What the label lists and what reports show
Brimonidine side effects
Brimonidine's FDA label: “Most common adverse reactions occurring in approximately 10 to 30% of patients receiving brimonidine ophthalmic solution 0.2% included oral dryness, ocular hyperemia, burning and stinging, headache, blurring, foreign body sensation, fatigue/drowsiness …” FAERS holds 17,837 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is eye irritation (779 reports).
- Generic listed
Check it at the source: the brimonidine FDA label on DailyMed (effective July 24, 2025, Micro Labs Limited); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of brimonidine topical gel?Brimonidine topical gel may cause serious side effects, including: • See “Important information” at the beginning of this Patient Information leaflet. • Problems with blood circulation. People who use brimonidine topical gel can have problems with blood circulation, including a slow heart rate, low blood pressure, and dizziness. These problems may sometimes be serious and lead to hospitalization. See “What should I tell my doctor before using brimonidine topical gel?” • Serious allergic (hypersensitivity) reactions have happened in people who use brimonidine topical gel. […]
Source: FDA drug label (BRIMONIDINE), Padagis Israel Pharmaceuticals Ltd, effective July 31, 2024 (SPL set c899b329-cc5e-4443-8e94-451314de47c9), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions occurring in approximately 10 to 30% of patients receiving brimonidine ophthalmic solution 0.2% included oral dryness, ocular hyperemia, burning and stinging, headache, blurring, foreign body sensation, fatigue/drowsiness, conjunctival follicles, ocular allergic reactions, and ocular pruritus.
Table 1 - Adverse Reactions Reported in Clinical Trials by at Least 1% of Subjects Treated for 29 Days
This table is printed in the Mirvaso label published by Galderma Laboratories, L.P. of October 24, 2024; the label quoted above does not print one.
| Preferred Term | MIRVASO Topical Gel (N=330) n (%) | Vehicle Gel (N=331) n (%) |
|---|---|---|
| Subjects with at least one adverse reaction, Number (%) of Subjects | 109 (33) | 91 (28) |
| Erythema | 12 (4%) | 3 (1%) |
| Flushing | 9 (3%) | 0 |
| Skin burning sensation | 5 (2%) | 2 (1%) |
| Dermatitis contact | 3 (1%) | 1 (<1%) |
| Dermatitis | 3 (1%) | 1 (<1%) |
| Skin warm | 3 (1%) | 0 |
| Paraesthesia | 2 (1%) | 1 (<1%) |
| Acne | 2 (1%) | 1 (<1%) |
| Pain of skin | 2 (1%) | 0 |
| Vision blurred | 2 (1%) | 0 |
| Nasal congestion | 2 (1%) | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious adverse reactions are described elsewhere in the labeling: Potentiation of Vascular Insufficiency [ see Warnings and Precautions ( 5.1 ) ] Severe Cardiovascular Disease [ see Warnings and Precautions ( 5.2 ) ] Contamination of Topical Ophthalmic Products after Use [ see Warnings and Precautions ( 5.3 ) ] Neonates and Infants (under the age of 2 years) [ see Contraindications ( 4.1 ) ] Most common adverse reactions occurring in approximately 10 to 30% of patients receiving brimonidine ophthalmic solution 0.2% included oral dryness, ocular hyperemia, burning and stinging, headache, blurring, foreign body sensation, fatigue/drowsiness, conjunctival follicles, ocular allergic reactions, and ocular pruritus. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Micro Labs USA Inc., at 1-855-839-8195 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. …
Source: FDA drug label, Micro Labs Limited, effective July 24, 2025 (SPL set 75c5f708-1afb-4505-94a6-a2c0afb0aedc), via openFDA; the full label on DailyMed
What do FAERS reports show?
17,837 reports list brimonidine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 753 are coded as a death and 3,057 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2020 (4,181, against a median of 1,073 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 19 reactions below, 10 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Brimonidine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions