Drugs › alpha-Adrenergic agonist
Generic name
Brimonidine tartrate: adverse event reports filed with FDA
1,012 reports list it as a suspect or interacting product, 2004–2026. Class: alpha-Adrenergic agonist.
- 1,012
- reports as suspect product
- 0% of all reports · about 45 a year
- 178
- reports, 12 months to June 2026
- 84 in the 12 months before
- 42.2%
- marked serious by the reporter
- 50.8% across the class
- 0.7%
- record death among outcomes, as reported
- 7 reports · not verified by FDA
Between March 2004 and June 2026, 1,012 adverse event reports received by FDA list brimonidine tartrate, a generic name as a suspect or interacting product. Reports that mention it only as a concomitant medication (2,184) are left out of every figure here.
In the 12 months to June 2026, 178 reports listed it, up 112% from 84 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 45 reports a year and 0% of the 20,646,523 reports in the database, and 4.3% of the reports for the alpha-Adrenergic agonist class. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded eye irritation (8.8%), drug ineffective (8.5%) and product use issue (8.2%). A report can list several reactions, so shares add to more than 100%; 278 different terms appear across these reports. Eye irritation is recorded in 8.8% of these reports, a larger share than in the median alpha-Adrenergic agonist drug (0.3%).
42.2% of the reports are marked serious by the reporter (50.8% across the class); 0.7% record death among the outcomes and 11% record hospitalisation, as reported. 63.7% of the reports came from consumers, and the largest patient age group is 75 and over (20.8%). 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 Brimonidine tartrate reports recording the termmedian drug in alpha-adrenergic agonist
- Eye irritationeye irritation8.8%89
- Drug ineffectivethe medicine did not work as expected8.5%86
- Product use issuea problem in how the product was used8.2%83
- Ocular hyperaemiaa red eye7.1%72
- Treatment failurethe treatment did not work7.1%72
- Vision blurredblurred vision6.2%63
- Eye paineye pain5.4%55
- Intraocular pressure increasedraised pressure in the eye4.8%49
- Product dose omission issuea dose was missed4.8%49
- Somnolencedrowsiness4.5%46
- Eye pruritus4.2%42
- Dizzinesslight-headedness or unsteadiness4.1%41
- Dry mouthdry mouth3.4%34
- Bradycardiaslow heart rate3.1%31
- Fatiguetiredness3.1%31
- Visual impairmentreduced vision3.1%31
- Dry eyedry eye3%30
- Product container issuea problem with the container3%30
- Headachehead pain2.9%29
- Hypotensionlow blood pressure2.9%29
- Lacrimation increasedwatery eyes2.7%27
- Hypersensitivityan allergic-type reaction2.5%25
- Drug hypersensitivityan allergic-type reaction to a medicine2.4%24
- Product delivery mechanism issue2.3%23
- Product quality issuea problem with the product itself2.1%21
- Inappropriate schedule of product administrationthe product was taken at the wrong times2%20
- Product storage errorthe product was stored wrongly1.8%18
Top 30 of 278 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
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. 80% 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 | 194 | 19.2% |
| Intraocular pressure increased | 20 | 2% |
| Open angle glaucoma | 18 | 1.8% |
| Cataract operation | 7 | 0.7% |
| Ocular hypertension | 5 | 0.5% |
| Intraocular pressure test | 4 | 0.4% |
The indication field is filled in by the reporter and is often blank; shares are of all 1,012 reports.
In context
| Measure | Brimonidine tartrate | alpha-Adrenergic agonist | All reports |
|---|---|---|---|
| Reports as suspect product | 1,012 | 23,291 | 20,646,523 |
| Share of that pool | — | 4.3% | 0% |
| Reports, latest 12 months | 178 | — | 1,332,454 |
| Marked serious | 42.2% | 50.8% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 7 | 156 | 91 |
| Hospitalisation recorded, per 1,000 reports | 110 | 199 | 213 |
| Consumer-filed share | 63.7% | 48.1% | 45.8% |
| Top term, share of reports | Eye irritation 8.8% | median 0.3% | 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 alpha-adrenergic agonist class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Pseudoephedrine hydrochloride | generic | 8,381 | 1,163 | 90.4% |
| Brimonidine | generic | 4,285 | 122 | 17.7% |
| Combigan | brand | 2,940 | 49 | 23.1% |
| Alphagan P | brand | 2,656 | 110 | 31.9% |
| Mirvaso | brand | 926 | 2 | 21% |
| Claritin-D | brand | 732 | 16 | 22.5% |
| Alavert | brand | 618 | 0 | 31.6% |
| Loratadine and pseudoephedrine sulfate | generic | 616 | 22 | 10.2% |
| Midodrine hydrochloride | generic | 595 | 51 | 70.1% |
| Pseudoephedrine hcl | generic | 530 | 0 | 94.7% |
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 Brimonidine tartrate reports
How many adverse event reports has FDA received for Brimonidine tartrate?
1,012 reports list Brimonidine tartrate as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 178 of them arrived in the latest 12 months. Another 2,184 list it only as a concomitant medication.
What reactions are recorded in Brimonidine tartrate reports?
eye irritation (8.8%), drug ineffective (8.5%), product use issue (8.2%), ocular hyperaemia (7.1%) and treatment failure (7.1%). 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 Brimonidine tartrate was responsible.
How serious are the reports?
42.2% are marked serious by the reporter. Among the outcomes recorded, 0.7% of reports include death and 11% 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 (63.7%), physician (16.2%) and other health professional (13.1%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Brimonidine tartrate rising?
178 reports in the 12 months to June 2026, up 112% from 84 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 Brimonidine tartrate 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 Brimonidine tartrate?
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 Brimonidine tartrate as a suspect or interacting product; reports listing it only as a concomitant medication (2,184) 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.