Mirvaso Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Mirvaso (brimonidine) Topical Gel is an alpha-adrenergic agonist used to treat persistent (nontransient) skin redness (erythema) of rosacea in adults. Common side effects of Mirvaso include redness, flushing, burning sensation of the skin, skin irritation, warm feeling of the skin, tingling sensation, acne, skin pain, blurred vision, or nasal congestion. Skin redness and flushing may happen about 3 to 4 hours after you apply Mirvaso topical gel.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Mirvaso FDA Prescribing Information: Side Effects
The following adverse drug reactions are discussed in greater detail in other sections of the label:
- Systemic Adverse Reactions of Alpha-2 Adrenergic Agonists [see WARNINGS AND PRECAUTIONS]
- Local Vasomotor Adverse Reactions [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
During clinical trials, 1210 subjects were exposed to MIRVASO topical gel. A total of 833 subjects were treated for persistent (nontransient) erythema associated with rosacea, and 330 of those were treated once daily for 29 days in vehicle-controlled trials.
Adverse reactions that occurred in at least 1% of subjects treated with MIRVASO topical gel once daily for 29 days and for which the rate for MIRVASO topical gel exceeded the rate for vehicle are presented in Table 1.
Table 1 - Adverse Reactions Reported in Clinical Trials by at Least 1% of Subjects Treated for 29 Days
|Preferred Term||MIRVASO Topical Gel (N=330)
|Vehicle Gel (N=331)
|Subjects with at least one adverse reaction, Number (%) of Subjects||109 (33)||91 (28)|
|Erythema||12 (4%)||3 (1%)|
|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|
Open-Label, Long-Term Study
An open-label study of MIRVASO topical gel when applied once daily for up to one year was conducted in subjects with persistent (nontransient) facial erythema of rosacea. Subjects were allowed to use other rosacea therapies. A total of 276 subjects applied MIRVASO topical gel for at least one year. The most common adverse events (≥ 4% of subjects) for the entire study were flushing (10%), erythema (8%), rosacea (5%), nasopharyngitis (5%), skin burning sensation (4%), increased intraocular pressure (4%), and headache (4%).
Allergic Contact Dermatitis
Allergic contact dermatitis to MIRVASO topical gel was reported in approximately 1% of subjects across the clinical development program. Two subjects underwent patch testing with individual product ingredients. One subject was found to be sensitive to brimonidine tartrate, and one subject was sensitive to phenoxyethanol (a preservative).
The following adverse reactions have been identified during post-approval use of MIRVASO topical gel. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure.
Nervous system disorders: dizziness
Skin and subcutaneous disorders: pallor
Read the entire FDA prescribing information for Mirvaso (Brimonidine Topical Gel)
Additional Mirvaso Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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