July 23, 2016
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Finacea Gel




Finacea Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 8/27/2015

Finacea Gel (azelaic acid) is a naturally occurring acid used to treat acne and rosacea. Common side effects of Finacea Gel include application site reactions (burning, stinging, tingling, dryness, tightness, scaling, itching, redness, irritation), dizziness, headache, diarrhea, nausea, stomach pain, loss of appetite, constipation, changes in taste, furry tongue, and dry mouth.

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. 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. 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 breast-feeding.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Finacea in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • severe burning, stinging, or warmth;
  • severe itching or tingling;
  • severe redness, dryness, peeling, or other irritation; or
  • changes in skin color.

Less serious side effects are more likely, and you may have none at all.

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.

Read the entire detailed patient monograph for Finacea (Azelaic Acid)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Finacea FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE 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.

Post-Marketing 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

Hypersensitivity: Adverse skin reactions due to hypersensitivity have been reported during post-marketing surveillance.

Read the entire FDA prescribing information for Finacea (Azelaic Acid)

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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