29
6. Treatment failurethe treatment did not work5.7%29
7. Eye pruritus5.1%26
8. Vision blurredblurred vision4.3%22
9. Bradycardiaslow heart rate3.8%19
10. Drug hypersensitivityan allergic-type reaction to a medicine3.4%17
11. Dizzinesslight-headedness or unsteadiness3%15
12. Product quality issuea problem with the product itself2.8%14
13. Blindnessloss of sight2.4%12
14. Cataractclouding of the eye lens2.4%12
15. Eye swellinga swollen eye2.4%12
16. Erythemaskin redness2.2%11
17. Deaththe patient died; cause not stated by this term2%10
18. Visual impairmentreduced vision2%10
19. Drug interactionan interaction between medicines1.8%9
20. Hypersensitivityan allergic-type reaction1.6%8
21. Hypotensionlow blood pressure1.6%8
22. Alopeciahair loss1.4%7
23. Blood pressure increaseda raised blood pressure reading1.4%7
24. Dyspnoeashortness of breath1.4%7
25. Painpain, site not specified1.4%7
26. Condition aggravatedthe condition being treated got worse1.2%6
27. Pruritusitching1.2%6
28. Skin exfoliationpeeling skin1.2%6
29. Anxietyanxiety1%5
30. Corneal deposits1%5

Top 30 of 200 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 22 drugs in the beta-adrenergic blocker 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 148,208 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. 71.7% 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 506 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 beta-adrenergic blocker 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 Timoptic as a suspect or interacting product; reports listing it only as a concomitant medication (1,325) 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.