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Finacea

Last reviewed on RxList: 12/10/2020
Finacea Side Effects Center

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.

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 Answer
Finacea Consumer Information

Get 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; 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)

IMAGES

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Finacea Professional Information

SIDE 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 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.

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 50.6 years.

Table 1: Adverse Reactions Occurring in ≥ 0.5% of Subjects Treated with FINACEA Foam Compared with Subjects Treated with Vehicle

System/Organ Class PreferredFINACEA 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 pruritus17 (2.5%)2 (0.3%)
Application site dryness5 (0.7%)5 (0.7%)
Application site erythema5 (0.7%)6 (0.9%)
* “Application site pain” is a term used to describe disagreeable skin sensations, including burning, stinging, paraesthesia and tenderness.

Local Tolerability Studies

In a 21-day cumulative irritation study under occlusive conditions, mild-to-moderate irritation was observed for azelaic acid pre-foam emulsion. In a human repeat insult patch test (HRIPT) study, no sensitization potential was observed for azelaic acid pre-foam emulsion.

Postmarketing Experience

Hypersensitivity, rash and worsening of asthma have been reported from the postmarketing experience of azelaic acid-containing formulations. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

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

SLIDESHOW

Rosacea, Acne, Shingles, Covid-19 Rashes: Common Adult Skin Diseases See Slideshow
Related Resources for Finacea

© 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.

QUESTION

Rosacea usually first appears on the ________. See Answer

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