Medical Editor: John P. Cunha, DO, FACOEP
What Is Finacea?
Finacea Gel (azelaic acid) is a naturally occurring acid used to treat acne and rosacea.
What Are Side Effects of Finacea?
Common side effects of Finacea Gel include:
- application site reactions (burning, stinging, tingling, dryness, tightness, scaling, itching, redness, irritation, swelling),
- acne,
- dizziness,
- headache,
- diarrhea,
- nausea,
- stomach pain,
- loss of appetite,
- constipation,
- changes in taste,
- furry tongue, and
- dry mouth.
Tell your doctor if you experience serious side effects of Finacea Gel including:
- severe application site reactions or
- changes in skin color.
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 pain or 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?
Apply a thin layer dose of Finacea Gel, 15%, and gently massage into the affected areas on the face twice daily, in the morning and evening. Do not use other topical preparations on the same area you use Finacea Gel unless directed by your doctor.
What Drugs, Substances, or Supplements Interact with Finacea?
Avoid abrasive, harsh, or drying soaps and cleansers such as alcoholic cleansers, tinctures, astringents, abrasives, or peeling agents while using Finacea Gel topical. Tell your doctor all medications you use.
Finacea During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant before using Finacea Gel. It should not be used during the first 3 months of pregnancy and used only with caution during the last 6 months, unless your infection has not improved on other antibiotics. This medication passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Finacea Gel (azelaic acid) 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.
QUESTION
Rosacea usually first appears on the ________. See AnswerGet emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using this medicine and call your doctor at once if you have:
- severe burning, stinging, or warmth;
- severe itching or tingling;
- severe redness, dryness, peeling, or other irritation;
- changes in skin color; or
- new or worsening breathing problems.
Common side effects may include:
- pain, burning, stinging, or tingling;
- dry or scaly skin; o
- itching or other irritation.
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.
SLIDESHOW
Rosacea, Acne, Shingles, Covid-19 Rashes: Common Adult Skin Diseases See SlideshowSIDE EFFECTS
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 FINACEA 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 FINACEA 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*
| FINACEA Gel, 15% N=457 (100%) |
Vehicle N=331 (100%) |
|||||
| Mild N=99 (22%) |
Moderate N=61 (13%) |
Severe N=27 (6%) |
Mild N=46 (14%) |
Moderate N=30 (9%) |
Severe N=5 (2%) |
|
| 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%) |
| Scaling/dry skin/xerosis | 21 (5%) | 10 (2%) | 5 (1%) | 31 (9%) | 14 (4%) | 1 (<1%) |
| Erythema/irritation | 6 (1%) | 7 (2%) | 2 (<1%) | 8 (2%) | 4 (1%) | 2 (1%) |
| 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%) |
| *Subjects may have >1 cutaneous adverse event; thus, the sum of the frequencies of preferred terms may exceed the number of subjects with at least 1 cutaneous adverse event. | ||||||
In patients using azelaic acid formulations, the following adverse events have been reported: worsening of asthma, vitiligo, depigmentation, small depigmented spots, hypertrichosis, reddening (signs of keratosis pilaris) and exacerbation of recurrent herpes labialis.
Local Tolerability Studies
FINACEA Gel and its vehicle caused irritant reactions at the application site in human dermal safety studies. FINACEA Gel caused significantly more irritation than its vehicle in a cumulative irritation study. Some improvement in irritation was demonstrated over the course of the clinical trials, but this improvement might be attributed to subject dropouts. No phototoxicity or photoallergenicity were reported in human dermal safety studies.
Postmarketing Experience
The following adverse reactions have been identified post approval of FINACEA Gel. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure:
Eyes: iridocyclitis upon accidental exposure of the eyes to FINACEA Gel.
Hypersensitivity: angioedema, eye swelling, facial swelling, urticaria.
Respiratory: worsening of asthma, dyspnea, wheezing.
Skin reactions: application site rash.
DRUG INTERACTIONS
No Information provided
Read the entire FDA prescribing information for Finacea (Azelaic Acid)
IMAGES
See Images© Finacea Patient Information is supplied by Cerner Multum, Inc. and Finacea Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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