Combigan: adverse event reports filed with FDA

2,940

reports as suspect product

0% of all reports · about 151 a year

49

reports, 12 months to June 2026

65 in the 12 months before

23.1%

marked serious by the reporter

50.8% across the class

0.7%

record death among outcomes, as reported

20 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 Combigan reports recording the termmedian drug in alpha-adrenergic agonist

1. Ocular hyperaemiaa red eye13.9%410
2. Eye irritationeye irritation13.3%392
3. Eye paineye pain8.3%243
4. Intraocular pressure increasedraised pressure in the eye6.9%204
5. Eye pruritus6.9%203
6. Vision blurredblurred vision6.1%179
7. Dizzinesslight-headedness or unsteadiness5.9%172
8. Drug ineffectivethe medicine did not work as expected5.1%149
9. Accidental exposure to product4.9%144
10. Hypersensitivityan allergic-type reaction4.2%123
11. Fatiguetiredness4.1%122
12. Lacrimation increasedwatery eyes3.7%108
13. Eye swellinga swollen eye3.6%105
14. Product storage errorthe product was stored wrongly3.5%104
15. Headachehead pain3.4%101
16. Incorrect dose administeredthe wrong dose was given3.4%101
17. Off label useused for a purpose or in a way not on the label3.3%97
18. Visual impairmentreduced vision3.2%94
19. Dry mouthdry mouth3%87
20. Dry eyedry eye2.9%84
21. Somnolencedrowsiness2.7%79
22. Product container issuea problem with the container2.6%77
23. Cataractclouding of the eye lens2.4%70
24. Dyspnoeashortness of breath2.3%68
25. Drug hypersensitivityan allergic-type reaction to a medicine2.2%66
26. Astheniaweakness or lack of energy2.1%62
27. Inappropriate schedule of drug administrationthe medicine was taken at the wrong times2%59
28. Product delivery mechanism issue2%59
29. Eye discharge2%58
30. Erythema of eyelid1.9%57

Top 30 of 343 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 11 drugs in the alpha-adrenergic agonist 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 23,291 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. 90.6% 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 2,940 reports.

Drugs most often listed in the same reports

Other products listed in reports where Combigan 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 alpha-adrenergic agonist 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 Combigan as a suspect or interacting product; reports listing it only as a concomitant medication (3,686) 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.