Medical Editor: John P. Cunha, DO, FACOEP
What Is Finacea Foam and how is it used?
Finacea Foam (azelaic acid aerosol, foam) is a dicarboxylic acid indicated for the topical treatment of inflammatory papules and pustules of mild to moderate rosacea.
What Are Side Effects of Finacea Foam?
Side effects of Finacea Foam include:
- application site reactions (pain, itching, dryness, and redness).
Seek medical care or call 911 at once if you have the following serious side effects:
Serious eye symptoms such as sudden vision loss, blurred vision,tunnel vision,eye painor swelling, or seeing halos around lights;
- Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
- Severe headache,confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Dosage for Finacea Foam
The dose of Finacea Foam is a thin layer applied twice daily (morning and evening) to the entire facial area (cheeks, chin, forehead, and nose).
Finacea Foam In Children
The safety and efficacy of Finacea Foam in children below the age of 18 years have not been established.
What Drugs, Substances, or Supplements Interact with Finacea Foam?
Finacea Foam may interact with other medicines.
Tell your doctor all medications and supplements you use.
Finacea Foam During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Finacea Foam; it is unknown how it might affect a fetus. It is unknown if Finacea Foam passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Finacea Foam (azelaic acid aerosol, foam) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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.
IMAGES
See ImagesSIDE EFFECTS
The following adverse reactions are described elsewhere in the prescribing information:
- Hypopigmentation [see WARNINGS AND PRECAUTIONS].
- Eye and Mucous Membranes Irritation [see WARNINGS AND PRECAUTIONS].
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in theclinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may notreflect the rates observed in practice.
Finacea Foam was evaluated for the treatment of papulopustular rosacea in two multicenter, randomized,double-blind, vehicle-controlled, 12-week clinical trials involving a total of 1362 (Finacea Foam, 15%: 681;vehicle: 681) subjects. Overall, 95.7% of subjects were White, 73.4% were female, and the mean age was 50.6years.
Table 1: Adverse Reactions Occurring in ≥ 0.5% of Subjects Treated with Finacea Foam Compared withSubjects Treated with Vehicle
| System/Organ Class Preferred |
Finacea Foam, 15% (N=681) n (%) |
Vehicle (N=681) n (%) |
| General disorders and application site conditions | ||
| Application site pain* | 42 (6.2%) | 10 (1.5%) |
| Application site pruritus | 17 (2.5%) | 2 (0.3%) |
| Application site dryness | 5 (0.7%) | 5 (0.7%) |
| Application site erythema | 5 (0.7%) | 6 (0.9%) |
| * “Application site pain” is a term used to describe disagreeable skin sensations, including burning,stinging, paraesthesia and tenderness. | ||
Post-Marketing Experience
Hypersensitivity, rash and worsening of asthma have been reported from the postmarketing experience ofazelaic acid-containing formulations. Because these reactions are reported voluntarily from a population ofuncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship todrug exposure.
Local Tolerability Studies
In a 21-day cumulative irritation study under occlusive conditions, mild-to-moderate irritation was observed forazelaic acid pre-foam emulsion. In a human repeat insult patch test (HRIPT) study, no sensitization potentialwas observed for azelaic acid pre-foam emulsion.
DRUG INTERACTIONS
No Information Provided
Read the entire FDA prescribing information for Finacea Foam (Azelaic Acid Foam)
QUESTION
Rosacea usually first appears on the ________. See Answer© Finacea Foam Patient Information is supplied by Cerner Multum, Inc. and Finacea Foam Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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