finacea
Finacea (Azelaic Acid) is a medication used to treat Acne Vulgaris, Rosacea.
Azelaic Acid · by Leo Pharma As
Key facts
- Active ingredient
- Azelaic Acid
- Form
- Topical
- Strength
- Azelaic Acid 15%
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- acne vulgaris, rosacea
- Manufacturer
- Leo Pharma As
- What the pharmacy pays
- ~$0.46 per gm — not your price
- FDA application
- NDA021470
What is Finacea?
From the FDA label:Azelaic acid gel, 15%, is an aqueous gel which contains azelaic acid, a naturally-occurring saturated dicarboxylic acid. It is for topical use. Chemically, azelaic acid is 1,7-heptanedicarboxylic acid. The molecular formula for azelaic acid is C 9 H 16 O 4 . It has the following structure: Azelaic acid has a molecular weight of 188.22. It is a white, odorless crystalline solid. It is poorly soluble in water at 20°C (0.24%) but freely soluble in boiling water and in ethanol. Azelaic acid gel, 15% is a white to yellowish white opaque gel for topical use; each gram contains 0.15 gm azelaic acid (15% w/w) in an aqueous gel base containing benzoic acid (as a preservative), disodium EDTA, lecithin, medium-chain triglycerides, polyacrylic acid, polysorbate 80, propylene glycol, purified water, and sodium hydroxide to adjust pH. Chemical Structure
How to use
Cleanse affected area(s) using only very mild soaps or soapless cleansing lotion and pat dry with a soft towel before application of azelaic acid gel. Apply and gently massage a thin layer of azelaic acid gel into the affected areas on the face twice daily (morning and evening). Wash hands immediately following application of azelaic acid gel. Cosmetics may be applied after the application of azelaic acid gel has dried. Reassess the diagnosis if no improvement is observed upon completing 12 weeks of therapy. Avoid the use of occlusive dressings or wrappings. Instruct patients to avoid use of alcoholic cleansers, tinctures and astringents, abrasives and peeling agents. For topical use. Not for oral, ophthalmic or intravaginal use. Apply a thin layer twice daily to affected area(s). ( 2 ) Use only very mild soaps or soapless cleansing lotion and pat dry with a soft towel before applying azelaic acid gel. ( 2 ) Wash hands immediately following application. ( 2 ) Cosmetics may be applied after the application of azelaic acid gel has dried. ( 2 ) Avoid use of alcoholic cleansers, tinctures and astringents, abrasives and peeling agents. ( 2 ) For topical use. ( 2 ) Not for oral, ophthalmic or intravaginal use. ( 2 )
Side effects
The most common adverse reactions are burning/stinging/tingling (29%), pruritus (11%), scaling/dry skin/xerosis (8%) and erythema/irritation (4%). ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact LEO Pharma Inc. at 1-877-494-4536 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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. In two vehicle-controlled and one active-controlled U.S. clinical trials, treatment safety was monitored in 788 subjects who used twice-daily azelaic acid gel for 12 weeks (N=333) or 15 weeks (N=124), or the gel vehicle (N=331) for 12 weeks. In all three trials, the most common treatment-related adverse events were: burning/stinging/tingling (29%), pruritus (11%), scaling/dry skin/xerosis (8%) and erythema/irritation (4%). In the active-controlled trial, overall adverse reactions (including burning, stinging/tingling, dryness/tightness/scaling, itching, and erythema/irritation/redness) were 19.4% (24/124) for azelaic acid gel compared to 7.1% (9/127) for the active comparator gel at 15 weeks. Table 1: Adverse Events Occurring in ≥1% of Subjects in the Rosacea Trials by Treatment Group and Maximum Intensity…
Warnings
Important safety information
Hypersensitivity : Hypersensitivity reactions, including cases of angioedema, eye swelling, facial swelling, dyspnea, urticaria, and adverse skin reactions, have been reported. In case of known hypersensitivity to any component of the gel, avoid the use of azelaic acid gel. If hypersensitivity develops, discontinue treatment and institute appropriate therapy. ( 5.1 ) Skin Reactions: Skin irritation (i.e. pruritus, burning or stinging) may occur, usually during the first few weeks of treatment. If sensitivity or severe irritation develops and persists, discontinue treatment and institute appropriate therapy. ( 5.2 ) Hypopigmentation: Isolated cases of hypopigmentation occurred after azelaic acid use. Monitor patients with dark complexion for early signs of hypopigmentation ( 5.2 ) Eye and Mucous Membrane Irritation: azelaic acid gel has been reported to cause irritation of the eyes. Avoid contact with the eyes and mucous membranes. ( 5.3 ) Exacerbation of Asthma: Consult a physician if asthma is exacerbated with azelaic acid gel use. ( 5.4 ) 5.1 Hypersensitivity Hypersensitivity reactions, including cases of angioedema, eye swelling, facial swelling, dyspnea, urticaria, and adverse skin reactions, have been reported during post marketing surveillance. Avoid the use of azelaic acid gel in patients with known hypersensitivity to any component of the gel. If hypersensitivity develops during treatment, discontinue azelaic acid gel and institute appropriate therapy. 5.2 Skin Reactions Skin irritation (i.e. pruritus, burning or stinging) may occur during use of azelaic acid gel, usually during the first few weeks of treatment. If sensitivity or severe irritation develops and persists, discontinue treatment and institute appropriate therapy. There have been isolated reports of hypopigmentation after use of azelaic acid. Since azelaic acid has not been well studied in patients with dark complexion, monitor these patients for early signs of hypopigmentation. 5.3 Eye and Mucous Membranes Irritation Azelaic acid gel has been reported to cause irritation of the eyes. Avoid contact with the eyes, mouth and other mucous membranes. If azelaic acid gel comes in contact with the eyes, wash the eyes with large amounts of water and consult a physician if eye irritation persists [see Adverse Reactions (6.2) ] . 5.4 Exacerbation of Asthma Worsening of asthma has been reported in patients using azelaic acid formulations including azelaic acid gel. Consult a physician if asthma is exacerbated with use of azelaic acid gel.
Who should not take Finacea
None. None. ( 4 )
Storing Finacea, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “Discard product 8 weeks after opening [see Dosage and Administration (2) ] .”
May treat (source: NIH RxClass)
Dosage forms
Topical
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Finacea treat?
- Finacea (Azelaic Acid) may be used to treat acne vulgaris, rosacea, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How much does Finacea cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.46 per gm, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Finacea?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Finacea. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Finacea?
- Finacea is marketed by Leo Pharma As. You can see Leo Pharma As's full profile, rating, and other products on pharmaranks.
- Is Finacea a brand-name or generic drug?
- Finacea is a brand-name product with the active ingredient Azelaic Acid.
- Is Finacea available over the counter?
- No. Finacea is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Finacea come in?
- Finacea is currently marketed as topical, per the FDA's National Drug Code Directory.
- Is Finacea FDA-registered?
- Finacea is on record with the U.S. FDA under application number NDA021470. You can verify this on its official FDA label.
- Is Finacea safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Finacea. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Finacea?
- Finacea's side effects are taken directly from its FDA label. From the label: The most common adverse reactions are burning/stinging/tingling (29%), pruritus (11%), scaling/dry skin/xerosis (8%) and erythema/irritation (4%). ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact LEO Pharma Inc. at 1-877-494-4536 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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