February 10, 2016
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Finacea Gel




Side Effects
Interactions

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 Finacea Gel (azelaic acid) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

There have been no formal studies of the interaction of FINACEA Gel with other drugs.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 1/6/2016

Side Effects
Interactions

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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