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MIRVASO

Rosacea Redness

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MIRVASO® (brimonidine) topical gel, 0.33%* is the first & only FDA-approved treatment developed and indicated for persistent facial redness of rosacea
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Not an actual patient. Individual results may vary. Results are simulated to show a 2-grade improvement of the facial redness of rosacea. At hour 12 on day 29, 22% of patients using MIRVASO experienced a 2-grade improvement of facial redness compared to 9% of people using the vehicle gel.

MIRVASO® (brimonidine) topical gel, 0.33%* is the first & only FDA-approved treatment developed and indicated for persistent facial redness of rosacea

Rosacea is a common skin condition that affects an estimated 16 million Americans. Facial redness is the most widely experienced rosacea symptom, and, according to the National Rosacea Society, may be the only symptom many people will experience. LEARN ABOUT THE FACIAL REDNESS OF ROSACEA

Important Safety Information
Indication:  Mirvaso® (brimonidine) topical gel, 0.33% is an alpha adrenergic agonist indicated for the topical treatment of persistent (nontransient) facial erythema of rosacea in adults 18 years of age or older.  Adverse Events:  In clinical trials, the most common adverse reactions (≥1%) included erythema, flushing, skin burning sensation and contact dermatitis.  Warnings/Precautions:  Mirvaso Gel should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension, thromboangiitis obliterans, scleroderma, or Sjögren’s syndrome. Alpha-2 adrenergic agents can lower blood pressure. Mirvaso Gel should be used with caution in patients with severe or unstable or uncontrolled cardiovascular disease. Serious adverse reactions following accidental ingestion of Mirvaso Gel by children have been reported. Keep Mirvaso Gel out of reach of children. Not for oral, ophthalmic, or intravaginal use.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

*Each gram of gel contains 5 mg of brimonidine tartrate, equivalent to 3.3 mg of brimonidine free base.

Phase 3 clinical studies of 553 subjects aged 18 and older. Half of the study participants used MIRVASO and the other half used a gel with no active ingredient (vehicle gel) for 29 days. Patients and researchers were asked to grade the improvement they saw at 30 minutes and at hours 3, 6, 9, and 12 following application.

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Important Safety Information
Indication:  Mirvaso® (brimonidine) topical gel, 0.33% is an alpha adrenergic agonist indicated for the topical treatment of persistent (nontransient) facial erythema of rosacea in adults 18 years of age or older.  Adverse Events:  In clinical trials, the most common adverse reactions (≥1%) included erythema, flushing, skin burning sensation and contact dermatitis.  Warnings/Precautions:  Mirvaso Gel should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension, thromboangiitis obliterans, scleroderma, or Sjögren’s syndrome. Alpha-2 adrenergic agents can lower blood pressure. Mirvaso Gel should be used with caution in patients with severe or unstable or uncontrolled cardiovascular disease. Serious adverse reactions following accidental ingestion of Mirvaso Gel by children have been reported. Keep Mirvaso Gel out of reach of children. Not for oral, ophthalmic, or intravaginal use.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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MIRVASO Study Description

MIRVASO was tested in 2 medical studies with 553 people aged 18 and older. Half of study participants used MIRVASO and the other half used a gel with no active ingredient for 29 days. Patients and researchers were asked to grade the improvement they saw at hours 3, 6, 9, and 12. On Day 29 of the trials, 2-grade improvement was observed with MIRVASO versus inactive gel at Hour 3 (28% vs 10%), at Hour 6 (28% vs 9%), at Hour 9 (22% vs 10%), and at Hour 12 (22% vs 9%). At 30 minutes on Day 1, 28% of patients using MIRVASO experienced 1-grade improvement of facial redness versus 6% for people using the inactive gel. Individual results with MIRVASO may vary.