Finacea Side Effects
Please note - some side effects for Finacea may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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For the consumer For the professional
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Side Effects of Finacea - for the consumer
Finacea Gel
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Finacea Gel:
Seek medical attention right away if any of these SEVERE side effects occur when using Finacea Gel:Dryness; temporary burning, itching, redness, stinging, or tingling at the application site.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in skin color; peeling, irritation, or inflammation of skin.
For the professional
Finacea
Overall, treatment related adverse events, including burning, stinging/ tingling, dryness/tightness/scaling, itching, and erythema/irritation/redness, were 19.4% (24/124) for Finacea Gel, 15%, and 7.1% (9/127) for the active comparator gel at 15 weeks.
In two vehicle controlled, and one active controlled U.S. clinical studies, treatment safety was monitored in 788 patients who used twice daily Finacea Gel, 15%, for 12 weeks (N=333) or for 15 weeks (N=124), or the gel vehicle (N=331) for 12 weeks
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Finacea® Gel, 15% N=457 (100%) |
Vehicle N=331 (100%) |
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Mild n=99 (22%) |
Moderate n=61 (13%) |
Severe n=27 (6%) |
Mild n=46 (14%) |
Moderate n=30 (9%) |
Severe n=5 (2%) |
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Burning/ stinging/ tingling |
71 (16%) | 42 (9%) | 17 (4%) | 8 (2%) | 6 (2%) | 2 (1%) |
| Pruritus | 29 (6%) | 18 (4%) | 5 (1%) | 9 (3%) | 6 (2%) | 0 (0%) |
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Scaling/dry skin/xerosis |
21 (5%) | 10 (2%) | 5 (1%) | 31 (9%) | 14 (4%) | 1 (<1%) |
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Erythema/ irritation |
6 (1%) | 7 (2%) | 2 (<1%) | 8 (2%) | 4 (1%) | 2 (1%) |
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Contact dermatitis |
2 (<1%) | 3 (1%) | 0 (0%) | 1 (<1%) | 0 (0%) | 0 (0%) |
| Edema | 3 (1%) | 2 (<1%) | 0 (0%) | 3 (1%) | 0 (0%) | 0 (0%) |
| Acne | 3 (1%) | 1 (<1%) | 0 (0%) | 1 (<1%) | 0 (0%) | 0 (0%) |
Finacea Gel, 15%, and its vehicle caused irritant reactions at the application site in human dermal safety studies. Finacea Gel, 15%, caused significantly more irritation than its vehicle in a cumulative irritation study. Some improvement in irritation was demonstrated over the course of the clinical studies, but this improvement might be attributed to subject dropouts. No phototoxicity or photoallergenicity were reported in human dermal safety studies.
In patients using azelaic acid formulations, the following additional adverse experiences have been reported rarely: worsening of asthma, vitiligo depigmentation, small depigmented spots, hypertrichosis, reddening (signs of keratosis pilaris), and exacerbation of recurrent herpes labialis.
Post-marketing safety-Skin: facial burning and irritation; Eyes: iridocyclitis on accidental exposure with Finacea Gel, 15%, to the eye.
TopMore resources:
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